Commercial Research

Academic studies and commercial studies are fundamentally the same; they are designed to answer a specific question and must go through the same rigorous approval process to ensure that they are safe and fit for purpose. 

All of the medication and devices that are currently being used today to treat patients around world would have first had to go through a series of clinical trials to deem them safe and fit for purpose. The progress of health care depends upon these trials, and ultimately the involvement of our patients.

All research studies (whether commercially or non-commercially funded) are reviewed by an independent national ethics committee who are responsible for ensuring that the research is robust and safe for patients to take part in. On the same note, research studies will also be reviewed by hospitals / sites who will be delivering the research to their patients.

Each patient is a volunteer. They will not be entered in to a study without their consent or without being fully informed of the requirements and any associated risks and benefits. Their eligibility for the study is also considered by taking in to account their full medical history. Every patient is closely monitored throughout the course of the study. Patients are able to withdraw their consent at any time!

Commercially funded research is responsible for a high percentage of medication and medical devices that are available today. Public funding is limited so it's critical to have support from these companies in order for our health care to progress.

Business is business and commercial companies do need to make a profit to survive however, any medicine or medical device must have proven patient benefits and been approved by the National Institute for Health & Care Excellence before the NHS will consider buying them!

Just like funding from academic sponsors, the commercial companies will provide payment to practices for the activities required to deliver the study. There is no conflict of interest as there are no personal payments provided to the staff delivering the research. 

There is enormous potential for the UK to drive economic growth from innovation and commercial companies also provide a ‘capacity building element’ for practices to be able to generate further research capacity in addition to study related and overhead costs. 

Acting as a Patient Identification Centre (PIC) - least burden on practice: You can refer potentially suitable patients to commercial trials taking place in local practices or hospitals by search and mail out or opportunistically during a consultation.

Observational studies: these can involve observing and collecting data on participants to learn more about their condition. Data is usually collected via questionnaires or interviews.

Interventional studies: these generally involve comparing a new or different type of treatment with the best treatment currently available.

Participants

• Participants will have access to novel treatments, and in some cases have the possible extension of medication (IMP - investigational medicinal product) once the study has finished.

Training

• All training is provided and funded by the company. Site initiation visits tend to be longer and more formal as these offer more opportunity for training.

• Good Clinical Practice update is required; usually online with each study.

• Trial protocols are usually more intricate and can be a little more complicated.

Procedures

• Study teams require a quicker set up time and you will need to recruit your first patient as soon as possible after the site is activated.

• Intricate study tests may be required in some instances e.g. ECP, Spirometry, Scans.

• Regular monitoring visits to review process and data collection; an opportunity to learn and discuss.

• All equipment will be provided and calibrated but you will need to have adequate facilities and storage on site. Generally more ordering IMP, dry ice, lab kits etc.

Commercial companies will come back to you again and again!

• Check suitability to run the study in your practice:

  1. Review patient population prior to starting a study and ensure that assess if you can meet the recruitment target.

  2. Check that your premises are suitable e.g. you have storage for site files, paperwork, IMPs, fridges, clinical rooms available and appropriate for procedures required to deliver the study.

• Be organised; use visit schedule, set up an ordering system for IMP, sample bottles etc. Have all equipment ready at hand.

• Teamwork; be prepared to work as a one team with the study team and help each other. Use expertise of other colleagues.

• Clear, concise and timely communication are key e.g. concerns, recruitment, targets. Know your contacts.

• Keep up to date on data queries, visits, amendments

• Make use of the monitoring visits; don't think of these a big brother watching over you....they are learning opportunities and a chance to review deviations or missing data.

• Be prepared by ensuring that you know the protocol and what is involved regarding visits and timelines. 

• Ensure that you know the SAE reporting procedure, who's responsible for IMP ordering / delivery

• Ask what happens at the end of a study - some companies provide IMP for further two years after study if patients have responded well.

• Reach out to your local research facilitator or RRDN research nurse

If you decide you would like to get involved, it’s useful to develop a ‘practice research team’. Whether it’s academic or commercial research, it’s beneficial to have whole practice buy-in and have a few members of the team involved. We would suggest having representation from each staff group i.e.  GP, practice nurse, administrator and practice manager with either the administrator and practice manager acting as a ‘project coordinator’. Forming this research team facilitates better communication, enables quick assessment of studies to determine interest and ensures efficient set up and delivery of commercial studies.

Commercial study protocols are usually more complicated/intricate with strict timelines and so having a team on board who know the study and can complete their allocated tasks in a timely manner will make your practice very attractive to commercial companies.

Our Industry Team provide training on how to complete high quality expression of interest. This can be delivered as a bespoke course at your practice.

• • Support set up of commercial studies at the practice including target setting, contract reviews, and cost negotiations

  • We can attend all study set up visits and oversee patient recruitment

  • Escalate any issues with delivering the study

  • Share hints and tips for best practice from experienced practices

Contact your Research Delivery Network and let us know that you’re interested. We only send out details of our studies to the contacts that we currently have for our practices. 

Your local facilitator will promote PIC studies as and when we are approached by commercial companies requiring practices in the area. Let your facilitator know if you’re interested and they will forward on any expressions of interest to the commercial company. 

Applying to take part in observational and commercial interventional studies is different to the way in which you would apply to take part in academic studies. The practice is required to complete a Site Identification form to demonstrate how you can reach the criteria specified. This needs to be completed in a timely manner as the commercial company need to quickly assess how many sites in the UK can deliver their study with the required number of patients needed per site.