PRM216 - What Value Can Operational Feasibility Studies Bring to Post Marketing Observational Studies (PMOS)? Example of Feasibility Study Performed in Eastern Europe to Assess Hepatitis C Viral Disease/Patient Management in Real World Setting

Abstract

Operational feasibility studies provide a good opportunity to assess practicality of large full-scale studies. They are an almost essential pre-requisite and should be well designed with clear objectives. Conducting a pilot study can enhance the likelihood of success of PMOS and potentially help to avoid serious design flaws. The objective of this research is to assess the value of feasibility studies prior to PMOS implementation and highlight the importance of local physicians’ feedback. A feasibility study in 6 Eastern European countries was conducted via collection of physician surveys to assess local standard of care. The feasibility questionnaire was developed to assess operational aspects, such as availability of patient population, site experience and time and willingness to participate. The 37 physicians who received the questionnaire were selected through PubMed; they were all experts who have published regarding HCV infection and were provided with the protocol synopsis Out of the 37 selected physicians, 18 gastroenterologists, hepatologists, and infectious disease specialists in Bulgaria, Croatia, The Czech Republic, Hungary, Poland and Romania completed the questionnaire. The participating Physicians were working exclusively in public institutions. The average number of HCV patients seen by year is 140 and out of them 78 are treated by Interferon. They specified that they can enrol 2 eligible patients per month on average. They see their patients frequently during treatment initiation (bi-weekly or monthly). However, the follow-up varies from one country to another (quarterly or semi-annually). Physicians indicated that patient records and data regarding blood tests and procedures are accessible for 100% of the cases. Over 60% of the sites were familiar with Patient Reported Outcomes. Overall, 12 physicians were interested in participating in the Study. The result of this survey helped us documenting routine medical practice and confirming the study design and methodology to be implemented.