Your trial is underway. Most sites are ready to enroll patients. Yet, your study is already behind schedule. Why? What can you do? Is a protocol amendment required? Our research provides some surprising answers to these questions.
When we discuss the reasons trials are behind schedule with our clients, we frequently hear things such as the eligibility criteria are too strict, or the patient outreach initiatives are unproductive.
However, based on insights from more than 400 studies, we find the following are the most common types of issues separating successful from unsuccessful studies. Next week we will begin a series of blogs providing potential solutions to each of these problem areas.
- Overall software experience
When study coordinators experience numerous study-related software problems, they de-emphasize that study in favor of other, smoother trials. This makes sense. Recall how you feel when struggling with a computer program and, when you contact technical support, they provide little assistance.
Sites often have 30 or more required study-related programs, each with their own particular nuances. They also have their own passwords, which change monthly.
In our research, the frequency of software-related issues is the biggest differentiator of successful from unsuccessful trials.
- Overall quality of training
Frequently, sponsors develop a list of training requirements based on hardware, software, protocol and regulatory requirements. Based on a checklist, training programs are developed individually for each activity.
Few sponsors take a site-focused approach to training. Few identify what training is truly required versus what simply requires evidence of competence. Here is an example – how many study coordinators with five or more years of experience have not undergone GCP training numerous times? So, instead of requiring them to participate in yet another GCP training program, why can’t they either provide evidence of recent GCP training, or test-out of training programs?
This type of site-focused approach to training will increase attention on the items that matter to your study, and show you are respectful of their time.
- CRA turnover
In our work we commonly hear complaints about CRA/monitors. They are not responsive. They do not understand the protocol. They are too pushy. Yet, when comparing successful to unsuccessful studies, only one CRA-related issue was significantly different – CRA turnover. Other CRA-related issues occur similarly for unsuccessful and successful studies. Then, why is minimizing CRA turnover so important?
A new CRA has different requirements and expectations. They can demand sites go back in time to capture data not required by a previous CRA. They can demand sites re-contact local HCPs with a different request for referral letter. They can modify how the study is interpreted. All of these can be problematic for sites.
- Pay on time
It is sad that this even requires mentioning, but it does. Sites are subcontractors. Consider this; if your employer told you that your pay was going to be delayed ‘a few weeks to a few months’ because paperwork was lost, or there was a disagreement in the amount due you, would that be acceptable to you?
Many sites are small clinic practices or dedicated research sites with significant overhead. They need predictable cash flow to focus on studies instead of cash flow management.
To learn more about what differentiates successful from unsuccessful studies, and to discuss a very simple metrics tool to keep your trials on track, contact me.