Patient perspectives influencing drug development

Support is growing for increased collaboration between pharmaceutical companies and patients in research processes worldwide, according to a new report by health care intelligence company GBI Research. The new report states that patient perspectives are increasingly being sought by drug regulators and reimbursement authorities, which hope to better meet the needs of their customer base.

Patient Reported Outcomes (PROs) are increasingly being seen as valuable assets to drug regulators, which recognize that patients should be brought in early in the regulatory process to help define an acceptable benefit-risk balance for particular disease areas. Both the US Food and Drug Administration and European Medicines Agency are working to establish processes to support this, and reimbursement authorities are looking to patients to help them define truly valuable new medicines. Pharmaceutical companies hope to measure PROs, but this requires a great deal of upfront planning, particularly in cases where a new appropriate measurement instrument must be developed and validated as part of the drug development program.

Successful patient involvement in setting research agendas can be seen in the James Lind Alliance, which was established in 2004 as a non-profit-making initiative. The alliance brings together patients, carers and clinicians who share an interest in a particular health problem, in order to identify ‘unanswered questions’ about the effects of treatments.