Being a Principle Investigator (PI) on a RCT – Tips from a first-timer!
Richard Pinder, PI on NINJA-Pilot
First of all, don’t be put off by the thought of it – if you’re even entertaining the idea of taking on the role, you’ll probably do well! I had little experience of formal research throughout my training, but having been PI for the NINJA pilot trial, I’ve learnt a lot.
A few tips that I have learnt (and I have no doubt there will be many more):
Before the trial
1. You must believe in the trial & have equipoise (if you don’t, read no further!)
2. As soon as you think you want to carry out, and lead an RCT at your site, look into exactly what the trial involves.
3. Discuss potential involvement with your department clinical lead and business manager.
4. Approach your Research and Development (R&D) department to:
a. Make contact and at least swap emails
b. Let them know about the proposed project in case any funding may be required and they can look into accounting for it if possible.
c. Find out what paperwork to start collating (see 3 & 4);
5. Organise a GCP training day for your department
6. Collate a Zip file of documents that will be required for the final submission.
a. Copies of all GCP certificates
b. 2 page CV of colleagues who may be partaking in the RCT.
7. Meet the rest of the trial team and other PIs – this makes future correspondence much better as names can be put to faces!
8. Work out how you are logistically going to run the trial.
9. Ideally at least get a research assistant to help with parts of the trial (not least the data collection/uploading).
The new IRAS system is much more user-friendly than before, and saves a lot of time. Also, a lot can be pre-populated especially with coordination with your R&D department and the trials unit who are leading the trial.
1. Liaise with your R&D department and the trials unit who are leading the trial so that you know the timelines for submission, target dates for recruitment etc. – THESE ARE VERY IMPORTANT as the clocks start ticking.
2. You will need to fill out quite a few details on the forms which takes abit of time depending on the nature of the trial (including title/details of colleagues – so find them out), but a lot can be transferred over from the lead site.
3. Get forms signed by your departmental business manager.
Running the trial
1. Have a meeting with your team before the site initiation visit (SIV) to tell them about the trial – questions may arise that you hadn’t anticipated – and make sure they have a copy of the protocol.
2. Make sure you have a lockable place for the trial documentation.
3. Organise a SIV, which will be attended by your and as many of your research team as possible, and representatives from the trial management team. At this the process of the trial will be discussed and there will be opportunity for you and your colleagues to ask any questions you/they may have, and also the fine details of the trial can be worked out.
4. Ensure everything is ready for Go Live!
5. Print out and display in relevant places:
a. A flow chart of the trial process
b. Inclusion and exclusion criteria
c. A checklist of what needs to be included at recruitment and follow-up.
6. Make readily available contact details of key members (yourself (the PI), members of the R&D team involved)
7. Enthuse everyone!!
During the trial
You do not necessarily need to be seeing and recruiting every patient. In fact, if you do, you may well struggle as it does take time. The key is delegation and involvement of all team members. In particular empower members such as nursing staff who may not be directly involved with recruitment, but may be a constant in a setting when the rest of the team vary, and may be key to completion of the screening log for example.
You will probably find that there is enthusiasm amongst your team initially, but then there is a risk of trial fatigue after a while, and it if key that you drive and maintain the momentum.
What can be very useful is to send round periodic updates on the trial, as a way of informing your team members how you’re doing, to encourage feedback to find out if there are issues they are facing, and with the undertones of a reminder that the trial is still on going and their participation is key to its success!
Tips for success
Overall, there are certain features you will need to be:
1. Enthusiastic and involved – your team members will feed off your engagement.
a. Team members may have questions that you can easily answer
b. PI meetings are a very important part of ensuring the smooth running of the trial, and also your feeling of involvement.
3. Good at communicating
a. Build up a good rapport with your R&D department – they can be a fountain of knowledge and invaluable to help you with the initial application process, and the administrative aspects of running the trial locally
b. Emails will form your main method of communication with the central team (you may need a bigger inbox!)
In summary, being a PI can be challenging at times, and certainly the time requirement varies depending on what stage you’re at in the process, and the involvement of the rest of your team. There will be times when it is frustrating, but the chances are others PIs will be having similar issues – ask the Chief Investigator or trial team if you do have issues – they will probably have the answer, of it may be very useful for them to know with respect to the trial going forward. However, it is extremely satisfying to be part of a successful team and to be contributing to the future health of our population by providing the best level of evidence we will have available to us.