The nightmare of any clinical research executive is the "Rescue Study" syndrome.
The definition of a "Rescue Study" is the kind of trial where recruitment is lacking far behind projections, ie. the contracted sites are not enrolling the number of patients they had promised.
Apparently, many trials end in this situation. Many teams experience that 30% or more sites end up not recruiting a single patient.
The consequences can be devastating:
- Budget erosion and blow-out: Starting up, managing and monitoring more sites than planned significantly impacts project budgets. Other resource requirements for project management and training tend to get out of control. In a small biotech company the available budget to the next value generating inflection point becomes severely impacted.
- Timeline slip and blow-out: Start-up delays for new sites - and subsequent delays in recruitment can be devastating for the pre-specified timelines. Depending on the indication and the availability of patients, increasing the number of sites late may not account for the overall slip in timelines.
- Quality compromise and give away: Identifying sites after trial initiation results in less optimal training conditions and the investment required to keep the training level high may not have been accounted for. Furthermore, sites added late in the process under suboptimal conditions may be like scraping the bottom of the barrel - including investigators less experienced or quality focused.
- Data delay, decrease in project value and jeopardized project survival: In the worst case, overall loss in revenue and project value due to prolonged time to market - and in the worst case discontinuation of a research program
Most clinical research professionals will have found themselves in the position that although they felt they did everything right - still find themselves in the unfortunate position of needing rescue sites from time to time.
In my experience there is a good chance of a direct correlation between the timing, creativity, effort and resources you put into the feasibility and site-selection process very early in the planning and execution process - and the subsequent recruitment success. However, you have to get below the surface of the traditional feasibility approach - which is a desktop exercise without true value.
In the coming weeks I will share with you some of my experiences. I will focus on the following elements of the feasibility and site selection process:
- Quality of and reliance on CRO data and approaches
- Sponsor leadership, investigator relationships and communication strategies
- Feasibility steps, timing and resources
- Integration of pre-screening data into the site selection process
- Site selection - and termination decisions
The dream of a clinical research professional - how to increase the likelihood of it coming true???
