Customers are no longer content to buy a drug simply because of a doctor’s recommendation. In a study of 13,000 patients, 89% initiated a conversation with their physician about alternative treatment options, and 70% think decisions made about their treatment should be a collaborative effort with their doctor. While the pressure is on physicians, patient engagement in drug development through digital means (see digital bonus copy on Meaningful Use and proposed changes to the requirements), pharmaceutical and biotechnology companies also need to get in the game of using technology to improve patient engagement in drug development.

Despite growing efforts to engage patients in research and regulatory activities, the pharmaceutical industry has yet to maximize patient engagement in the drug development process. As healthcare systems continue to evolve and establish patients as the primary stakeholders in their own healthcare decision making, the pharmaceutical industry will need to find innovative ways to demonstrate the value of its products relative to the outcomes experienced by the ultimate consumers of healthcare: patients

Patient engagement in the drug development process solutions should incorporate a patient’s real-world behavioral needs and facilitate the skills and motivation necessary to optimally self-manage a condition on a daily basis. Additionally, programs need to go beyond a one-way push or collection of information. Developing treatments that can truly help improve patients’ lives should be rooted in a firm understanding of the daily challenges patients face, their needs, and the trade-offs they are willing to make to gain relief. To create valuable treatments, patient needs must be aligned in all aspects of the healthcare system, including research priorities, product development, trial design, regulatory approval, access, reimbursement, and treatment decisions. This realignment has started to take place on the payer side with the use of health technology assessments (HTAs), which stipulate that patients’ preferences or perspectives be integrated in value demonstration. Such HTAs are in use in several European countries, and similar value frameworks are beginning to emerge in the United States, bolstering hopes that these nascent efforts to increase patient involvement in various aspects of healthcare will develop and expand in scope.