07 Jan 2025
Why Inclusive Clinical Research Matters
Author:
Sasha TyndaleDirector, Diversity and Patient InclusionAbbVie
Imagine a world where medical treatments are tested on and work effectively for all populations, not just a select few. Where diverse populations are appropriately represented in clinical trials and where scientific excellence meets health equity. That’s what we strive for at AbbVie. As a leading global biopharmaceutical company, we are working to ensure that all clinical research programs are inclusive, and representative of
the people affected by the disease area being studied.
Whether it’s a transformational therapy or even cure for cancer, Parkinson’s or mental health conditions, our ambitions are bold and courageous and backed by a robust clinical approach.
We are committed to continuously reviewing and critiquing the very foundations of the ways we work so that our clinical research programs can stand up and elevate healthcare for all.
We aim to take into account both differences and similarities in an individuals’ genetics, demographics, environmental, and social factors to ensure that the outcomes of our programs are appropriately representative.
the people affected by the disease area being studied.
Whether it’s a transformational therapy or even cure for cancer, Parkinson’s or mental health conditions, our ambitions are bold and courageous and backed by a robust clinical approach.
Elevating healthcare for all
We are committed to continuously reviewing and critiquing the very foundations of the ways we work so that our clinical research programs can stand up and elevate healthcare for all.
We aim to take into account both differences and similarities in an individuals’ genetics, demographics, environmental, and social factors to ensure that the outcomes of our programs are appropriately representative.
We are intentional in our efforts, focused on all we can do to minimize health disparities and ensure new medicines are universally effective.
Research that involves people like me
We also understand that there can be unintentional barriers preventing participation in a clinical study. Whether you are a patient or a health care provider looking to move into the research space, it helps to see yourself reflected in the ways you might participate. That’s why we set up ADMIRE – a program focused on Advancing Diversity Matters through Inclusive Representation and Equity. This initiative seeks to:
- Engage patients to destigmatize clinical research
- Create a pathway for the next generation of AbbVie researchers
- Support not-for-profit community and advocacy group initiatives designed to
drive clinical trial diversity and inclusion
Training, mentorship, advocacy and support are at the heart of ADMIRE. We know we can’t do it alone: patients, investigators, clinical trial site staff all play a role in making change possible. And we believe meaningful change comes when experiences are heard.
Real world expectations
The paperwork involved in a study, known as a protocol, can be laborious and difficult to interpret and understand. We are making efforts to simplify the language used and address as many burdens as we can to optimize the experience for both patients and investigating teams involved in our studies.
The improvements to date are making our studies more flexible, patient-centered and operationally efficient. They include:
The improvements to date are making our studies more flexible, patient-centered and operationally efficient. They include:
- Reducing patient onsite visits, and where possible, adopting decentralized elements
- Updating participation inclusion and exclusion criteria to eliminate unintended barriers
- Alleviating unnecessary burdens to clinical trial participation
Partnerships with academic institutions, patient advocacy groups, and regulatory bodies are crucial in overcoming intrinsic barriers that affect enrollment and retention in a clinical research program, and we have embraced the opportunity to listen and learn in two-way dialogue, co-creating solutions that reflect the widespread perspectives of everyone involved.
Tracking progress
Attention to the inclusivity of clinical research is also driven at a government level by regulatory agencies. The FDA has rolled out draft guidance to ensure that people from all different backgrounds participate in studies. AbbVie has been an early adopter, preparing study specific action plans that track the steps taken to recruit participants from various communities, remove barriers that might prevent them from joining, and ensure the research team itself is diverse.
We provide milestone updates to the FDA, closely monitoring enrollment progress to ensure our actions set the study up for success.
We provide milestone updates to the FDA, closely monitoring enrollment progress to ensure our actions set the study up for success.
Accelerating access to the next wave of treatments
Everything we do to drive an equitable trial experience for all also pushes us another step towards identifying new indications and treatments in less time. We leverage advanced technologies and data analytics, to enhance the efficiency and inclusivity of clinical trials, using real-world data and predictive analytics to identify diverse populations for recruitment. Our innovative strategies aim to expedite the drug development process while ensuring they are representative as described further in this article: 5 Ways AbbVie Works to Deliver Medicines in Half the Time.
The Broader Impact
AbbVie’s commitment extends beyond clinical research, permeating our corporate social responsibility. By fostering an inclusive workforce culture rich in varied perspectives, we can enhance our approach to healthcare innovation. Ensuring our strategies and innovations are informed by a broad spectrum of experiences and insights.
In a world striving for equity, there can be no question that inclusive clinical research matters! We are proud that our endeavors are supporting a future where every patient can access the highest standards of care.
In a world striving for equity, there can be no question that inclusive clinical research matters! We are proud that our endeavors are supporting a future where every patient can access the highest standards of care.
You can learn more about our commitment and register your interest in being an ADMIRE advocate for change here: go.abbvie/admire.
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