A clinical trial is a research study conducted in human patients with one or more of the following goals:
- To test new treatments such as new drugs, new therapies and new vaccines.
- To test new combinations of existing treatments, or change the way they are administered, to increase their effectiveness and/or reduce side effects.
- To compare the effectiveness of drugs used for controlling symptoms.
- To assess which treatments are the most cost effective.
Types of clinical trial
The Trust is involved in multiple types of clinical trials.
These can be grouped based on their design:
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.
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 trial methodologies
Clinical trials use a range of testing methodologies to ensure that the quality of the data collected is of a high standard.
Patients are followed over a period of time.
Patients are randomly assigned to either a treatment group or a control group who receive either the current standard treatment or a placebo.
Patients receive both the treatment and the placebo at different times.
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.
Clinical trial formats
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.
Clinical trial phases
- Phase I
Tests the new drug or treatment in a group of 20-100 people to evaluate its safety and monitor any side effects.
- Phase II
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 III
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 IV
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.
Examples of recent trials
Clinical research has always been vital to medicine, and that role has been felt acutely during the COVID-19 pandemic.
Without it, the vaccines and treatments that are now saving lives and improving recoveries simply could not be possible.
Here are just a few of the COVID-19 clinical trials that the Trust has been involved in during the pandemic:
SIREN is trying to understand whether prior infection with SARS-CoV2 protects against future infection with the same virus by carrying out regular swab and blood tests over time
ENSEMBLE-2 is evaluating if the Janssen Ad26.COV2.S investigational vaccine can prevent symptomatic COVID-19 after a single dose
ComFluCOV is seeing what side effects, such as fever and tiredness, people get when they are given their second dose of the COVID-19 vaccine at the same time as the currently recommended flu vaccine
The primary purpose of REMAP-CAP is to test treatments that can be applied during the coronavirus pandemic in order to reduce deaths, Intensive Care Unit (ICU) use, and morbidity in severely ill patients with COVID-19 infection
PRIEST is identifying the most accurate triage method for predicting severe illness among patients attending the emergency department with suspected respiratory infection caused by COVID-19
PHOSP-COVID aims to identify whether there are longer term health problems of COVID-19 for people who were admitted to hospital
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