Over 50% of breast cancer patients are not well represented in clinical trials.

By Solomon Banjo

This study adds to a growing body of evidence highlighting ways that the lack of representation and under-representation of women and people from marginalized communities in clinical trials impacts patient outcomes. To be clear, we have long known that the lack of representation in clinical trials means that we as an industry do not know the benefits and burdens of many treatments for broad swaths of the patient population. In this example we are understating the harms, but there was also research from last year that suggests that we are actually understating the potential benefits of lung cancer screening based on the lack of representation in research. Which is why my teammates and I have been focusing on untapped ways to increase early-stage lung cancer diagnosis to reduce the health disparities in the nation’s number one cancer killer.

Clinical trial diversity has been an ongoing research focus for my team since 2020 and we held a cross-industry event on this topic in 2021 to understand why the ecosystem has not made more progress given how long we have known about the problem, its impacts, and the wealth of available information on operational changes to make trials for inclusive. One of our takeaways, supported by what the study authors found, is the need for sponsors and researchers to interrogate who we exclude from trial participation both clinically and non-clinically. This study focused on the former, but it would not surprise me if ways in which the analyzed studies were designed would have made it difficult for the populations identified as unrepresented and under-represented to participate. Where were these sites located? How often did patients have to go in-person and during what times? We saw a similar dynamic play out in the initial push to vaccinate the country where many of the assumptions built into the early programs disadvantaged people based on socio-economic, geographic, and other grounds. Recognizing these design choices—and questioning their necessity—will be vital if we want to make progress.

At the end of the day, patients, their loved ones, and their clinical teams want to be able to say that they made the best possible decision for the patient because they had all the necessary information. My hope is that we are on a path to make that true for all patients, not just some.