Health equity and ease of trial access

A fully stocked pharmacy can still mean empty shelves for many 

Two babies being born right now will have life expectancies that can differ by a span of decades just because of differences in their biological genders, races and ethnicities. And, one of the contributing factors to this disparity is their access to effective medicines. 

Before a new medicine is approved for use, it must go through rigorous testing – Clinical Trials – and thorough review by regulatory agencies, such as the Food and Drug Administration (FDA) and European Medicines Agency (EMA).  

Once approved, the medicine is then made available to patients, typically through pharmacies. When you walk into a pharmacy today, the shelves are usually well stocked with medicines and treatments. Without clinical trials, those well stocked shelves would be empty.  

Unfortunately, today pharmacy shelves that appear well stocked are still empty for many because of a lack of diversity in clinical trials. 

Typically, it would never occur to someone to read the detailed patient information leaflet that comes inside a box of medicine. From antihistamines for hayfever, paracetamol for headaches to more serious medications for life-threatening conditions, once the packet is in hand, the only question most people will have is the dosage. But for large groups of people, this lack of diversity during the testing process means their medicine is not tested on people like them, and their reaction – positive or negative – to it is therefore unknown. Therefore, there is no quality for them and no confidence that those medicines will work for their condition.  

According to a Tufts impact report which looked at 371 new drugs and biologics approved by the FDA between 2007 and 2017: 

• Women were 7.3% underrepresented in the clinical trials 
• Black patient participation was 65% below US census levels 
• Only 37% of these studies, spanning a decade, provided ethnicity data at all

This is important because drugs can work differently based on gender, race and ethnicity. 

One simple example is that in Black patients with heart failure, a new vasodilator proved more effective than standard ACE inhibitors and resulted in fewer adverse reactions. So, it works better for Black patients. The data suggests that Black patients exhibit a 39% risk reduction in first hospitalization for heart failure. 

The problem is that this information was not discovered during the clinical trials. It was discovered after the drug was approved and in widespread use because too few Black patients participated in the clinical trials of this drug. Knowledge of this difference during clinical trials, which is prior to drug approval,  would no doubt have saved lives. 

In another example of a drug for colorectal cancer, Japanese patients exhibit lower Cmax and area under the curve than Caucasian patients. Cmax is a value that shows the highest concentration of a drug’s absorption into the blood, cerebrospinal fluid, or target organ after a dose is given.

This means that it works differently in Japanese patients than it does for Caucasian patients. Dosing may need to be adjusted based on these differences, without which the efficacy or effectiveness of the drug in treating the disease may be affected. In short, the efficacy of the medicine is often uncertain across patient populations until we have researched and found the key adjustments needed based on differences like gender, race and ethnicity.  

The spotlight is now on solving the lack of patient diversity in clinical trials. Below are three areas of clinical trial design and delivery that clinical research professionals should strategize on  to increase diversity in clinical trials: study design, site selection and patient recruitment. 

Study Design 

The design of a study must be built around the patient, keeping them at the heart of the trial. In the past, new study protocols were often designed in a copy/paste fashion from previous ones.  

The problem with that approach is that the barriers to inclusion that exist for a potential study volunteer today, stem in part from a time where the design of a study was determined by a workforce that predominantly represented a single point of view. There was one voice in designing a study protocol – and it was not the patients. If we keep designing studies primarily based on previous ones, we create systemic room for the barriers to inclusion to thrive. 

Today, the patient, all types of patients and not just the privileged few, not just those who have traditionally had access to clinical trials, must be at the heart of a study’s design. To be inclusive of the needs of all types of patients, a study protocol must be designed by a diverse workforce and include real input from real patients – patients of all backgrounds and all walks of life. 

Site Selection  

Site selection, that is choosing the sites, like hospitals or doctor’s practices where a patient will go to participate in the trial and receive the study medication, is another challenge inherent to our industry.  The traditional industry practice is to search site databases and select sites that have previously run similar trials. This means that if trials have previously lacked diversity, they will continue to do so. This is a systemic practice that has fueled the continued lack of clinical trial diversity. 

Our industry has been risk-averse and slow to select new sites even though electronic patient records and other data sources tell us where diverse patient populations are. In 2021, Tufts – the Center for the Study of Drug Development – published findings from a survey of approximately 4,000 clinical research site staff and healthcare practitioners. In it, they articulated a strong association between staff diversity and patient diversity. They noted that staff at sites in urban settings tended to be more diverse, recruited more diverse patients, and usually have the infrastructure in place, such as standard operating procedures, to engage and enroll diverse patients. 

Some of these sites may not be as experienced, but it is still worth including and investing in them, because they are the gateway to more diverse trials. One common explanation for excluding less experienced sites is that we would be risking data quality. The reality is, however, that we are already risking data quality by not running diverse trials. In fact, lack of patient diversity is a bigger quality risk because there is no quality for those underrepresented in those clinical trials. 

Patient Recruitment  

Patient recruitment is another challenging area. It is the biggest source of delays in a clinical trial and something our customers are always looking for solutions to address. 

We must actively leverage available data, like electronic health records, to find diverse patients, and develop the correct communication strategy to fully engage and enroll patients from underrepresented groups. 

Communication designed for the same groups of patients that have always been recruited will fail to win over new groups and do nothing to remove inclusion barriers, such as a lack of trust. 

When engaging potential trial volunteers, our communication must include what is in it for them and why they should be a part of it. It must be inclusive, respect the patient perspective, and use language as well as an informed engagement strategy to remove barriers. We cannot come across as big pharma doing experiments, which is how some groups see us, and they have good reason to, based on historical abuse. 

We have a problem with recruiting sufficiently diverse patient groups but have the tools to solve this problem. We just need to remove the barriers. 

Making a difference

So study design, site selection and patient recruitment are challenging, but doable. 

As a company, we look at important topics like diversity in clinical trials and see a challenge that we have both the duty and ability to help tackle. Our focus on unlocking better evidence for our clients through our software and technology solutions is also a focus on the patient and enabling ease of trial access.  

Clario’s track record of investing early in cutting-edge technology remains one of its most strategic advantages, and it is one that pays off for both our clients looking to run better clinical trials and patients who need new and effective medicines.  

For example, since 2007, we have been offering technology that allows patients to participate in clinical trials remotely or outside the traditional clinic environment. Having such solid infrastructure in place allowed us to quickly pivot during the pandemic and allow our clients to continue hundreds of clinical trials without the need for traditional visits to a hospital or doctor’s office. We are stewards of health equity and our work in simplifying access to clinical trials will serve to reduce the life expectancy gap that these two babies have inherited – because medicines are a key gateway to achieving health equity.