Patient Reported Outcomes Drive Drug Development while Improving Patient Involvement Remains a Challenge, States GBI Research22 Jun 2012 • by Natalie Aster
Support is growing for increased collaboration between pharmaceutical companies and patients in research processes worldwide. The new report "Patient Perspectives - Patient Reported Outcomes Drive Drug Development, but Improving Patient Involvement Remains a Challenge" by GBI Research states that patient perspectives are increasingly being sought by drug regulators and reimbursement authorities, who hope to better meet the needs of their customer base.
Patient Reported Outcomes (PROs) are increasingly being seen as valuable assets to drug regulators, who 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 FDA 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.
Patient Perspectives - Patient Reported Outcomes Drive Drug Development, but Improving Patient Involvement Remains a Challenge
Published: May, 2012
Price: US$ 3.500,00
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.
PatientPartner identifies barriers within patient organizations and pharmaceutical companies that need to be overcome for successful partnerships to be built. Patient organizations can suffer from a lack of expertise and awareness of clinical research, and a lack of organizational structure. In contrast, pharmaceutical companies can suffer from concerns over potential negative publicity, possible delays of clinical trial processes, and loss of control when proprietary information is shared.
Nevertheless, most large pharmaceutical companies have integrated PRO strategy within their drug development planning activities, with guidance from the FDA and EMA providing support. GBI analysis suggests that companies should aim to consider what will be of most relevance to patients in the development of their overall strategy, as well as within each drug development, so that clinical trials can be designed with these points in mind. In this way, companies will be able to better meet the needs of patients, regulators and reimbursement authorities.
More information can be found in the report “Patient Perspectives - Patient Reported Outcomes Drive Drug Development, but Improving Patient Involvement Remains a Challenge” by GBI Research.
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