Identifying eligible patients for clinical trials has always been a challenge in clinical research. Although hospitals are already aware of their patient population this does not mean that all their patients will agree to participate in research or that they will be eligible to do so. Another critical aspect of the challenge is the short recruitment timeline, which for some clinical trials could be just couple of months. Also research teams are not allowed to approach patients without full approval of the study and not to mention that using EMR has made even more complicated to identify patients due to system structure.

These challenges require a new approach in supporting recruitment in clinical trials. Research registers are gaining popularity and some of them have reached national level, for example Scottish Health Research Register (SHARE), which links patients with their electronic medical records.

What is the philosophy of the research register?

Although there are numerous research registers they all follow the same concept. Research register is a web-based system, which health care staff use to identify potential patients for the clinical trials. Patients listed in the register have already agreed to be contacted and have allowed research teams to use their EMR for pre-screening for different trials.

  • Access to a data base with potential participants who have already expressed interest in participating in research
  • Available medical history to quickly identify eligible participants
  • Available contact details for potential participants

What are the benefits of research registers?

Research registers could be very useful for clinical trials teams who are under pressure to identify patients and manage their workload at the same time.

What are the challenges of research registers?

Registers have their challenges too so clinical trials teams have to take them into consideration as well.

  • Additional costs for the hospital to use registers
  • Some local regulations prohibit contacting directly patients and sending them leaflets and other study materials 
  • People change their mind – the fact that someone has agreed to be contacted does not mean they will participate in the study. Same apply for participants who decline to be contacted – it is possible over time to change their mind and it will not be ethical to be excluded from new treatment options just because they have declined to be contacted.
  • Maintaining up to date data base could be very time and resource-consuming (data discrepancies, changes in contact details, changes in medical conditions, etc.)
  • Participants may not feel comfortable their medical history to be stored in a external data base.

Although research registers have their own challenges they are still an excellent opportunity which is worth exploring in attempt to improve recruitment in clinical research.

Author: Olga Peycheva

Olga is a clinical research professional who has been working in clinical research since 2005. She has extensive experience in clinical research in Eastern and Western Europe. 

Originally published on 1 July 2016