Why Sponsors Must Build Trials That Acknowledge All Patients' Needs

By Susan Pandya, vice president of clinical development and global head of oncology, Servier

In oncology drug development, we spend years pursuing treatments that have the potential to change lives. But that work only fulfills its promise if our research truly reflects the people we aim to serve.

As a former practicing hematologist-oncologist and now a leader in clinical development, I’ve seen how the benefits of clinical research don’t always reach the patients who need them most.

Events held by the American Association for Cancer Research and the American Society of Clinical Oncology continue to spotlight remarkable progress in science and clinical research — but there is still much to be done to ensure these advances reach all patients, especially those from underrepresented and underserved communities.

That’s why I’m deeply committed to a patient-centric approach to clinical trials. For me, that includes expanding the reach of research to include diverse populations, improving accessibility, and embracing technologies that reduce burdens and open doors. The value of innovation lies not only in the science itself but also in our ability to make that science accessible to the patients whose lives it’s meant to improve.

There is a broad consensus that including patients with a range of backgrounds matters. The challenge now is turning that belief into action by creating more accessible, inclusive, and patient-friendly pathways to participation.

The Risk Of One-Size-Fits-All Medicine

Our population spans different genetic, racial, and ethnic backgrounds, age groups, socioeconomic circumstances, and health histories. Yet, clinical trial participation has often been limited to a narrow slice of that reality.

Many studies overrepresent certain groups while excluding others, whether due to restrictive eligibility criteria that screen out people with comorbidities or age-related limitations or a lack of outreach to underserved populations. These limitations reduce the generalizability of research findings and leave gaps in our understanding of how therapies will perform in the real world.

By studying a broader range of participants, we gain insight into meaningful differences in how therapies are metabolized by the human body and tolerated with respect to safety findings, and ultimately whether they are effective at treating the disease. This data can influence the recommended dose and schedule of a treatment, helping ensure that patients can remain on treatment and receive its full benefit without sacrificing precious quality of life. It also enhances our ability to detect variations in efficacy across populations, generate new scientific hypotheses, and refine patient selection for future trials.

The Barriers To Broader Representation

Less than 10% of adults participate in clinical trials in the U.S. The reasons for underrepresentation in trials are complex, but they are not a mystery. Many patients face very real financial, logistical, and structural hurdles: the cost of traveling to a distant research facility, time away from work, childcare needs, language/cultural barriers that make the process intimidating and confusing, and the fear of potential known and unknown side effects of an experimental treatment. These challenges and burdens often fall disproportionately on patients from marginalized communities. Furthermore, patients often rely on their health care providers (HCPs) for information about clinical trials, which can also be a barrier to access depending on the awareness of the HCP and/or potential biases that could impact the recommendation to a patient.

It is also important to note that both historical experiences and present-day factors have created challenges in ensuring public trust in clinical research. While much progress has been made to ensure legal and ethical practices of conducting clinical trials, there is still a responsibility for each of us to support access to accurate information and resources. Establishing trust takes commitment, transparency, and humility.

Education Builds Awareness

Ultimately, the advancement of innovative drug development depends on patients who are willing and able to participate. Improving access and awareness helps us reach those patients faster — expediting enrollment and bringing innovation to more people in less time.

One of the most powerful tools we have is education and awareness for both HCPs and patients. When patients — and their families — have access to clear, accurate information about clinical trials, they are empowered to make informed decisions about their care.

Educating patients about clinical trials is especially critical in the context of rare diseases, where limited epidemiologic, genomic, and clinical data often hinder the development of new therapies. These conditions are frequently understudied, and patients may face suboptimal treatment options—or no established standard of care at all.

In such cases, clinical trials are more than a research tool; they can represent the best available opportunity for patients to access a potentially beneficial therapy. Trials also offer a controlled environment to collect and analyze much-needed data, helping advance scientific understanding and drive future innovation.

However, many patients aren’t aware that participating in a trial is an option for them or misunderstand what doing so would entail. HCPs are often the first resource for patients to gain insights into their treatment options and thus educating this community on which trials are available and how they can be accessed through referrals or other avenues becomes rate-limiting.

How To Reduce The Burden On Patients

If we want clinical trials to reflect the real world, we must meet patients where they are — literally and figuratively.

That means rethinking how we design, promote, and conduct trials. Decentralized clinical trials (DCTs) have emerged as one practical solution. By allowing remote consenting procedures, local visits for lab and imaging assessments, and telehealth assessments, we can significantly reduce points of friction, enabling better access and compliance.

But we can, and should, go further in our efforts to make clinical trials work for everyone.

1. Building trust through transparent communication

Building credibility and trust starts with sharing information in a patient-friendly format. That includes translating materials into multiple languages, using simplified medical terminology, and presenting information in ways that feel approachable rather than intimidating.  One example from our Phase 3 glioma study included proactive Spanish translations of study documents, including informed consents and patient reported outcome tools, in U.S. locations with a high concentration of Spanish-speaking populations. We extended this effort across countries globally enabling multiple language translations to support patient access and understanding.

Collaborating with patient advocacy organizations to co-create resources and host educational presentations—with space for open Q&A—can help foster meaningful dialogue and reduce misconceptions. Our Patient Office plays a central role in building these partnerships with patient advocacy groups, and we’ve seen the impact of their work firsthand. With the Cholangiocarcinoma Foundation, we shared our Phase 3 study design and gathered patient feedback before finalizing the protocol. Similarly, we partnered with the National Brain Tumor Society to host a patient focus group that shaped our clinical development plan for treating diffuse glioma.

These collaborations remind me that we make the greatest progress when we work in partnership with the community — united by a shared purpose to bring innovation to the patients who need it most.

Equally important is involving patients in the process itself. As part of our Patient Plan, we actively seek direct patient feedback on our protocols and informed consent forms prior to finalization to make sure the patient voice is embedded in the design. Vendor partnerships enable us to identify potential participants and streamline site activation, helping ensure patients have timely access to trial sites near them.

When patients help review clinical protocols, trial designs, and informed consent forms, it not only improves clarity but also demonstrates respect for their perspectives. Together, these efforts encourage participation from a broader range of backgrounds and create space for the kind of open exchange that builds lasting trust.

2. Improve study feasibility and local access to trial sites

Broadening site selection beyond major cities to include suburban and community-based locations can make participation more feasible for patients who live farther from city hubs. To improve the feasibility of patient participation from remote locations, sponsors can include the cost of travel, parking, overnight accommodations at local hotels, and meals as part of the study budget to improve accessibility. This feasibility strategy is often summarized into a diversity plan which is what we at Servier have incorporated into our best practices approach for our pivotal studies.

Furthermore, sharing study details with healthcare providers — along with patient-friendly materials like one-page summaries or study-specific websites — enables them to help their patients quickly understand whether they may be eligible to participate. These resources can also direct patients to nearby trial locations and offer clear contact information to learn more.

3. Minimize procedural barriers

Clinical studies often require frequent laboratory, imaging, and sometimes invasive procedures to sample tumor tissue. In precision medicine approaches that include molecular testing to identify biomarkers or mutations often ask patients to undergo screening tests that may not be covered by insurance. Offering these tests as part of the study can help limit out-of-pocket costs while providing critical information for treatment planning. Additionally, proactively including remote assessments in study protocols, such as consenting procedures done electronically or lab and/or other procedures to be performed at facilities local to the patient, can alleviate the demands on patients’ time. Finally, critically assessing not only the frequency but also the need to collect certain data points becomes essential in alleviating the procedural demands patients must face. More data is not always useful to collect and analyze.

On a broader scale, improving trial design through the use of real-world data, synthetic control arms, and eventually AI-based modeling can reduce the number of procedures patients undergo and the total number of participants needed — making studies more efficient and cost-effective.

Shaping A Patient-Centric Future For Clinical Research

At Servier, we’ve embraced several practical strategies to make our trials more patient-centric. We’ve implemented decentralized procedures across many of our trials and developed specific plans to support the recruitment of populations that reflect those who will ultimately receive the therapy if approved.

Looking ahead, I’m eager to deepen our partnerships with advocacy organizations and healthcare professionals, particularly in underserved communities. I envision forums and focus groups that bring people together — both in person and online — to share information, raise awareness, and break down barriers to participation. 

Progress won’t come from a single solution. It will come from building multiple paths to participation in clinical research.

We can’t change the past, but we can shape a better future, where trust is earned, where easy access to trials is the norm, and where the diversity of our patient population is reflected in the data that drives the next big breakthroughs in medicine. 

About The Author:

Susan Pandya M.D., is the vice president, clinical development & global head of oncology LS/LCM at Servier Pharmaceuticals. She leads Servier’s oncology clinical development from early studies through pivotal Phase 3 programs and FDA approvals, including TIBSOVO® (ivosidenib tablets) for cholangiocarcinoma (2021), newly diagnosed AML (2022), and R/R MDS (2023), and VORANIGO Grade 2 Glioma (2024).

A passionate oncologist with nearly 20 years of drug development experience in academia and the pharmaceutical industry, Susan previously led oncology clinical development at Agios Pharmaceuticals and early-stage development at Acceleron Pharma. Earlier, she was associate director of the Phase 1 experimental therapeutics program at Beth Israel Deaconess Medical Center.

She earned her M.D. from Tufts University and completed her residency/fellowship at Beth Israel Deaconess Medical Center.