Successful completion of any study is based on enrollment. An important outcome of a study’s feasibility review is defining—before the study even begins—how subjects will be recruited and retained, as well as how the study will be implemented.
Not only is it essential to have a recruitment plan in place prior to starting a study, but to also re-evaluate that plan at key points during the study (based on study length and projected enrollment rate). Failure to enroll the study’s required sample size is not only problematic to determining whether endpoints are met, but failure to enroll a study could ethically be said to put those enrolled at unnecessary risk, because the proposed endpoint could not be met.
Many recruitment techniques require advanced IRB approval:
- Presentations to local groups
- Mail/phone canvasses of caregivers
- Neighborhood network promotion
- Public-site postings
- Print-media notices
- Use of health controls
- Social media postings
After enrollment, successful execution of a study requires vigilant management. General principles of executing a study are comprised of oversight, communications, and organization.
- The principle investigator is designated to oversee the entire study. S/he can delegate responsibility and should do so, to be well-trained and knowledgeable coordinators and, if possible, regulatory and financial staff.
- The research team should be in constant communication from prior to starting a study to it its closure. All team members should be engaged and all can contribute. Frequency of meeting and reviewing study progress can contribute to a study’s success.
- Each research team member should have designated tasks and be responsible for those tasks.
The general categories of tasks involved in research implementation are the following:
- Regulatory (including but not limited to IRB submission and annual review)
- Subject recruitment and retention
- Subject visits with required procedures and assessments
- Regular required reporting
- Management of monitor visits and preparation for potential audits
- Invoicing sponsor(s) and reconciling budgets
The entire scope of study implementation travels through pre-study to closure.