How Stakeholder Input Shapes Better Therapies
Listening to patients, caregivers, healthcare providers, and payors helps ensure new treatments are innovative and practical, accessible, and impactful.

When charting the uncertain waters of drug development, researchers often focus on the intricacies of molecules, assays, and regulatory milestones. But successful therapies do not begin with chemistry. They start with the people who will benefit most from a new drug.
That’s why a medical needs assessment or evaluation of unmet clinical need should always guide early decision-making in drug development.1 By identifying gaps in current treatments, researchers can target innovation where it matters most. A thorough literature review is essential, but it is just the beginning. To gain a full picture, researchers must speak directly with stakeholders who will ultimately use, prescribe, and pay for a new treatment. Getting stakeholder input is an important part of the SPARK NS starting with the end in mind approach.

Listening to Patients and Caregivers
Patients are the most obvious and critical source of insight. They are, after all, the ones who will take the medication. Their perspectives can shape fundamental choices about drug design, from delivery route and dosing regimen to the specific symptoms a therapy should address.
For instance, do patients using current therapies consistently take these medications as prescribed or do side effects or complicated dosing schedules interfere? What would make them more likely to adhere—a once-daily pill, a patch, or an injection? Are there nice-to-haves such as cost, convenience, or reduced side effects that might transform quality of life? Answers to these questions can reveal needs not found in clinical data alone.
In addition to patients, caregivers and patient advocates can provide a broader view of daily challenges. They are often the ones juggling complex medication regimens, lifestyle adjustments, and emotional burdens that accompany chronic illness. Their concerns may differ from patients’, highlighting unmet needs in areas such as family support, treatment logistics, or ease of administration.
Researchers can learn a great deal by asking caregivers: How do current treatments fall short? What would make caring for someone with this disease easier? What worries do you have about new therapies? These perspectives can expose needs that directly affect both treatment adherence and overall well-being.
Consulting Providers
Physicians, specialists, nurses, and community health workers also play an important role in determining which therapies patients ultimately receive. Their willingness to adopt a new treatment is critical to its success.
Engaging these providers early can uncover practical hurdles: Do they see a clear benefit over the current standard of care? How complex is the therapy to administer? What training or infrastructure would be required? Providers’ input not only validates clinical relevance but also flags barriers that could prevent a promising drug from reaching patients.
Considering Insurers and Public Payors
Even with all these perspectives taken into account, a drug may struggle to reach patients if insurers or public payors decline to cover it or limit its use. For many patients, access hinges on whether insurance companies, Medicare, or Medicaid will authorize and pay for a therapy. Developers who engage with payors early can better understand the thresholds and data needed to support coverage decisions.
Drug development might begin with a molecule, but the path to a truly transformative therapy begins with listening to the unique perspectives of all stakeholders. In the end, the question is not just what can be developed in the lab, but what will make a meaningful difference in people’s lives.
Reference
- Stevens A, Gillam S. Needs assessment: from theory to practice. BMJ. 1998;316(7142):1448-1452. https://www.bmj.com/content/316/7142/1448.long.
Learn More
- Meet Danielle and the SPARK NS team
- Learn more about SPARK NS