Investigator-Initiated Trials

Investigator-Initiated Trials (IITs) are clinical trials in which the investigator assumes the roles of both the sponsor and the investigator.

In an IIT, the investigator conceptualizes the research, develops the protocol, and takes on the immediate responsibility of administering or dispensing the investigational product to the subjects. 

At Clinixir, we take pride in our clinical data management and statistical analysis services, ensuring a smooth and successful research journey. 

In an IIT, the sponsor investigator plays an important role in creating, coordinating, and conducting the study. They shoulder the obligations of both a sponsor and an investigator, leading the trial with their expertise. 

It is important to note that the individual roles of investigator and sponsor still exist within an IIT.

Key Considerations for a Successful IIT Application

Conventionally, the process of initiating an IIT involves presenting a concept note to a sponsor. After this, a comprehensive proposal must be submitted. These proposals are subjected to and then assessed against the following criteria:

The Applicants Background
& Expertise

The applicants background and expertise – to ensure the applicants are able to effectively execute the study.

Addressing Gaps in Literature
& Unmet Medical Needs

The study’s ability to address any gaps in existing literature or unmet medical needs is thoroughly evaluated.

The Overall Quality of the Study

This includes the design of the study, rationale, methodology, endpoints and statistical approach.

The Study’s Financial Feasibility

This means taking into consideration the: availability of the budget and additional financial resources for its support.

Adherence to Ethical Standards

This includes Good Clinical Practice (GCP), local laws, guidelines and regulations.

The inclusion of non-industry sources of data in IITs strengthens the credibility of the generated data, adding to the scientific evidence supporting the company’s products. 

By filling knowledge gaps and improving clinical outcomes, IITs contribute to the continuous development and refinement of products in the market. 

Clinixir recognizes the value of Investigator-Initiated Trials and supports researchers in their pursuit of knowledge and innovation through our clinical data management and statistical analysis services.

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