Subject/Patient recruitment for clinical trials is on the forefront of every Biotech/Pharma executive’s and Clinical Operations leader’s mind when starting a clinical trial. Particularly for Phase 2 and Phase 3 clinical trials the critical time is from clinical protocol approval to first patient randomized thus, enrolled. This critical measure depends on many factors, to name a few that I focus on; country selection, clinical site selection, investigator grants, IRB approval, clinical supply material availability. If there are no significant regulatory hurdles to address, every company should consider conducting a clinical trial outside the United States. That being said, it is most important to assess the regulatory landscape including the understanding and acceptance of GCP in the country you are considering, you obviously want to make certain that you are benefiting and not creating a liability when conducting a clinical trial outside the United States. When recruitment is the elephant in the room many Biotech/Pharma companies utilize a recruitment firm; in my opinion, this is a bad idea which usually cost a lot with no positive results that I have seen.
Clinical Research Organizations (CROs) have been perfecting and assessing subject/patient recruitment strategies for decades and can provide a Sponsor with data regarding preferred sites (US & Ex US) and countries depending on disease type, as well as, Regulatory issues and GCP compliance. Many times a CRO is the best way to go. I am very sensitive to the clinical timeline; most CROs live by the timeline without sacrificing quality which is clearly a good thing.
The industry buzz word or thought is “cycle time assessment”. Cycle time assessment is basically assessing past performance and establishing metrics. My concern with this approach is the fact that I am not sure if it forces one to initiate more effective enrollment strategies and cost control measures. “Recruitment consumes the most financial resources” and delays or slowdowns only adds time to the timeline. Developing a recruitment plan may be an important first step in starting to address recruitment concerns.