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Patient Evolution in U.S. Clinical Trials

Patient Diversity in Clinical Trials

Patient enrollment for clinical trials is a complex process that involves not only patients, but physicians and trial professionals. Clinical trials strive to execute drug treatments on a sample group that is large enough to be statistically significant while also being representative of the population that the drug intends to serve. Differences in age, gender, race, and ethnicity all play a part in how effective a drug will be on an individual patient, which is why pharma companies must be diligent to include a diverse group of patients in their sample population.  But this hasn’t always been easy to do.  Join PharPoint Research as we explore who participates in clinical trials, why patient diversity is important, and what we can do to increase patient enrollment.

The History of Clinical Trial Participation

Diversity in Clinical Trial TimelineCompanies performing clinical research trials are required to follow stringent guidelines set forth by the National Institute of Health (NIH), which is the primary agency of the U.S. government responsible for biomedical and health-related research. The NIH is part of the U.S. Department of Health and Human Services and is the largest biomedical research agency in the world.

Over the years the NIH has enhanced their clinical trial policies to increase safety and patient representation in clinical research that better accounts for variations of a drug’s effects across gender, ethnic, and racial bounds. But these policies have evolved over time and have not always been in place.

For example, as late as the 1990s some researchers were hesitant to include women in clinical trials who had likelihood of becoming pregnant. The researchers feared the drugs being evaluated could lead to birth defects, so certain experimental drugs were mainly tested in men. Makes sense, but when a subset of these drugs finally made it to market there were select instances where female patients experienced unforeseen adverse events.  While not the only factor, the lack of an all-encompassing sample population was a major component that allowed these adverse events to occur.

In 2001 the NIH updated its policy on the inclusion of women and minorities as subjects in clinical research, so that “all NIH-funded clinical research will be carried out in a manner sufficient to elicit information about individuals of both sexes/genders and diverse racial and ethnic groups and, particularly in NIH-defined Phase 3 clinical trials, to examine differential effects on such groups.” These updates help to ensure that clinical trials include a more robust sample population, but this doesn’t mean it is always easy for clinical trials to recruit minorities and patients from certain backgrounds.

Obstacles for Patient Recruitment

So the question becomes “Why can it be difficult to recruit certain patients for some clinical trials?” Unfortunately, there is no one single answer, but rather a group of factors that when brought together can create a burden for patient recruitment.

One problem stems from a clinical site’s geographical location and a prospective patient’s inability to make feasible travel arrangements.  Another problem is the lack of translation resources due to budget restrictions. This leads to information only being provided in English which is a significant deterrent for non-native speakers.  However, one of the most significant indicators of participation for a clinical trial is a prospective patient’s socioeconomic status. Patients with annual household incomes below $50,000 are 32% less likely to participate in clinical trials than higher income patients. This is due to factors such as the inability to schedule time off work, travel costs, insurance co-pays, and insufficient information about clinical trials as a treatment option.

The good news is that trends are changing.  Between 2010 and 2014 the proportion of African American participants in Phase 3 clinical trials increased from 10% to 23% and as of 2016 the average participant population in all NIH clinical trials more or less matches the racial and ethnic makeup of the U.S.  To better serve the needs of our diverse population, the industry is also adopting new ways to include underrepresented communities for clinical trials through patient-centric trials, where patients play an active role in the development of the trial they participate in.

The Growth of Patient-centric Trials

The vast wealth of information available through online resources has led to modern patients who are better informed about the medicines they use. The pharma industry has reacted by experimenting withDiversity in Clinical Trials patient-centric clinical trials that include greater patient involvement in the research, development, and planning stages. Pharma’s goal in using this technique is to boost recruitment, reduce costs and ultimately, speed up a drug’s timeline to market.

So, what does “patient-centric” really mean and how can this approach be used for clinical trials?  Patient-centric trials are designed to focus on society, technology, patient lifestyles and the realization that trials can be better designed and executed if the needs of patients are more adequately addressed.

Some of the ways pharma companies are finding ways to integrate patient voices into clinical trials are through social media and engaging patients early on in the trial process.

Social Media and Wearable Sensors

The capabilities of online communication and technological monitors have made the connection between physicians and patients stronger than ever.  Social media and advocacy groups such as the Michael J. Fox Foundation and the ALS Association provide online forums for participants to share health information, and a similar approach can help clinical trial professionals collect health data from patients and increase communication with physicians. Likewise, wearable sensors provide physicians with up-to-date health information from trial participants when geographic or time constraints may be a factor in clinical trial participation. (For more information on how doctors are communicating with patients through technology, check out PharPoint’s wearable sensor blog post).

Early Engagement

Getting patients involved in the clinical trial enrollment early on is key. This goes beyond just enrolling patients, but also encouraging engagement throughout the process. Inviting patients to review draft protocols and procedural schedules gives patients better insight into the maintenance of a clinical trial and how their own health will be managed. Additionally, asking patients how and when they prefer to be involved can have a big impact on how a development team designs a trial. Educating patients on the drug development process and how the clinical trial will affect their lives gives patients a more active role in the trial and can increase enthusiasm for playing a part in extending medical research.


Innovative drug development continues to work towards more effective patient processes. Through the means of patient-centric trials, enrolled patients are more involved in the clinical process, enabling faster drug development and a more accurate sample population.  This process is only in the beginning stages, but is a step in the right direction and our team at PharPoint is excited to see where it goes.

If you are interested in participating in a clinical trial or would like to find clinical trials near and relevant to you, visit The Center for Information and Study on Clinical Research Participation.  Have you or someone you know participated in a clinical trial? Have you experienced first-hand a patient-centric trial? Tell us about it in the comments below!


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