Medstar Partnership Supporting the Design of Clinical Trials

Guest Blogger:
Petros Okubagzi, MD
AVP, Research Operations

The Clinical Trials Transformation Initiative (CTTI) is a public-private partnership to develop and drive adoption of practices that will increase the quality and efficiency of clinical trials. Once a specific aspect of the clinical trials process is targeted for improvement, CTTI establishes a project in order to more thoroughly explore the various elements that create the issue at hand, as well as novel solutions for it. The ever-increasing membership now comprises more than 80 organizations from across the clinical trial enterprise allowing it to innovate through collaboration. MedStar Health, through MHRI has been an active participant for a very long time and is represented at the Steering committee level. One of the unique characteristics of CTTI is the variety of its members (FDA, Industry, Patient advocacy groups, Universities as well as Nonprofit groups).

One of the initiatives that CTTI had undertaken was working on standardization and integration of clinical trials using mobile technology. This was made through task groups which consisted of teams looking at Legal-Regulatory issues, Mobile Device Selection, Novel endpoints and Stake holder perceptions. The latter, the group I worked in, looked at ways to reduce patient burden, streamline operations and optimize data collection when designing clinical trials using mobile technology. This was done using a survey of 193 potential research participants and qualitative interviews with a dozen investigators of varying backgrounds. This has led to CTTI developing a comprehensive evidence-based set of recommendations for incorporating patient and site perspectives in digital health trials.  

The actual study and conclusions have also been published this week in the journal of Contemporary Clinical Trials Communication that you can access here. This is one of the many ways Medstar Health contributes not only in the conduct of clinical trials, but also upstream in setting the ground rules for conduct of future clinical trials through research and advocacy.

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