Solution to Clinical Trial Enrollment Lies Hidden in FDA Guidance

Solution to Clinical Trial Enrollment Lies Hidden in FDA Guidance
Solution to Clinical Trial Enrollment Lies Hidden in FDA Guidance

New medications take too long to get into the hands of people who need them – a decade, on average. The leading cause of delays is finding patients for clinical trials, but it shouldn’t be this slow. The industry agrees finding more patients is the key, and the solution lies within making clinical trials easier and more accessible to patients, but there’s still a piece missing to the puzzle… our doctors.

To make the matter more interesting, we know patients are willing participants. More than 75% would consider enrolling in a clinical trial, yet only 9% are typically invited. In contrast, a whopping 90% of clinical trials fail to meet enrollment timelines and 27% of sites fail to enroll a single participant. The funny thing is, it’s never been easier to identify patients for clinical studies, so what’s the problem?

While it’s become easier to identify patients, that’s only half the battle. What’s still missing is access to those same patients. Typically, clinical trial candidates are siloed behind a treating physician who doesn’t refer to clinical trials for fears of patient leakage, additional workload, and control of care.

It’s been an industry goal to find a way to motivate our treating physicians to offer access to their patients. In fact, Craig Lipset, ex-head of innovation for Pfizer says, “Enabling physicians to offer “clinical trials as a care option” is the holy grail of participant enrollment.” However, for treating physicians to access advanced medicine, it comes with limited and unfavorable options: Either become an investigator or send their patient away to another doctor.

Fortunately, new technologies have created another option, and it’s staring us in the face. For example, tools like telemedicine could help solve the patient access problem by enabling our treating physicians to “host” clinical trial appointments from their community practices. This solution could realign the incentives of treating physicians and investigator teams, and exponentially accelerate time to market for new medications.

The concept is simple — current thinking suggests the patient must physically be at the clinical trial site. However, telemedicine and patient wearables create pathways for patients to participate in clinical studies away from the clinical trial site. What are the regulatory and compliance ramifications of this?  In short … we’re missing a huge opportunity.

According to the FDA guidance“Many data elements (e.g., blood pressure, weight, temperature, pill count, resolution of a symptom or sign) in a clinical investigation can be obtained at a study visit and can be entered directly into the eCRF by an authorized data originator. … For these data elements, the eCRF is the source.”

This establishes “the source” to be where patient information is recorded, rather than where it is collected. Before technologies like telemedicine, data was collected and recorded at the same location. Now, these technologies give the industry flexibility for separation of these locations making a provider’s office possible for patient engagements without necessitating a new PI or virtual site.

In fact, a former FDA Associate Office Director and co-author of this guidance says“Using technology to connect patients from alternate locations to a PI site does not trigger any new clinical sites or clinical investigators. The FDA is open to new technologies that make it easier for patients to participate in clinical research, whether it be from their home, a local clinic, or a provider’s office.”

This realization enables treating physicians to essentially “prescribe” a clinical trial as a care option without losing control of the coveted patient relationship and continue to be their patient’s biggest advocate, without having to deal with the logistics and paperwork of joining the trial themselves.

We’ve known that our treating physicians were the missing ingredient to clinical trials all along, and now we have the tools and regulatory clarity necessary to move forward. By using this path, we can fill clinical studies faster, create more diverse pools of participants, and allow pharma to save lives, faster.

Photo: Deidre Blackman, Getty Images

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