How can the charity perspective shape guidance on core outcomes for clinical research?

Posted on April 19, 2013 by

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Medical research charities can bring unique knowledge of the needs of patients and how this relates to research to discussions about Core Outcome Sets – guidance for clinical researchers on which measurements to get from participants.

The COMET initiative brings together people with expertise in a particular research area to collect evidence on what the core outcomes should be for clinical research in their field, and wants charities to contribute to those discussions

What are Core Outcome Sets?

Clinical trials aim to show that drugs, devices or therapies are effective. To do this, they need to measure effects (outcomes) in patients.

These might be something physiological, like blood pressure or levels of a particular hormone or chemical in the blood, or participants could fill in a survey about their experience, like their pain levels.

A “Core Outcome Set” (COS) is an agreed set of what should be measured and reported in all trials in a specific disease or condition area. This allows researchers and regulators to compare the results of different trials.

Who should decide what is a common outcome measure?

Standardising these measurements across the research community is a huge task requiring input from a range of stakeholders. The COMET initiative  has built up a database of studies relating to defining what should be considered core outcomes, and from this, is developing the sets of agreed measurements for all trials in a particular area of research.

To ensure the right measures are chosen, the entire research community, including patients and clinicians has to feed into this development.

COMET is keen to hear from a range of stakeholders including charity research funders and patient groups.

AMRC member charities can bring detailed expert knowledge of their research area, and are uniquely placed to bring knowledge of what healthcare outcomes really matter to patients, and so ensure that this knowledge is built into guidelines for researchers.

How charities can get involved

  • Research staff can promote the relevant COMET data set in information to applicants and if possible, include a requirement to consider them in terms and conditions. The COMET outcomes are recognised by NICE in their sources for setting clinical guidelines, and so aligning your charity’s research with these will help simplify process of getting new treatments approved for use in patients in the NHS.
  •  Work with COMET to develop outcome sets. You can attend their conference in Manchester on 20-21 July  to learn more about Core Outcome Sets and meet other stakeholders and researchers working in this area.
  •  Fund research to develop new Core Outcome Sets. The initiative is looking to list charities with an interest in this area, so that COS developers seeking partners and funders will be able to easily find charities that might be willing to help them. Contact COMET to get involved.
Posted in: Research