Everyone expects their clinical trial to be completed successfully, on time, and within budget. Unfortunately, the vast majority of trials fall short of those expectations (up to 90%, according to industry research). However, there are 10 simple steps that, if followed, will virtually guarantee a successful outcome. They are:
1. Specific expectations and roles
2. Project team communication plan
3. Study team communication plan
4. Well designed data forms
5. Quality investigators
6. Thorough site training
7. Active subject recruitment
8. Frequent monitoring visits
9. Timely data review
10. Test article controls
In last month’s article (Animal Pharm 692, p1 1), I detailed the first five of these success factors. In this article I discuss the other five.
6. Site Training
The crucial importance of thorough study training cannot be overstated. Whether you conduct centralized training for all study personnel or train each study site individually, devoting time to a comprehensive review of the protocol, data forms, GCPs, confidentiality, and other procedures will pay big dividends in data quality and time to completion Many sponsors view centralized training as the preferred method but may opt for individual site training to save money. Such savings have, in my experience, often evaporated as remedial training for most sites became necessary to maintain data quality. I am convinced that centralized training results in deeper understanding of the protocol, better awareness of the data form requirements, stronger commitment to the study and more enthusiasm for enrolment among all of the investigators and dispensers — and all of this at a lower total cost.
7. Subject Recruitment
This may be number seven on the list of ten steps but it is, in many respects, the most important because nothing happens until a subject is enrolled. And successful enrolment requires careful screening of potential investigators for adequate subject populations, thorough training of the appropriate site staff in inclusion/ exclusion criteria, constant encouragement and support of each site, creative recruitment strategies and regular tracking. Develop a back-up plan for each site to rejuvenate enrolment should their pace slacken and be ready to replace or add study sites to get enrolment back on track. Enrolment is every study’s critical path.
8. Study Monitoring
Some sponsors allow budget constraints to dictate the frequency of study site monitoring visits. The resulting number of visits may be sufficient if they satisfy GCPs and everything goes according to expectations. However, the optimal monitoring plan would schedule visits to match expected enrolment, with contingency schedules that accommodate accelerated or depressed enrolment, as well as protocol deviations and adverse events. Remember, a phone call may get you the answer to a question about a site, but there is no substitute for a field visit to learn why the question arose in the first place.
9. Data Review
The longer you wait to review data forms, the longer it will be before you discover errors and omissions, and the less likely it will be that the investigator will remember every detail of the corresponding subject visit. So, don’t delay. Collect data forms from each site as soon as they are completed, and review them as soon as you receive them. Promptly return erroneous forms to the respective investigator for correction, and review the corrections as soon as they are made. Maintaining a regular schedule of timely data review and correction will uncover error trends early, accelerate study completion and enhance overall data quality.
10. Test Article Accountability
Accurate accounting for test article begins with a system of strict procedures and controls to assure that drug counts are exact at every step in the delivery and dispensing process. Shipments should be verified when they are received at each site, and test article should be stored in a secure location separate from each clinic’s other medications and supplies. Test article should be counted by the dispenser at each subject visit, and owner diaries should be checked for accuracy as well. The monitor should verify counts at each site visit. Diligent adherence to these procedures throughout the study will assure an accurate inventory at close-out.
Ten steps, easy to list and explain, a little more difficult to implement and follow. However, I encourage you to make the effort because the success of your next trial depends on how well you stride.