Challenges
Sponsors of clinical trials face many challenges in their efforts to complete trials on time. Some of the more important challenges include:
- Maximizing Principal Investigator involvement
- Increasing study awareness
- Limiting screen failures
- Improving patient retention
- Enhancing site-team communication and coordination
Maximizing Investigator Involvement
“The success or failure of multi-center clinical trials will remain dependent in large part on the engagement of the site Principal Investigator”
Mentz and Petersen, Circulation 2017
As a company established by senior PIs with many decades of experience in clinical trials, RSL is very aware of the growing trend amongst PIs to relegate their responsibilities to their site’s Study Coordinators, Physician Assistants and/or trainees. This practice can negatively impact patient enrolment, retention and data quality.
To reverse the trend, RSL developed a convenient, user-friendly platform (PI-Enroll®) that saves PIs valuable time and effort, thereby enabling them to become more involved and complete their tasks more efficiently.
Principal Investigators are empowered to
Saving Time and Effort
To save PIs time and effort PI-Enroll enables PIs to select the most important of the many inclusion and exclusion criteria from the study protocol and prioritize those criteria such that the most challenging are displayed at the top of the screen – thereby eliminating the need for extensive scrolling through criteria that will be more fully addressed at screening. It also enables PIs to summarize certain aspects of the study so that answers to patient queries are readily at hand without having to find and review study protocols and investigator manuals. Finally, if competing trials are underway at their site, PIs can conduct side-by-side comparisons of each trial to ensure the right patients are enrolled into the right trials.
Increasing Study Awareness
Study awareness is crucial to establishing and maintaining study patient referrals. The majority of such referrals tend to come from sub-investigators who are seeing the required profile of patients and community-based health care providers (HCPs) who represent the original source of patient referrals. Unfortunately, both sub-investigators and HCPs often have limited awareness of the studies underway and as a result, feel somewhat uncomfortable discussing the study option with their patients for fear of appearing uninformed and unable to respond to their queries
Improving Patient Retention
Much time and effort can be wasted and data quality jeopardized if patients withdraw from studies early or fail to adhere to the study protocol. Thus, it is particularly important to ensure the right patients are enrolled into the right studies.
PI-Enroll provides side-by-side comparisons of all aspects and any number of competing studies underway at a site. This feature allows immediate comparisons of the Inclusion/Exclusion criteria, number of study visits, number/nature of invasive procedures, etc. all of which help to ensure the right patient is invited into the right study.
Enhanced Communication and Coordination
When Sponsors make amendments to study protocols, that information is typically conveyed to PIs and SCs but not Sub-Investigators or community-based practitioners. And when PIs or SCs are on vacation, patient referrals may linger in emails or voice mail until the individual returns. These and many other communication and coordination challenges can be met with a study-site bulletin board that allows site teams, Sponsors and CROs to post messages relevant to the study and coordinate their efforts.
PI-Enroll contains two bulletin boards, one for intra-site messaging that relates to site and team issues and another for inter-site messaging where PIs and SCs can share their respective challenges and solutions with their colleagues at other trial sites. In doing so, it not only facilitates site and overall trial communication and coordination but also communication between Sponsors and CROs, thereby ensuring that all parties are kept informed and up to date.
