Clinical Researcher—March 2021 (Volume 35, Issue 2)

OVER THE TRANSOM

Gary W. Cramer

As I write this, I have very recently observed my 15th anniversary of working for ACRP (gifts of crystal and ruby are appropriate, thank you very much), and while a lot of things about the clinical research enterprise have stayed more or less the same since my introduction to it, many other things have changed—mostly for the better. For example, as may be appreciated from the following snippets of content from a variety of sources (no endorsements implied), organizations still recognize the huge importance of effective patient recruitment and retention in the pursuit of drug and device development—only now, they are far more likely to be vocal about research ethics and the steps they have taken (or that should be taken) to make participation in studies easier and more rewarding for would-be volunteers.

**You Can Get There from Here**

Ride Health, a provider of transportation for patients in need, has partnered with the COVID-19 Prevention Trials Network of the National Institute for Allergy and Infectious Disease to ensure the network’s vaccine trial participants can get to study sites when experiencing symptoms of COVID-19 after receiving a vaccine or placebo. Tracking and verifying COVID-19 infections among participants is crucial for obtaining enough data between vaccine and placebo arms to draw conclusions on safety and efficacy, making timely and safe transportation an important resource for study teams at more than 100 trial sites across the country currently testing the vaccines.

Study coordinators can request rides on behalf of participants within the Ride Health platform, where a native COVID-19 screening captures each participant’s COVID-19 status. This screening is factored into the automated decision logic for trip assignments and ensures rides are fulfilled by individually vetted transportation providers equipped to meet driver and passenger safety standards. Once the platform schedules a trip, participants navigate rides via text message, automated phone call, or inbound phone system to ensure consistent access regardless of their comfort with technology.

Let’s Talk Research Ethics

The exposure of research participants to the risk and burden of the research process must be justified, and research ethicists like Jen McCormick with the Penn State Clinical and Translational Science Institute study the balancing of research principles. The following commentary by McCormick comes from a recent podcast aimed at helping listeners learn about the research process and the benefits of health research conducted at institutions such as academic medical centers to their local communities.

Research ethics is conducting research in an ethically and socially responsible way. Research ethics can be referred to as responsible conduct of research, but ethical research actually takes it one step further than responsible conduct. Responsible conduct of research is following the rules and the regulations—which is very important, and that’s part of ethics—but ethical research is taking a step beyond that and thinking about how the research fits into social values.

…[Y]ou have to think about who benefits? Is there any social good that can come out of this? And in particular, when humans are participating in the research, are people adequately informed? There’s an element of what’s right and wrong, but there is a huge gray area.

Personal health information, medical record information, genomic information, and public perceptions around those are some things that I am personally interested in. It’s a really important ethical issue to make certain that researchers are using appropriate mechanisms to access and use that information, and to determine whether they’re able to share it or not share it. I’m really interested in this idea of data sharing and data use and access. When people are participating in research, a lot of times, researchers want to share that information broadly. So, it’s really important to have language within the consent document that reflects that these data will be shared broadly.

…Another thing I can think about is the return of research results—whether a research finding should be returned to a participant or whether it’s still too much research and doesn’t have clinical utility or usefulness. And if that research finding should be returned, I can help the investigator think about how it should be returned.

Elevating Access to an Art

The MMS Holdings contract research organization has joined a historic alliance of 50 life sciences and healthcare organizations that seeks to accelerate the broad adoption of patient-focused, decentralized clinical trials and research. The Decentralized Trials & Research Alliance (DTRA), which launched in late 2020, plans to unite industry stakeholders, including healthcare companies, regulators, patient groups, and research organizations with a singular mission to make clinical trial participation widely accessible by advancing policies, research practices, and new technologies in decentralized clinical research.

“We believe that innovation and growth has a place in every part of our industry, and the proliferation of decentralized clinical trials is set to become one of the biggest changes that we’ve seen in industry in the past decade,” said Eric Harvey, director of biostatistics and data science for MMS.

Decentralized, Not Dehumanized

THREAD, a technology and service provider that enables decentralized clinical trials (DCTs), and 1nHealth, a digital technology company that works with study sponsors on patient recruitment goals, have formed a new strategic partnership to enhance recruitment and retention outcomes in DCTs. According to the companies, the partnership integrates THREAD’s globally leveraged DCT platform with 1nHealth’s global digital recruitment solution to provide research organizations a differentiated approach to implementing scalable, best-practice digital recruitment for DCTs. The platforms are said to work together to reduce startup timelines, increase enrollment effectiveness, and ensure participant satisfaction.

“DCT approaches are enabling sponsors and [contract research organizations] to reach a larger and more inclusive participant population. To successfully engage this broader population, an innovative, remote approach that reduces participant and site friction is necessary,” said Joss Warren, director of partnerships at THREAD.

Dispensing with Disparities in Designing Medicines

In a perspective piece published in the February 5 issue of Science, pharmacologist Namandie Bumpus, PhD—who recently became the first African American woman to head a Johns Hopkins University School of Medicine department, and is the only African American woman leading a pharmacology department in the country—outlines the molecular origins for differences in how well certain drugs work among distinct populations. She also lays out a four-part plan to improve the equity of drug development.

Genetic variants can be more likely to occur in some ethnic groups versus others, and, as a champion for diversity in science, Bumpus advocates that these differences make it even more important to increase diversity in clinical trials of new drugs and therapies. Yet, many clinical trials continue without diverse participation, potentially leading to poor outcomes for people of color and less access to emerging therapies.

Now, as new treatments and vaccines sweep us toward a critical turning point in a pandemic that has disproportionately affected people of color, the need for better standards for diversity in clinical trials is greater than ever, says Bumpus. However, simply increasing the number of underrepresented minorities in clinical trials is not enough to solve the systemic problems, she adds.

Bumpus’ framework for better drug development includes a four-part plan involving the laboratory research of cellular and animal models to study genetic variability; better hiring practices to diversify the scientific workforce; diversity requirements for funding agencies; and diversity reporting requirements on clinical trial demographics in articles published in scientific journals. She says the framework may compel the drug development field to take steps toward a future where “treatments are most likely to work for all people” and “existing health disparities are not further exacerbated.”