Can you guess what percentage of clinical trial participants were white in 2019?
It was nearly three-fourths.
To be exact, it was 72%.
In response to this statistic, the FDA stepped in last November to release new guidance aimed at increasing diversity in clinical trials and their populations.
Lacking Diversity in Clinical Trials
For much of the history of western medicine, the knowledge that helped inform practices, treatments, and remedies was gathered by observing only one group of people: white men.
For decades, white men were considered the “universal model” when studying anatomy and physiology. Other patients were often not taken seriously, or even mistreated due to incorrect bias.
For example, women have been historically controlled and abused through diagnoses of hysteria. There are also racist and false beliefs that Black patients have thicker skin and are therefore less influenced by pain.
While steps have been made in recent years to correct these damaging imbalances in the healthcare and life sciences fields, the effects of these biases remain today.
In order to create a more balanced system for all patients, inclusivity needs to be made a priority. If we don’t study the full breadth of human physiology, how can we know how to properly treat everyone?
The new guidance document from the FDA has a variety of important suggestions. It’s a step forward to dismantling inequality, and we’ve broken it down for you.
Who Would This Study Help Most?
The most obvious way to make clinical drug trials more inclusive is to make sure a wide variety of people are invited to participate. For most medication trials, observing women, as well as men, is crucial to detecting differences in drug reactions based on sex.
Likewise, by including participants of many races and ethnicities, studies are better able to detect varying responses to medications. These responses could depend on intrinsic factors, including genetics and metabolism, or extrinsic factors, such as a person’s diet and environment.
However, not all people will be a good fit for every clinical trial. The balance lies in ensuring participants accurately reflect the patient population who will use and benefit from the drug, while also taking care to set sensible participant criteria.
For example, a drug that could have adverse effects on patients with liver problems should have criteria that limits the participant pool to those without a serious liver condition. These criteria can be modified during later stages of the trial, so as to glean information on the benefit-risk profile of the drug, while avoiding unnecessary limits that could exclude participants.
Without these important considerations of who is appropriate and clinically relevant for trial participation, the safety information learned could be insufficient and could lead to drug mislabeling or ineffectiveness.
Planning Ahead for Change
In order to take all of the necessary factors for inclusion into consideration, a clinical trial needs an adaptive design and advanced planning. Early steps such as characterizing the drug metabolism across different groups can help the trial avoid excluding appropriate participants and prepare for dose adjustments from the start.
Each clinical trial may require different considerations. For some, developing a pediatric program could be beneficial. For others involving rare diseases, which can be difficult to study due to a limited patient pool or travel limitations, consulting patients with the disease and experts on how to design the trial can be the deciding factor that leads to a successful study.
As a trial continues and more data on the drug becomes available, the best way to establish inclusivity is by being ready to change study design and criteria. This could mean starting with a limited population if there are safety concerns and then broadening eligibility in later stages. It could also mean using enrichment strategies to demonstrate the effect of the drug on certain populations.
Ensuring Accessibility For All
One of the most effective ways to bring inclusion and diversity in clinical trials is to ensure accessibility for participants every step of the way. Start by hosting patient recruitment events in trusted public locations, including community centers or cultural event venues. Include evening and weekend hours as well as online options to help make wider contact with diverse populations.
For many people, financial costs are a factor prohibiting them from participating in a trial that requires multiple site visits. Discussing reimbursement options for travel expenses or other costs incurred (childcare, missing work, etc.) can help bring in patients who might otherwise be excluded.
The geographic location of clinical test sites can also be either a help or a hindrance. Steps should be taken to ensure sites are easily accessible to all. This is essential, particularly for locations with high indigenous populations and rural areas with limited public transportation and internet access, where accessible medical care can already be severely lacking.
Once the participants are on site, it is important to have trained staff to provide assistance in various forms. For instance, some patients may have cognitive disabilities. Others may require interpreters or translated documents, and some may require the accompaniment of a caregiver. Having cultural competency and proficiency training for staff members and equipping site locations with multiple communication options widens the spectrum of people able to participate and benefit from a study and, in turn, the drug itself.
In order to build a trusting relationship between clinical research staff and participants, information needs to be shared so participants feel knowledgeable and comfortable. Collaborating with patient advocacy groups or medical associations can help educate participants about a trial and encourage participant retention.
How Can You Get Involved?
At G3 Life Sciences, we understand that inclusivity is the best way forward—for the health of all people around the world, and for the continuous improvement of medical and pharmaceutical knowledge. From translations of clinical trial documents to remote and in-person interpreters and market research solutions, we want to bring diversity to the life sciences field and opportunities for communication to as many people as possible.
To find out more about how we can help you with your clinical trial, contact us here.