Introduction to Patient Engagement in Drug Development
An ever-expanding area of collaboration is occurring between patients, patient organizations, industry, regulators, and governmental organizations to ensure that new drugs developed both represent value to the patients they aim to treat, and that the timeframe for providing new innovations to patients is accelerated. Integrating the patient experience from the early stages of drug development through approval and post-marketing is now an accepted norm. However, for many companies, understanding why this is important as well as convincing leadership to invest in these activities can be confusing and elusive. These courses provide fundamentals about why and how to build such a function.
This module is designed to provide the foundational knowledge for integrating the patient perspective into the full medicines lifecycle, including regulatory decision making and post-marketing efforts, which can improve patient outcomes and increase the success of the product. The concepts covered in this course apply to drugs, biologics, devices, and any medical/therapeutic products developed for patient use.
This module takes an average of 1 hour to complete.
- What Is Patient Engagement?
- Key Drivers of Patient Engagement
- Benefits and Challenges of Patient Engagement
- Building an Engagement Plan
- Compliance Issues
- Evaluating the Patient Engagement Program: Quality and Impact
This module is designed for professionals involved in:
- Patient Advocacy, Patient Engagement, Patient Experience and Access (Including Chief Patient Officers)
- Patient Communications
- Medical Affairs and Medical Communications (Including Chief Medical Officers)
- Health Outcomes
- Study Endpoint Development
- Clinical Trial Design and Optimization
- Clinical Research
- Clinical Operations
- Benefit-Risk Assessment
- Pharmacovigilance and Risk Management
- Medical Science Liaisons
- Patient Support Services
Upon completion of this module, learners should be able to:
- Describe why integration of the patient perspective is integral for drug development programs
- Explain how other companies have executed and benefited from such programs
- Explain, from a patient point of view, what constitutes meaningful engagement
- List steps a company can take to build a culture of patient engagement, and what resources exist to help