Patient trials are the silent crisis in clinical research

The pharmaceutical industry is racing in unprecedented ways to develop therapies to treat Covid-19 and vaccines to prevent it. But outside of Covid-19, pharma has been slow to adopt technology that can speed new therapies of all types.

Well before December 2019, much of the world had adopted digital and mobile experiences — mobile banking, online grocery orders, on-demand video streaming, and more — for everyday life. The pharma industry, however, largely follows the same analog processes it did more than 40 years ago. Most clinical trials still require patients to attend in-person doctor visits, some lasting several hours, sometimes multiple times a week. They rely on patients writing in paper diaries to document how they are following their treatments. Recruitment is often done via primary care physicians.

As a result, the woman who works an hourly wage job with little paid time off or the single father who lives in a rural town and needs child care arrangements are unable to access clinical research as an option for care. The burden to participate is just too high, despite how critical the research may be to their health.

One solution is to increase the use of decentralized trials. Instead of depending solely on in-person visits, decentralized trials fully or partially use telehealth, connected devices, mobile apps, and other technology to aid patient participation. The industry had been slow and unwilling to embrace this model. Then Covid-19 happened.

During the height of the pandemic, clinical trial sites became inaccessible due to global shutdowns, which made recruitment difficult and prevented patients from making in-person visits. This forced pharma to temporarily reconsider decentralized trials as a means to continue some operations virtually from patients’ homes.

I applaud this agility. Yet I worry that the industry will see it as a temporary adaptation rather than widely embracing decentralized and hybrid trials for good because patient recruitment — the lifeline of clinical research — depends on it.

According to a survey by the Kaiser Family Foundation, 45% of millennials don’t have a regular primary care doctor, while 85% of those between the ages of 50 and 64 and 88% of those age 65 and older do have one. The low percentage among millennials is a problem for clinical trials because primary care doctors are the most relied-on source for recruiting participants. If many of those in the largest living adult generation have no trusted relationships with primary care physicians, where and how will pharma conduct recruitment for trials?

Even if they are recruited, how will clinical trial sponsors convince a demographic that relies on mobile solutions for everything from working, banking, and shopping to stay in a clinical trial that doesn’t use virtual or mobile technologies?

Add in the issue of diverse representation. The way diseases present themselves and the way drugs act can vary greatly by gender, race, and ethnicity. Diversity is not just a moral imperative but a scientific one that matters biologically. As treatments become more precise and address the molecular and genetic differences in people, it will become impossible to ignore diversity in clinical trials. Yet pharma continues glossing over the barriers that inherently preclude women, Black and Latino Americans, and people living in poor and rural communities from participating in clinical research.

Patient recruitment and retention is the longest, most difficult part of the clinical trial process. And shown by its inability to keep up with the way people use technology, the industry has become complacent and comfortable with spending billions of dollars and taking a decade or so to bring new treatments to market. More than 80% of clinical trials in the U.S. fail to meet their patient enrollment timelines and 30% of patients drop out.

Patients are rightfully expecting that health care be delivered more conveniently, but pharma is not listening. Unlike the pressures from Covid-19 that suddenly interrupted clinical trial operations, these challenges and others will slowly degrade recruitment one trial at a time and drive development costs to unsustainable heights.

But there’s a way forward.

It starts by resetting the definition of decentralized trials. The industry must move away from the paralyzing myth that decentralization means that everything becomes virtual. To be sure, some types of trials and diseases are appropriate for full decentralization. But many trials and diseases will still require some in-person visits for radiology procedures, biopsies, endpoints that must be evaluated by trained professionals, and the like.

A hybrid model that combines traditional and virtual components offers a new approach for designing clinical trials. Rather than copying and pasting old procedures, start with a clean slate and pose new questions: What is the minimum number of onsite visits needed? How can onsite visits be supplemented with telehealth visits? How much data can be collected from home through remote monitoring and connected medical devices? Can the data be collected accurately?

It’s helpful to start with technologies patients are already using. E-signatures, for example, can be applied to informed consent forms; text messaging can be used for medication reminders. Hybrid trials that deploy familiar technology in a new environment represent a stepwise approach to being intentionally flexible and patient-centric.

Although a decentralized strategy must start at the top of an organization, it must permeate into every level of it. I’ve had dozens of conversations with C-suite pharma executives who agree, “Decentralized trials are a fantastic idea,” but the intent breaks down once it reaches the operational level. Drug development culture is naturally risk averse, and teams generally shy away from being first adopters. Instead of fearing the unknown, establishing an agile, flexible culture that accepts obstacles as part of the change-management process can encourage teams to step up.

The decision to move forward with hybrid or fully decentralized trials must also be reinforced with investments. In the current environment, there is no immediate incentive or consequence to change how clinical trials are run. To foster thinking differently about problems, it can help to invest in training that shows teams how to be adaptable, nimble, and creative in their approach to designing hybrid clinical trials.

Finally, conducting a hybrid trial isn’t just about buying a product with patient-facing technology. To be successful, the trial needs the appropriate technology platform that can support and adhere to data privacy and security compliance. Pharma is highly regulated and laws like the General Data Protection Regulation and the Health Insurance Portability and Accountability Act exist to ensure patient privacy and protection.

How the trial reaches compliance is different in a decentralized or hybrid model. Every element of a trial must change in a hybrid or decentralized approach, down to the standard operating procedures that give instructions on how to run the trial properly. How a decentralized or hybrid model will create new implications and how to best address these changes in a highly regulated, global environment must be carefully considered.

The pharma industry is at an inflection point. Rather than solely using decentralized trials as a short-sighted business continuity response to Covid-19, it can resolve the silent problem of patient recruitment before it becomes the industry’s next crisis. This is the moment to make access to clinical research available to all, regardless of where they live or their gender, race, ethnicity, or financial status. Improving clinical trials must be done to advance clinical development and, most importantly, save more lives.

Kent Thoelke is the executive vice president and chief scientific officer at PRA Health Sciences, a global contract research organization and health care intelligence company headquartered in Raleigh, N.C.

https://www.statnews.com/2020/10/28/recruitment-retention-silent-crises-clinical-trials/