Site & Investigator Appraisals
The selection of appropriate sites and Investigators are critical to achieve the specified numbers of evaluable subjects and this in turn will contribute to the success of the study. A good feasibility survey must be conducted at an early stage in the selection process to assess whether a study can be conducted in the country or at the site of choice. The survey will gather and analyze data on the availability of potential subjects fulfilling the inclusion and exclusion criteria, realistic recruitment rates within stated timelines, current and comparator treatments, competitor studies, and regulatory and ethical issues. The initial feasibility survey may also check investigators for proven experience in trials in a particular indication. The questions need to be structured in such a way that the responses are sufficiently well-founded to permit a decision on which countries and sites are to be used.
Good feasibility will make an immeasurable difference to a study. The monitor will feel comfortable about the site’s capabilities and there will be fewer dropouts and fewer site replacements due to poor or no recruitments. The online/remote feasibility survey should be carried out prior to visiting the site for a site selection visit.
We at Consortium Clinical Research, deploy our technical expertise and networking skills in ensuring selection of credible sites and interested investigators who are available in the country. Thus, we add value to the Clinical Trial endeavours of a sponsor, by meaningfully evaluating the feasibility of various sites for the clinical study under consideration.