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CTTI Project: Quality by Design
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.
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CTTI Project: Patient Group Engagement
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.
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CTTI Project: Investigator Community
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.
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CTTI Project: Patient Engagement Collaborative
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.
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CTTI Project: Patient Engagement Collaborative
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.
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CTTI Project: Real World Data
During a public webinar today, the Clinical Trials Transformation Initiative (CTTI) will release new recommendations and resources on how to use real-world data (RWD) to evaluate trial eligibility criteria and recruit potential research participants.
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CTTI Project: Pregnancy Testing
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.
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CTTI Project: Preparing a Site
During a public webinar today, the Clinical Trials Transformation Initiative (CTTI) will release new recommendations and resources for engaging patients and research sites when planning and conducting mobile clinical trials. By doing so, sponsors, contract research organizations, and other stakeholders can maximize the opportunities of mobile technologies to advance the development of new medical products.
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CTTI Project: Supporting Decentralized Trial Approaches
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.
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CTTI Project: Developing Novel Endpoints
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.
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