Clinical trials are key tools in advancing the understanding of medical treatments and the efficiency of patient care. The data obtained provides invaluable insight into the required dosage and administration of a drug, the likely responses of patients, and also aids in the discovery of new methods to detect and diagnose disease.
Despite their vital importance, clinical trials are also known to historically be somewhat exclusive in terms of the diversity of participants that are studied, with a number of demographics being significantly underrepresented. Despite recognition of this in the contemporary world and the introduction of laws promoting inclusion that have followed, a lack of diversity persists. Failing to have a diverse participant sample in a clinical trial generates data that does not cater for every demographic, and is a moral issue that needs to be addressed. Having equal representation within clinical trials ensures equality within the healthcare system, and will make it capable of serving the health needs of every population group both safely and effectively.
Why diversity and inclusion matters in clinical trials
A whole host of factors from age, race, and gender, to the socioeconomic status and geographic location can significantly impact how one responds to drug treatment. The dosage of a drug and how it is administered can vary and, in some cases may not be effective at all. If a trial uses participants of similar backgrounds, the data will fail to bring to light any alterations in the dosage needed for certain groups and thus produce guidance that is less applicable to those who may be at greater risk. For example, if a trial investigating a treatment for high blood pressure excludes many people over 65 years old, who are more likely to have these conditions, the specific dosage needed for it to be effective for them will not be found. The risk-benefit ratio is therefore altered for different groups within society creating a set of clinical data that does not equally apply to them. As a result, inequality within the healthcare system persists and minority populations continue to face negative effects on their health.
Diversity within clinical trials is also beneficial to the researchers themselves. They can explore and discover how environmental and genetic factors play key roles in how individuals fight certain diseases – data which expands and widens the knowledge on disease pathophysiology and contributes to genetic profiling which can be used to help develop future drugs.
A recent example of the importance of addressing ongoing racial disparities in clinical trials was made apparent during the COVID-19 pandemic. During the vaccine trials, there was a greater push for the involvement of ethnic minority participants due to being disproportionately affected by the disease across the world. They needed to be highly represented within the trials so that the correct method of how the vaccine should be administered for it to be effective for them was found.
Another example has been seen in the importance of socioeconomic and environmental disparities in clinical trials that study drugs for treating asthma. It’s been found that those who live in urban areas where exposure to air pollution tends to be higher may have different experiences with asthma symptoms and thus a different treatment option or dosage is required.
Why there is still a lack of diversity in clinical trials?
Despite its importance, improving diversity in clinical trials is difficult. Many barriers make it extremely hard to incorporate participants from all demographics.
Research shows that these challenges are related to various factors such as:
• Differences in language and communication
• Lack of trust from past historical abuses, or relating to certain beliefs
• General lack of knowledge around clinical trials
• Economic, logistical and practical issues that prevent access to trials
• General lack of awareness and advertising of trials
How diversity can be improved in clinical trials
To overcome these multiple barriers, several methods are being encouraged and used by drug regulators and sponsors to help ensure equal participation in a clinical trial:
• Increased awareness of clinical trials
Clinical trial sponsors such as Pfizer are taking more holistic and innovative approaches to increase the awareness of research. Outreach programs are being developed where sponsors work with a variety of grassroots organisations and institutions such as schools, community centres, and faith-based organisations. Culturally and linguistically appropriate resources are provided to help educate communities about the benefits of clinical trials, address their fears and concerns and offer opportunities to participate. It’s also being made a priority to display education materials in a variety of ways such as on social media platforms to reach a wider and more varied demographic.
• Listening to patients’ concerns and offering flexibility within trials
Research groups are prioritising understanding and listening to the voices of patients before, during and after the clinical trial. Participants provide invaluable information for researchers from understanding what their barriers are, to how the trial can be made feasible for them at every stage. Physicians/doctors have a crucial role to play in this. Social determinants of a patient’s health, as well as their concerns, can be gained through doctors engaging with them and listening to how their views and opinions about research.
It’s important that research groups then act on the concerns of patients and adapt the clinical trial so that it better caters for them. For example, transport can be offered to the research facility, options for weekend or evening appointments should be offered for those who can’t afford to take time off work, and in-person visits can be reduced to virtual consultations where possible. The locations of clinical trials should also be held in places that offer access to all population groups. It’s common for sponsors to recruit patients in large medical centres where minority populations and individuals who don’t have adequate access to healthcare don’t attend. It should be ensured that the clinical trials are offered in a range of locations including areas of high ethnic minority groups to allow for the recruitment of a more diverse participant sample.
• Ensuring diversity within research teams
Participants need to see that there is diversity within the clinical trial team too. They need to be assured that the staff are well-educated and competent enough to provide support and care for patients of various social backgrounds. Having a diverse research team will demonstrate the commitment to inclusion and show that it is being considered throughout all levels and stages of the clinical trial.
In conclusion, research shows that despite some improvements in eliminating exclusion, diversity is still absent from many clinical trials. Drug sponsors, drug regulators and research teams must continue to increase awareness and incorporate ways to make the trials accessible for all. This will ensure future medical treatments are tailored and most importantly safe and effective for every single demographic across the globe.
Our Pharma Partners team are experts in life science recruitment, and specialise in pharmaceutical physicians, medical affairs, R&D, and the pharmacovigilance space. You can take a look at all our roles here,or get in touch with use for a confidential discussion.