Chicken Soup for the Busy Coordinator Nov 2010 PROTOCOL FEASIBILITY

Dr Peter Tan received a feasibility questionnaire for a Phase III randomized controlled clinical trial on a Hepatitis B vaccine for adults aged between years. The expected recruitment target was 50 per site. What are the factors to be considered to ensure that sufficient resources are available to meet the recruitment target? Case Study

Eligibility criteria  Review the eligibility criteria to assess if existing subject pool would be eligible for participation.  Estimate the number of subjects who may be keen to participate in a clinical trial based on existing subject pool. This estimate may be deduced from past clinical trial experience. Study Staff  Ensure sufficient study staff are available.  Ensure that study staff are adequately qualified in terms of education, training and experience to conduct the clinical trial.  Assess if study staff have sufficient time to conduct the clinical trial considering their current workload. Current Clinical Trial Involvement  Consider if there are any conflicting clinical trials competing for the same subject pool. Answers

Subject Recruitment Procedures  Physician referral  Medical records review  Database  Clinical practice  Subject response to recruitment materials Equipment and Facilities  Ensure that equipment and facilities required for conduct of clinical trial are available.  Ensure sufficient outpatient clinics are available for subject recruitment and follow- up. IRB and Regulatory Authority review and approval timelines  Determine the possibility of initiating the clinical trial within the Sponsor’s expected timelines. Budget  Assess if the budget is sufficient to cover operational costs incurred in conducting the clinical trial. Answers

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