What is a Clinical Trial?
A clinical trial is a type of research study involving people where a treatment or treatments are compared to gather evidence about which is the most effective to treat or prevent a disease. The treatment may be a medicine but could also be a device such as a pacemaker or even a new surgical technique.
Clinical trials are considered to the best way to help make decisions on which is the best treatment for healthcare professionals to provide for patients because:
• They are designed to collect information fairly and in a standardised way
• An ethical review takes place to ensure protection of the rights, safety, dignity and wellbeing of people taking part
• For trials involving medicines, approval from the Medicines and Healthcare products Regulatory Agency is required
• An independent committee must be in place throughout the trial to review safety information
• Analysis of the results is completed and reviewed by qualified statisticians
• The findings should be published and shared with healthcare professionals and publicly
Clinical trial participants are asked to provide their consent before taking part in a trial. This means participants must be provided with information about the reason and background of the trial, what will happen during the trial, including: the way the treatments will be given and any potential side-effects; any additional visits or tests required, for example, extra trips to hospital, extra blood samples taken, X-rays or other scans; and about how the data would be handled.
These potential participants must have the chance to ask questions before making an informed decision. Once each participant has provided consent, they will be enrolled into the trial.
Where the purpose of a trial is to make comparisons of treatments or interventions, the trial team will place participants into two or more groups. Participants will be allocated at random, or ‘randomised’, to one of these groups – this is like flipping a coin or rolling dice. Randomisation is the basis of a fair comparison as it helps make sure the groups are as similar as possible and so any difference in outcomes between the groups is likely due to the treatment or intervention.
Gathering clinical trial data
Clinical trials require information or data to be gathered about each participant, this may be health data such as blood test results, MRI scan or X-ray results. The data can also be demographic data such as your date of birth, age etc.
This usually requires the hospital site team to copy this information on a dedicated form, often onto paper to be sent to a place for data entry, or directly into a dedicated computer system. This needs to be signed off by the healthcare provider.
Before recruiting, health care professionals must identify participants that may be suitable to invited to take part in the trial whom they can approach. They may have to review existing data to help find people e.g. patients in a defined age category that have high blood pressure or patients that are going to have a certain operation. During recruitment healthcare professions also consider equality, diversity and inclusion, you can read more about this here.
This data gathering can is normally completed by health care professionals and can take a time and resources. Information gathered about participants during a clinical trial is kept confidential and stored securely. When the information is analysed or shared, it is anonymised, participants data is linked to a ‘Trial ID or patient number’. In this way none of the information is ever ‘identifiable’.
What is a data-enabled trial?
Healthcare providers already must record information in electronic health records (EHR). These could be at a hospital or a GP surgery and can be collected into national databases and registries. These may be called ‘routine-collected healthcare records or ‘electronic health records.’
Accelerating the use of EHR in research could make trials run more efficiently by:
- Finding potential participants more easily
- Ensure the diversity of people in the trial is close to the population
- Decrease effort in data collection and data entry at sites by removing duplication of effort
- Decrease the need for monitors to visit sites to check data
- Follow-up participants over a longer period
- Potentially increase the number of clinical trials being undertaken
Ultimately, this will lead to more accurate and representative information, resulting in better prevention of disease and treatment for patients. And, by decreasing effort and costs, it should allow much research to be done from the same funding envelope.
Why are the BHF Data Science Centre involved?
Only a small number of clinical trials have been using electronic health records in recent years. The BHF Data Science Centre would like to make it easier for researchers and clinicians running clinical trials to access and use electronic health records to support, or replace, data that is collected just for a clinical trial. We want to facilitate this transformation in the way clinical trials can be done.
Our work to date
In 2021, the BHF Data Science Centre carried out a survey of UK Clinical Trials Units to explore the use of routinely collected health records within trials. From the responses the survey highlighted clear challenges to the access and use of this data.
Following this, we invited the same community to participate in a workshop along with members of National Cardiac Surgery Clinical Trials Initiative. During the workshop the existing challenges were discussed, and initiatives identified for the BHF Data Science Centre to support the trials community.
The initiatives are:
- Providing guidance
To help trials teams navigate the process of gaining access to, and using, electronic health records by providing independent information, PPIE (Patient and Public Involvement and Engagement) feedback and guidance
- Developing best practice
To develop and publish best practice guidelines for access and use of electronic health records in clinical trials, drawing on what we have learnt from case studies, guidance and driver project activity.
- Standardising clinical outcomes for CVD trials using electronic health records
To work with the research community and patient representatives to agree best practices to derive clinical trial outcome measures from electronic health records
- Using leverage to improve processes
To leverage the BHF Data Science Centre’s role as a community champion to influence changes that improve the accessibility and usability of electronic health records for cardiovascular clinical trials.
- Targeted driver project activity
To support driver projects that are designed to gather evidence regarding the utility of electronic health records to successfully support clinical trials.
If you are interested about finding out about current trials, please visit the NIHR website ‘Be Part of Research’.
If you would like to find out more about using electronic health records, NIHR and Kings College London have created a video you can view here.
Cardiff University Centre for Trials Research in collaboration with ICO and the UKCRC have created a resource for researchers called CENTRIC focusing on enhancing researchers understanding of public perspectives and governance requirements when working with administrative data.