Clinical trials are the gold standard for getting new drugs and products on the market, but this lengthy process can often leave many unanswered questions, or in some cases, even spark new ideas. For instance, could there be other therapeutic applications of the drug or ways to improve its efficacy and safety? How does the drug compare with another product from a different company in terms of efficacy, safety, and cost-effectiveness? In these situations, an Investigator-Initiated Trial, also known as an IIT, can help shed light on these questions and possibly even lead to exciting new information, discoveries and innovations.
What are IITs?
An IIT is a clinical study that is initiated by an independent investigator, researcher, a research group, or institution. IITs are also known as Investigator-Initiated Studies, Investigator-Sponsored Trials, Non-commercial Trials, Academic Clinical Trials, Physician-led Studies and Investigator-Driven Clinical Trials. The basis for an ITT stems from unanswered questions that arise during clinical trials. Alternatively, it could also be driven from real-world experiences or problems with a particular product in the market.
For an ITT, the company only funds the study but does not act as a sponsor in the traditional sense. In doing so, any legal liabilities and responsibilities associated with the study rest entirely with the investigator. The funding can also come from other non-industry sources, including academic bodies and the government. One of the distinguishing requirement for an ITT is that it is a spontaneous and unsolicited request by the investigator.
Benefits to Industry and Researchers
IITs can provide several advantages to both the researcher and the company:
- Gain more information on product safety and efficacy
- Answer questions that clinicians face in a real word setting in their practice
- Non-industry sources of data improve the credibility of data generated by the company
- Generation of new ideas and intellectual property
In summary, ITTs help fills knowledge gaps that have not yet been addressed. The overall result is a significant improvement in the clinical outcomes of products that will come to market or further enhance those that are already marketed.
Criteria for a Successful ITT Application
An ITT begins as a concept note to a company, followed by a full-fledged proposal outlining the study protocol. It is evaluated based on several rigorous criteria:
- Background and expertise of the applicants to execute the study as described in their Curriculum Vitae
- The unmet medical need of the study to fill a knowledge gap in the literature
- Quality of the study design (rationale, methodology, endpoints, statistics)
- Budget and financial resources available to support the study
- Compliance with Good Clinical Practice (GCP), local laws, guidelines, and regulations
The outcome of an ITT does not need to benefit the company and therefore this criterion is typically not required for approval. The success of an ITT application, however, will depend on satisfying (and exceeding) the above criteria. In addition, the chances for a successful applicationwill also depend on the number and quality of other ITT submissions, as well as the company’s available budget to support these studies.
Ready for an ITT Submission?
So, do you have an idea that is ready to be submitted as an ITT? Sengi offers resources and services to draft and improve the quality of your ITT applications. Also stay tuned for our next article detailing the key steps for a successful ITT submission.
- Suvarna V. Investigator Initiated Trials (Iits). Perspect Clin Res 2012;3:119-21.
- Konwar M, Bose D, Gogtay NJ, Thatte UM. Investigator-Initiated Studies: Challenges and Solutions. Perspect Clin Res 2018;9:179-83.