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Why Trust, Diversity, and Equity in Clinical Trials is Importance?

Clinical trials test the safety and efficacy of treatment options in drug therapies, medical devices, and therapeutics for patients and establish new standards of care. Much like the healthcare industry, biopharmaceutical and life sciences companies have lacked in efforts to incorporate diversity and inclusion in trial investigators, sites, and participants.

Why Trust, Diversity, and Equity in Clinical Trials is Importance?

Read this article to learn how data intelligence and analytical insights based on clinical expertise and diversity focus are changing the way companies optimize drug development from trial success to commercial launch.

Content Summary

It Starts with Inclusion
Prioritizing vulnerable populations by design
Streamlining clinical research, drug development
Building trust in underserved communities
How social determinants of health impact clinical trials
The power of trust and inclusivity
Conclusion

Clinical trials test the safety and efficacy of treatment options in drug therapies, medical devices, and therapeutics for patients and establish new standards of care. Ultimately, clinical trials drive progress forward and provide patients with early access to new treatments that lead to better health equity, access to care, and outcomes. If the latter is to be true, then it’s paramount that the patient segments and investigators represented in the clinical trial process be as diverse and inclusive as possible.

Clinical trial diversity should be at the core of medical advancement and healthcare innovation; however, that isn’t always the case and certainly hasn’t been for a long time. Clinical trials for a new drug or therapy need to accurately represent the population impacted by the illnesses to provide significant benefits and improve the quality of life of diverse populations.

It Starts with Inclusion

Inclusion is the precursor to building trust between patients and doctors and the bridge leading to a more equitable healthcare system for all. Clinical operations and feasibility teams have begun to shift their approach to ensure trials are run by a more diverse group of researchers.

Both the public and private sectors have initiated efforts to address clinical trial diversity. The Food and Drug Administration (FDA) has issued guidance to encourage diversity from the design to execution of clinical product development. Meanwhile, the Pharmaceutical Research and Manufacturers of America (PhRMA) announced the release of industry-wide principles on clinical trial diversity.

Despite these relatively recent efforts, racial and ethnic diversity in clinical trials is lacking. According to a 2021 study, less than 2% of trials over a two-year period had a minority group as its primary focus. In 2020, among 32,000 clinical trial participants, the FDA found that 75% identified as White, and only 6%, 8%, and 11% identified as Asian, Black, or Hispanic, respectively. Even the federal agency’s own efforts to improve clinical trial diversity for Black patients resulted in failure, with a five-year action plan still leading to Black individuals being underrepresented in 85% of all trials and disease categories.

Less than 2% of trials over a two-year period had a minority group as its primary focus.

  • 6% Asian
  • 11% Hispanic
  • 8% Black or African American
  • 75% White

Less than 2% of trials over a two-year period had a minority group as its primary focus.

Prioritizing vulnerable populations by design

The first step involves addressing the overall scientific development of drugs.

“We need to focus on how we can ensure more lifesaving drugs come to market and at the same time increase access and availability to the trials themselves,” says H1 Co-founder and CEO Ariel Katz.

Biopharmaceutical companies must test drugs in different patient populations and communities to ensure that the people receiving the approved drugs are appropriately represented during all stages of clinical development.

Differences in people can often lead to different responses to the same medication. Age, genetics, gender, weight, ethnic origin, and geographic location may play a role in treatment safety and efficacy.

Streamlining clinical research, drug development

The second piece in addressing clinical trial diversity centers on the clinical trials themselves. Suppose a new drug comes to market in the US and other regions globally. Numerous regulatory agencies require the drug to be proven safe for the patient populations receiving the drug in their specific niche.

“In order to look at the clinical effectiveness for a drug or therapy, we have to start with engaging the right researchers and healthcare providers and for the patients, consider health literacy, patient education material about the drug benefits, trial availability and the long-term output and outcomes of the drug or therapy,” notes Katz.

There is a notably high benefit of initially conducting a clinical trial in a diverse patient population: Companies are no longer responsible for initiating additional trials to prove that the drug is also safe and effective in other regions.

“The benefit here is getting the drug to market in a more efficient and cost-saving manner so it can be available sooner and to more people. We saw this to be true with the COVID-19 vaccine,” says Katz.

Building trust in underserved communities

The third angle is a matter of perception, namely a lingering negative perception of the biopharmaceutical industry as a whole.

Nearly half (49%) of Black Americans said they would not get a COVID-19 vaccine, according to a 2020 Kaiser Family Foundation (KFF) report. Patients cited safety concerns (39%) and distrust (35%) as the top reasons. But a majority of Black adults (61%) had little to no confidence that the vaccine development process took the needs of Black people into account, with two-thirds (66%) not confident that vaccines would be distributed fairly.

“Trust plays a big role in new therapies launching successfully. As health literacy improves, more patient populations demand proof that medications have been tested in the patient populations they feel most comfortable with and with providers they trust,” Katz explains. “Trust also impacts the longevity of the drug and its ability to reduce the long-term impact of the disease on communities.”

Additionally, companies that focus on good general practices and ensure that minority groups are included in trials are more likely to reposition themselves as partners in care rather than impediments or antagonists, which can help with the increasing focus on access to and equity in care.

How social determinants of health impact clinical trials

The pandemic shined a bright light on long known and rarely recognized health disparities. As a result, social determinants of health (SDOH) have not only entered the healthcare lexicon but have also become a key priority for providers, payers, and biopharmaceutical companies to address to advance health equity.

SDOH are the conditions in which people live, learn, work, and play, which affect health access, outcomes, and overall quality of life. Collectively, they contribute significantly “to the social patterning of health, disease, and illness,” according to the Centers for Disease Control & Prevention (CDC).

Nearly half (49%) of Black Americans said they would not get a COVID-19 vaccine.

Confidence in Vaccine Development Process Taking the Need of Black People into Account, and Confidence that Vaccines Would be Distributed Fairly

A key determinant of a successful clinical study is efficiently recruiting and retaining an adequate number of the study population. However, the average enrollment efficiency is currently less than 40% for Phase 3 and 4 clinical trials. Globally, experts agree that more than 80% of trials fail to enroll on time.

Average enrollment efficiency is currently less than 40% for Phase 3 and 4 clinical trials. Globally, experts agree that more than 80% of trials fail to enroll on time.

An attending physician’s lack of encouragement or support represents one of the most significant barriers in clinical trial recruitment. Many physicians are unaware of clinical trials that could benefit their patients. Therefore, biopharmaceutical companies must work with diverse and bilingual healthcare providers who have a better chance of connecting with underrepresented patients. Taking these approaches creates a bond and a trusted patient-provider relationship.

“We need to stop thinking about it from a lecturing perspective and start thinking about it much more like a trusted conversation,” Katz says.

Katz emphasizes that this approach makes patients feel like it’s not a doctor telling them they’re not taking care of their health. Instead, the focus is on understanding the individual concerns of patients by supporting their hesitancy with disease treatments.

A patient’s social life or family situation can often become a roadblock to clinical trial participation, Katz adds. For example, a single mother may find it challenging to participate in a clinical trial due to the inability to go to trial sites for treatments. Therefore, biopharmaceutical companies are working to make clinical trials more accessible by allowing patients to complete certain steps from the comfort of their homes or at a nearby pharmacy. “Companies are thinking about what is important for the patient outside of the hospital walls,” Katz notes.

During the pandemic, virtual care and connected health have helped expand access to care, mitigate disease exposure for staff and patients, preserve scarce supplies of personal protective equipment, and reduce patient demand on facilities.

Biopharmaceutical companies are now looking into financial lifts, Katz says. If patients participate in clinical trials that require a significant time off of work, study participants may receive financial compensation for their volunteered time.

“By making a trial accessible, we can ensure that a patient is not going to drop out and can be adherent to benefit from the therapy,” Katz explains. “If companies send nurses to patient homes to give them specific treatments, it increases the likelihood of participation, success, and potentially good outcomes.”

Generally, these decisions come down to eliminating barriers to accessing clinical trials that jeopardize the viability of these studies.

“The ultimate goal in increasing diversity and inclusion is that getting access to that specific treatment is going to benefit patient health, and their specific needs. At the end of the day, that’s what it’s all about; creating more effective, accessible, and affordable drugs to serve patients,” Katz stresses.

The power of trust and inclusivity

Trust and transparency are crucial to the future of clinical trials, especially those involving underrepresented groups. Communication through trusted channels ensures that patients understand the value of their participation in clinical trials. And as it stands, the most trusted channel remains to be doctors who serve and are a part of these very communities.

Embedding health literacy into clinical trials from the beginning of the process can improve recruitment and retention. Well-established research shows that more than 72% of Americans would participate in a clinical trial if recommended by their doctor. However, only 22% said a doctor or other healthcare professional has talked to them about medical research.

“There are a couple of problems when it comes to clinical trial communication, and they begin with awareness,” Katz reveals. “How can you make sure that more people are made aware of a disease without utilizing complicated language? You need strategies that meet the patients where they are, with technology they have access to and from doctors they trust in a straightforward communication that highlights the long-term benefits to them and their communities,” he states.

Providers with established patient relationships can educate the latter about the benefits of a specific treatment or trial and explain these reasons in an understandable and approachable way.

In addition to providers, community pharmacists can be leaned on as trusted members of the healthcare industry and the community. Recent research conducted by the Columbia University Mailman School of Public Health and Express Scripts Pharmacy found that U.S. pharmacists are highly trusted by patients and projected to play an increasingly crucial role in healthcare management. Pharmacists in ambulatory clinics, health systems, and home delivery pharmacies are at the forefront of this trend.

About 80% of patients stated that they see pharmacists as an integral part of their healthcare system.

Conclusion

Clearly, a new approach is needed to increase clinical trial diversity. This approach hinges on the trusted relationship of providers with hard-to-reach communities. Only in this way can biopharmaceutical companies advance health equity and global value. Inclusivity enables vulnerable and at-risk populations to participate in and benefit from effective and safe drug developments. To shift this paradigm, biopharmaceutical companies must establish trust within target communities and ensure that patients understand the clinical value of their participation. Successfully doing so will depend heavily on partnerships with important members of the clinical trial ecosystem like healthcare providers who care for underserved individuals, communities, and populations. These devoted providers serve as linchpins to build and maintain mutually beneficial relationships between researchers and participants.

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