The National Institutes of Health (NIH) has selected the Clinical Trials Transformation Initiative (CTTI) to support a workgroup that will develop a comprehensive plan for assessing the NIH’s new single institutional review board (sIRB) policy. The policy, which became effective in January, requires U.S. sites participating in nonexempt multicenter human subjects research funded by the NIH to use a sIRB for ethical review, with the goal of improving the quality and efficiency of clinical research.
The Clinical Trials Transformation Initiative (CTTI) unveiled recommendations and resources that propose a new approach for investigator qualification--one that goes beyond repetitive training and includes individual experience and protocol-specific preparation.
The Clinical Trials Transformation Initiative (CTTI) will unveil new recommendations to speed the use of decentralized clinical trials (DCTs)—trials run through telemedicine and mobile health care providers—today at the DPharm: Disruptive Innovations to Advance Clinical Trials conference in Boston, Mass.
In a special event at the U.S. Food and Drug Administration (FDA) today, the Clinical Trials Transformation Initiative (CTTI) will unveil recommendations for the use of mobile technologies in clinical research. The evidence-based recommendations and resources address an unmet need by outlining best practices for the use of mobile devices and applications to capture objective data—an approach that has the potential to increase the quality and efficiency of clinical trials.
The Clinical Trials Transformation Initiative (CTTI) and the U.S. Food and Drug Administration (FDA) announced newly selected representatives for the Patient Engagement Collaborative (PEC) today. The group of 16 patients, caregivers, and patient group representatives will meet with the FDA several times a year to discuss topics such as communication, transparency, and the best ways for patients to participate in the FDA’s regulatory discussions about medical products.
In a public Celebration Symposium on Feb. 6, leaders from across the clinical trials enterprise will gather to celebrate CTTI's 10-year anniversary. The exciting lineup of speakers will share case studies illustrating the benefits of applying CTTI’s clinical trial recommendations and moderate a vibrant exchange of ideas on the future of the clinical trials enterprise.
CTTI has been engaged by the U.S. Food and Drug Administration (FDA) to support its Patient Engagement Collaborative (PEC), an effort created in partnership with CTTI to bring together members of the patient community to discuss the best ways for patients to participate in the FDA’s regulatory discussions about medical products.
The Clinical Trials Transformation Initiative (CTTI) will unveil new recommendations aimed at reducing high rates of turnover among U.S. clinical trial site investigators at the Society for Clinical Research Sites (SCRS) Global Site Solutions Summit on Oct. 7. CTTI’s practical solutions address the administrative, financial, and logistical burdens that are causing investigators to abandon clinical research.
The Clinical Trials Transformation Initiative (CTTI) today released new recommendations and an online tool to help research sponsors, investigators, and institutional review boards develop and review pregnancy testing plans, in an effort to conduct safer, more efficient clinical trials.
Mobile technologies hold enormous promise for clinical research, but uncertainty about how to use the data captured by these devices has slowed progress. CTTI's newly released recommendations and tools aim to change this by providing a pathway for using information gathered from mobile technologies to accelerate the development and evaluation of urgently needed therapies.
Newly released recommendations from the Clinical Trials Transformation Initiative (CTTI) have the potential to streamline clinical trials by using registry information. Registries are data collection tools typically used to better understand long-term trends in a specific population, such as patients with a particular disease or patients exposed to a certain treatment.
Challenges in conducting antibacterial drug trials for pediatric patients can delay the safe and effective use of treatments for this vulnerable group. CTTI’s new recommendations for making pediatric antibacterial trials more successful. These practical, evidence-based strategies can be applied by research sponsors, investigators, and site staff to improve the quality and efficiency of pediatric antibacterial trials or pediatric trials in other therapeutic areas.
CTTI’s two new sets recommendations outline innovative approaches to designing clinical trials for HABP/VABP, including early enrollment strategies and the streamlined collection of safety data. CTTI convened multi-stakeholder teams to analyze the challenges associated with HABP/VABP trials and develop the proposed solutions. The feasibility of these new approaches will be tested in an upcoming pilot study, the findings of which are expected to help drive adoption of streamlined practices for antibacterial drug development across the clinical trial enterprise.
CTTI has released new recommendations and tools for enhancing the efficiency of clinical trial recruitment that are now available for download at http://bit.ly/recruitment-recs. Patient recruitment is a leading challenge in the efficient completion of clinical trials, which can result in wasted resources and delays in bringing new therapies to market. The foundational principle for this new approach is that recruitment planning should be started earlier in the clinical trial development process and continue throughout the implementation.
CTTI has issued recommendations and an associated toolkit to improve the quality and efficiency of clinical trials by helping sponsors to focus on study activities that are essential to the safety of trial participants and the reliability of study results, and to reduce or eliminate those activities that are not.
Despite legal and ethical mandates for disclosure, results from most clinical trials of medical products are not reported promptly on a registry specifically created to make results of human studies publically available, according to Duke Medicine researchers.
The Clinical Trials Transformation Initiative (CTTI) has announced recommendations to streamline Good Clinical Practice (GCP) training of investigators who participate in clinical trials.
Potential participants in clinical trials may not have a clear understanding of the methods used by researchers to ensure the safety of investigational drugs they are given.
The Clinical Trials Transformation Initiative (CTTI) has named new members to its Executive Committee, expanding the breadth of expertise for leaders advising CTTI on its strategy for transforming clinical research.
Fueled in part by an inclination to speed new treatments to patients, research studies for cancer therapies tend to be smaller and less robust than for other diseases.
Research for diabetes is far more focused on drug therapies than preventive measures, and tends to exclude children and older people who have much to gain from better disease management, according to a Duke Medicine study.
As part of an effort to improve the way clinical trials are conducted, the Clinical Trials Transformation Initiative (CTTI) has formed a 16-member council to engage patient advocates in its mission.
A collaborative research team established by the Clinical Trials Transformation Initiative (CTTI) created a new tool and recommendations to improve the efficiency and quality of multi-center clinical trials.
The number of clinical trials enrolling children is far lower than for adults, and the scope of research is also narrower, according to an analysis of public-access data conducted by researchers at Duke University.
The Clinical Trials Transformation Initiative (CTTI) has named a 14-member Executive Committee, resetting CTTI’s strategic direction, and ensuring that the organization informs and facilitates meaningful improvements to clinical trial design and conduct.
The largest comprehensive analysis of ClinicalTrials.gov finds that clinical trials are falling short of producing high-quality evidence needed to guide medical decision-making.
Results from a study assessing how clinical trial quality is monitored in the U.S. reveal a variety of monitoring approaches, the choice of which appears to relate to the type of organizational sponsor for the trial.
A public-private partnership comprising over 60 organizations has announced recommendations to improve clinical trials by ensuring quality with effective and efficient monitoring and improving safety through better methods of reporting unexpected serious adverse events to investigators.
The Clinical Trials Transformation Initiative (CTTI) has named a 12-member Executive Board that will oversee its activities.
Under an agreement between the U.S. Food and Drug Administration and Duke University Medical Center, Duke will host a Public-Private Partnership that will include broad representation from government, industry, patient advocacy groups, professional societies, and academia.
The U.S. Food and Drug Administration and Duke University Medical Center have begun a collaboration aimed at modernizing the way clinical trials are conducted.