Phase I Clinical Trials: Site Identification and Selection

A phase I clinical trial includes humans with the goal of evaluating the safety (toxicity) of a new drug (or combination of drugs) and its maximum tolerated dose (MTD) to be used in subsequent stages of clinical development based on previously competed animal toxicology studies.¹

Identifying and selecting Phase I clinical sites to support one's drug development program can be challenging. The process of finding qualified sites with appropriate capabilities and staffing (clinicians/principal investigators, coordinators, and research teams) greatly contributes to the success of the clinical trial.²

There are common challenges faced with these types of studies which further reinforces the need to identify the best sites. Common challenges include targeting the population of interest, feasibility of subject enrollment, and trial capabilities, described below.

1. Targeting the Population of Interest

When selecting a site for a Phase I clinical trial, it is important to determine if the site has the population outlined in the protocol. Most sites have access to a patient database that can be utilized to determine if the criterion matches the trial.1

2. Feasibility of Subject Enrollment

Even though enrollment is typically not a major concern in Phase I studies given the small sample size, it is still important that the site(s) can meet the target. Feasibility questionnaires are a quick and reliable tool that helps guide sponsors towards the most.

3. Trial Management Capabilities

Although sample size is not a major concern as noted above, there are challenges unique to this type of trial. For example, patients are monitored more closely in early-stage studies, oftentimes staying overnight to monitor for safety and potential toxicity concerns.1 These operational complexities require many resources and demand a higher level of staffing to execute the schedule of assessments outlined in the protocol.
In addition to overnight stays, the protocol oftentimes includes a detailed biological specimen collection schedule, further reiterating the training required of the research team.

Summary

There are many elements to consider when choosing a phase I research site. Understanding the areas of expertise for the site to target a specific population and its ability to enrollment subjects to meet the sample size outlined in the protocol is crucial to trial success. Identifying skilled research teams who can manage the trial from start to finish is also essential. As always, the sponsor should be proactive and prepared with additional sites on standby in the event unforeseen challenges occur throughout the clinical trial. To learn more about additional characteristics of clinical research sites and working with a CRO, please check out 5 Qualities of Successful Clinical Research Sites: Site Identification and Selection Toolkit and Advantages of Working with a CRO.

MyMD Pharmaceuticals Inc. published data in Drug Research from is recently completed Phase I clinical trial entitled, A Double-blind, Placebo-controlled, Randomized, Single Ascending, and Multiple Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral Dose of MYMD1™ Capsules in Healthy Male and Female Adult Subjects.

References

1. SOFPROMED 1 Clinical Trials: Previously Asked Questions. Retrieved from https://www.sofpromed.com/phase-1-clinical-trials-frequently-asked-questions#:~:text=As%20a%20general%20rule%2C%20phase,phase%202%20and%203%20studies
2. Brager, J. 5 Qualities of Successful Clinical Research Sites: Site Identification and Selection Toolkit. Retrieved from https://tnfpharma.com/news/5-qualities-of-successful-clinical-research-sites-site-identification-and-selection-toolkit

Dr. Jenna Brager, PhD, RN, MS, is the Vice President of Drug Development at MyMD Pharmaceuticals. Prior to joining MyMD, Dr. Brager served as the Director of Clinical Research for LifeBridge Health and was a clinical investigator at Johns Hopkins Hospital. Dr. Brager received her B.S. in Nursing from the University of North Florida, graduating cum laude and received her Ph.D. from the Johns Hopkins University School of Nursing. Dr. Brager welcomes comments, questions, and requests for future blog topics. Please email [email protected].

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