Working on clinical trials requires very high qualified staff and some of the most important resources when working in clinical research are sub-investigators. Sub-investigators are qualified consultants who have relevant experience not only in the disease area but also in clinical research. The role of the sub-investigators is to support the Principal Investigator in identifying eligible patients and perform medical assessments and medical decisions for their treatment. Selecting the right sub-investigators can guarantee the success of the study.

What are the challenges in identifying sub-investigators?

  • Workload – Majority of the experienced in clinical research physicians work on clinical trials already. They may be too busy to handle new studies.
  • Friends – Although selecting colleagues who are your friends may sound like the best option sometimes they may not have the research experience to work on clinical trials or may not be interested in research in general. 
  • Different treatment opinions – Some consultants may have specific opinion on treatment and may not be enthusiastic with the study medication or device. If your sub-investigators do not feel comfortable with the new treatment this could seriously jeopardise recruitment efforts.
  • Establishing new contacts – Involving different hospitals or GPs could be challenging if there is no established relationship with them already and yet they may turn into a valuable partners. However, working with new team members always require extra supervision until the work relationship is settled.
  • Temporary staff as sub-investigators – Although it looks tempting to include registrars as sub-investigators and they can indeed be very helpful, you need to consider the amount of time they will spend at the site. If they are on 6 month rotation they may not be the best choice. 

In order to evaluate if someone is suitable for sub-investigator it is important to have honest discussion with them and understand what motivates them. You need to set realistic expectations from the beginning and make sure your team of sub-investigators receives appreciation and respect for their work.

According to Spilker (1991) there are 11 motivators (1):

  1. Enhance one’s career – This is especially applicable for academic research. The disadvantage of this type of motivation is that if the study is not successful this could demotivate the physician.
  2. Participate in scientifically exciting research
  3. Obtain medical benefits for one’s patients
  4. Obtain new medical or scientific equipment provided by sponsor to enable trial 
  5. Obtain new staff to help with clinical trials
  6. Obtain money that may be used for personal interest – this is applicable for countries where investigators are paid directly
  7. Obtain money that may be used to conduct unsponsored trials of personal and professional interest
  8. Publish scientifically and medically important journal articles – This may not always be an option with commercial studies
  9. Develop a long-term relationship with you and your treatment team
  10. Repay a favour – This could be very limited as opportunity for future work together
  11. Be part of a team – This could be applicable for GPs and solo practices 

Whatever the motivation of the sub-investigator is it is important to set clear expectations at the beginning and be open about the workload involved. Least but not last the Principal Investigator is responsible for overseeing the study at the site so you will need a plan to monitor the clinical trial.

Source: A Manager’s Guide to the Design and Conduct of Clinical Trials

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 3 Jan 2017