The benefits of diversity and inclusion (D&I) for businesses are well known. Numerous studies provide evidence of the positive impact on staff morale, recruitment and retention, innovation and bottom line performance. But in the pharmaceutical industry, one area continues to suffer from a lack of diversity and inclusion – clinical trials.
This lack of diversity (in terms of race, ethnicity, gender, age, genetics, social determinants of health or other types of diversity) is not new – minority groups are significantly and routinely under-represented in clinical trials. But health equity concerns and regulatory pressure are making it an increasingly urgent issue for pharmaceutical companies.
The case for diversity
It is well acknowledged that some diseases affect different racial and ethnic populations disproportionately. For example, Hispanic women are 40% more likely to be diagnosed with cervical cancer (and 20% more likely to die from it) than non-Hispanic white women, while black men are 15% more likely to develop lung cancer than white men.
However, these differences are often not well reflected in many clinical trials, because they don’t include all the populations most likely to use the drug. For example, according to the American Cancer Society black men have a 76% higher incidence rate and 120% higher death rate from prostate cancer than white men. However, a study of clinical trials for prostate cancer revealed that more than 96% of trial participants were white.1
This under-representation means trial results may not translate well into real-world situations. It also raises risks for drug safety and effectiveness, because we simply don’t have sufficient data about the effects on different populations.
In fact, 20% of new drugs approved by the FDA in a five year period (2008-2013) were found to have different effects across racial and ethnic groups. For example, the blood thinner Plavix was found to be less effective at preventing blood clots in black patients with stents, because these patients metabolize cytochrome P450 (CYP) enzymes differently.2
Patient advocacy groups, politicians and health professionals are increasingly vocal about the need for greater diversity in clinical trials as a key factor in improving health equity. Regulators are also increasing the pressure on pharmaceutical companies to raise their game in this area.
In fact, 20% of new drugs approved by the FDA in a five year period (2008-2013) were found to have different effects across racial and ethnic groups.
The FDA has long advocated for the enrolment of more diverse populations in clinical trials and has issued a number of guidances and action plans on the topic. In November 2020, the FDA issued specific guidelines for industry on enhancing diversity in clinical trial populations.
Meanwhile, the European Union introduced a new Clinical Trial Regulation in January 2022 which includes guidance that ‘the subjects participating in a clinical trial should represent the population groups that are likely to use the product.’
The industry recognizes the need to respond – for example, in 2020 the PhRMA (Pharmaceutical Research and Manufacturers of America®) published the first industry-wide principles for clinical trial diversity. However, turning these principles and guidelines into tangible outcomes continues to be a challenge.
While these barriers are significant, they can and are being addressed.
For example, many companies have taken steps to address financial barriers by compensating trial participants for the time and expenses involved in taking part. Time, travel and other logistical constraints are being mitigated by increased use of virtual trials, reduced need for study visits, and trial design which provides greater flexibility for participants. Efforts are also being made to broaden enrolment where appropriate, for example by targeting and building engagement with certain populations.
But despite these efforts, and a genuine commitment from pharmaceutical companies, there continues to be a significant gap between the goal of greater diversity and inclusion and the reality. Data from the 2018 FDA Drug Trial Snapshots shows that:
- Caucasians make up 67% of the US population but 83% of clinical trial participants
- Black/African Americans make up 13.4% of the US population but only 5% of clinical trial participants
- People of Hispanic or Latino origin make up 18.1% of the US population but less than 1% of clinical trial participants
People of Hispanic or Latino origin make up 18.1% of the US population but less than 1% of clinical trial participants
Barriers to diversity
Despite increasing recognition of the need for greater diversity, numerous barriers to achieving it remain, including:
- Lack of awareness or understanding of clinical trials amongst under-represented populations
- Time constraints – especially when participants need to travel to trial locations
- Financial constraints – for example, lower income groups may be less able to take time off work to participate in clinical trials or have access to electronic devices needed to take part
- Language constraints – for example, people who are less proficient in English may be unwilling to take part because of perceived difficulties understanding trial instructions (the shift to remote / virtual trials in the wake of the Covid pandemic has exacerbated this)
- Investigator bias – despite their best intentions, investigators may make unconscious assumptions that influence their selection of participants
- Cultural factors – for example, in some cultures high emphasis is placed on involving wider family members in medical decisions, which may deter potential participants
- Mistrust of clinical trials among some populations is another major factor. There are numerous examples of historical injustices in the name of clinical research. For example, in the 1950’s cancerous cells were taken from Henrietta Lacks, a black woman, and used for medical research without her consent. After her death, her name and medical records were shared publicly without consent from her family. In another study of untreated syphilis in 400 black men in Tuskegee, Alabama, participants received ineffective treatments, leading to death and severe health consequences. Even after penicillin became widely recognised as a safe and effective treatment for the disease, it was not offered to study participants.
Breaking through the barriers – an integrated approach
Given all the effort and good intentions, why does this lack of diversity persist? We believe a major reason is that diversity and inclusion initiatives are typically undertaken in isolation, or in a piecemeal fashion.
The design and execution of clinical trials involves many different organizations, including sponsors, trial sites, investigators, contract research organizations and multiple functions within these organizations. All of these people and groups have different perspectives on diversity, different levels of understanding and awareness, and different business practices for ensuring diversity and inclusion in clinical trials. The result is a lack of clarity, loss of focus on the overall goal, and a disjointed approach that dilutes the effectiveness of initiatives.
In our experience, success requires an integrated, end-to-end approach, from asset strategy through to trial design, execution, and close-out. Rather than looking at different issues and barriers in isolation, it’s critical to ensure everyone involved in the clinical trial process understands the importance of diversity and inclusion, and their role in achieving it.
A three step approach
The first step is to set a clear direction by defining a set of broad principles outlining why diversity and inclusion in clinical trials is important, and how the organization intends to enhance it. For example, these may include:
- Building partnerships with a wide range of communities and stakeholders to raise awareness of clinical trials and the importance of diversity
- Ensuring that trials have specific diversity and inclusion targets and metrics
- A commitment to addressing common barriers to participation amongst different populations
- Increasing diversity amongst the clinical trial staff
The second step is to formalize and embed those principles throughout the clinical trial process. This is done by defining specific diversity and inclusion goals, deliverables and milestones at each stage.
For example, the diagram below shows potential diversity and inclusion (D&I) objectives at each step in a typical clinical trial process:
The last step is helping those involved to translate these high-level objectives into tangible outcomes. For most people, this will require both a change in mindset and some new skills.
Diversity and Inclusion in Clinical Trials Playbook
In our experience, enabling your people to implement the changes needed is best achieved by developing a comprehensive D&I in Clinical Trials playbook, along with a set of supporting resources including analyses, best practices, templates, tools, subject matter experts and training.
The playbook needs to be detailed enough to guide participants at each stage of the process. For example, in the clinical trial process above one of the deliverables in the Protocol Development and Planning stage is a Patient Recruitment & Retention (PR&R) strategy. Here is an example of the kind of guidance a playbook may provide for this activity:
D&I in Clinical Trials Playbook
OBJECTIVE: Enable trial sites to achieve D&I recruitment targets
- Consider issues around access, awareness and education for target groups
- Develop recommendations for recruitment including:
- Communication and outreach with target groups
- Identification and engagement with key stakeholders (e.g. community leaders, patient and advocacy groups, health professionals etc.
- Identify potential retention pain points for target groups and identify ways to mitigate these (e.g. use of / access to technology, reducing visit burden, addressing language barriers through translation of materials, etc.)
DELIVERABLE: PR&R Strategy Recommendations for review and approval
KEY PEOPLE: Key people involved and their roles and responsibilities
Making it happen
Like any change to existing ways of working, building a diversity and inclusion culture into your clinical trial process will take time. In our experience there are some critical success factors which will increase your chance of success:
1. Create a big picture that clearly communicates what you’re trying to achieve and why, and the key principles that will guide you on the journey.
2. Enable your people – develop a comprehensive playbook and provide the resources (training, tools, etc.) they need to succeed .
3. Appoint a Clinical Trial Diversity & Inclusion Champion with deep experience in end-to-end clinical development and crucially, the organizational ‘clout’ to drive change.
4. Depending on the size of your company, support the D&I Champion with a small specialist team who can work alongside and provide guidance to clinical development staff and investigators in each trial.
5. Carefully plan and follow up on diversity and inclusion touchpoints. As part of this, track diversity and inclusion KPIs and communicate them consistently to all stakeholders throughout the trial process.
There’s no doubt that enhancing clinical trial diversity is an increasingly important health equity and business issue, and one that pharmaceutical companies are committed to addressing. Taking a systematic, end-to-end approach is key to building diversity and inclusion principles into the clinical trial process - and making them simply ‘business as usual’.
For more about how Genioo can help you enhance diversity and inclusion in clinical trials, contact Sharad Rastogi
A Healthy Approach to Drive Diversity and Inclusion in Clinical Trials
How we helped a leading pharma develop a comprehensive D&I in clinical trials operational playbookRead case study
1 Rencsok EM, Bazzi LA, McKay RR, et al. Diversity of enrollment in prostate cancer clinical trials: current status and future directions. Cancer Epidemiol Biomarkers Prev. 2020;29(7):1374–1380.
2 Clinical Research Pathways: Diversity in clinical trials