A Comprehensive Guide to Investigator-Initiated Trials
What are investigator-initiated trials? Many people, including those who own a medical device business, are wondering about that. In short, it refers to clinical trials conducted by independent researchers. Usually, they are not tied to any specific company or corporation.
You might be familiar with its other name: IITs, an abbreviation for investigator-initiated trials. To learn more about its definition, roles, and the regulations behind it, see the comprehensive guide below!
Investigator-Initiated Trials: How to Define Them
From the explanation above, you already know the overview of what an investigator-initiated trial is. It refers to clinical trials of a product, but not within the company. The concept is similar to an external auditor in the economic sector. But the object is a product itself, not a financial statement.
If you want to compare an investigator-initiated study vs a clinical trial, both of them are the same thing. An investigator-initiated study is one of the types of clinical trials that is common. Japan legalized it in 2003.[1] It also expanded in Indonesia over the past 15 years, growing by 83% in 2024.[2]
An independent investigator (alone or with a team) can conduct a trial or research with funds from their own resources or from institutional sponsorship.
Medical device companies or any other pharmaceutical and biotechnical organisations can also sponsor the trial, especially if they own the product. You will know it as a sponsor-initiated trial (SIT). Even though the trial processes are similar, there are a few differences between investigator-initiated trials and sponsor-initiated trials.
IITs are usually more focused on academic aspects, while SITs are more driven by profit.
IITs’ Roles and How They Are Important
Many people are becoming aware of the importance of investigator-initiated trials (IITs). Their roles are to:
1. Expanding Products Knowledge
Most of the time, investigators conducted trials to expand product knowledge for the benefit of the wider community, especially in health. After thorough research, they will know whether its features, performance, and other components match the claim.
2. Ensuring Product Safety and Effectiveness
Aside from that, IITs also ensure the safety and effectiveness of products. Usually, medical device companies will need it to gain pre-market approval from authorities. Without a clinical trial, your products’ market entry will most likely be denied. It applies in almost all countries and regions.
The regulation exists to protect consumers from defective, damaged, and potentially dangerous products. So they can only buy and use products that are guaranteed safe and effective.
3. Identifying New Ideas to Improve and Correct the Products
If the investigators find defective, damaged, or potentially dangerous products in the pre-market stage, it will benefit business owners. They can help you identify new ideas to improve and correct the products. This step can minimize problems when the products have entered the market.
How to Conduct IITs
Interested in conducting IITs or sponsoring ones? Make sure to comply with these requirements and regulations!
1. Make A Plan
It’s hard to do anything without a proper plan, including IITs. That’s why, before conducting a trial, make sure to know:
- Who will conduct the trial (alone or with a team) and who will be the sponsor.
- The purpose of the trial. Must be specific with backgrounds, aims, outcome measurements, and the importance of it.
- Conduct a literature review and propose. Don’t forget to consult an expert if necessary.
- Create a Steering Committee, including:
- Mentor (two people minimum).
- Clinical trial project coordinators or managers.
- Statistician
- Finance team.
- Legal team.
- Specialists in the field under test.
- Study budget.
- Study the regulation in your country or region.
- Prepare the requirements.
2. Start the Trials
If your plan is already proper, you can start the trials. During the research, you should:
- Make sure to submit a request for IITs to the authorities and already get answers regarding the trials from them.
- Setting up a site for the trials with complete equipment.
- Confirm a Schedule Site Initiation Visit with the authorities. Schedule recurringg status meetings to reviewkeyt metrics.
- Finish the project.
- Provide study results to the study team and subjects before you publish the results.
- Publish the results.
You already know what investigator-initiated trials are are and how important they are. That’s why you have tocomply withf all regulations related to this. Naramedic can help you with it, especially for medicaldevice businesss owners. Contact us via WhatsApp or email and choose us as your regulatory partner!
