This is the first of two posts containing excerpts from our forthcoming ebook on proactive recruitment planning.
CenterWatch data tells us that in clinical trials, too many patients who volunteer don’t qualify, or they leave the study after they are enrolled.
69% fail prescreening
58% decline consent
32% fail screening
18% drop out after enrollment
Why are these metrics meaningful? Too often, the protocol comes first, then patient considerations come later. These statistics could improve greatly through proactive protocol planning.
When planning your protocol, ask yourself:
- Am I looking at the study from the patient’s perspective?
- Does my protocol take into consideration whether these patients really exist?
- Are the obligations put on the patient fair?
The graphic below, also from CenterWatch data, presents additional considerations to take in account during the protocol design process as well as communication with the patient:
By addressing these specific issues early on, it will be easier to establish realistic expectations on patients before they join the study, and it will limit them as reasons for attrition.
Protocol crowdsourcing is growing in popularity. This, along with other new market research methods and focus group surveys, are bringing protocols to the patient early to get a patient perspective on protocol components. This is useful information.
It is also vital to consider the caregiver requirements if they will be helping a patient participating in the study. With the increase in the number of Alzheimer’s and oncology studies, more caregivers are playing a critical role in the retention and compliance of patients.
This is an open opportunity for our industry. When prospective patients (and caregivers when applicable) are able to provide feedback around items such as informed consent, site visit requirements, and procedures, this information can be applied to make proactive adjustments to protocols. This collaboration will lower the rates of attrition — dollars will be saved and more studies will finish on time.
next week: my colleague Melynda Geurts discusses where prospective patients get their information