This is your one stop shop for updates on CTTI projects, developments in the clinical trials enterprise and other relevant news. To read the full-length entry, or to share a specific blog post, click on the title of the article of interest.
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CTTI released new recommendations proposing a new approach for investigator qualification today during a public webinar. This approach goes beyond repetitive one-size-fits-all training and includes individual experience and protocol-specific preparation.
While Good Clinical Practice (GCP) training is widely used as the industry standard for investigator qualification, there is little evidence that completion of GCP training alone sufficiently qualifies investigators and...
CTTI will release new recommendations that propose a new approach for investigator qualification during a public webinar on Thurs., Nov. 15. This approach goes beyond repetitive one-size-fits-all training and includes individual experience and protocol-specific preparation.
Current regulations from the U.S. Food and Drug Administration (FDA) require that sponsors and their delegates select qualified investigators. Good Clinical Practice (GCP) training is widely used as the...
CTTI released new recommendations on overcoming the legal, regulatory, and practical hurdles for planning and conducting decentralized clinical trials (DCTs) today during the DPharm: Disruptive Innovations to Advance Clinical Trials conference in Boston, Mass.
DCTs, which are run through telemedicine and mobile health care providers, offer several potential advantages, such as faster recruitment, improved retention, greater control and convenience for participants, and increased...
The use of real world evidence (RWE)—derived from sources such as electronic health records (EHR) and claims data—has the potential to provide a more complete picture of patient experiences, reduce costs, and offer unique insights into important scientific questions. At the same time, there are relatively few examples to inform efforts to integrate RWE into clinical trials, as well as a lack of consensus among researchers about valid approaches for leveraging these data sources.
To...
Most clinical trials exclude pregnant women in order to minimize risk to the embryo or fetus. However, there are currently no specific guidelines for how pregnancy testing should be conducted for female trial participants of reproductive potential, nor how risks should be clearly communicated with them.
In a recent article in PLOS ONE, CTTI shares recommendations developed by experts in academia, industry, and regulatory agencies on pregnancy testing in clinical research. They...
