One of the major requirements for a clinical trial to be successful involves the recruitment of an adequate number of participants so that?accurate scientific conclusions can be made. “Adequate” means that an appropriate sample size has been calculated such that even when some drop out of the study, as is commonplace in clinical research, the remaining enrollment will be adequate to allow meaningful evaluation of data.
A problem arises when a study is in progress, but too many participants leave the program so that the remaining number is too small to provide the required amount of data to provide a statistically significant result. It is our experience that this occurrence often leaves the Sponsor in a position where they begin to seek alternative options in managing the study.
Analyzing the fall-off to get back on track
As a CRO we are experienced clinical trial project management specialists. We know how to turn a slow recruiting or high dropout study into one that fulfills the requirements of the statistical analysis plan. We return the study to a viable and productive state using the most cost effective methods. We analyze recruitment and retention plans and identify the problems.
Once identified, we provide suggestions and an implementation plan for how they can be resolved. Our step-by-step approach includes the following:
1) An intense review of the study with the study team. We develop a thorough understanding of all aspects of the clinical trial including the recruitment strategy that was implemented to understand the shortfalls.
2) We gather as much information as possible in order to identify what the recruitment and retention problems might be caused by through the conduct of the following types of field interviews.
- People working at sites that are successful and sites that are struggling
- Other identified knowledgeable sources that are not actively involved in the study but may provide valuable input,
- Physicians and community groups who have the potential to provide referrals
3) We analyze the data we have collected in order to identify the factors that are responsible for recruitment and retention obstacles.
4) We provide you with a detailed report of our findings and the most cost effective solution(s).
5) We meet with you in person, whenever possible, to review, discuss and brainstorm ensuring that we rank the obstacles from most to least critical.
In this way, we prioritize the solutions — especially when dealing with budgetary constraints. By gaining important feedback, using our own experience and by working together through a team approach, our clinical trials project management team is able to provide you with a complete understanding of the recruitment and retention obstacles faced by your study.
Our experience and confidence in this approach allows you to take immediate action to get your study back on track towards meaningful and significant results.
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