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Resources to Support and Promote DE+I in Clinical Trials

Considering diversity, equity, and inclusion (DE+I) in clinical trials design and delivery allows investigators to more accurately detect a disease, identify potential treatment methods, and understand their impact on affected populations. Below, we outline DE+I in clinical trials and resources available to support and promote DE+I training, patient recruitment, and financial assistance.

As clinical trial sponsors and coordinators strive for more inclusive and representative studies, there are a number of educational and financial resources available that can help ensure a trial is accessible for all patients. Government legislation, academic institutions, and non-profit partnerships can give investigators the tools to build a diverse trial and create an inclusive environment for participants.

These organizations provide an opportunity for trial coordinators to learn more about equitable trial design, encourage patient recruitment, and financially support enrolled participants.

DE+I Training for Clinical Trial Design

Many studies have found that diversity and inclusion are necessary for accurate clinical trials, but how is a diverse clinical trial designed? These external organizations have multiple opportunities to learn about the population impacted by disease and how to accurately represent them in a study.

Training and seminars for designing equitable clinical trials are offered by academic institutions in partnership with the Food and Drug Administration. For example, the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT) has conducted multiple virtual training sessions for investigators to learn best practices for building an inclusive study. Many of these seminars are also a great opportunity to earn Continuing Medical Education (CME) credits for those volunteering their time and efforts.

Healthcare professional associations can also assist in educating clinical trial coordinators and stakeholders about DE+I efforts. Organizations like the American Association of Medical Society Executives (AAMSE) host workshops and learning series for investigators to learn about diversity and inclusion.

Patient Recruitment with Patient Advocacy Organizations

As clinical trial coordinators seek patients who have not been included in past studies, a third-party organization can function as the bridge between patients and doctors. Patient Advocacy Organizations have direct contact with the patient and their family, which provides helpful insight into the patient experience. While logistical factors like financial burden can impact diverse participation in studies, it’s also important to understand and address a patient’s potential distrust in clinical trials.

Clinical trial organization Medable’s Patient Advocacy Council highlights the importance of building patients’ trust in healthcare professionals – as underrepresented patient populations have experienced “years of perceived exploitation by the healthcare industry.”

Advocacy groups serve as patient allies, connecting patients with resources and information to illustrate the credibility of a trial and its benefits. These organizations create educational materials for patients and help patients discuss a trial with their healthcare professionals.

Financial Assistance for Clinical Trials Participants

Socioeconomic disparities between potential clinical trial participants can negatively impact the inclusivity of the study. Multiple nonprofit organizations and cancer foundations and societies have established resources and programs to financially support patients enrolled in a trial, giving sponsors and investigators the opportunity to include a wider pool of participants in their study.

As clinical trials are more accessible to all patients, investigators can run more inclusive studies. Cancer foundations like Lazarex, for example, can provide financial assistance and advocacy support for patients. Its Lazarex Care program reimburses the cost of clinical trials for participants, such as the gas expenses for a family to drive their child to trial locations.

The Leukemia and Lymphoma Society (LLS) stated that multiple studies have found over 50% of cancer patients don’t have access to a local clinical trial. In addition, patients often have to pay significant costs for routine medical care during the trial. LLS supports legislation that requires all private health insurance and Medicaid to cover the full cost of patient care while enrolled in a trial, which is a significant initiative to create greater access to clinical trials for all participants who may otherwise not consider that option due to financial concerns.

The Future of Clinical Trial Design and Delivery

We have continued to see greater focus on inclusive clinical trial design and delivery in recent years; however, there is still significant work to be done. In 2020, the FDA reported that 75% of all clinical trial participants for the COVID-19 vaccine were white. While just one example of the representational imbalance, the historical lack of diversity in clinical trials has continued to contribute to health disparities globally, impeding the quality of healthcare decision-making and the development of effective treatments for all.

The goal of DE+I in clinical trials is to become more patient-centric for all patients, ensuring that all patient demographics are taken into account when testing a therapeutic. Organizations that are directly connected to patients can provide insight, education, and resources for building clinical trials that are representative of all patients.

For more information on increasing diversity, equity, and inclusion in clinical trials, download our eBook. You can also learn more about our DE+I services here.

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Tags: Clinical Operations, Diversity + Inclusion