In order to ensure a successful outcome of a trial, it is imperative that some aspects are clearly planned, and executed. One such aspect is site feasibility, which basically evaluates whether the proposed site has all the required facilities to ensure smooth operation. The following factors might influence this decision:
- Qualifications and experience of the site staff and investigator
- Site infrastructure
- Ability of the site staff to allocate time to the trial (if similar trials are being conducted at the same site, it might impact the site staff’s ability to allocate adequate time, and might also impact enrolment rates).
- Site Ethics Committee’s timelines for obtaining the necessary approvals.
- Any other protocol specific requirements – for example, a particular equipment, storage conditions, previous track record with clinical trials, etc.
The monitoring team should ideally conduct site qualification visits to each proposed clinical site to ensure its feasibility. Ideally a site feasibility questionnaire should be developed for this step. It is also recommended that the monitoring team assesses the feasibility of a few additional sites. This is suggested as an option for the future, in case there is an issue with the selected sites during trial conduct.
Before entering into an agreement with an investigator or institution (site) to conduct the study, the Sponsor should ideally provide the following documents or information to the potential investigator or institution:
- Protocol (latest version)
- Investigator’s Brochure (to provide the available information about the Investigational Product)
- Relevant information about the Sponsor
- Information about the required study population
- Process of participant recruitment
- The general requirements of the trial, in terms of medical equipment, facilities, etc.
- Proposed financial terms and projected timeline
- Any other information that might be important for the conduct of the trial.
References and further reading
- Rajadhyaksha, V. (2010), Conducting feasibilities in clinical trials: an investment to ensure a good study, Perspectives in Clinical Research, available online (last accessed on 26.02.2019).
- Good Clinical Practices for Clinical Research in India, Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, 2001, available online (last accessed on 26.02.2019).
- ICH Harmonised Guideline, Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2), current step 4 version, dated 9th November 2016, available online (last accessed on 26.02.2019).