What’s Keeping You Up at Night?

Clinical Researcher—October 2022 (Volume 36, Issue 5)


Edited by Gary W. Cramer


Years ago, I (mostly in jest) tried to convince a former Editor-in-Chief for ACRP that we should take advantage of having an October issue of Clinical Researcher by putting pumpkins on the cover and calling it our Fall Harvest Special, or something of that nature. She failed to appreciate my initiative. However, the urge to tie the theme for an issue into spooky season has never dimmed in my heart and now, at last, I have a decent excuse to get it out of my system.

As I write this during and in honor of Michael Causey’s last week as Editor-in-Chief for the Association, I wish to further a fact-finding mission he recently launched in the ACRP Community to learn about “What’s Keeping You Up at Night Professionally?” Please feel free to contact me directly at gcramer@acrpnet.org with your feedback on this topic so that Michael can enjoy his return to the world of freelancing after seven years in the clinical research trenches.

In the meantime, here are excerpts of missives from organizations outside ACRP about how they are tackling some of the thorniest “monster in the closet” challenges keeping their leaders, staff, and stakeholders up at night (no endorsements implied).

Diversity Worries and Woes

U.S. Food and Drug Administration (FDA)-approved clinical trials have historically lacked diversity among participants who are largely white adults (mostly males) from affluent socioeconomic backgrounds, and in trials that are often based in majority-white regions of the world. Meanwhile, the Indian subcontinent is home to about a quarter of the world’s population, yet less than 2% of global clinical trials have any study sites in India. Moreover, clinical trial participants do not reflect the racial and ethnic makeup of the global population affected by various targeted diseases. This lack of diversity in patient clinical trials is counter-productive to research goals, particularly in studies involving ultra-rare diseases where a small number of affected patients are sparsely distributed geographically within the U.S. and globally.

The U.S. biopharmaceutical industry struggles to enroll the required number of patients in orphan drug clinical trials within the U.S., requiring a more global enrollment strategy. From the perspective of rare diseases patients located in countries without local access to clinical trials, they remain unable to access novel treatment options. Neither science nor patients are well served, causing an increased burden on the orphan drug development process.

“The current process for developing new treatments for rare diseases leaves India and the Indian diaspora on the outside looking in,” says Harsha Rajasimha, PhD, founder and executive chairman of the Indo-US Organization for Rare Diseases (IndoUSrare). “Indian patients miss out on opportunities to avail clinical research as a care option or join a clinical trial that offer the best hope for timely care management. Then when drugs are eventually approved, they are based on safety and efficacy data from mostly non-Indian patients.”

In 2021, the Indian government revived the National Policy for Rare Diseases to assist people with rare diseases. Eight centers of excellence for rare diseases recognized by the policy are working with patients and medical geneticists to identify individuals needing this help.

To Decentralize or Not?

Velocity Clinical Research, an integrated research site organization, has announced the findings of a U.S. patient survey aimed at better understanding patient preference for study decentralization activities in clinical research. Conducted in the first half of 2022, the survey gathered 1,129 responses. Questions focused on study design and decentralization methods, in order to understand people’s previous experience with trials and preferences for future participation. The major findings include:

  • Patient-facing technology is not widely used in research today and most patient experience of technology is of relatively simple modalities such as eDiaries. However, volunteers of all ages are overwhelmingly willing to use it.
  • Home visits will not solve racial and ethnic diversity issues, and could exacerbate them.
  • Sixty percent of volunteers ages 18 to 34 have participated in multiple studies.

Velocity says the research shows that people like the flexibility of decentralized methods and a hybrid model of in-person and virtual study visits, with in-person visits taking place at the clinic rather than at home. According to the company, the findings have implications on protocol design, patient recruitment techniques, and technology development, which should all be focused on reducing patient burden. You can access a presentation on the report here.

Putting Your Data to Work

STAT, a media company reporting on health, science, and medicine, has partnered with Applied XL, a company that builds real-time information systems rooted in computational journalism principles, to release a new platform called STAT Trials Pulse, which allows for early detection of potential outcomes in clinical trials data.

In the last 12 months, more than 2.5 million changes were recorded in the U.S. clinical trials registry alone. That’s an average of more than 6,800 updates every day. Trying to analyze these changes, identify patterns, and connect the dots between other sources is a staggering undertaking, but is also essential for investment firms and pharmaceutical companies seeking competitive intelligence. From the enormous stream of data, Applied XL’s algorithms detect important clinical trials updates, add context against historical data, and fill in the blanks with additional data sources to deliver a curated drip of what the partners call “actionable alerts.”

STAT Trials Pulse has been in beta since January 2022.

Making Room for Inclusivity

To stay ahead of the urgent needs of equitable healthcare, Martis Capital, a middle market healthcare fund, has announced its investment in Alcanza Clinical Research. Founded in December 2021 and named for the Spanish word “reach,” Alcanza is a clinical research site network platform dedicated to creating a sustainable and inclusive clinical trial environment for all.

As patient advocacy groups, research stakeholders, and regulators urge sponsors to expand clinical trial inclusion, Alcanza is actively transforming the model for research access to underrepresented populations across different races, ethnicities, genders, sexual orientations, disability statuses, and more while enhancing clinical research quality and patient recruitment efforts. As a first step, Alcanza has acquired five high-performing clinical research companies. These include Coastal Carolina Research Center, Boston Clinical Trials, ActivMed and Allcutis Research, Quest Research Institute, and Charlottesville Medical Research across eight locations in Massachusetts, Michigan, New Hampshire, South Carolina, and Virginia.

“This partnership is a unique opportunity to drive sustainable improvements in the highly fragmented clinical trial space by focusing on improving disparities in clinical research,” said Mario E. Moreno, managing partner at Martis Capital.

Gary W. Cramer (gcramer@acrpnet.org) is Managing Editor for ACRP.