How Pharma Companies Are Navigating the New Clinical Trial Landscape: A Mixed Response

In the wake of recent regulatory changes regarding diversity in clinical trials, pharmaceutical companies have begun revealing their strategic positions. After previously exploring the various paths companies could take – from maintaining comprehensive diversity programs to reverting to traditional trial methods – we now see how these organizations are actually responding. Their decisions reflect the challenging balance between maintaining established diversity initiatives and adapting to the new political climate.

The responses from pharmaceutical companies have largely fallen into three distinct categories: those maintaining their explicit commitment to diversity initiatives, those pivoting away from previous positions, and those remaining notably silent on the matter. This divergence in approaches highlights the industry’s struggle to balance scientific integrity, business interests, and regulatory compliance in an increasingly complex environment.

Standing Firm on Diversity

Several major pharmaceutical companies have chosen to maintain their strong stance on clinical trial diversity. Eli Lilly emphasizes their “unwavering commitment to developing safe and effective medicines for all patient populations,” implementing innovative approaches like community-based trials and remote visits to reduce access barriers.

Similarly, Sanofi has demonstrated its ongoing commitment through substantial financial investments, including an $18 million commitment to historically Black medical schools for developing clinical trial infrastructure. Bristol Myers Squibb and Genentech have also reaffirmed their dedication to inclusive research, with Genentech specifically maintaining its Site Alliance program, which has shown success in increasing enrollment of Black and Hispanic/Latinx patients.

Ambiguous Signals on Trial Diversity

Several major pharmaceutical companies are changing their approach to DEI initiatives, but they have not made clear commitments regarding maintaining diversity in clinical trials or moving away from them. Pfizer, notably, has made changes to its website content regarding diversity initiatives. When questioned about these modifications in February, a Pfizer spokesperson stated that they “constantly update and evolve the content and design of our website to reflect our current programs, initiatives, and commitments.”

However, the company has remained notably silent on specific questions about its ongoing commitment to diverse clinical trials and the future of its trial diversity programs. This lack of clear communication about clinical trial diversity strategies raises questions about how it will approach patient recruitment and representation in future studies.

This shift was followed by Johnson & Johnson’s careful repositioning, where they’ve stripped phrases regarding DEI from their corporate filings and now only speak of “compliance with legal requirements,” falling back on their company credo which conspicuously omits any mention of clinical trial diversity. Other industry giants like Biogen and Alnylam have followed suit, scrubbing language around diversity from their filings. These aren’t subtle tweaks but rather calculated moves to align with the new political climate, signaling a clear retreat from their previous diversity commitments in clinical trials.

The Silent Observers

While many have taken clear stances, some pharmaceutical companies have chosen to maintain strategic silence on the issue, neither publicly reaffirming nor denying their commitment to diversity initiatives. While some of these companies still maintain their clinical trial diversity web pages, they have refrained from making new public statements about their positions or future plans. This silence might indicate a wait-and-see approach as the industry continues to adapt to the changing regulatory environment.

Shaping Tomorrow’s Clinical Research

The pharmaceutical industry’s varied responses to the changing clinical trial landscape reflect broader uncertainties about the future of diversity initiatives in healthcare research. While some companies view diversity as fundamental to scientific integrity and market success, others appear to be reevaluating their approaches in light of the new political climate.

Removing the unpredictable political landscape and equally elusive public sentiment from the equation, everyone should agree that the ultimate goal is better health outcomes. Good science in clinical trials ensures the reliability and validity of results, leading to safer and more effective medicines. Testing medicines on a diverse patient population is crucial for understanding how different demographics respond to treatments and how they experience side effects.  In the end, robust science requires diverse testing, which will improve transparency, enhance public trust, and lead to better health outcomes globally.

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Region Technical Pilot1 Implementation Dates2 Implementation Documents
MHLW/PMDA, Japan 2Q 2021 (Completed) 2022 (Voluntary)
2026 (Mandatory)
MHLW/PMDA, Japan regional implementation page
EC, Europe 2024 CAPs (Started) 2025 (Voluntary for CAPs2)
2026 (Voluntary for MRP/DCP/NP)
2027 (Mandatory for CAPs)
TBC (Mandatory for MRP/DCP/NP)
EC, Europe regional implementation page
Health Canada, Canada 2025 (Planned) 2026 (Voluntary)
2028 (Mandatory)
Health Canada, Canada regional implementation page
FDA, United States 2022 - 2Q 2023 (Completed) 2024 (Voluntary)
2029 (Mandatory)
FDA, United States regional implementation page
Swissmedic, Switzerland 2026 (Planned) 2027 (Voluntary)
2030 (Mandatory)
Swissmedic, Switzerland regional implementation page
ANVISA, Brazil 4Q 2025 (Planned) 1Q 2026 (Production Pilot2)
2026 (Voluntary)
TBD
MFDS, Republic of Korea TBD 2027 (Voluntary)
TBD (Mandatory)
TBD
TGA, Australia 4Q 2025 (Planned) 2026 (Voluntary)
TBD (Mandatory)
TGA Implementation of ICH eCTD v4.0 Specification

Amy Flynn is a Managing Director with alliantConsulting. With over three decades of experience in the pharmaceutical, medical device, and diagnostic industries, Amy’s expertise spans various business functions, from clinical and regulatory, to marketing and business development. Her career includes roles as Global and National Life Sciences Industry Lead at Grant Thornton and General Manager of Genomics at Whatman Biosciences, as well as founding partner of CatMa Consulting. She has led major change initiatives, mergers and acquisitions, and quality systems implementations. Amy has an M.Ed. in Counseling Psychology from Temple University, as well as an M.B.A. and a B.S. in Engineering from Rutgers College of Engineering. She also holds certifications in change management and leadership coaching, and has been recognized as an HBA Life Science Luminary and a Consulting Report Top 50 Consultant.

Sondra Leibner alliantConsulting Managing Director: Transformational Leader and Strategic Visionary. She is an executive level consultant who doesn’t just support leaders but revolutionizes their strategy development, leadership alignment, change management, culture design, and talent development. When you meet Sondra, you will feel the depth of her experience and her understanding that your challenges, culture and circumstances are unique. She will bring flexible, creative and pragmatic approaches to create truly customized and workable solutions. Sondra’s ability to communicate complex messages in simple and memorable ways enhances her ability to achieve unprecedented levels of engagement and adoption. When you begin working together you will be excited about your next meeting.

Amy Flynn

Managing Director

Amy is the Life Sciences Industry Lead and a Managing Director of alliantConsulting. She has driven global change initiatives for life science companies across Clinical Development, Regulatory Affairs, Quality, Supply Chain, and Medical Affairs and has supported clients with all aspects of Integration and Separation planning and execution.

She is energized by helping companies deliver on their most important strategies and passionate about developing the business acumen and capabilities of her client’s teams. Specializing in large scale transformation, Amy combines a strategic mindset with hands on execution and attention to detail to help clients realize and sustain the intended value of their efforts.

History of Proven Success

Amy has driven transformational change initiatives for life science companies across Clinical Development, Regulatory Affairs, Quality, Supply Chain, and Medical Affairs and has supported clients with all aspects of Integration and Separation planning and execution. She is energized by helping companies deliver on their most important strategies while expanding the experience and capabilities of her client’s teams.

Amy has directed major transformation projects for:

Chris Unruh

Managing Director of ERP and Business Applications

Chris Unruh brings over 25 years of experience in technology transformation and consulting to his role as Managing Director of ERP and Business Applications at alliant. His extensive background in leadership development, talent management, and business strategy enables him to drive results-oriented solutions. Chris’s expertise spans operational transformation, practice development, market-making, and technology program management. With leadership roles at Grant Thornton and MarketSphere Consulting, as well as experience as an independent executive advisor, Chris employs a business-first approach. By leveraging technology as a key enabler, he consistently delivers tangible results for clients across various industries.

History of Proven Success

A serial entrepreneur, Chris founded a successful management consulting practice that was later acquired by Grant Thornton. As the Managing Principal of Product Automation at Grant Thornton, Chris helped develop over 200 internal and client-facing automation products and was recognized for his ability to lead integrations, acquisitions, and technological implementations.

Chris has directed major transformation projects for:

Chris Stephenson

alliantDigital Managing Director: Intelligent Automation and Al

Chris Stephenson is the Managing Director of Intelligent Automation, Al & Digital Services at alliantDigital. Chris has a 25 year history in tech consulting and developing emerging technology solutions for nearly every sector. As a leader in the Al space, Chris has already delivered on multiple internal and client-facing Al products.

History of Proven Success

A serial entrepreneur, Chris founded a successful management consulting practice that was later acquired by Grant Thornton. As the Managing Principal of Product Automation at Grant Thornton, Chris helped develop over 200 internal and client-facing automation products and was recognized for his ability to lead integrations, acquisitions, and technological implementations.

Chris has directed major transformation projects for:

Sondra Leibner

alliantConsulting Managing Director: Transformational Leader and Strategic Visionary

Sondra is an executive level consultant who doesn’t just support leaders but revolutionizes their strategy development, leadership alignment, change management, culture design, and talent development. When you meet Sondra, you will feel the depth of her experience and her understanding that your challenges, culture and circumstances are unique. She will bring flexible, creative and pragmatic approaches to create truly customized and workable solutions. Sondra’s ability to communicate complex messages in simple and memorable ways enhances her ability to achieve unprecedented levels of engagement and adoption. When you begin working together you will be excited about your next meeting.

History of Proven Success

Sondra offers comprehensive services to help business leaders maximize stakeholder value and drive organizational success. She works with teams to craft visions, align leadership, manage changes, and build effective cultures that foster growth and innovation. By focusing on key areas such as communication, collaboration, clarity, and accountability, Sondra helps organizations improve profitability, increase engagement, and realize long-term value.

Leadership Alignment

Leadership teams that are aligned are able to drive business success more effectively. Communication, collaboration, clarity and accountability are the foundations for successful leadership teams. Sondra works to align teams behind your desired destination with the objective of increased engagement, buy in, visible support and clarity of goals to drive success and value realization.

Change Management

It is possible to engage large groups of people and motivate them to do things differently and decrease disruption when thoughtful change management practices are deployed. Change Management requires clarity of purpose, leadership alignment, sponsor leadership, engagement, simple and targeted messaging, crisis and risk management and many others. Sondra will work to develop and execute a scalable approach to manage the people side of change through assessing impacts, readiness and educational needs of stakeholders.

Culture Design

The success or failure of an organization is driven by leadership and culture. Actively taking steps toward building your culture means focusing on the alignment of your leadership, values and behaviors. Sondra will assess current state behaviors, beliefs, norms and structures of your organization to identify similarities and differences inherent in the culture and subcultures and together we will create a roadmap to increase engagement to realize the intended culture.

Talent Development

Customized talent strategies that resonate with your vision, values, and culture are Sondra’s forte, empowering your team to excel and drive the company’s strategic objectives.

Sondra has directed major transformation projects for:

Joy Taylor

alliantConsulting Managing Director:
A Visionary Leader and Proven Change Management Expert

Joy Taylor isn’t just a consultant; she’s a force of nature in the world of business transformation. With over twenty-five years of cross-functional experience, Joy applied her expertise in program transformations, project leadership, strategy and execution, team facilitation, change management, communication, and Lean Sigma to everything from startups to multibillion-dollar enterprises. Her impressive track record speaks volumes, but her accolades and career milestones set her apart as a critical advisor for CEOs.

Award-Winning Leadership and Proven Success

As National Managing Principal at Grant Thornton, Joy demonstrated her unparalleled ability to steer complex, global programs and initiatives. Her tenure as CEO of a $60 million business underscores her credibility and reliability as a peer for other CEOs seeking strategic guidance and impactful change management.

Joy’s career is also studded with achievements including:

Brava! Award,

EY Entrepreneurial Winning Women Class of 2013 member, and a

2022 Life Sciences Voice Top Industry Leader Award.

Award-Winning Leadership and Proven Success

Joy's career is studded with achievements including a Brava! Award, EY Entrepreneurial Winning Women Class of 2013 member, and a 2022 Life Sciences Voice Top Industry Leader Award. As National Managing Principal at Grant Thornton, she demonstrated her unparalleled ability to steer complex, global programs and initiatives. Her tenure as CEO of a $60 million business underscores her credibility and reliability as a peer for other CEOs seeking strategic guidance and impactful change management.

Master of Complex Transformations

Joy's unique talent lies in her ability to manage intricate, large-scale programs that span continents and cultures. She has a proven ability to manage complex, global programs and initiatives, drive process and productivity improvement efforts and lead change in a fast-paced environment.

A Visionary with Tactical Precision

Joy is not just a big thinker; she's a visionary who can translate high-level strategies into actionable goals that people are eager to achieve. Her ability to collaborate with leaders to shape vision and strategy is matched by her meticulous attention to the necessary steps and tactics required to bring those visions to life. She aligns people, process and technology to deliver results that are truly exceptional.

Joy has directed major transformation projects for: