Participate In Initial Industry-FDA Meetings
Securing an Invitation
FDA regulators are increasingly interested in having patients and patient group representatives participate in these early discussions, but the Sponsor is the one who will invite you to a pre-IND meeting. It is your job to make certain the Sponsor is aware of the benefits of your participation. Studies are often designed with hard data and statistical measures in mind, but this approach may not produce results that the patients and caregivers find valuable. Your participation in pre-IND meeting can ensure the FDA that the study objectives are designed with the needs of the patient community in mind.
Participation by your group representatives in initial meetings between the Sponsor and the FDA can reduce therapy time to market by:
- Ensuring that studies are designed to provide useful information.
- Enhancing the understanding of data proposed to be gathered by clinical trial.
- Providing a platform for the patient voice.
- Creating or further growing a relationship between your group and the FDA.
- Minimizing clinical holds on therapy development (an order issued by FDA to delay or suspend an ongoing trial/investigation).