Partnering With Patients in the Development and Lifecycle of Medicines: A Call for Action

Area of Science:

• Pharmaceutical Sciences
• Health Services Research
• Patient Advocacy

Background:

• Patient involvement in medicine development is recognized as essential but lacks a systematic, universal framework.
• Current patient engagement is inconsistent, leading to inefficient drug development and suboptimal patient outcomes.

Purpose of the Study:

• To highlight the need for a master framework for systematic patient involvement in medicines research, development, regulatory review, and market access.
• To emphasize how improved patient involvement can enhance medicine development efficiency and patient-centered outcomes.

Main Methods:

• The study is a conceptual analysis and synthesis of existing knowledge on patient involvement in the pharmaceutical lifecycle.
• It draws upon the consensus among stakeholders regarding the necessity of enhanced patient engagement.

Main Results:

• Inconsistent patient involvement results in inefficient drug development, unmet medical needs, and increased costs.
• Systematic patient involvement can lead to better research prioritization, improved trial design, enhanced recruitment, and more relevant medicines.

Conclusions:

• A joint, precompetitive, and international approach is required to develop a universal framework for patient involvement.
• Stakeholder collaboration is essential for adopting and implementing this framework to embed patient needs at the heart of medicine development.