Regulators and many in the clinical research industry emphasize patient diversity, but how do contract research organizations (CROs) and sponsors achieve it?
The US Food and Drug Administration (FDA) recently released its Drug Trials Snapshots for 2019 – a document that shares the demographics of clinical trial participants in approved clinical trials. Here are some key findings:
While these demographics shift from year to year, patient diversity is a critical is a growing trend and crucial aspect of successful research. To adequately prepare for the future and to best serve populations in need, we encourage you to consider this during eClinical vendor selection. Let’s take a deep dive into patient diversity’s significance, main obstacles, and see what eClinical features can help:
For study results to show safety and efficacy for all people, participant demographics need to mirror the country’s population. For example, when the US FDA approves a treatment, it can be prescribed to people of all ages, genders, races, and ethnicities.
Some diseases, however, disproportionately affect specific demographics. There is also growing evidence that drugs have different effects on different populations. With the rise of personalized medicine, one-size-fits-all medicine is becoming a thing of the past. On top of this, more effective treatments for all communities means more safety and overall better public health.
Regulators are also starting to demand it. In 2015, the FDA began publishing the demographics of clinical trials for newly approved drugs. Although the organization can’t set official guidelines for age, gender, and racial representation, they have called out the lack of diversity. Enrollment should reflect the patients most likely to use a medical product. Therefore, better diversity can improve your treatment’s chances of regulatory approval.
One of the main reasons is the fact that many are unaware that clinical trials exist. Even though many organizations are harnessing new technology to increase awareness, connecting participants to trials is a great challenge.
Then, there are logistical and financial challenges. Data shows that people making less than $50,000 per year are significantly less likely to participate in clinical trials. Traditional clinical trials often require participants to take time off off work, commute long distances to sites, and find childcare. This means that those in rural areas or with lower incomes will likely not consider joining a traditional study.
Distrust of the health care system and clinical trials also exists for some groups. Because clinical trials are inherently risky, building trust with the target demographic of your study is essential to research success.
Improving awareness is a fundamental way to help boost patient diversity. Research shows that patients are more likely to enroll in trials if their health care provider recommends it. Many have also turned to social media to get the word out.
From an eClinical perspective, decentralized clinical trial capabilities can greatly expand inclusivity – and you don’t have to go entirely virtual to accomplish this. Reliable tools like ePRO can reduce patient burden by allowing participants to provide patient-reported outcomes from home. Participants will spend less time traveling to sites and avoid needing childcare or time off work.
eConsent can also help in efforts to boost trust and engagement. Although this tool is relatively new, it’s proven tremendously useful in increasing patient comprehension and patient retention.
Lastly, even in developed countries, the internet can be spotty when outside of urban areas. Having Direct Data Capture (DDC) that can collect data offline and sync directly with the EDC once connectivity can expand your data-capture capabilities and give you more flexibility.
The benefits of boosting patient diversity are huge: more people will benefit from your discoveries. Also, your results will be more representative and relevant to all segments of the population. For us at Medrio, we’ll continue doing our part to support patient diversity in clinical research with our EDC and eSource suite. By increasing access to clinical trials for all, we can have a more substantial impact on public health and health equity.
Decentralization of clinical trials is proving to make great strides towards reaching diverse patient populations. We offer a path to the decentralization of your trials, and we can help guide you on your journey.