May 18, 2018 Patient-Centered Clinical Trial Design Workshop

From P-values to Patient Values:

MDIC to Reveal Patient-Generated P-Values from Parkinson’s Patient Preference Study

In September 2016, MDIC launched a new initiative in patient-centered clinical trials.

With CDRH, the Michael J. Fox Foundation for Parkinson’s Research, MIT, and RTI Health Solutions, we developed and tested a novel method for incorporating patient preference information as an explicit means to set significance levels in clinical trial design.

Setting patient- and therapy-specific significance levels may be a pathway to treatment access for patients with a higher risk tolerance and no effective therapies.

On May 18, 2018, at the Westin Arlington Gateway in Arlington, VA, we are pleased to present the results, implications, and next steps for this initiative.

What we’ll discuss:

  1. The number – we’ll be revealing the p-value for Parkinson’s patients
  2. The project methodology and specific aims:
    • Identify the outcomes important to patients, family members, and caregivers
    • Design and conduct a patient preference assessment study
    • Design methods for clinical trials based on explicit patient input
  3. What does this all mean? Project implications and next steps
    • Conversation with FDA, statisticians, patients, and clinicians on the viability of this study and the general concept of medical device clinical trial designs based on patient preference

Who is speaking:

  • Sohini Chowdhury, Deputy CEO, The Michael J. Fox Foundation for Parkinson’s Research
  • Andrew Lo, Ph.D., Charles E. and Susan T. Harris Professor of Finance; Director, Laboratory for Financial Engineering, MIT
  • Jeffrey Shuren, M.D., J.D., Director, Center for Devices and Radiological Health (CDRH), US Food and Drug Administration
  • Margaret Sheehan & Anna Donnelly, Patient Scientists, The Michael J. Fox Foundation for Parkinson’s Research, Patient Council

…and more.

Register to attend in person or via WebEx here

To Learn more about the project visit or contact MDIC Science of Patient Input (SPI) Program Director, Stephanie Christopher at