A movement of patients, carers and relatives

Harnessing the patient voice to build confidence in the use of patient data to save lives and improve outcomes


An article published in BMJ Open in June 2021 titled “Realising the full potential of data-enabled trials in the UK: a call for action” raised interest with Sarah Markham, Advisory Group Member for use MY data.  She gives her thoughts on the article from a lay perspective.

Sarah Markham

Clinical trials are viewed as the best means of determining whether a health care intervention has any value, for instance whether a new medication is effective in treating a health condition. During COVID-19 clinical trials relating to the development and testing of vaccines regularly made the news headline and they have become part of our everyday conversations. The pandemic has also made it even more important to be able to run better, faster, and more efficient trials for patient benefit.

There is a lot of similarity between the type of patient data which is collected and used in trials and that which is already collected routinely in electronic healthcare records (EHRs). This means there are ways in which routinely collected data can be used to improve the recruitment of eligible people to participate in clinical trials, the ways in which trials are run and how the health related effects of participants are tracked both during and after the trial has finished.

The National Institute of Health Research, Health Data Research UK and Clinical Practice Research Datalink co-organised a national workshop to accelerate the agenda for what are called ‘data-enabled clinical trials’, i.e. clinical trials which used routinely collected patient data. The workshop shared many successful examples of such trials and imagining future possibilities.  The plenary talks, panel discussions, group discussions and case studies covered: design/feasibility; recruitment; conduct/follow-up; collecting benefits/harms; and analysis/interpretation.

Some key messages for me are:

  • The types of routinely collected patient data which are most useful to clinical trials include outcome measures (such as screens for levels of mental health symptoms), which are easily captured in the electronic record and other forms such as safety (which need detailed work to in order to be reported reliably).
  • There is a clear need for the various data systems to be better connected.
  • Researchers running carefully regulated trials need to think hard about how the quality of real-world data can be best assessed.
  • Involvement of patients in discussions between researchers, clinicians to share views of the issues and experiences of how best to do this could support wider adoption of EHR-based methods in the design and running of clinical trials.

The full BMJ Open article is available here

About Sarah Markham

Sarah Markham is a member of the use MY data Advisory Group.  She is both a long-term patient and a Visiting Researcher in the Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King's College London.

Sarah is also active in raising public and patient awareness of the benefits of using patient data in clinical research, the clinical trial process and the nature and experience of patient participation in research.

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