In many cases we don’t always know (due to a lack of evidence) which of the large number of existing treatments routinely used in the NHS is best for an individual patient, or group of patients. It’s important, therefore, to compare the medicines and other treatments used in order to better inform evidence-based treatment.
The best way to get the evidence is to carry out large-scale randomised controlled trials with the help of patients who are willing to take part so that we can reliably compare the different treatments available. This can be costly and time-consuming.
However, such trials could be carried out more simply and efficiently by GPs and other healthcare professionals (HCPs) recruiting patients into the research at the time they are prescribed their medicine or treatment at the GP Surgery or hospital.
These trials in a real life setting are often referred to as “pragmatic trials”, and can be cheaper to run than large scale explanatory trials which are designed to measure efficacy in a well-defined and controlled setting. Pragmatic trials are especially suitable for testing the effectiveness of existing treatments. Such trials present little or no risk to the participant as they would receive a standard treatment routinely prescribed within the NHS for their condition anyway. In many cases this will be exactly the same treatment they would receive if they decline to take part in the research.
The patients recruited to these trials can be followed up through their electronic health records held by their GP or, where applicable, their hospital medical records. For the vast majority of these types of trials the patient would not be asked to do anything other than agree to be randomised (rather like tossing a coin or rolling a die) to a standard treatment and to the use of their data for purposes of the research. For some trials it might also be necessary to ask them to agree to some additional research procedures such as extra blood tests or answering a simple questionnaire.
These ‘simple and efficient trials’ can be randomised in two ways:
- Individual randomisation where each patient who is suitable to join the trial will be individually allocated to an intervention, or
- Cluster randomisation where whole units rather than individuals are randomised, for example, GP practices, hospitals, or wards are randomised to provide different interventions.
This latter type of trial is known as a cluster randomised trial2 or ‘cluster trial’ for short.
A forthcoming piece of European legislation (the ‘Clinical Trials Regulation’, likely to come into force in 2016/17) will allow informed consent to be obtained in cluster trials involving drugs by what is referred to as ‘simplified means’ in the Regulation. Whilst this EU Regulation is not yet applicable to drug trials we need to consider what the practical and ethical implications of this important provision are now so that that we are able to provide appropriate guidance regarding the seeking of consent by simplified means once this Regulation is in force.
Seeking informed consent for simple and efficient trials in the NHS – Draft guidance:
CHCUK Note: Surely if simplified consent is applicable to low risk pragmatic trials, then it would also be applicable to non-interventional studies?