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Why are Investigator-Initiated Trials (IITs) important?

Updated: Jan 12, 2023

MEDSIR is a company specialized in helping investigators develop their ideas for Investigator-Initiated Trials or IITs, with wide experience in the design, negotiation and management of these kind of trials.

What does IITs exactly mean?

Generally, the public knows clinical trials are studies that are run by healthcare companies used to provide evidence for that company to obtain approval and then market and sell their drug. An IIT, in contrast is brought about by an investigator or group with a specific scientific question in mind based on clinical experience and healthcare companies are only involved by providing the drug and/or funding for the study. This method of clinical research can alleviate some of the public’s distrust in pharmaceutical companies and biotechs, as the investigator oversees the design and analysis of the trial and maintains ownership of the data.

These studies are often developed from questions that arise during drug development that were not answered during the clinical trial. These can include utilizing a licensed and promising drug in a different therapeutic indication, a head-to-head comparison of two treatment options, or even an evaluation of cost-effectiveness of a given treatment.

What are the challenges of an IIT?

While an IIT is attractive because of transparency and increased control for the investigator, they bring with them a unique set of challenges.

For the investigator, taking part in an IIT instead of a pharmaceutical-sponsored trials means that they are responsible for initiating and sustaining the trial. This means that they will be responsible for securing funding, submitting documents for regulatory submissions, overseeing the trial and data management, as well as the medical writing and publication of results.

What are driving the need for IITs?

Despite the challenges, taking part in an IIT can be extremely rewarding for an investigator because it gives them the direct ability to generate evidence based on their clinical experience and answer questions that they have in their day-to-day practice. IITs are crucial in driving translational research by helping address critical unmet needs that arise from clinical trials.

For healthcare companies, IITs are highly attractive because this unsolicited, independent research can be judged on scientific merit and company interested and can promote unbiased company research.

How MEDSIR can help with IITs?

At MEDSIR we aim to simplify the process for investigators with the goal of making sure the best clinical ideas get developed:

  • We provide full support throughout, from development of the idea to the final publication.

  • We understand that your time is valuable, and we want to make IITs as easy as possible.

  • Therefore, you will work with our highly skilled scientific team will help develop your idea into a thoroughly researched and written protocol.

  • Once the protocol is developed our strong business team will get to work on getting your trial funded.

  • With funding secured our operations team will take care of running the trial and once complete our communications team will help in publishing and dissemination.

Our goal is to bring promising treatments to patients and we need your help!

If you have an idea for an IIT, we can offer you a cross-functional system fully integrating the strategic, scientific, and operational aspects of independent clinical research.

Reach out today to get the process started on your own IIT!



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