Research and innovation

The Trust is involved in multiple types of clinical trials.

These can be grouped based on their design:

• Interventional: A clinical study in which participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the intervention. The main type of interventional trial, and the gold standard for clinical research, is the Randomised Control Trial (RCT), where the patients entering the trial are randomly assigned to one or other treatment to allow a direct comparison of outcomes.
• Non-interventional: A study where the patients treatment is not changed due to inclusion in the trial. The study may involve the collection of routine blood and scan results, adverse events or quality of life assessment. These studies are often called observational studies. 

Trials can also be described by the key parties involved in managing and conducting the trial:

• Commercial/industry research: Trials sponsored and funded by pharmaceutical companies. These trials often investigate new medicines or interventions.
• Academic research: Trials sponsored by universities or NHS Trusts. The scope of these trials are often broader focussing not only on new medicines, but also on new uses for medicines, quality of life and sometimes even whether less treatment can have similar outcomes.

Clinical trials use a range of testing methodologies to ensure that the quality of the data collected is of a high standard.

• Prospective: Patients are followed over a period of time.
• Randomized: Patients are randomly assigned to either a treatment group or a control group who receive either the current standard treatment or a placebo.
• Cross-over: Patients receive both the treatment and the placebo at different times.
• Double-blinded: Neither the patient nor the researcher knows if the patient is receiving the treatment or the placebo.
• Open label: Both the patient and the researcher know that the patient is receiving the treatment and not the placebo.

There is a range of clinical trial formats.

• Natural history studies: Collect health information over time to see how diseases develop.
• Prevention trials: Find ways to prevent a disease in people who have never had it before, or to prevent the disease from returning.
• Screening trials: Test the best way to detect certain diseases or conditions.
• Diagnostic trials: Look for better tests for a particular disease or condition.
• Treatment trials: Test new treatments, new drugs, new surgical methods and new therapies.
• Quality of life trials: Find ways to improve the comfort and quality of life of people with long-term illness.

• Phase 1: Tests the new drug or treatment in a group of 20-100 people to evaluate its safety and monitor any side effects.
• Phase 2: Tests the new drug or treatment in a larger group of 100-300 people to determine how well it works and to further evaluate its safety.
• Phase 3: Tests the new drug or treatment in large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects and compare it with the standard drug or treatment.
• Phase 4: This take place after a new drug or treatment is made available to the public. Researchers track the use of the new drug or treatment to find out more information about the risks, benefits, and the best way to use it.

Commercial research is a vital part of the Trust's research portfolio and provides significant opportunities for both researchers and patients.

The Research and Innovation department is committed to supporting commercial research at the Trust wherever possible.

The Trust offers access to outstanding investigators across clinical disciplines, dedicated clinical trials infrastructure and a high level of patient involvement from a population of approximately 300,000.

If you would like to discuss the possibility of conducting commercial research at the Trust, please contact the Research and Innovation team.

If you are a researcher in the Trust and have been approached by a company about taking part in a commercial study, or you have an interest in getting involved in industry led research at the Trust, please contact the Research and Innovation team.