For the past several years, trends in the healthcare/pharmaceutical industry have increased the importance of patient experience and patient outcomes in decision-making. The emphasis on cGCP/GMP processes is being driven by the increasingly competitive environment resulting from payer mandates, patient engagement and patient choice. Patient experience is often a less direct consideration, and data for making informed decisions on the basis of patients’ experiences or preferences is extremely limited or non-existent.
While individual companies may have conducted some in house surveys or solicited feedback from patient focus groups, there has not been an industry-level approach to answering important patient-related questions. Regulators also are keen to get first-hand feedback on patient views to ensure future guidance and regulations meet their needs and ensure patient safety.
ISPE believes that it is uniquely positioned to serve as a bridge between companies with common interests and the patient community. As a neutral, nonprofit global organization made up of highly skilled technical and scientific professionals, ISPE can conduct research that is credible and ultimately beneficial to all the stakeholders. When necessary, ISPE will also work with other organizations like CISCRP, the Center for Information and Study on Clinical Research Participation, to identify and reach patients and to ensure that the study designs are rigorous.
In the second quarter of 2013 ISPE launched its first patient survey, a study focused on the patient experience with clinical trial materials. ISPE believe that this initial survey will be an important step towards listening and responding to the patient experience which could positively impact many aspects of the industry’s approach to meeting patient needs. The survey results will provide areas of focus that could enable a follow up task team to develop an industry-first good practice guide on patient-friendly clinical materials. Additional studies will follow as appropriate projects and funding are identified.
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