PLAYBOOK | Getting Started
Getting Started: Initiating a Collaboration Between Advocacy Organizations & Industry for Engagement throughout the Drug Development Process
It is the recommendation of PALADIN, that interactions are initiated in the discovery and pre-clinical stages. Every stage of medicine development, from the concept of pathway discovery through Phase 4 should be established in collaboration with patient community stakeholders and representatives. Regardless of the stage, or topic, the earlier discussions are initiated, the more impactful and effective they will be in meeting timelines, resource demands, and overall collaboration objectives.
Suggestions for Effective Collaboration Among Patient Advocacy Groups & Biopharmaceutical Companies
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For clinical trials conducted in the United States, all activities, including those related to patient engagement and recruitment, need to adhere to a set of laws and regulations set forth by the US FDA, as well as an international set of guidelines (International Council for Harmonization). These laws, regulations and guidelines are established to ensure the safety and proper oversight of individuals participating in clinical research, and also safeguard approaches that provide individuals with the ability to freely decide, without undue influence, if a clinical trial is the right option for them.
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Pharma companies can pay outside of fair market value for services: Compliance and transparency reporting exist to ensure collaborations are conducted outside of undue influence. Fair market value is used to provide a common standard relative to the cost of goods and services, including external advisory support. It supports practices that remain in alignment with government regulations and industry best practices.
View an example of how to understand and identify rate structures here.
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Document Templates: Contracts and Agreements
PALADIN members have gathered sample agreements and contracts to serve as resources for engaging in collaborative activities: