Innovation
Clinical trials
Clinical trials and research are a critical part of bringing new medicines to patients. They afford patients an opportunity of hope, irrespective of socioeconomic status or geographical region. Through the data generated from clinical trials, we answer important scientific questions and gain a better understanding about the efficacy and safety of these study medicines and their potential as treatment options for patients. With the complexity and length of clinical trials, we design and launch programs to determine safety and efficacy and meet health authority expectations for a new product or new indication applications.
Ethics and integrity
Our clinical trials are highly governed externally by health organizations around the world. Our internal processes manage governance and risk and involve oversight from Clinical, Compliance, Quality and our Executive Leadership Team where the BMS Board Chair and CEO has responsibility for portfolio execution. Clinical trial programs are managed through our Commercialization and Development Operating Committee (CDOC), Research and Early Development Operating Committee (REDOC) and Portfolio Strategy and Governance Committee (PSGC), the same committees responsible for the development of our Access and Pricing strategies.
We remain committed to sponsoring clinical research that fully complies with all legal and regulatory requirements. We are committed to the principles set forth in internationally recognized standards like the Declaration of Helsinki and the Guideline for Good Clinical Practice of the International Conference on Harmonization (ICH). We also participate in patient advocacy and partnerships in pursuit of our goal to increase effective, ethical and safe trials.
One global development organization
The BMS Global Development Operations team (GDO) resides within Global Drug Development and supports clinical work across the organization, including Research and Early Development, as well as Medical, which is part of Commercialization. GDO also supports clinical trials around the world (>40 countries), covering all programs and all therapeutic areas from First in Human through to Early Access phases. With the acquisition of Celgene and MyoKardia, we evolved the team to lift a new single operating model across our diverse portfolio. The GDO team leveraged the BMS Oncology operating model to align the entire clinical trial operation, focusing on 80% internal and 20% external resources. This model is further supported across the organization by our Global Procurement (GP) Business Insights and Analytics (BI&A), Quality, Finance and Operational Excellence teams.
“Ensuring that clinical trials work for everyone equally not only is critical to the health of patients, but to the health of the healthcare system. It will take all of us working together—right down
to the office visit—to make that
a reality.”
Global Development Operations
Clinical trials during COVID-19
With the outbreak of COVID-19 in the first quarter of 2020, BMS established guidelines and principles for our own decisions and actions. In order to protect the safety of study participants, our employees and staff at clinical trial sites, and ensure regulatory compliance and scientific integrity of clinical trial data, the following decisions were taken regarding the conduct of clinical trials:
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For ongoing studies (i.e., those that have passed First Patient First Visit):
- Existing sites could continue to recruit new patients when appropriate.
- No new sites were to be activated until provided notice.
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For new studies (i.e., those that have not yet passed First Patient First Visit):
- No new sites were initiated nor activated until provided notice.
Clinical studies began to recover during July 2020 following completion of reassessments to commence operations and the opening of additional sites. Patient enrollment for certain new clinical studies and ongoing studies at new sites are carefully being started as the safety of study participants, our employees and staff at clinical trial sites, regulatory compliance and scientific integrity of trial data can be assured. In the third quarter of 2020, global clinical studies continued to recover, driven in large part by decreased COVID-19 incidence, clinical trial sites beginning to permit on-site visits and greater remote access to electronic medical records at sites in the U.S.
Many studies are now underway following the completion of feasibility assessments, rigorous planning, and selected protocol simplifications. We are working with health authorities and investigators to protect our trial participants and personnel at BMS and our clinical trial sites, while continuing to ensure regulatory compliance and the integrity of our science. We have provided clinical trial investigators with overarching principles and guidance regarding the conduct of our clinical trials worldwide in light of COVID-19 and are taking into account guidance from health authorities, where applicable.
Our experience during COVID-19 led to the development of efficiencies in our clinical trials. Remote check-in options for patients via telemedicine streamlined trials while adding significant convenience for trial participants. We commenced facilitating direct-to-patient shipping for some medications. These changes, while disruptive at first, are helping to accelerate our clinical trial diversity efforts, and to become better able to accept clinical trial applicants from a broader patient base, making geography less of a barrier than it was before the pandemic.
Diversifying trials
Diversifying patient trials is a challenge that has a lot to do with national healthcare policies and networks. While we are committed to improving our clinical trial patient participation, we know that some barriers remain beyond our control. We firmly believe that a focus on diversity in discovery leads to better science—because researchers are better able to understand the varied effects of a therapy across populations and demographics. Better science in turn leads to safer and more appropriate medical practice and care, creating a more inclusive, equitable health system for everyone.
Growing the Immuno-Oncology community
Building a support system of friends, peers and advocates is important in the fight against cancer. No one can do it alone. Take a look at how Bristol Myers Squibb is investing in research, awareness building and advocacy in Immuno-Oncology.
Diversity in clinical trials
It is well documented that there is significant need for greater diversity in clinical research. Currently in the U.S., whites make up 67% of the population, but 83% of research participants. Conversely, Black/African Americans comprise 13.4% of the U.S. population, but only 5% of trial participants, and Hispanic/Latinos represent 18.1% of the U.S. population, but less than 1% of trial participants. While these statistics illustrate the situation in the U.S., the need for increased diversity in clinical trials is global.
Bristol Myers Squibb understands that increasing the diverse patient participation in clinical trials accelerates innovation and development of transformative medicines to all patients. Improving racial and ethnic diversity in clinical trials helps ensure that the data collected will provide scientific evidence about those therapies’ safety and effectiveness in treating the disease or condition in multiple patient subgroups. And, given that by 2050 minorities in the U.S. will make up more than 50% of the population, increasing the participation of diverse populations in clinical trials will help ensure the safety and efficacy of new BMS medicines is studied in diverse patient populations to benefit all patients who may need them.
Diversity in Clinical Trials initiative
As part of our long-term work to advance diversity in clinical trials, Bristol Myers Squibb established a Diversity in Clinical Trials initiative in 2019 and accelerated those efforts in 2020 as part of a series of commitments to Health Equity and Diversity and Inclusion along with adopting the PhRMA members’ new clinical trial diversity principles. The centerpiece of the Diversity in Clinical Trials initiative is a dedicated team with representatives spanning a range of R&D functions. The team receives critical input from the company’s Global Diversity and Inclusion Council, as well as the People and Business Resource Groups (PBRG) Advisory Group, which includes representation from the company’s eight employee resource groups, or PBRGs, as well as Patient Advocacy and other relevant functional areas.
The initiative provides an integrated framework with the goal to ultimately improve recruitment of diverse patients in our clinical studies. This will ensure BMS has clinical trial patient participation that is more reflective of the real-world population, which is also aligned with the guidance that the FDA provides and the epidemiology of the disease studied. Clinical trial diversity directly confronts global health disparities and mitigates drug development risks.
The objective of the BMS Diversity in Clinical Trials program is to improve recruitment of diverse patients in our clinical trials. In line with our 2020 commitments, our ambition is to locate 25% of U.S. clinical trial sites in highly diverse communities by 2022.
Toward that goal, the team is focused on:
- Site selection: Strategy and processes for operationalizing clinical trial sites with a diversity lens.
- Protocol design: Understanding and addressing eligibility criteria impact.
- Patient support: Facilitating patient participation by reducing practical and logistical barriers.
- Communication and engagement: Collaborating with community groups and institutional partners.
- Training: Developing inclusive curricula for research sites staff.
- Metrics and measures: Developing and instituting measurement and progress tracking.
The Bristol Myers Squibb Foundation’s Diversity in Clinical Trials Career Development Program
Building upon its more than 20-year legacy of addressing health disparities throughout the world, the Bristol Myers Squibb Foundation announced enhanced commitments to health equity and diversity and inclusion in 2020. One of these new commitments addresses diversity in clinical trials. In a five-year, $100 million program, the Foundation, in partnership with National Medical Fellowships and the American Association for Cancer Research, will train 250 new clinical trial investigators who are racially and ethnically diverse or who have demonstrated commitment to increasing diversity in clinical trials.
The Foundation’s program also will expose 250 promising underrepresented minority medical students to clinical research career pathways. Increasing diversity of clinical trial investigators and future specialists helps increase diversity in patient enrollment in clinical trials. The goal of the Bristol Myers Squibb Foundation Diversity in Clinical Trials Career Development Program is to increase diversity of patients enrolled in clinical trials, and ultimately enhance the development of therapeutics for all populations. The Foundation and its program partners believe that physicians who are established in their communities are well positioned to build trusting relationships with diverse patients that will lead to their increased participation in clinical trials. Therefore, the program will collaborate with communities to facilitate an approach to clinical and translational research that is community-informed, designed and conducted. It will provide the sponsorship, support and tools that emerging investigators need to conduct clinical trials that will yield the development of new treatments that are studied in all populations.
Learn more:
Bristol Myers Squibb Foundation Diversity in Clinical Trials Career Development program.
Patient and caregiver support
We know that cancer impacts many parts of a patient’s life, and we are taking clear actions to address all aspects of care, from diagnosis to survivorship. That means supporting patients and caregivers beyond our medicines with the resources and education they need about their disease, help with navigating the healthcare system and ensuring our life-changing therapies are accessible to patients who need them.
Patient Expert Engagement Resource
Weaving the patient perspective into the development and commercialization of medicines has become increasingly important industry-wide, particularly at Bristol Myers Squibb. In 2020, BMS has worked closely with expert patient advocates to define and implement an innovative new process spanning all markets and therapeutic areas: Patient Expert Engagement Resource, or PEER. PEER fills a need for more systematic and seamless engagement of expert patient advocates. This formalized approach builds on and integrates efforts already underway across the organization to bring patient perspectives into the company’s work. PEER ensures that the patient perspective is heard and considered at every step of the drug discovery and development process—one of the first times this kind of all-encompassing approach has been implemented at a biopharmaceutical company. A major action already implemented through PEER requires that all pivotal trial protocols include expert patient advocate engagement prior to internal sign-off.
