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Delivering Industry Studies

1. What is an Industry Research Site?

Any GP practice acting as a host for industry clinical trials where a nominated GP acts as principal investigator (PI) during the trial, liaising directly with the pharmaceutical company to recruit patients from their list, and to deliver the intervention according to the research protocol. Practice staff undertake the set-up and running of the trial.

What is involved?

The Clinical Research Network (CRN) sends summaries of industry clinical trials adopted onto the NHS National Institute of Health Research (NIHR) Portfolio. You will be asked to review the summary and, without commitment, if you would like further information, complete and return the Expression of Interest (EoI) within the specified time. If your EoI is accepted, you will liaise with the pharmaceutical company directly.

It is essential that anyone involved in these clinical trials is Good Clinical Practice (GCP) trained

 What are the benefits?

· Patients have access to treatments not routinely be available to them

· You can contribute to the development of treatments which may improve patient outcomes

· Delivering industry clinical trials can provide a significant additional income stream for your practice

· Patients will be reimbursed for any related travel costs

Your local CRN Primary Care Industry contact can provide guidance on accessing GCP training, help to identify potential studies for your practice and provide support on research management and governance issues.

2. What is a GP Participant Identification Centre? (PIC)

A PIC is any organisation responsible for identifying and informing potential patients about a trial taking place in another organisation.

What is involved?

The CRN will send details of an ethically approved co-adopted industry clinical trial taking place in a local research site. A search of your clinical system will identify potentially eligible patients - the CRN can assist with this - prior to GP screening of the list.

A patient invite, using your GP letterhead will be sent to potentially eligible patients to inform them of a clinical trial taking place which may be of interest to them. Patients need to contact the team at the research site for further information if they wish to be involved

A PIC is not:

x A research site

x Responsible for subsequent assessment of potential patients and their possible recruitment into the trial

x Responsible for the delivery of procedures specified in the research protocol

 What are the benefits?

· Patients have access to treatments not routinely available and will have any travel costs reimbursed

· Acting as PIC site will provides an additional practice income stream

GP practices acting as PIC sites will be paid per trial to cover stationery and postage for patient invite letters, for the time taken to search and screen the patient list and, after patient consent, for providing a brief medical history. In addition a further reimbursement will be made for any patient randomised into a trial.

If you would like further information, please contact Lauren Thakrar, Assistant RM&G Project Manager email: lauren.thakrar@uhcw.nhs.uk