STRATUS ->Curavit’s Virtual Clinical Site: Integrating Local HCPs into Clinical Research

The FDA Guidance published September 2024, “Conducting Clinical Trials With Decentralized Elements” opens up local healthcare infrastructure to support clinical research.? Specifically,?

“Depending on the trial protocol, in-person visits and trial-related activities may also be conducted by HCPs who are located close to trial participants’ homes. Investigators may use these local HCPs (such as doctors or nurses) to perform certain trial-related activities... The trial-related activities local HCPs perform should not differ from those that they are qualified to perform in clinical practice and should not require a detailed knowledge of the protocol, investigator’s brochure, or IP… These local HCPs would not be considered trial personnel, nor would they be considered sub investigators in a drug trial.?

We wholeheartedly welcome the recent FDA guidance. At Curavit, we specialize in designing and executing decentralized clinical trials (DCTs), many of which require study subjects to complete visits at physical medical sites. The FDA’s acknowledgment that the vast majority of these visits do not necessitate healthcare providers (HCPs) to have protocol-specific knowledge aligns seamlessly with our approach. While this guidance reduces regulatory burdens, significant challenges remain in implementing these processes at scale.

For instance, directing a study subject to their local, trusted therapist for a required six-minute walk test may sound straightforward, but the reality is far more complex. Does the subject have access to a qualified therapist nearby? Is the therapist accredited to meet protocol standards? Can the appointment be scheduled within the study’s time window? Who facilitates the booking? How is the therapist compensated? And critically, how is the data collected, validated, and reviewed for quality? Most importantly, is the Principal Investigator (PI) confident in signing off on that data?

At Curavit, we are committed to overcoming these challenges and scaling DCTs to their full potential. We are purposefully building our organization to optimize DCTs, with a strong emphasis on leveraging local healthcare infrastructure. This commitment begins at the protocol design phase, incorporating insights from PIs and target study populations to ensure trials are both feasible and effective. By integrating the advantages of utilizing local HCPs, we aim to enhance both study efficiency and patient experience. These steps mark the beginning of an exciting journey, driven forward by the FDA's transformative DCT guidance.

Curavit’s Virtual Clinical Trial Site has proven results

Faster Recruitment: Enroll 2-3x faster than traditional site based trials.

Diverse Study Subjects: Meet the target enrollment for underrepresented populations.

Higher Retention: Provide your study subjects with the convenience of participating from home.

Lower costs: Reduce costs by eliminating site based screening, startup and closeout fees.

Learn more about STRATUS, Curavit’s virtual clinical site by visiting www.curavit.io ?

Decentralized Trials & Research Alliance (DTRA) is an excellent resource to learn more about DCTs