2nd Feb 2017, 04:09 PM
Physician initiated research with approved products
At what point does the free supply of a product (P category) to a physician in the UK become a clinical trial in which the company providing the product becomes the sponsor?
Companies are not infrequently asked to provide products free of charge to physicians who are either interested in gaining experience with the product or planning to include it in their own research. I am looking for guidance on where the boundary between the supply of free product and the company being seen as the sponsor of any subsequent research might fall? In some cases the company might also be asked to provide some additional support such as one or more of the following:
- grant to support the planned research
- input into approriate research design
- support to analyse data
- support to write a publication
Does anyone have an opinion on when the company should consider themselves to be the study sponsor rather than simply meeting a request for free product?
10th Feb 2017, 10:13 AM
As per GCP définitions :
An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial.
An individual who both initiates and conducts, alone or with others, a clinical trial, and under whose immediate direction the investigational product is administered to, dispensed to, or used by a subject. The term does not include any person other than an individual (e.g., it does not include a corporation or an agency). The obligations of a sponsor-investigator include both those of a sponsor and those of an investigator.
If the company is not responsible for initiating the trial (protocol writing, CT application , Regulatory approvals ...) and giving support to investigator (whatever support includes) it is considered as Sponsor Investigator Study.