An important part of advancing medical research and drug development is making participation in clinical trials easier and more inclusive. To develop treatments that work on men, women, and children of all ages and different ethnicities we need to have clinical trial data that represents our diverse population. Right now, when the FDA approves a new drug we know that it will be effective in some – but not all – patient populations.
The lack of diversity in clinical trials has widespread implications; in fact, the majority of oncology drugs used today were developed based on clinical trial data that is representative of less than 5 percent of cancer patients. An 2018 editorial in Scientific American sums it up well: “Nearly 40 percent of Americans belong to a racial or ethnic minority, but the patients who participate in clinical trials for new drugs skew heavily white—in some cases, 80 to 90 percent. Yet nonwhite patients will ultimately take the drugs that come out of clinical studies, and that leads to a real problem. The symptoms of conditions such as heart disease, cancer, and diabetes, as well as the contributing factors, vary across lines of ethnicity, as they do between the sexes. If diverse groups aren’t part of these studies, we can’t be sure whether the treatment will work in all populations or what side effects might emerge in one group or another.”
Fortunately, telemedicine is a game changer when it comes to accelerating drug development capabilities and extending patient reach. Enabling patients to participate in clinical trials from their home by giving them access to mobile nursing and video encounters with doctors opens up a whole new playing field. Virtual clinical trials mean that any qualifying patient who wants to participate in clinical research regardless of where they live, what insurance plan they have (if any) and which doctor they see regularly can be a part of ground-breaking research. Reducing the barriers for clinical trial participation means that more people who live in rural communities, have limited transportation, or restricted access to health care can participate in patient-centric clinical trials.
There have been significant strides in democratizing science due in large part to advances in telemedicine, but there is still more work to be done. Looking ahead, I see three main areas of opportunity that will truly change the health care landscape and make clinical research more inclusive, accessible and efficient.
Expand partnerships. By expanding partnerships with physician groups, medical associations, and patient advocacy organizations, we can communicate more broadly that there are various options for participating in clinical trials and that previous barriers to entry no longer exist. Increasing patient and provider education about the benefits of virtual clinical trials is critical as well as collaborating on outreach to help ensure full patient diversity.
Make research more accessible. Not only does telemedicine have the extraordinary capability to make clinical trials more accessible to a diverse set of patients, but it also has the unparalleled ability to democratize science for researchers. I believe conducting health outcomes clinical research is just as important as new drug development research because it can have important impacts on health policies and can accelerate scientific discoveries. For example, California Health and Human Services offers access to 383 datasets to aid researchers in identifying insights and creating innovations by cross-examining multiple factors such as demographics, diseases and workforce conditions.
Increase the use of technology and artificial intelligence in clinical trials. Like the advances realized by telemedicine, there are likely new technologies that can be used in drug and treatment development that will significantly benefit patients, researchers, and clinicians. For example, Boehringer Ingelheim (Canada) Ltd. and IBM Canada announced at the recent Healthcare Information and Management Systems Society (HIMSS) conference in Orlando, Florida, their plans to explore the use of blockchain technology in clinical trials. Researchers are already using AI to improve outcome measurement; for example, teaching machines to look at photos of dermatology patients to recognize changes over time can generate valuable and actionable outputs. In fact, FDA Commissioner Scott Gottlieb recently said in his remarks at the Bipartisan Policy Center conference that “digital technologies are one of the most promising tools we have for making health care more efficient and more patient-focused.” Collaboration between the medical community and biotech companies is critical to further integrating AI into the health care system.
As we collectively work to increase access to medical research and expand diversity, I’m hopeful that our efforts to democratize science will result in better outcomes for everyone. This is critical for our current underserved communities and will be even more important as our multicultural patient population grows in the future.
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