Diversity in clinical research is key to the next generation of COVID treatments, explains Health Wallet CEO Tom Rico Pamukcu in the San Francisco Chronicle. Read more below or click here to go to the Chronicle.

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COVID keeps evolving. Clinical drug trials need to evolve along with it

Alpha. Beta. Delta. Omicron. BA.5

The list of COVID variants and subvariants continues to grow. And the threat of prolonged symptoms from long COVID becomes clearer every day. Our best defense — research to produce new and effective treatments — must keep advancing. But our clinical research system has a problem, and the Food and Drug Administration is only now making some headway in trying to fix it.

Clinical trials are how we know vaccines and medicines work and that they’re safe. If you’ve ever taken a medicine or a vaccine, you’ve benefited from these clinical trials.

But some people benefit more than others.

The best way to ensure that a drug is safe to take is to create clinical studies that test its effects on the different types of people who will eventually take it. For most drugs, like those that would treat COVID, that means essentially the whole population — broadly representing every age, gender, racial or ethnic background.

But the people who enroll in clinical trials often don’t look like our population; they’re disproportionately white and male, and people over age 65 are frequently underrepresented. This has been noted in cancer drug trials and vaccine studies, among many others.

That’s a problem.

Drugs and vaccines sometimes have different effects in different groups. Older people, for example, process drugs differently than younger ones. Women process many drugs differently than men, leading to higher rates of side effects and safety concerns. And we know that differences in body weight between men and women don’t explain those findings.

There can also be racial differences in outcomes as well.

For example, a common blood thinner used to reduce the risk of heart attack or stroke was belatedly found to be ineffective for many Asians and Pacific Islanders due to a particular gene that is more common in some populations. But this disparity wasn’t discovered until the drug went to market because Asian American and Pacific Islander patients weren’t adequately represented in the clinical research.

Sometimes a drug will work better or be safer in one group than in others. For example, Black patients taking the cholesterol-lowering drug simvastatin had a lower rate of side effects than white individuals taking the drug.

Failure to study diverse populations means we don’t know everything we could about new medical products when they’re approved. But that’s not all. For people with life-threatening conditions like hard-to-treat forms of cancer, enrolling in a drug trial could be their only chance at life-saving treatment.

Everyone should have a fair shot at these opportunities.

While these problems exist across the field of clinical research, they have particularly worrisome implications for COVID research.

First, with a new infectious disease — and SARS-CoV-2 is still pretty new — clinical trials can impact the whole population. The first people to receive the COVID vaccine through clinical trials went back into their communities and helped stop the spread. But those initial vaccine trial participants were disproportionately white and male. Meanwhile, people of color were disproportionately exposed to the virus, with many serving as essential workers and living in households that could not easily quarantine sick family members.

All of this contributed to COVID-19 taking a disproportionate toll on communities of color.

Unless we make changes now, we are on track to continue these disparities in the next generation of COVID research, much of which will focus on long COVID. We now know that for about 1 in 5 COVID patients, the initial infection is just the start, and that the virus continues damaging other systems, with effects persisting long after that first infection.

We have just started to study long COVID, and we urgently need to avoid repeating the same mistakes of those early studies. In addition to implications for communities of color, some research suggests that many long COVID symptoms disproportionately impact women.

Disproportionately white, male studies won’t cut it.

Why are some groups chronically underrepresented in such vital studies? Some of it, sadly, seems to stem from explicit or implicit bias among doctors and researchers. In one recent survey, Black cancer patients said they were interested in clinical trials but were only rarely offered the opportunity to participate.

Sometimes, it’s an outreach failure — research teams simply not recruiting in ways that are likely to reach women, older people or racial and ethnic minorities.

In April, the FDA issued a draft guidance for industry and others sponsoring clinical trials urging them to develop a plan to promote racial and ethnic diversity in their studies. The guidance, culminating a process that began six years ago, takes a critical first step by asking trial sponsors to put their diversity plans in writing.

That’s important because it can push researchers to put effort and thought into diversifying their patient pool. But the draft guidance focuses only on race and ethnicity, not age or gender

We can’t wait for the FDA to fix this, though it should certainly finalize and toughen up its guidelines. Legislation has been introduced in Congress that may help, but its fate is uncertain.

Everyone involved — drug companies, academic institutions, researchers — must recognize the seriousness of this problem. The next COVID variant won’t wait for us to get this right.

Tom Rico Pamukcu is a clinical researcher and the founder and CEO of Health Wallet, a South San Francisco company connecting prospective clinical study participants and researchers.