Clinical trial diversity and Direct-to-Patient models key to better global healthcare

Jaqueline Escotero: For the most part, society expects that all drugs pharma develops should be safe and effective for the majority of the population. In this regard, the relevance of having a diverse population as part of clinical trials and drug development is critically relevant.

Thirty years ago, most clinical trial studies generally focused on patient groups in developed countries, rarely targeting developing or underdeveloped countries. Given the global expansion of pharmaceutical-based healthcare, over time this became recognized as an unsustainable strategy. A discussion started to take place between healthcare providers, patients and the greater society about how to create an agenda to change the orientation and inclusiveness of clinical trials.

Supported by global health and medical societies, the imperative to be more diverse and inclusive has become an industry-wide call, however, there is still room for improvement. It is abundantly clear representative and diverse research participation is necessary to establish fair standards of care, minimize outcome disparities between populations, and achieve and sustain social equity.

Jaqueline Escotero: Failing to acquire meaningful diversity in health research can have considerable social and ethical implications. With advanced pharmaceutical science and understanding of the human genome it has become abundantly clear that pharma must address this diversity to advance the development of safe effective drugs for all the people on the planet. Individuals and entire subgroups that are traditionally under-studied were potentially blocked from accessing potentially beneficial research.

Jaqueline Escotero: On May 13th, 2022, the FDA has posted publicly: "Clinical trials are research studies involving human volunteers to evaluate medical products like medications, vaccines, or devices for safety and effectiveness. Ensuring people from diverse backgrounds join clinical trials is key to advancing health equity. Participants in clinical trials should represent the patients that will use the medical products."

Many think this is often not the case and that people from racial and ethnic minority and other diverse groups are underrepresented in clinical research. This is a concern because people of different ages, races, and ethnicities may react differently to certain medical products.The FDA’s guidance reinforces the relevance of Clinical Trial Diversity and how important it is not to limit to the US but extend to all regions globally. A paper from the FDA “Collection of Race and Ethnicity Data in Clinical Trials” (Oct 2016), states this guidance is to articulate FDA expectations for recommendations on the use of a standardized approach for collecting and reporting race and ethnicity data in submissions for clinical trials. Regulators understand using standard terminology for age, sex, gender, race and ethnicity will help ensure that subpopulation data is collected consistently.

Jaqueline Escotero: The clinical trial landscape is continually adapting its focus on patient-centric practices to improve access and participation. Aside from designing trials to reach diverse patient populations, whether defined by race, ethnicity or location, every aspect of the interaction must be attuned to the needs of the patient, and that includes how patients access treatments or prescriptions. Of the emerging approaches, the Direct-to-Patient (DtP) approach is capable of offering invaluable support to patients.

In concept, DtP is an integrated supply chain model that enables patients to receive their clinical trial treatments in their home or workplace. DtP services by necessity are comprehensive and can include dispensing the therapeutic product, transporting it to the patient, preserving chain of custody in a temperature-controlled manner, as well as patient sample collection and unused drug/supply return.At-home clinical trial participation can succeed, and it must – because like the wave of all self-administered drugs, convenient, private access to the treatment delivers a cascade of patient- and trial-centered benefits, especially dose compliance. Ultimately, broadening access to therapeutic areas and patient populations will therefore contribute to assuring clinical trial diversity.From my personal and professional perspective, a multisector approach is needed. The effort though will require developing partnerships with organizations and health entities, and engaging patients and providers. It will also require increasing awareness and understanding, educating the public about clinical trials, and improving the coverage of clinical trials costs. Lastly, it is about sharing best practices are opportunities to continue to advance diversity inclusion in clinical trials.

The level of customization and support we offer through our operations, in and of itself, supports enhancing diversity in clinical trials. With our comprehensive flexible logistics through World Courier, AmerisourceBergen can not only effectively and efficiently reach patients in developed economies and health systems, but in remote places with limited infrastructure and healthcare resources. Our packaging solutions are engineered to go the distance. No matter where, or how far they travel our packaging systems maintain temperature and conditions perfectly to patients assure that when patients receive their treatments they remain safe and effective. Ultimately, our mission for all our customers and their patients is to assure everyone has access to the life-changing potential of investigational new drugs.