Institute for Clinical and Economic Review Launches Program to Accelerate the Consideration of Value into Drug Development Programs

— ICER will leverage its health technology assessment (HTA) expertise to encourage better evidence development in clinical trial programs —

BOSTON, March 25, 2026 – The Institute for Clinical and Economic Review (ICER) today formally launched ICER’s Scientific Advice, a new offering to advise companies on evidence generation strategies that will support a more comprehensive assessment of clinical effectiveness and value.  

“Today, ICER joins its HTA colleagues across the world who have for years provided scientific advice on clinical trials. ICER’s Scientific Advice will address a key concern that current clinical trials fail to capture the elements of value that matter to key stakeholders. Identifying the right kind of evidence needed from clinical trial programs will ensure that value assessments are a foresight, not an afterthought,” said ICER President and CEO Sarah K. Emond. “Our goal is to improve the evidence that is developed by companies during clinical development to ensure value assessors have the information they need to do a fair assessment at the time of FDA approval.”

Drawing on ICER’s experience having conducted over 100 value assessments geared towards clinicians, payers, and patients, the program will advise on trial designs that successfully capture:

• Clinically meaningful, patient-centered outcomes
• Appropriate surrogate outcomes that predict clinical outcomes
• Data collection outside of the trial environment
• Data that can help inform payer decisions

Based on potential trial results and analogous conditions, ICER will show potential evidence ratings and realistic price ranges, giving a clear view of what different outcomes could mean for a future commercial strategy. One of ICER Scientific Advice’s key goals is to help companies prioritize their clinical assets so the therapies that ultimately receive FDA approval are those with the greatest potential to meaningfully improve patients’ lives. ICER will also help provide consideration of what outcomes patients prioritize through structured focus groups and advise on recruiting diverse patient populations.

ICER Scientific Advice is a completely separate workstream from ICER’s independent and publicly available evidence assessments. Working with ISA does not impact the likelihood that ICER will conduct a health technology assessment of a company’s product in the future, nor will it impact the independence of our assessment should it be selected through our topic selection process.

For more information on the program and its offerings, visit isa.icer.org.

About ICER

The Institute for Clinical and Economic Review (ICER) is an independent, non-profit research institute that conducts evidence-based reviews of health care interventions, including prescription drugs, other treatments, and diagnostic tests. In collaboration with patients, clinical experts, and other key stakeholders, ICER analyzes the available evidence on the benefits and risks of these interventions to measure their value and suggest fair prices. ICER also regularly reports on the barriers to care for patients and recommends solutions to ensure fair access to prescription drugs. For more information about ICER, please visit www.icer.org.