The former is limited selleck in extrapolation or generalizability and therefore the other RCT or the Real world Clinical Trial needs to be initiated. Of course, IITs can also be done pre-marketing, e.g., in a phase IIIb setting. While companies do conduct such phase IV studies, it is also good if investigators initiate their own research in the post-marketing environment. In some cases it is part of a company’s strategy to expand information around the product and/or therapeutic area. Some IITs are in scope and some are not in scope from the company’s perspective. Whether data from IITs, funded by a company, can be used for regulatory submissions to get new indications approved is a matter of debate since these studies are generally not monitored by the company per its SOPs. There are some important caveats.

The trial request must be initiated by the investigator and not by the company. It has to be a spontaneous, unsolicited request. The same needs to be directed to the medical department. The request, in the form of a concept note, is evaluated based on objective criteria such as credentials of the investigator (Curriculum Vitae showing s/he has designed and conducted original research; not black-listed), need for such a study (meets unmet medical need or fills a gap in medical literature), quality of design of the study, and cost-effectiveness (needs to be reasonable enough to fit into the budget). Whether the company will benefit from the study or whether it involves the product or therapeutic area or whether the investigator is important to the company should not be criteria for approval.

Scientific rationale, study design, endpoints, formulation, statistics, budget and availability of local human and financial resources as applicable to oversee and support the study should be the criteria for approval, and compliance with ICH-GCP or local GCP regulations and all laws, rules, guidelines and regulations applicable to the planned IIT, including local, anti-corruption, anti-bribery and anti-kickback laws. Once a go/no go decision is reached, based on the above criteria, the same is communicated to the investigator. Hence expectations need to be managed upfront. If yes, then a protocol template may be sent to the investigator who is then expected to flesh out the concept note into a full-fledged protocol. The same is again reviewed locally by the medical department, and AV-951 sent to the regional and global medical team for further inputs into the scientific aspects. Funding of the study is generally done by the local affiliate, though in some cases selleck bio the global team may also fund. Once approved/rejected, the same is communicated back to the investigator.