Navigating the Complexities of Clinical Trial Success
Clinical Site Selection
Selection of an investigational site for a clinical trial is critical to success. Throughout a clinical trial, the clinicians are responsible for patients’ safety, rights, and welfare. Additionally, data integrity and regulatory compliance are necessary to secure study success. A clinical site plays a role in each of these factors. Selecting investigators qualified by training and experience is Good Clinical Practice and a requirement of US 21 CFR 312 (Investigational New Drugs) and 21 CFR 812 (Investigational Device Exemptions). Sponsors may have a list of investigators in mind while planning a trial, but CRO site databases are useful to find additional investigators. MED maintains a list of sites and investigators interested in participating in clinical studies (Site Registry).
Once potential sites and investigators have been identified, site assessment is performed. Quality procedures including standardized site assessment templates help ensure consistency and objectivity in the selection process. Evaluation criteria should be detailed and tailored to the specific trial. The following may be considered in the evaluation:
Consideration Factor | Rationale |
Number of patients with the target condition or disease state treated at the site | Knowing the expected patient enrollment will help inform the budget and resource allocation. Sponsors are not willing to pay high start-up fees if there is going to be low enrollment. |
Similar product experience | Experience with a similar product will help increase patient safety since the site understands the required procedures and follow-up. |
Clinical study experience | If the site is familiar with GCP requirements, then they are likely to have less documentation issues. |
Participation in concurrent clinical studies | It may be challenging to book equipment and competition with the site staff if there are too many other concurrent studies. |
Appropriate facilities and equipment | The site should have access to the necessary equipment or be able to outsource it in order to collect data and follow patients. |
FDA/Regulatory history | Being aware of any previous warning is important so that there are processes in place to avoid repeated noncompliance. |
Research team | A site is more than just the PI. Having research coordinator(s) and technician support is vital, especially for more complex and larger studies. |
Budget/Contract and IRB/EC timelines | Choosing a site that will be activated in a timely manner is important, especially when you need to add a site for more patients to finish enrollment. |
The results of the evaluation are documented in a site selection report. This report verifies investigator qualification and adequacy of the investigational site as well as provides the rationale for selection.
Overall, clinical site selection is an important process that should be executed with careful consideration to promote patient safety, data integrity, compliance, and ultimately ensuring the overall success of a clinical trial.
MED Institute offers a variety of clinical trial services including site selection and is a full-service CRO. We have over 40 years of experience designing and executing clinical trials, ranging from early feasibility studies to multinational, controlled pivotal trials to post-market registries.
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