Commercial Research

Practices can get involved in commercial research by being:

• a research site - any NHS/Non-NHS site where research is taking place. This involves a clinician or other healthcare professional obtaining consent and/or collecting data from a patient 

or involvement as a:

• Participant Identification Centre (PIC) - NHS/HSC organisations that identify potential research participants for a research study (e.g. through search of patient databases) and have no other involvement in the research are referred to as PICs

Being involved as a PIC is a good place to start as you do not need to be set up as a site.

For a site-based study, you need to identify the correct trial for your site in terms of complexity and experience within the team. 

It may be best to start with an observational study before an interventional study. It is generally Phase III and IV studies that recruit from primary care (though on occasions there may be Phase II studies depending on the trial). 

If you have specific expertise within the team (for example, special interests or training), then try to capitalise on this with the type of study you are expressing interest in.

Certain clinical trials (Clinical Trial of an Investigational Medicinal Product / CTIMPs), such as vaccine studies, may have specific drug (Investigational Medicinal Product / IMP) storage requirements such as a -20 or -80 degree C freezer.
Sponsors may loan sites equipment required for specific studies. Also, look out for any funding calls that may support purchase of research equipment. 

If you are interested in taking part in commercial research, please contact: sc.rrdn@nihr.ac.uk and the industry team will get in touch with you. 

There is an NIHR national site identification process for helping industry teams identify sites (including GP practices) to take part in research studies. It is a competitive process. 

You will need to create a practice profile that will be available for sponsors to view. This will include information about your practice, any previous research experience/ expertise and infrastructure and staffing at your practice to support research.

Please contact South Central RRDN sc.rrdn@nihr.ac.uk who can support you in creating and submitting a practice profile. 

You can use this template to help complete your practice profile. 

GP practices will receive limited, non-confidential information about the study:

• Submission B form – overview of study, inclusion and exclusion criteria, key outcomes, recruitment targets and study timelines

• Schedule of events - outline of study visits and associated procedures

You will be invited to express interest in the study, via an online form which goes directly to the sponsor. 

The GP practice will need to provide an estimate on potential recruitment numbers for the study (feasibility).  This needs to be your best estimate based on the information you have available from the sponsor. The protocol (and participant inclusion / exclusion criteria) may still be in the draft stage. Be realistic about the figure.  

Your practice profile will be visible to the sponsor and will be used for all expressions of interest.

If a sponsor is interested in you as a potential site, you will then be contacted for further feasibility discussions. You will be asked to sign a Confidentiality Disclosure Agreement (CDA) to receive further information on the study (e.g. study protocol) and asked to complete a sponsor feasibility form / questionnaire (usually submitted online). 

You may then be invited to attend a Site Qualification visit (SQV). This may also be referred to as a site selection or pre-study visit. 

Following the SQV, the sponsor will contact the GP practice with the outcome of the visit and whether the practice has been selected for the study.

• Study not going ahead in the UK or study withdrawn

• Limited number of sites allocated to the UK for the study

• Lower predicted recruitment from the site compared with other sites

• Less commercial experience compared with other sites 

• Sheer volume of interested sites: sponsor may only include a proportion of interested sites due to their budget 

If you are not selected for a study, the company may say they will be in touch regarding future studies. It is sometimes the case that an opening becomes available for additional study sites should a selected site fail to set up in a timely manner or meet their recruitment target. 

It is important to keep good relationships with the sponsor when not selected for a study as they may have future opportunities to collaborate with you on other studies.

They will have met your research team and seen your practice and it may be that a more suitable opportunity will come along.

Once contracts have been signed, you will be required to have a Site Initiation visit (SIV) including any specific training required for the study. There is likely to be additional online training to be completed outside of the SIV. Once all training has been completed by all the team, you will be given the greenlight to start recruitment.

Clinical trials best practice guide 2024 suggest you maintain ongoing contact with the sponsor to make sure targets are achieved.  Ensure you respond in a timely manner for requests (e.g.  data checks).