Best Ways To

Increase PI

Involvement In

Clinical Research

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A PI or a principal investigator is the person responsible for practically everything that happens in a clinical trial. PIs are in charge of the protocol as well as obliged to work in compliance with GCP (good clinical practice) and according to FDA and other laws. Although the PI can delegate his/her work to other staff members, he/she will be the one responsible if something goes wrong during the trial.

A good example for an activity that the PI shouldn’t delegate but follow directly is adverse effects and events, and if those side effects come from the research drug. This is a serious task that should be closely followed directly by the PI.

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PI oversight is one of the most important practices that ensure successful trials. For this reason, many site owners wish to increase and improve PI oversight.

Since PIs usually delegate most of their work to other staff members, at one point it can happen that they aren’t involved in the study at all.

This is when most sites encounter problems. Although delegating work tasks is okay in some cases, in others it can be impossible and irresponsible to do this.

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There are many cases when the PI owns the research clinic (which is also his own private practice). Usually, when a PI owns the clinic they don’t get a fixed salary out of doing research. For this reason, they tend to focus more on their private practice and less on the actual research. This can be a tricky problem because the research won’t generate money for the PI unless he gets more involved. However, most PIs focus on the income that they can get today from their private practice and completely forget to invest their time in research (which can bring them more income in the near future).

In this second example, maybe your PI is employed in a University clinic or also works for another site. If this is the case then probably he won’t be too involved in your research. This usually happens when sites don’t properly communicate with PIs and they don’t tell them what they expect of them.

1st example - When they own the research clinic but don’t get money from it

2nd example - When the PI is employed elsewhere

So, why aren’t PIs more involved?

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Figure out what the PI wants - and give that to him! This is one simple thing that every site should do in order to increase their PI oversight and involvement. Figure out what the PI wants and what would make him or her more interested in being involved! What can you use to motivate your PI?

Simplify and make things easier for your PI! Another thing that sites can try doing is making things easier for the PI. In some cases, this might mean working in accordance to his timeline or free time or maybe hiring someone to help him when he’s too busy… Try to simplify all the things in your power in order to make it easier for the PI to be involved.

Adapt the site’s schedule to the PI’s schedule! Many sites make the mistake of expecting the PI to adjust to their schedule. In reality, PIs are usually extremely busy! For this reason, the best thing you can do as a site is adapt. Try to fit patient visits according to your PIs schedule, or monitor visits when the PI is free… These things can really help you a lot in keeping your PI more involved.

Give them more benefits!Finally, if nothing else works, try to give the PI more benefits. This depends on the structure and situation of the site, but some sites would even give equity to the PI. Giving equity to the PI will make him feel like he’s your partner, not just an employee, thus giving him the right motivation to increase his involvement. If this is not an option for you, then you can give him or her a higher percentage of your income. Regardless of what you choose to do, giving the PI more benefits will definitely help you to increase oversight!

How to increase PI involvement?

To sum up, a PI who isn’t properly motivated or compensated for his work will probably be less involved than a PI who has some benefits out of doing research. For this reason, try to do your best in order to give the best motivation and/or benefits to the PI. Apart from this, also try to clearly communicate your needs and expectations of him/her.