Clinical Researcher—August 2021 (Volume 35, Issue 6)

OVER THE TRANSOM

Gary W. Cramer

Although he later denied ever being so pithy, bank robber Willie Sutton, who in a 40-year career of being dastardly stole some $2 million, once supposedly replied to a reporter’s line of questioning about why he robbed banks by saying “because that’s where the money is.”

Things are less straightforward for clinical researchers. One simply doesn’t walk into “the place where the potential participants are” and start signing folks up for clinical trials. The challenges abound: Where are the people with the condition under study? How many of them are willing to join the study? How many from that group match up with the inclusion criteria? How many still remaining will comply with the protocol and stay engaged in the study through to its conclusion?

Taking a “first things first” approach, this column initially offers up portions of communications from stakeholders outside the confines of ACRP (no endorsements implied) about the never-ending quest just to find those blessed would-be participants and get the ball rolling. We’ll also delve a bit into the follow-on efforts necessary to retain participants and then keep them satisfied after their “work” is done by sharing study results. As you’ll see, much of the attitude being invested in recruitment these days honors the spirit of “we’ll meet you where you are” as much as “you only get what you give.”

Virtual Trial of COVID-19 Rapid Detection Test Starts with Drive-Through Consent

Curebase and InBios International Inc. in July announced that InBios successfully utilized Curebase’s virtual site solution to power clinical studies for its SCoV-2 Ag Detect™ Rapid Test, which was granted Emergency Use Authorization by the U.S. Food and Drug Administration on May 6. For this study, Curebase converted drive-through COVID-19 testing centers in southern California into clinical research sites with its decentralized clinical trial software platform and virtual site support model.

Study participants were able to be screened and offer consent in real time from the safety of their vehicles while they were waiting for a COVID-19 test. By accessing a specific study website on their own phones, candidates could answer screening questions and consent to participate in the InBios study all in the time it took to wait in line at the drive-up clinic. The process required no physical interaction with patients and enabled hundreds of people to be screened in a few weeks.

Companies Collaborate to Speed Studies to Rare Disease Patients

uMotif and Xperiome in July announced a collaboration focusing on what they call a new approach to patient recruitment for rare disease studies. The partnership aims to bring value to both life science companies conducting clinical trials and the patients participating in them through outreach to a community of “motivated, research-ready patients” using a recruitment platform designed to drive retention.

The partnership will leverage Xperiome’s knowledge bank for the lived experience of rare disease to build an understanding of hard-to-reach populations and combine these insights with a specialized matching engine to connect potential participants to clinical and real-world study opportunities. Once enrolled, uMotif’s patient-engagement app will capture participants’ electronic patient-reported outcome, eDiary, and symptom data in real time throughout the duration of a clinical study.

According to the partners, the effort “is designed with patients in mind, to help sponsors and research professionals capture the best quality data in a way that suits study participants” and recognizes that, in orphan drug studies, “populations are hard to reach and participation in research can add significant burdens for patients and their families.”

Mobile Communications Approach Confronts One of the Biggest Problems in Trials

ScienceMedia in July announced that its SMi Trial mobile communication technology aims at keeping clinical trial stakeholders “in the loop” with educational support throughout the research lifecycle. Noting that “the complex communication between doctors, nurses, pharmacists, and patients all around the world makes closing the loop difficult,” the company goes on to indicate that its approach addresses a concern of the European Medical Writers Association—namely that, “for studies of long duration, educational and engagement efforts should ideally be continued throughout the study to support retention of participants.”

Depending on the needs of the participant population and the study specifics, the company says this may take the form of a comprehensive, multichannel participant support and communications program, or may be a simple, automated text messaging service that sends motivational, informational, or reminder messages at set points in time. In any event, “an educational program throughout the life of a clinical trial is paramount,” a company executive stresses, adding that you “don’t just build the education so that it can be consumed, [you] ensure that it’s being consumed by every single participant throughout the trial and tailored to their learning needs.”

Happy Birthday! Here’s Your Report Card

As noted in a recent ACRP Blog entry, the All of Us Research Program from the National Institutes of Health (NIH) is celebrating its third birthday this month and touting recent successes in recruiting participants for the program, including more than 24,000 volunteers from the Southeast region with a high percentage of them being minorities who are under-represented in medical research. By asking 1 million or more volunteers across the nation to share different types of health and lifestyle information, the initiative aims to speed up health research breakthroughs to improve health outcomes and deliver precision and personalized medicine to patients.

Not mentioned in the blog, but highlighted in a press release from the University of Miami Miller School of Medicine, were details about how participants are being kept engaged in the long-term program. According to Jacob L. McCauley, PhD, director of the Hussman Institute’s Center for Genome Technology at the school, “We are really excited that participants have started receiving some of their genetic results from the biosamples that they have donated. The initial results will provide insights into the participants’ genetic ancestry and traits, with additional health-related results coming at a later phase. This is one of the first opportunities to return value to our participant partners in this groundbreaking research program.”