- All
- Quality By Design
- Informing ICH E6 Renovation
- Analysis of ClinicalTrials.gov
- Diversity
- Recruitment
- Engaging Stakeholders in Trial Design
- Pregnancy Testing
- State of Clinical Trials
- Measuring Trials Transformation
- All
- Investigator Community
- Investigator Qualification
- Study Start-Up
- All
- Planning Decentralized Trials
- Developing Novel Endpoints
- Selecting and Testing Digital Health Technology
- Testing a Digital Health Technology
- Managing Data
- Delivering an Investigational Product
- Supporting Sites
- Interacting with Regulators
- All
- Real World Data
- Master Protocol Studies
- Trials in Clinical Practice
- ABDD HABP/VABP
- ABDD Peds Trials
- ABDD Streamlining HABP/VABP
- ABDD Unmet Need
- Registry Trials
- Electronic Healthcare Data
- Large Simple Trials
- Sentinel IMPACT-AFib
- Using Disease Progression Modeling to Advance Trial Design and Decision Making
- All
- Single IRB
- Informed Consent
- Safety Reporting
- Data Monitoring Committees
CTTI Publication Explores Perceived Barriers and Recommendations Surrounding the Adoption of Decentralization
Despite widespread support for decentralization, real and perceived challenges remain, limiting wider implementation of decentralized elements. A new CTTI publication, published in the Journal of Therapeutic Innovation & Regulatory Science, explores three perceptions that are commonly heard...
New CTTI Steering Committee Positions Open for Patient/Caregiver Representative(s)
One of the ways that the Clinical Trials Transformation Initiative (CTTI) engages with and integrates patients into our work is by having patient/caregiver representatives on our Steering Committee. We are currently accepting applications for this position until 11:59 p.m. ET, Tuesday, April 2....
Recording Now Available: CTTI Unveils New Tool for Embedding Clinical Trials into Clinical Practice
A recording of CTTI’s Feb. 29 webinar unveiling a new tool that aids in assessing the feasibility of embedding clinical trial elements into clinical practice is now available. The one-hour webinar included a welcome from CTTI Director of Projects Sara Calvert; a project overview from CTTI...
CTTI to Launch New Embedding Trials Feasibility Assessment Tool
CTTI will host a free public webinar on Thursday, Feb. 29 at 12:00 p.m. EST to unveil a new tool for assessing the feasibility of embedding clinical trial elements into clinical practice. The webinar will include a welcome from Sara Calvert; a project overview from Lindsay Kehoe; a panel...
Report Now Available: Mitigating Clinical Study Disruptions During Disasters and Public Health Emergencies
The report on the two-day virtual public meeting, “Mitigating Clinical Study Disruptions During Disasters and Public Health Emergencies (PHEs),” convened by the U.S. Food and Drug Administration (FDA) in collaboration with the Clinical Trials Transformation Initiative (CTTI), is now available. ...
CTTI and FDA Share Strategies for Improving Timely, Accurate, and Complete Registration and Reporting of Summary Results Information for Applicable Clinical Trials on ClinicalTrials.gov
Timely, accurate, and complete registration and reporting of summary results information for applicable clinical trials on ClinicalTrials.gov allows access to current research and evidence for all partners in the clinical trials enterprise, including patients, providers, sponsors and...
Patient Engagement Collaborative Announces Eight New Members
Today, the U.S. Food and Drug Administration (FDA) and the Clinical Trials Transformation Initiative (CTTI) announced eight newly selected representatives for the Patient Engagement Collaborative (PEC). The group of 16 patients, caregivers, and patient group representatives meets with the FDA...
Congratulations and Best Wishes to CTTI Executive Director Sally Okun on Her Retirement
Today, Sally Okun, who has served as CTTI’s Executive Director since October 2021, is retiring after five decades in healthcare. “On behalf of the entire CTTI community, we congratulate Sally on her exceptional career and on her retirement,” said CTTI’s incoming executive director, Morgan...
Holiday Greetings from CTTI: Reflecting on 2023 & Embracing the Future
Throughout this year, we’ve had the pleasure of crossing paths with many of you at diverse locations around the world – from San Francisco and Boston, to the nation’s capital and the Big Apple, to Montreal and Riyadh. We shared our work at more than two dozen meetings, conferences, and events,...
Recording of Virtual Public Workshop Now Available: Enhancing Diversity in Clinical Studies
A recording for the virtual public workshop to enhance clinical study diversity convened by the U.S. Food and Drug Administration (FDA) and Clinical Trials Transformation Initiative (CTTI), held November 29 and 30, is now available. Day 1 of the virtual public workshop opened with welcoming...
CTTI Publication Explores Stakeholder Reflections on Implementing the National Institutes of Health’s Policy on Single Institutional Review Boards
A new CTTI publication, published in the Journal of Ethics and Human Research, explores stakeholder reflections on implementing the National Institutes of Health’s policy on single Institutional Review Boards (sIRB). CTTI interviewed 34 stakeholders with various roles in the single IRB process...
Recording of Virtual Public Meeting Now Available: Mitigating Clinical Study Disruptions During Disasters and Public Health Emergencies (PHEs)
A recording of the virtual public meeting “Mitigating Clinical Study Disruptions During Disasters and Public Health Emergencies (PHEs),” convened by the U.S. Food and Drug Administration (FDA) and Clinical Trials Transformation Initiative (CTTI) held October 18th and 19th, is now available. ...
CTTI Announces Promotion of Morgan Hanger to Executive Director
Today, CTTI proudly announced Morgan Hanger as its next Executive Director. “CTTI has been at the center of advancing clinical trial transformation through public-private collaboration, and that leadership will continue under Morgan Hanger,” said Dr. Mark McClellan, CTTI Executive Committee...
New CTTI Project to Develop Common Framework to Assess Progress Towards TT2030 Vision
Clinical trials are critical components of the evidence generating system in research. Launched in 2021, CTTI’s Transforming Trials 2030 vision outlines five pillars for how clinical trials should be performed by 2030. This vision establishes that clinical trials need to be patient centered and...
FDA, CTTI Convening Virtual Public Workshop on Enhancing Clinical Study Diversity
The U.S. Food and Drug Administration (FDA), in collaboration with the Clinical Trials Transformation Initiative (CTTI), is convening a virtual public workshop to solicit input on increasing the enrollment of historically underrepresented populations in clinical studies and encouraging clinical...
CTTI Executive Director Sally Okun Announces Retirement
I wanted to let you know that after much consideration and reflection I am retiring from my position as Executive Director of the Clinical Trials Transformation Initiative by the end of 2023. My time at CTTI has been incredibly rewarding both professionally and personally and my decision to...
FDA, CTTI Convening Virtual Public Workshop to Discuss FDA Emergency Recommendations to Mitigate Clinical Study Disruptions
The Food and Drug Administration (FDA), in collaboration with the Clinical Trials Transformation Initiative (CTTI), is convening a virtual public meeting on Oct. 18 and 19, 2023 to discuss recommendations provided by the FDA during the COVID-19 public health emergency (PHE) to mitigate...
Now Accepting Applications for FDA and CTTI Patient Engagement Collaborative (PEC)
The FDA and CTTI are currently accepting applications from patient advocates interested in becoming members of the Patient Engagement Collaborative (PEC). The PEC is an ongoing, shared forum in which the patient community (PEC members), FDA, and CTTI discuss a variety of topics such as...
CTTI Publication Investigates Challenges and Solutions Surrounding Digitally Derived Endpoint Acceptance
A new CTTI publication, published in Digital Biomarkers, investigates the challenges sponsors encounter when using digitally derived endpoints and offers potential solutions. Digital health technologies – including mobile apps, smart devices, sensors, and wearables – can capture robust data...
Recording Now Available: CTTI Webinar Unveiling New Recommendations on Increasing Diversity in Clinical Trials
A recording of CTTI’s May 18 webinar unveiling the new recommendations on increasing diversity in clinical trials is now available. The one-hour webinar includes a welcome from Sally Okun, CTTI; opening remarks from Richardae Araojo, U.S. Food and Drug Administration (FDA); a project overview...
CTTI to Launch New Diversity Recommendations at Free Public Webinar
CTTI will host a free public webinar on Thursday, May 18 at 12:00 p.m. EDT to unveil new recommendations for increasing diversity in clinical trials. The webinar will include a welcome from Sally Okun, CTTI; opening remarks from Richardae Araojo, U.S. Food and Drug Administration (FDA); a...
CTTI Holds Meeting to Discuss Engaging Stakeholders in Trial Design
The Clinical Trials Transformation Initiative (CTTI) held a multi-stakeholder Expert Meeting on April 4 to discuss high-value approaches and situation-specific considerations for meaningful engagement of internal and external stakeholders in clinical trial design and implementation. Engaging...
CTTI at 15: Thanks for 15 Years of Collaboration & Commitment
CTTI was founded over 15 years ago in the fall of 2007, holding our first Executive Committee meeting on March 4, 2008. Since then, CTTI has continued to work towards our mission of developing and driving the adoption of practices that increase the quality and efficiency of clinical trials....
CTTI at 15: Reflections on Progress & the Future of Transforming Trials 2030 from CTTI Leadership
By: Sally Okun, CTTI Executive Director Take a moment and think back to 2007. In that year Apple released its first iPhone, which has since sold more than 1.5 billion units worldwide. NASA launched the Phoenix Mars Lander, which entered the Martian atmosphere within nine months and shortly...
CTTI Holds Meeting to Discuss Strategies for Advancing the Use and Acceptance of Disease Progression Modeling (DPM) in Clinical Trial Design & Decision Making
The Clinical Trials Transformation Initiative (CTTI) held a multi-stakeholder expert meeting on March 6 to discuss strategies for advancing the use and acceptance of disease progression modeling (DPM) in clinical trial design and decision making. Meeting attendees discussed DPM and its current...
REPORT NOW AVAILABLE: ICH M11: Clinical electronic Structured Harmonised Protocol (CeSHarP)
The report of the public webinar on “ICH M11: Clinical electronic Structured Harmonised Protocol (CeSHarP),” organized by the International Council for Harmonisation (ICH) and convened by the Clinical Trials Transformation Initiative (CTTI), is now available. More than 1,700 people registered...
CTTI Publication Investigates Organizational Practices to Promote Diversity and Inclusion in Clinical Trials
A new CTTI publication, published in the Journal of Clinical Pharmacology & Therapeutics, investigates organizational-level practices for enhancing diversity and inclusion in clinical trials as one component of advancing health equity and improving health outcomes. When clinical trial...
Recording of Public Webinar Now Available: New ICH M11 Harmonised Guideline, Protocol Template, and Technical Specification
A recording for the International Council for Harmonisation’s public webinar, held January 26th, “New ICH M11 Harmonised Guideline, Protocol Template, and Technical Specification,” is now available. The webinar opened with welcoming remarks from Jacqueline Corrigan-Curay of the U.S. Food...
ICH Public Webinar Will Provide an Update on the Latest Developments Concerning the M11 Harmonised Guideline and Protocol Template
The International Council for Harmonisation (ICH) M11 Expert Working Group (EWG) is organizing a public webinar to describe the latest developments on the ICH M11 Guideline. The EWG is holding this webinar on Thursday, Jan. 26, 2023 from 10:00 a.m. – 12:00 p.m. EST. Registration is open for...
Patient Engagement Collaborative Announces Eight New Members
Today, the U.S. Food and Drug Administration (FDA) and the Clinical Trials Transformation Initiative (CTTI) announced eight newly selected representatives for the Patient Engagement Collaborative (PEC). The group of 16 patients, caregivers, and patient group representatives will meet with the...
CTTI Publication Investigates Use of Preventive Statins among Older Patients with Cardiovascular Disease
A new CTTI publication, published in the Journal of the American Geriatrics Society, investigates the use of preventive, high-intensity statins among patients 75 and older diagnosed with atherosclerotic cardiovascular disease (ASCVD). The study, which used pharmacy and medical claims data from...
CTTI Thanks Our Amazing Community for its Contributions to Our Work This Year
In 2022, our organization embraced innovation at the intersection of science, culture, disciplines and people. We believe it’s the crossroads of where change and creativity occur and it has led us to reaffirm our commitment to doing clinical research differently. Through diverse collaboration...
Recording Now Available: CTTI Webinar Unveiling New Recommendations on Embedding Clinical Trials into Clinical Practice
A recording of CTTI’s December 15 webinar unveiling the new recommendations on embedding clinical trials into clinical practice is now available. The one-hour webinar includes a welcome from Sally Okun, CTTI Executive Director; a keynote presentation from Robert M. Califf, U.S. Food & Drug...
CTTI Unveils New Recommendations for Embedding Clinical Trials into Clinical Practice
CTTI today released new recommendations for embedding clinical trials into clinical practice. The goal is to have care inform research and research inform care, which will enable higher quality, more efficient, and more representative evidence for care. When clinical trials have...
CTTI to Launch New Recommendations for Embedding Clinical Trials into Clinical Practice
CTTI will host a free public webinar on Thurs., Dec. 15 to unveil new recommendations for embedding clinical trials into clinical practice. The webinar will include a welcome from Sally Okun, CTTI Executive Director; a keynote presentation from a special guest with the FDA; a project overview...
CTTI Conducting Survey on Registering and Reporting Clinical Trial Information on ClinicalTrials.gov
The ClinicalTrials.gov Reporting Challenges Project is conducting a survey following in-depth interviews that were conducted in late 2021. We invite individuals who provide oversight, register, and/or report trial results information on ClinicalTrials.gov to complete the survey. You may also...
CTTI Holds Meeting to Discuss Conducting Trials as Part of Clinical Practice
The Clinical Trials Transformation Initiative (CTTI) held a multi-stakeholder Expert Meeting on September 21 to discuss embedding aspects or elements of trials into clinical practice. The goal is to have care inform research and research inform care, therefore, CTTI created a set of...
CTTI Welcomes Four New Members to its Executive Committee
Today, CTTI welcomed four new members to its Executive Committee, which is responsible for making decisions about the overall direction and strategy for the organization. The new Executive Committee members, whose three-year term runs from 2022-2025, include: Barbara Bierer, The Multi-Regional...
FDA, CTTI Accepting Applications for Patient Engagement Collaborative (PEC)
The FDA and CTTI are currently accepting applications from patient advocates interested in becoming members of the Patient Engagement Collaborative (PEC). The PEC is an ongoing, collaborative forum where patient community representatives and regulators come together to discuss strategies for...
New CTTI Publication Investigates Best Practices for Driving Adoption of Master Protocols
In a new publication, CTTI applies expertise from industry sponsors, regulatory agencies, patient groups, and academic institutions to identify best practices for driving the widespread adoption of master protocols. Master protocol studies use a single protocol to guide the design and conduct...
CTTI Holds Meeting to Discuss Embedding Clinical Trials in Health Care Settings
The Clinical Trials Transformation Initiative (CTTI) held a multi-stakeholder Expert Meeting on May 11 to discuss recommendations for embedding elements of clinical trials into routine care. Different elements of clinical trials can be embedded into care, such as randomization, administration...
Recent CTTI Publication Investigates HABP/VABP Risk and Antibiotic Trial Eligibility for Hospitalized Patients in Europe
A new CTTI publication investigates the prospective identification of hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) risk factors and antibiotic trial eligibility among hospitalized, critically ill patients at seven European hospitals. The study, PROPHETIC EU:...
Recent CTTI Publication Explores Educational Strategies for Increasing Use of Anticoagulants Among AFib Patients
A new CTTI publication from collaborators including CTTI investigates the impact of educational mailings in increasing the use of oral blood thinners among patients with atrial fibrillation (AFib). For many of these patients, use of blood thinners can reduce their stroke risk by about 70%....
CTTI Publication Investigates Use of Preventive Statins among Patients with Cardiovascular Disease
A new CTTI publication, published in the Journal of the American College of Cardiology, investigates the use of preventive, high-intensity statins among patients diagnosed with atherosclerotic cardiovascular disease (ASCVD). The study, which used pharmacy and medical claims data from a...
Recording Now Available: CTTI Webinar Introducing New Digital Health Trials Hub
A recording of CTTI’s April 6 public webinar introducing the new Digital Health Trials Hub is now available. The one-hour webinar includes presentations from Megan Doyle, Amgen, and Jörg Goldhahn, ETH Zurich; a stakeholder panel featuring Phil Green, CTTI, Elizabeth Kunkoski, FDA, Jeremy Wyatt,...
CTTI to Launch New Online Digital Health Trials Hub
CTTI will host a public webinar on Wed., Apr. 6 to introduce a new online Digital Health Trials Hub featuring enhanced recommendations and additional resources. “This updated and expanded resource drives CTTI’s bold Transforming Trials 2030 vision by helping sponsors, investigators, CROs and...
New CTTI Project Aims to Promote the Use of Disease Progression Modeling to Advance Trial Design and Decision Making
Modeling and simulations are powerful tools that can be leveraged to inform clinical trial design, support regulatory decision making, and accelerate the process of bringing treatments to patients. Despite the benefits of these methods, their use is still not widely accepted among sponsors,...
CTTI Announces Leadership Appointments & Promotions
Today CTTI announced the appointments and promotions of a new leadership team including Sara Calvert as Director of Projects, Morgan Hanger as Director of Strategic Programs and Zachary Hallinan as Director of Strategic Engagement & Communications. In addition, team members Rae Holliday,...
New CTTI Project Aims to Engage All Stakeholders in Clinical Trial Design
Engaging patients and all stakeholders from the earliest stages of trial design is increasingly recognized as fundamental to planning and conducting high quality clinical trials. Yet important gaps remain, including a lack of comprehensive resources for engaging all stakeholders and a unifying...
Happy Holidays from the Clinical Trials Transformation Initiative
CTTI ushered in 2021 with a new vision for Transforming Trials 2030 – one that requires cross-system collaboration from the entire research and healthcare community to create true and lasting change for better clinical trials by 2030. On behalf of everyone at CTTI, thank you for joining us on...
CTTI Holds Meeting to Discuss the Systemic Changes Needed to Increase Diversity in Clinical Trials
The Clinical Trials Transformation Initiative (CTTI) held a two-day multi-stakeholder expert meeting on Oct. 12 & 21 to discuss the systemic changes needed to ensure that U.S. clinical trials better meet the needs of diverse populations, including racial minorities, ethnic minorities, and...
Patient Engagement Collaborative Announces Eight New Members
Today, the U.S. Food and Drug Administration (FDA) and the Clinical Trials Transformation Initiative (CTTI) announced eight newly selected representatives for the Patient Engagement Collaborative (PEC). The group of 16 patients, caregivers, and patient group representatives will meet with the...
Report Now Available: ICH E6 Guideline for Good Clinical Practice (GCP) – Update on Progress
The report of the public web conference on “ICH E6 Guideline for Good Clinical Practice (GCP) – Update on Progress,” organized by International Council for Harmonisation (ICH) and convened by the Clinical Trials Transformation Initiative (CTTI), is now available. The web conference, which...
CTTI Announces New Executive Director Sally Okun
Today, CTTI proudly announced its new Executive Director: Sally Okun, a seasoned thought leader in clinical research, care, and policy. “Sally’s wealth of experience, distinct perspective, and passion for driving change uniquely position her as the ideal leader for CTTI at this particular...
Recording Now Available: “Next Steps for Obtaining Novel Endpoint Reliability & Acceptance” Webinar
A recording of CTTI’s public webinar on “Next Steps for Obtaining Novel Endpoint Reliability & Acceptance” is now available. During the webinar, presenters Lindsay Kehoe (CTTI) and Alicia Staley (Medidata) discussed CTTI’s current work to obtain reliability and acceptance of meaningful,...
CTTI Holds Meeting to Refresh and Enhance Decentralized Clinical Trials Recommendations
The Clinical Trials Transformation Initiative (CTTI) held a two-day multi-stakeholder expert meeting on Aug. 25-26 to discuss best practices on conducting research in remote and virtual settings, including lessons learned from the COVID-19 pandemic. The insights gathered will be used to refresh...
CTTI to Host 10/5 Webinar on “Next Steps for Obtaining Novel Endpoint Reliability & Acceptance”
On Oct. 5 at noon ET, the Clinical Trials Transformation Initiative (CTTI) will host a public webinar on “Next Steps for Obtaining Novel Endpoint Reliability & Acceptance” – the third in a series of webinars on using novel digitally derived endpoints in clinical trials for medical product...
CTTI Holds Meeting to Advance Novel, Digitally Derived Endpoints in Clinical Trials
Despite the increased use of digital health technologies (DHTs) in trials over the past several years, few examples of a digitally-derived primary endpoint exist today. Working to fill this gap, CTTI held an “Obtaining Novel Endpoint Reliability & Acceptance” Expert Meeting on July 27-28 to...
FDA, CTTI Accepting Applications for Patient Engagement Collaborative (PEC)
The FDA and CTTI are currently accepting applications from patient advocates interested in becoming members of the Patient Engagement Collaborative (PEC). The PEC is an ongoing, collaborative forum that brings the patient community and regulators together to discuss ways to increase patient...
New Case Studies Reveal Real-World Experience with Quality by Design (QbD)
Organizations are gaining experience using CTTI’s Quality by Design (QbD) recommendations to design and conduct better clinical trials. CTTI today announced four new QbD case studies, adding to its robust QbD toolkit. Three of the case studies are also now featured in CTTI’s...
New CTTI Project to Explore the Challenges Preventing Timely and Complete ClinicalTrials.gov Reporting
Timely and complete registration and results reporting of clinical trial information is an important part of keeping patients, providers, researchers, and the public informed about clinical trials. The Food and Drug Administration Amendments Act of 2007 (FDAAA) requires that the responsible...
CTTI Updates DCT Recommendations in Response to COVID-19
COVID-19 forced the clinical trials ecosystem to plan and conduct research in remote or virtual settings. In an effort to support this shift, CTTI is launching a project to update its Decentralized Clinical Trials (DCT) recommendations to ensure they reflect the latest learnings and emerging...
Recording of Public Web Conference Now Available: Listen to ICH E6 Guideline for Good Clinical Practice (GCP) – Update on Progress
Recordings for the International Council for Harmonisation’s public web conference, held May 18 & 19, “ICH E6 Guideline for Good Clinical Practice (GCP) – Update on Progress,” are now available. The web conference, which consisted of identical meetings at different times over two days to...
ICH Public Web Conference will Provide an Update on the Progress to Revise the Important and Impactful Good Clinical Practice Guideline
The International Council for Harmonisation (ICH) E6 Good Clinical Practice (GCP) Expert Working Group (EWG) is organizing a public web conference to provide an update on the progress to revise this important and impactful guideline. The EWG is holding two similar web conferences, convened by...
Recording Now Available: The State of U.S. COVID-19 Treatment Clinical Trials Public Webinar
A recording for CTTI’s public webinar, The State of U.S. COVID-19 Treatment Clinical Trials, held Apr. 15, is now available. In the webinar, moderated by CTTI Acting Executive Director Leanne Madre, CTTI presented findings from an analysis of data downloaded from the database for the Aggregate...
CTTI to Host Free Public Webinar on the State of U.S. COVID-19 Treatment Clinical Trials Featuring Robert Califf, Harlan Krumholz, and Deborah Zarin
CTTI will host a free public webinar on the state of U.S. COVID-19 treatment clinical trials on Thurs., Apr. 15 at noon EST. The U.S. has recently marked the one year anniversary of the official declaration of the COVID-19 pandemic by the World Health Organization. The pandemic thrust clinical...
CTTI Launches New Case Study Resource to Help Drive Better, More Efficient Clinical Trials
Building better clinical trials would be easier if organizations shared the practices that helped them successfully overcome obstacles. CTTI’s new resource, Building Better Clinical Trials: A Case Study Exchange, provides users with easy access to participating organizations to request more...
CTTI Selects Three New Patient/Caregiver Representatives for Steering Committee
CTTI is delighted to welcome three new patient/caregiver representatives, Jamil Rivers, Phil Green, and Nuru Noor, to our Steering Committee. The new patient/caregiver representatives will play a key role alongside the existing CTTI members in CTTI activities to advance CTTI’s vision...
CTTI Announces New Playbook for Designing High-Quality, Diverse COVID-19 Trials
As the pandemic continues to endure worldwide, CTTI is leading the way in uncovering best practices for conducting COVID-19 trials. Following up on its first playbook focusing on conducting successful trials during the pandemic, CTTI is now releasing a second playbook with eight essential...
CTTI Announces New Vision for Clinical Trials Ecosystem and Beyond: Transforming Trials 2030
The time to create true and lasting change in clinical trials is now. Together, we can harness our experiences and momentum from COVID-19 to shape a future of smarter, faster research. CTTI’s vision, Transforming Trials 2030, is that clinical trials in 2030 will be: Patient-centered and easily...
Recording Now Available: The Fastest Path to Effective COVID-19 Treatments: Using Master Protocol Studies Public Summit
A recording for CTTI’s public summit, The Fastest Path to Effective COVID-19 Treatments: Using Master Protocol Studies, held Jan. 13, is now available. The summit, conducted as a webinar, opened with a welcome from Janet Woodcock, Operation Warp Speed; a call-to-action from Robert M. Califf,...
CTTI to Host Jan. 13 Public Summit, The Fastest Path to Effective COVID-19 Treatments: Using Master Protocol Studies, Featuring Research & Healthcare Leaders
CTTI will host a public summit, The Fastest Path to Effective COVID-19 Treatments: Using Master Protocol Studies, on Wednesday, January 13. The summit, conducted as a webinar and moderated by CTTI Executive Director Pamela Tenaerts, will include a welcome from Janet Woodcock, Operation Warp...
CTTI Paper Highlights Clinical Criteria that Can Help Identify Patients at High Risk of HABP/VABP
Although treatment of possible nosocomial pneumonia is common with patients in the intensive care unit (ICU) receiving respiratory support, more than half of those treated do not fit the standard clinical definitions of hospital-acquired and ventilator-associated bacterial pneumonia...
Recording Now Available: CTTI Releases New Resources for Adoption of a Quality by Design Approach
A recording is now available of the public webinar held on Thurs., Nov. 12 to launch CTTI’s new resources for implementing a Quality by Design (QbD) approach to clinical trials. The webinar was led by Greg Pennock, EMD Serono; David Rodin, Amici Clinical Research; Karlin Schroeder, Parkinson’s...
New CTTI Project Aims to Improve Clinical Evidence with Practical Approaches for Embedding Trials Into Health Care
Integrating trials that are intended for medical product review into clinical health care offers the promise of data that reflect real-world populations and settings, and improve efficiency by avoiding duplication of activities that already occur in clinical care. However, there are currently...
New CTTI Steering Committee Positions Open for Patient/Caregiver Representative
One of many ways that CTTI engages with and integrates patients into our work is by having patient/caregiver representatives on our Steering Committee. Now, through 11:59 p.m. ET, Sun., Nov. 22, we are accepting applications for this position. We are looking for patients or caregivers who are...
CTTI to Release New Resources for Adoption of a Quality by Design Approach During Nov. 12 Webinar
CTTI will host a public webinar, Accelerating Evidence Generation: New CTTI Resources for Implementing a QbD Approach to Clinical Trials, on Thurs., Nov. 12. “We have worked with leaders and all stakeholders across the clinical trials ecosystem to develop new resources that can help research...
Recording Now Available: CTTI’s New Robust Set of Resources to Assist with Designing and Running Master Protocols
A recording is now available of the public webinar held on Tues., Oct. 13, to launch CTTI’s new set of resources that can be used to collaborate, communicate, and design master protocol studies. The webinar was led by Abby Bronson, Edgewise Therapeutics; Marianne Chase, Massachusetts General...
CTTI Paper Features Tool to Help Sponsors and Patient Groups Identify Mutually Beneficial Opportunities for Collaboration
Effective engagement between patient groups and research sponsors can enhance the quality and efficiency of clinical trials, improve patient recruitment and retention, reduce costs, and speed the pathway toward new medical treatments. One opportunity for sponsors is to identify and prioritize...
Report Now Available: Stakeholder Engagement on ICH E6 Guideline for Good Clinical Practice
The summary report of the web conference on “Stakeholder Engagement on ICH E6 Guidance for Good Clinical Practice,” organized by the U.S. Food and Drug Administration (FDA) in collaboration with the Clinical Trials Transformation Initiative (CTTI), is now available. The two-day Pan-American web...
CTTI to Release Resources for Designing and Running Master Protocols During Oct. 13 Webinar
CTTI will host a public webinar on Tues., Oct. 13 to announce new resources that provide a roadmap for designing and running master protocols. A master protocol approach allows researchers to answer multiple scientific questions within a single clinical trial infrastructure. With a flexible...
CTTI Collaborates with Multiple U.S. Organizations on First Successful Embedded Trial Using National Health Plans’ Data
Today, at the ESC Congress 2020 – The Digital Experience, a group of U.S. investigators from several organizations including CTTI announced their collaborative findings from the Implementation of a randomized controlled trial to imProve treatment with oral AntiCoagulanTs in patients with Atrial...
CTTI Paper Features Recommendations for Incorporating Patient and Site Perspectives in Digital Health Trials
Digital health technologies offer the potential to improve the conduct of clinical trials. If harnessed correctly, they can reduce patient burden, streamline operations, and optimize data collection. The key to unlocking these benefits is to ensure that patient and site perspectives are...
CTTI Paper Offers Suggested Solutions for Improving Good Clinical Practice Training
A new CTTI paper, detailing its findings from a project designed to assess challenges and burdens associated with Good Clinical Practice (GCP) training, has published in Contemporary Clinical Trials Communications. The paper, “More than a Box to Check: Research Sponsor and Investigator...
Navigating the New Normal: CTTI Announces Playbook on Best Practices for Conducting Trials During COVID-19
As the world adapts to the COVID-19 pandemic, CTTI is leading the charge to help the clinical trials ecosystem evolve and move forward. Since March 2020, CTTI conducted a series of initiatives to help the research community successfully navigate the challenges associated with adjusting trials...
New CTTI Project Aims to Increase the Use of Clinical Trial Endpoints Derived from Digital Technologies
While digital health technologies (DHT) offer clinical trial researchers the promise of more efficient and potentially accurate data, there are very few examples of digitally derived primary endpoints that can support regulatory labeling claims. To address this issue, CTTI is conducting a new...
New CTTI Project Aims to Increase Inclusion of Minority Populations in Clinical Trials
The lack of diversity in U.S. clinical trials limits understanding of the risks and benefits of medical products. To address this issue, CTTI is conducting a new project to demonstrate the value of engaging racial minorities, ethnic minorities, and women in clinical trials. The objectives of...
CTTI Paper Discusses Development of Patient Group Engagement Tool to Benefit Clinical Trials
Patient groups can offer sponsors a wealth of support that can boost clinical trial efficiency but there are few frameworks to help identify priorities. In a new preprint manuscript, CTTI discusses the development and application of an evidence-based prioritization tool to help sponsors and...
CTTI Paper Discusses Suitability of Patient Registries for Embedded Clinical Trials
Embedding clinical trials into patient registries can lead to high-quality, efficient prospective research. However, methods for assessing which registries are appropriate to serve as the platform for the conduct of a clinical trial can be problematic for researchers. A new CTTI...
CTTI Feasibility Studies Database Adds New Resources
CTTI has added 172 new studies to its Feasibility Studies database, bringing the total number of resources up to more than 440 studies. This free, one-of-a-kind repository of feasibility studies using digital health technologies to capture data in clinical research can help the entire clinical...
Recording Now Available: Strategies for Engaging Racial and Ethnic Minority Patient Populations in COVID-19 Trials
Given the recent statistics showing that COVID-19 disproportionately affects racial and ethnic minority communities, the recruitment and enrollment of diverse populations are crucial. In a webinar from Thurs., June 18, “Engaging Racial and Ethnic Minority Patient Populations in COVID-19...
Web Conference Recordings Available: Listen to Stakeholder Engagement on ICH E6 Guideline for Good Clinical Practice
A recording for FDA and CTTI’s two-day Pan-American web conference held June 4-5, “Stakeholder Engagement on ICH E6 Guideline for Good Clinical Practice,” is now available. Khair ElZarrad, FDA, and Pamela Tenaerts, CTTI, opened the web conference by welcoming attendees. Then, FDA and CTTI...
Webinar to Share Strategies for Including Ethnically Diverse Populations in COVID-19 Trials
COVID-19 disproportionately affects racial and ethnic minority communities, and clinical trial professionals are struggling to recruit the diverse participant demographic needed to find an effective COVID-19 treatment that can work for everyone. To help, CTTI is hosting a webinar, Engaging...
Share Your Experiences: Recognizing The Need for Diversity in COVID-19 Clinical Trials
COVID-19 is disproportionately impacting racial and ethnic minority communities across the United States. We are asking everyone involved in clinical trials right now – IRB professionals, investigators, sponsors, participants, and others – to share their experiences and insights for creating...
New CTTI Publication Highlights Stakeholder Preferences for Informed Consent Language in HABP/VABP Studies
A peer-reviewed article recently published in JAMA Network Open details CTTI work to get stakeholder feedback on informed consent language for hospital-acquired and/or ventilator-associated bacterial pneumonia (HABP/VABP) studies. The article describes the process of gathering feedback from 52...
CTTI Paper Reveals Investigator Perspectives on Advantages and Challenges of Digital Health Trials
Now more than ever, mobile technology is affecting every aspect of our lives, including the way we conduct clinical research. In a new preprint manuscript, CTTI examines the investigator experience in digital health trials.* In-depth interviews conducted with 12 investigators representing an...
Webinar Recording Available: Listen to Adapting Clinical Trials during COVID-19: Solutions for Switching to Remote and Virtual Visits
A recording for CTTI’s May 20 webinar, “Adapting Clinical Trials during COVID-19: Solutions for Switching to Remote and Virtual Visits” is now available. Earlier this month, CTTI surveyed stakeholders to identify challenges and solutions related to switching to remote or virtual visits for...
Now Available: Searchable, Real-Time COVID-19 Clinical Studies Spreadsheet
The urgent need to rapidly identify safe and effective medical therapies has led to a spike in clinical studies on COVID-19. To help the global scientific community address this need, CTTI has created a searchable spreadsheet of COVID-19-related studies posted on ClinicalTrials.gov. The AACT...
CTTI Webinar on Adapting Clinical Trials during COVID-19: Solutions for Switching to Remote and Virtual Visits
The COVID-19 pandemic has caused many ongoing trials to switch to remote and virtual visits midstream, despite it being unchartered territory for many. On Clinical Trials Day, Wed., May 20, join the Clinical Trials Transformation Initiative (CTTI) for a webinar at 10 a.m. ET, to hear how...
FDA to Organize Two-Day Web Conference with CTTI to Gather Feedback from Stakeholders to Update ICH E6
The International Council for Harmonisation (ICH) is revising ICH E6 Good Clinical Practice (GCP) and requests stakeholder feedback to inform the process. The U.S. Food and Drug Administration, in collaboration with CTTI, will help connect the issues by organizing a free two-day public web...
CTTI Report Finds Contracting and Budgeting are Significant Pain Points for Study Start-Up
It’s no secret that the entire clinical trials ecosystem is affected by painfully slow study start-up timelines. CTTI recently sought to investigate the factors that influence this crucial problem. After conducting a literature scan, in-depth conversations with sites and sponsor groups, and a...
Share Your Experiences on Switching to Remote Visits for Clinical Trials during COVID-19
Now, more than ever, there is urgency to adopt telehealth for clinical research. But where do we begin? Exchanging ideas is the first step. As a valuable member of the clinical trials community, we need your help – please tell us how your clinical trials are evolving to use telehealth (this can...
Recording Now Available: Designing High-Quality COVID-19 Treatment Trials
Designing clinical trials during a pandemic presents significant challenges. However, it is possible to build trials that yield high-quality results without slowing down the process. In a webinar from Thurs., April 23, titled “Designing High-Quality COVID-19 Treatment Trials,” a diverse group...
Advancing Clinical Trials in the Age of the COVID-19 Pandemic
The COVID-19 pandemic has turned our world upside down. Every aspect of our ways of life are experiencing unprecedented disruptions. For the clinical trials community, we are seeing steep declines in patient enrollment and, in some cases, complete pauses of trials. A report from Medidata showed...
CTTI to Host Webinar on Designing High-Quality COVID-19 Treatment Trials
As the research community races to identify safe and effective COVID-19 therapies, researchers are in need of accelerating trial design without sacrificing quality. The Clinical Trials Transformation Initiative (CTTI) will discuss designing high-quality COVID-19 treatment trials via a...
Open Comment Opportunity on CTTI’s Master Protocol Draft Resources
Amid the COVID-19 pandemic, the value of master protocol studies has become clear: we need agile clinical trials that foster collaboration to address major public health threats and ongoing research challenges. CTTI invites members from across the clinical trials ecosystem to provide feedback...
Webinar Recording Available: Listen to Best Practices on Conducting Clinical Trials during COVID-19
During March 23-27, CTTI collected experiences from stakeholders across the clinical trials ecosystem – including insights on safety considerations, remote study visits, remote consent, consulting with IRBs, and more – related to the FDA’s new guidance on the conduct of clinical trials of...
Webinar on Best Practices on Conducting Clinical Trials during COVID-19
This week, stakeholders from across the clinical trials ecosystem submitted experiences and insights related to the FDA’s new guidance on the conduct of clinical trials of medical products during the current COVID-19 pandemic. The Clinical Trials Transformation Initiative (CTTI) collated the...
Webinar Now Available: Findings & Reflections from CTTI’s ICH E6 Renovation Work
A recording is now available of a CTTI webinar on new stakeholder-informed research to identify areas within ICH E6 GCP that are in the greatest need of renovation. The webinar, held Thurs., March 19, included several perspectives about how this research could further the international...
Share Your Experiences Related to the New FDA Guidance on COVID-19
CTTI Will Collect, Share Findings & Best Practices at a March 31 Webinar Last week, the FDA issued new guidance on the conduct of clinical trials of medical products during the current COVID-19 pandemic. While we never could have imagined conducting clinical trials in this situation, by...
New CTTI Paper Outlines Risk Factors to Aid in HABP/VABP Pediatric Trial Enrollment
A CTTI paper recently published in the Pediatric Infectious Disease Journal sheds light on risk factors that make children more likely to contract hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP). These risk factors are important because they could aid in earlier and...
Webinar to Provide Findings & Reflections from CTTI’s ICH E6 Renovation Work
As the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) begins revisions to ICH E6 GCP, new CTTI research highlights opportunities for changes and improvements. CTTI will host a webinar Thurs., March 19, at noon ET providing an overview...
Webinar Now Available: CTTI Resources for Assessing the Value of Patient Engagement
A recording is now available of a CTTI webinar held on Thurs., Feb. 27, which provided an overview of resources that can help you embed patient engagement in your research. The webinar, which was led by Joseph DiMasi (Tufts University) and Jaye Bea Smalley (formerly of Celgene), featured an...
CTTI Webinar to Provide Insight on How to Embrace the Value of Patient Engagement
Engaging patients at every stage of clinical research is no longer a “should,” it is a “must”. And, from quick online tools to in-depth financial reports, there are resources that can help you embed patient engagement in your research. The Clinical Trials Transformation Initiative (CTTI)...
New Paper Offers Suggested Solutions for Improving Good Clinical Practice Training
CTTI has released a new preprint paper detailing its findings from a project designed to assess challenges and burdens associated with Good Clinical Practice (GCP) training. The paper, “More than a Box to Check: Research Sponsor and Clinical Investigator Perspectives on Making GCP Training...