CTTI In the News

Collaborative Research Effort Represents First-Ever Trial Using National Health Plans’ Data

An 80,000-patient trial that used an FDA network of data from national health plans found that mailed education information did not increase the use of oral anticoagulants (OACS) among patients with atrial fibrillation (AF) who were not being treated.

Source: CenterWatch

Creating Leaner and Meaner Clinical Trials in the Long Run

The clinical trial enterprise has been due for a reckoning for a long time. The good news is that a fundamental re-thinking of how clinical trials are done – one that could bring lasting positive changes – has started to happen.

Source: Timmerman Report

Will COVID-19 change how Big Pharma does clinical trials?

Sumathi Sivapalasingam, senior medical director at Regeneron, the New York–based biotech, has spent recent weeks, like many Americans, working from home. But even hunkered down in her Brooklyn apartment, Sivapalasingam, an infectious disease specialist and physician who previously worked at Bellevue Hospital and battled outbreaks around the world for the CDC, has felt very much in the thick of the fight against COVID-19

Source: Fortune

The Latest Obstacle in the Search for a Coronavirus Treatment: Too Many Drug Trials

Scientists and drug companies searching for a coronavirus treatment have launched so many clinical trials that some now fear they will run out of patients to enroll, trial sites or personnel to carry out the tests.

Source: Politico

Pandemic Prompts Trials to Reinvent Themselves, Woodcock Says

COVID-19 should come as a prompt to the clinical research sector to rapidly reinvent itself as it works to design and launch clinical trials for vaccine and therapeutic candidates “in the teeth of the epidemic,” says Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research.

Source: CenterWatch

Manhattan Project approach to COVID-19 could change drug development

The urgent need to have at least a few proven COVID-19 therapies approved in the U.S. before the pandemic’s expected resurgence in the fall has become biopharma’s Manhattan Project – a coming together of industry, researchers and government agencies to take on a single global enemy in an effort that could fundamentally change future drug development by introducing more efficient ways of demonstrating safety and efficacy.

Source: BioWorld

Clinical Trials Transformation Initiative: A Conversation with Executive Director Dr. Pamela Tenaerts

Spencer Health Solutions has invited Dr. Pamela Tenaerts to join us on the “People Always, Patients Sometimes” podcast to learn more about an important initiative to improve clinical trials. Dr. Tenaerts is the Executive Director of the Clinical Trial Transformation Initiative known as CTTI.

Source: Spencer Health Solutions

Overcoming Barriers in Conducting Decentralized Clinical Trials

Traditional clinical trials are often expensive, inefficient, include highly selective populations, and can create significant participant burden via travel and other logistical demands. Remote or decentralized clinical trials (DCTs)—those executed through telemedicine, mobile/local healthcare providers (HCPs) and/or mobile technologies that are not bound by geographic limitations—are gaining traction, but adoption has been slow and variable.

Source: Applied Clinical Trials

Tools for Doctors Key to Increasing Clinical Trial Diversity, Say Experts

Sponsors should ‘continually’ think about providing tools to help healthcare professionals discuss clinical trials with women and older people.

Source: Outsourcing-pharma.com

Novel endpoints in the digital age

Technology is changing how we define success in drug research according to experts who say the digital age is facilitating use of novel endpoints in trials.

Source: PMLiVE

Clinical trials in special patient populations webinar is now available

Outsourcing-Pharma’s webinar on special patient populations happened this week but you still have the chance to catch-up on the discussions on demand.

Source: Outsourcing-pharma.com

Virtual Clinical Studies: Finding a Path to Execution

At a recent conference, a lawyer explaining blockchain stated: “Technology is advancing faster than it has at any point in history—and it will never move this slowly again.”

Source: Applied Clinical Trials

Use Commonly Available Data Early to Inform Eligibility and Recruitment, Experts Say

Getting study teams to consider using readily available data to help design and enroll clinical trials can be more difficult than it should be.

Source: CenterWatch

CTTI Unveils New Recommendations to Improve Clinical Trials

The Clinical Trials Transformation Initiative (CTTI) has unveiled new recommendations for the use of real-world data (RWD) sources to improve the quality and efficiency of clinical trials.

Source: Clinical Trials Arena

Engaging Patients in Medicines Regulation: A Tale of Two Agencies

The European Medicines Agency and the US Food and Drug Administration have committed to engaging patients in their regulatory processes to promote patient-focused medicinal product development, as well as improve transparency and trust in the regulatory system. Here, we highlight exchanges of experience between the agencies and some impacts on patient engagement.

Source: Nature Reviews Drug Discovery

Giving Patients a Sense of Belonging

Clinical research professional and patient advocate Kristina Wolfe tells us how pharma can collaborate better with patients and give them a place in the healthcare conversation.

Source: Pharma Phorum

Viewpoint: Stronger Regulations Are Necessary to Weed Out 'Digital Snake Oil' From Wearables, Apps

With technology companies constantly rolling out new mobile apps and wearable devices claiming to monitor, treat and cure various health conditions, strict standards are necessary to make it clear to consumers which of these tools are actually medically valid.

Source: Becker's Hospital Review

FDA Affirms Interest in Promoting Decentralized Clinical Trials

“We’re all in the process of learning what [decentralized clinical trials] are about,” Isaac Rodriguez-Chavez, PhD, MHSc, an Officer for the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research in the Clinical Research Methodology, Regulatory Compliance, and Medical Policy Development area, told attendees of the Direct-to-Patient Clinical Trials conference sponsored by CBI in Philadelphia today (August 9).

Source: ACRP Blog

A ‘Best Practice’: ACRO, Pharma Respond to FDA Draft Guidance as RBM Adoption Increases

Risk-based monitoring should be described as a “best practice,” says ACRO, which recently released a survey that found the majority of new trial starts in 2018 employed some form of RBM.

Source: Outsourcing-pharma.com

Q&A: A New Society Targets Digital Medicine Alongside FDA Officials

The Massachusetts-based Digital Medicine Society (DiMe) launched this week with a strategic advisory board that includes Amazon, as well as top drugmakers like Novartis, and a scientific leadership board including US Food and Drug Administration (FDA) officials.

Source: Regulatory Affairs Professionals Society

DCRI Helps FDA Map Strategy to Broaden Use of Real-World Evidence

Through projects such as ADAPTABLE CTTI, and the NIH Collaboratory, the DCRI is defining how to use RWE in clinical research.

Source: DCRI

World Health Organization Releases Guidelines for Digital Health Adoption

From drones delivering blood in Rwanda, to blockchain health records in Estonia it is clear to see that digital health tools have spread worldwide. But how these systems are being implemented varies greatly depending on the government, region and resources. 

Source: Mobi Health News

Statement by FDA Commissioner Scott Gottlieb, M.D., on new strategies to modernize clinical trials to advance precision medicine, patient protections and more efficient product development

Modernizing clinical trials is an agency wide priority. As more diseases are being redefined based on genomic subtype, researchers have more novel targets and more opportunities to precisely modulate or even repair the basic biological drivers of illness.

Source: FDA

CTTI Addresses Patient, Site Engagement in Latest Mobile Clinical Trial Recommendations

It is critical to understand the patient and site perspective to “maximize opportunities and minimize challenges” associated with the use of mobile technology in clinical trials, says CTTI executive director.

Source: Outsourcing-pharma.com

Digital Healthcare Growth Drivers in 2019

The digital transformation of healthcare will see significant growth in the next 12 months fueled by institutional interest in driving down costs and improving patient engagement. Expect increased pharma investment, improving regulatory status, payer engagement with digital tools and better telemedicine connectivity through consolidation.

Source: Forbes

Our Door Is Open: FDA Puts Patients First

We believe patients are experts when it comes to their health conditions. Ultimately, they’re the ones who can share aspects of their diseases that even our most qualified doctors and scientists couldn’t possibly know. This valuable patient input is a critical part of our understanding of diseases and conditions that may help us to advance medical product development.

Source: FDA Voice

Tackling the Hospital-Acquired Pneumonia Enrollment Paradox

Hospital-acquired bacterial pneumonia (HABP) is the most common hospital-acquired infection, the most common cause of hospital-onset sepsis, and a highly morbid complication for patients. The estimated mortality rate is between 15% and 30% for both ventilated and nonventilated patients. There is consequently a pressing need for better strategies to prevent and treat this condition. 

Source: JAMA Network Open

Collaboration Created the Cornerstone of Better Clinical Trials – Now, It’s Time to Build

We entered 2018 with a solid foundation in place for building better, more efficient clinical trials. Throughout the year, progress – particularly in the areas of mobile technologies, real-world evidence, and patient engagement – resulted in new, tangible building blocks for constructing the future of clinical trials.

Source: Outsourcing-pharma.com

CTTI’s New Recommendations Target Investigator Qualification

The Clinical Trials Transformation Initiative (CTTI) recently released recommendations and resources proposing a new approach to investigator qualification - and approach that CTTI Executive Director Pamela Tenaerts said "goes beyond repetitive, identical training, and includes individual experience and protocol-specific preparation." 

Source: Outsourcing-pharma.com

FDA's Gottlieb Addresses Effort to Advance New Innovations

In a nearly 3,700 word missive by Scott Gottlieb, posted on August 29, 2018, the FDA commissioner attempts to bring some clarity to efforts by the agency to bring more innovation into the drug development process. Noting FDA’s goal of ensuring the right drug or device is delivered to the right patient at the right time, Gottlieb states the vision is moving closer to reality with innovative new products becoming available to pharma companies and its researchers.

Source: Clinical Leader

FDA’s Comprehensive Effort to Advance New Innovations: Initiatives to Modernize for Innovation

Our longstanding goal for medical care is to ensure that the right drug or device is delivered to the right patient at the right time. This vision is increasingly possible with the innovative products that are becoming available. Many of these opportunities are enabled by new technology platforms such as digital health, targeted medicines, and regenerative medicine, including cell and gene therapies. These new technologies offer transformative opportunities. But they also challenge the U.S. Food and Drug Administration (FDA) to modernize its approach to evaluating new innovations. In many cases, we’ve had to refashion our regulatory approach to create more modern platforms that are better suited to the efficient evaluation of these advances.

Source: FDA Voice

CTTI Unveils Recommendations for Using Mobile Technologies in Clinical Research

The clinical research community has long shared an exciting vision of using mobile technologies to collect objective, reliable data in clinical trials. Mobile technologies have the potential to capture more informative real-world data from patients, reduce barriers to trial participation, and lower the costs associated with conducting clinical trials. However, technical, clinical, operational and regulatory challenges have been barriers to widespread adoption of mobile technologies in regulated clinical trials – until now.

Source: Society for Clinical Research Sites

How to use mobile tech for data capture and improve clinical trials: CTTI recommendations

CTTI’s latest recommendations will help researchers deploy mobile technologies in clinical trials and “pave the way for improving how we develop medicines,” says Pfizer exec.

Source: Outsourcing-pharma.com

Don’t Let Technology Bury Your Clinical Trials with Frivolous Data

A dazzling new array of wearable and other mobile technologies can provide a more complete clinical trial picture, increase efficiency, and reduce the burden on patients, says Ken Skodacek, part of the U.S. Food and Drug Administration’s (FDA) Clinical Trials Program and Payer Communication Task Force at the Center for Devices and Radiological Health (CDRH). However, he also cautioned collecting too much data or flawed data will undermine all those potential gains.

Source: ACRP Blog

US FDA and CTTI pick patient advocates to boost engagement in trials

The advocates will work to enhance the US FDA’s understanding of how to best engage across patient communities, according to CTTI.

Source: Outsourcing-pharma.com

Collaboration and Transparency Key to More Effective Clinical Research

Much of the credit for improving the quality and efficiency of clinical trials in recent years goes to joint reform initiatives and greater disclosure of regulatory decisions and study results. Bioresearch sponsors are listing more studies on the ClinicalTrials.gov website, although the record is weaker for timely disclosure of research results for newly approved medical products. Under pressure to share more research data to avoid repeated errors and waste, biopharma companies also are providing qualified experts with access to confidential studies. And some sponsors are pledging to publish new research reports only in open access journals.

Source: Applied Clinical Trials

CTTI: Transforming clinical trials is going to take continued dedication, collaboration, and innovation

Last week CTTI and industry professionals gathered to celebrate the initiative's 10-year anniversary. To learn more about some of the key projects completed and challenges faced over the last decade - and what to expect from the next 10 years - we caught up with CTTI Executive Director Pamela Tenaerts. 

Source: Outsourcing-pharma.com

More Streamlined Clinical Research Arises from Collaborative Effort

Leaders of the biomedical research community recently celebrated progress over the last decade in devising strategies to improve the quality and efficiency of clinical trials. The 10th anniversary of the Clinical Trials Transformative Initiative (CTTI) last week provided an opportunity for FDA officials to join with study sponsors and research experts to examine the policy achievements and plans for future efforts of this multi-faceted initiative.

Source: Applied Clinical Trials

CTTI: Instituting Quality Measures Early in Trial Design Pays Off in the Long Run

At a symposium marking the Clinical Trials Transformation Initiative’s 10th anniversary, industry and regulatory discussed the progress made by its Quality by Design initiative and the additional work needed to encourage the research industry to be more focused on trial quality and efficiency.

Source: CenterWatch

CTTI Recommendations Look to Lure ‘One and Done’ Investigators Back into the Fold

Nearly half of all so-called “one and done” principal investigators who retreat from clinical research after conducting a single study want back in if they can find resources and advice to help on their second attempt, according to findings from a new Clinical Trials Transformation Initiative (CTTI) survey and recommendations project.

Source: ACRP Blog

CTTI suggests ways to prevent ‘one and done’ syndrome in trial investigators

It can be seriously disruptive when the site investigator for your trial leaves or decides to step down, but new recommendations from the Clinical Trials Transformation Initiative (CTTI) aim to mitigate that risk.

Source: FierceBiotech

How to reduce clinical trial site investigator turnover

CTTI has released new recommendations that can be implemented by sponsors, CROs, and others, in order to decrease the number of ‘one and done’ clinical trial site investigators.

Source: Outsourcing-pharma.com

Proactive pregnancy testing planning to improve safety, efficacy of clinical trials

CTTI's new evidence-based recommendations provide a standard way to plan for and make decisions about pregnancy testing in clinical trials, and also improve communications and transparency with trial participants," Calvert explained.

Source: Outsourcing-pharma.com

Drug Regulation and Pricing — Can Regulators Influence Affordability?

"Clinical drug development is generally an inefficient process. The cost of conducting clinical trials drives R&D spending, and much of the elaborate superstructure involved needs to be reassessed and could be pared down without harming participants. The EMA actively promotes better design and more efficient trial conduct and supports the efforts of the Clinical Trials Transformation Initiative, created by the Food and Drug Administration and Duke University, and other efforts to streamline trials."

Source: The New England Journal of Medicine

On the path to a science of patient input

"Some of the first formal efforts to outline the science of patient input borrow, from software development, the use of frameworks to provide a logical structure for organizing information, identifying sources of the information, and suggesting ways it might be used and viewed by distinct parties… The Clinical Trials Transformation Initiative (CTTI) created perhaps the most recognizable tool, and its work has become a guidepost.”

For more information of CTTI's Patient Groups & Clinical Trials Project, click here.

Source: Science Translational Medicine

Clinical Trials Need More Subjects

CTTI is featured as a driver of action-oriented solutions in this Wall Street Journal article that explores the critical need for improved patient recruitment rates. “We want to create trials that everyone involved can champion, and that doctors can feel good about engaging their patients in,” says Jamie Roberts, senior clinical project manager for the CTTI Recruitment Project.

Source: Wall Street Journal

Throwing Your Hat in the Ring

CTTI participated in MediaplanetUSA’s Clinical Trials campaign, where associations and industry experts came together to spotlight the need for more clinical trial participants, to change the public perception and showcase why clinical trials are so important in helping those in need. The campaign was distributed within the centerfold of USA Today on December 18, 2015.

Source: MediaPlanet

CTTI Releases Recommendations and Tools to Maximize Engagement between Research Sponsors and Patient Groups

"In recent years there has been an increasing focus on patient engagement, centering on new opportunities for FDA to incorporate the patient perspective into its regulatory decision making. These discussions have resulted in Congress and FDA establishing new policies and programs... However, the public dialogue has largely left out the opportunities for meaningful engagement between patients and research sponsors (academia and the medical product developers). That changed in 2014, when Clinical Trials Transformation Initiative (CTTI) initiated the Patient Groups & Clinical Trials (PGCT) Project. "

Source: FDA Law Blog

Make QbD A Part Of Your Clinical Trial Process

On CTTI's Quality by Design work: “Those principles were tested and refined through a series of workshops,” says Glessner. “I can’t speak highly enough about the power of those workshops. They actually involved putting materials into individual’s hands and testing them. Then after a period of time CTTI wanted to know whether the workshops were effective, and to determine that approximately 20 individuals were interviewed. These were deep, detailed interviews asking participants what they were able to take away from the workshops, what they were able to apply in their own businesses, and what problems continued to be a struggle for them.”

Source: Clinical Leader

Mobile technologies and clinical trials, a chance for a change

"In the words of Doctor Hans-Georg Eichler, Senior Medical Officer at the European Medicines Agency (EMA): 'We understand that trials as we do them today are not sustainable, they're expensive, they're inefficient, they take too long-patients complain why they have to wait so long for new medicines-and they're very bureaucratic.' EMA is part of the Clinical Trials Transformation Initiative (CTTI), established by the FDA and Duke University (Durham, USA), that aims to improve the quality and efficiency of trials."

Source: Mobile Health Global

Director's Corner Podcast

“We've been working [for] the past many years on trying to reform the clinical trial system in both the United States and worldwide because clinical trials are very resource wasteful in a sense… We're also working with the… Clinical Trials Transformation Initiative, to bite off different pieces of the current trial conduct and design and re-design those, and I think we've made significant progress there.”

Source: FDA

Insider Insights

“One of our biggest successes is [the] forum we created, in which there is trust for open dialogue… This atmosphere allows us to have all the stakeholders in clinical trials involved in being part of the solutions.” –Pamela Tenaerts, M.D.

Source: CenterWatch

FDA's Margaret Hamburg: Angle on Patient Engagement and Regulatory Systems Reform

“We think that there is a lot of merit in supporting improvements in the clinical trial infrastructure itself. The Clinical Trials Transformation Initiative has contributed so much in terms of innovative trial design, as it is working on establishing centralized IRBs for multicentered trials, which is an important advancement.”

Source: Applied Clinical Trials

Call to Action

“FDA’s active participation in partnerships like the Biomarkers Consortium, the Critical Path Initiative, and the Clinical Trials Transformation Initiative is critically important. What has the agency learned from these partnerships, and have officials taken necessary steps to implement new data as broadly and consistently as possible? Much progress remains until efficient trials with flexible designs aided by innovative technologies are no longer the exception to the rule.”

Source: 21st Century Cures