There is still a considerable disconnect between the research and development being done in health care and the diverse populations around the globe, which the industry aims to serve. Diversity in clinical research goes far beyond a language barrier. It’s about understanding the mindset of a patient within a larger context of culture, gender, ethnicity, religion and socioeconomic realities. And it’s something that remains a major obstacle when it comes to clinical trials and drug development.
This is a problem for two reasons: New treatments need to be tested on diverse populations to provide an accurate indication of its efficacy, and all individuals, regardless of background, should be given the opportunity to partake in clinical trials and gain access to new drugs in development. For example, only 3% of adult patients with cancer have access to participate in clinical trials and, therefore, access to potentially life-saving drugs.
Saving Lives With Diversity
Having a diverse patient population in clinical trials is important because medicines can affect people differently. This, coupled with the fact that health systems around the world are entering the era of genomics and precision medicine, means it is crucial to test as many patients as possible. Given that the average timeline of getting a drug to market is 10 years, this is something that needs to be addressed immediately — and even then, we will only see a true impact in a decade’s time.
Without adequate diversity in the clinical trial process, the outcome is undoubtedly flawed and misrepresentative. Early studies of the Alzheimer’s disease biomarker APOE overstated its health impact because the clinical trials focused on white men. When you don’t have the inclusion of diverse communities, you run the risk of making assumptions about drug safety and effectiveness that may not be accurate.
Participation in clinical research also opens the door to potentially life-saving treatments. Being part of a clinical trial gives someone access to a new drug or treatment that could save their life. That’s something everyone of any ethnicity, background, social or economical standing could be given the opportunity to take.
Challenges To Overcome
Addressing the diversity issue is not straightforward; there is a multitude of barriers and challenges. They include everything from geographical limitations and inability to get to a site through to financial barriers, and a lack of resources for patients and clinicians to support clinical trial enrollment and retention.
There are huge disparities in what facilities are available and in what region. The prevalence of refrigeration can be an issue, for example, while some areas have difficulty achieving diversity simply because the population set doesn’t lend itself to it. Additionally, communication around which trials are being conducted and are available, as well as a clear understanding of how to participate in them, is far from consistent.
Luckily, we’re seeing a big drive from both researchers and regulators to address these issues.
Role Of Regulators
Although the number of countries submitting clinical trial data to the FDA has doubled over the past two decades, the proportion of white participants declined only modestly, from 92% to 86%. As a result, measures have been put in place to ensure more diversity and inclusion in the clinical trial process.
Over 25 years ago, the U.S. National Institutes of Health mandated proportional representation of patients by race and ethnic group. More recently, a law passed in 2012 required the FDA to report on the inclusion of demographic subgroups in clinical studies. Last year, the FDA issued draft guidance on how the industry could increase diversity in clinical trials through trial design, adjusting eligibility criteria and improving enrollment practices.
Technology Creating A Tipping Point For Trials
One of the main reasons participation in clinical trials has come such a long way is because of the prevalence of technology to measure and capture health-related data. According to IBM, the average person is likely to generate approximately 1 million gigabytes of health-related data in their lifetime.
While not a direct driver of this vast amount of information, the impact of wearables on the global health care industry cannot be understated. This year, approximately 460 wearables studies are underway, and 70% of clinical trials are expected to incorporate sensors by 2025. For patients with chronic conditions such as diabetes, high blood pressure and obesity, making the decision to invest in a wearable device is now often the first step in taking an active role in their health, which has clear benefits and can have an immediate impact.
This boom in wearable health tech has coincided with the rise in remote trial participation. The commonality of smartphones and tablets has made these devices legitimate and accepted sources to collect reliable clinical data remotely, without a clinic and without supervision. Many trials can now be conducted entirely on a virtual basis.
Social media is also making a difference by providing a new gateway for connecting with larger and hard-to-reach population groups about research opportunities. These platforms not only allow improved communication between researchers and patient groups but also act as virtual support networks that can help encourage others to partake in trials. This is important, as patient recruitment is one of the most challenging issues for researchers.
More recently, the global fight against the COVID-19 pandemic has heightened public awareness and understanding of clinical trials and drug development, and the importance of getting involved. The world has grasped the “we’re in this together” mantra, and thousands of people have signed up for antibody testing and analysis as we look to obtain long-term assurances over vaccination and prevention.
Diversity: Key To The World’s Health
When it comes to our health, diversity matters, and while much is being done to ensure it has a rightful consideration at the forefront of drug development, more needs to be done. Technology is helping to drive better research and development of treatments and ensuring that historically excluded communities are given the same access to medical advancements and progress.