MSA Trust

What is research?

The aim of clinical research is to gather evidence that can be applied for improved understanding of health and healthcare, and the development of safe and effective treatments.

Most clinical research in the NHS will take the form of a research study or a clinical trial. A research study aims to better understand health and health conditions and may gather information from a person about their history, medical condition, treatments and outcomes. A research study collates information but does not introduce new or experimental treatment. Experimental research usually takes the form of a clinical trial. A clinical trial compares the effects of two treatments, usually either a new drug (but can include new technologies or methods), or the use of an existing drug in a medical condition that it has not previously been used for.

Phases of clinical trials

Pre-clinical studies gather information about feasibility and safety in a laboratory setting before any testing in humans can begin.

Phase I – is the first clinical phase, often called first-in-man studies, and usually involves small groups of healthy volunteers or patients, to assess the safety of the drug

Phase II – involve slight larger numbers of people, usually patients, and assesses the safety and effect and optimal dose and side-effects of the drug.

Phase III – involves testing the drug in large numbers of the patient population, to compare the drug to current or placebo treatment, assess effectiveness and safety and longer-term effects.

Phase IV – usually once the drug has been shown to work and licenced for use, a phase IV study can examine how well the drug works when used more widely, long term risks and benefits and possible rare side-effects

 

Research Results and Clinical Practice

Research projects differ in their size and duration, and historically it can take quite some time, in some cases many years, to get new products to market. In recognition of the delay, there has been a move to reduce time taken for research results to be translated into clinical practice (called ‘from bench to bedside).

However, clinical trials can take some time to gather all the information needed to determine if the trial has been a success and make any new treatment available to the general population. For a new treatment or medication to be approved for use in the NHS, it must be approved by the National Institute for Health and Care Excellence (NICE).

You can search for research results here:

https://clinicaltrials.gov/ct2/home