Representation of published core outcome sets for research in regulatory guidance: protocol

Dodd, Susanna ORCID: 0000-0003-2851-3337, Fish, Rebecca, Gorst, Sarah ORCID: 0000-0002-7818-9646, Hall, Deborah ORCID: 0000-0002-3804-1452, Jacobsen, Pamela ORCID: 0000-0001-8847-7775, Kirkham, Jamie, Main, Barry, Matvienko-Sikar, Karen ORCID: 0000-0003-2777-6581, Saldanha, Ian J, Trépel, Dominic ORCID: 0000-0002-1421-2966
et al (show 1 more authors) (2021) Representation of published core outcome sets for research in regulatory guidance: protocol. HRB Open Research, 4. p. 45.

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<ns3:p><ns3:bold>Background: </ns3:bold>The <ns3:ext-link xmlns:ns4="" ext-link-type="uri" ns4:href="">COMET Initiative</ns3:ext-link> promotes the development and use of ‘core outcome sets’ (COS), agreed standardised sets of outcomes that should be measured and reported in all studies in a particular clinical condition. COS are determined by consensus amongst key stakeholders, including health professionals, policymakers and patients, ensuring that the priorities and expertise of these representatives inform the choice of the most important outcomes to measure for a given condition. There is increased recognition of the need to integrate COS across the healthcare system and with existing regulatory apparatus, to ensure that outcomes being recorded are those of key relevance to important stakeholders. The aim of this study is to assess the degree of concordance between outcomes recommended in COS for research and in guidance provided by two key regulators: US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).</ns3:p><ns3:p> <ns3:bold>Methods: </ns3:bold>COS for research published during 2015-2019 with patient involvement and covering drug or device interventions will be compared against relevant regulatory guidelines, matched by condition. Guidance documents which match in scope (relating to intervention and population) to a COS for research will be scrutinised to identify all suggested outcomes for comparison against the core outcomes in the corresponding COS.</ns3:p><ns3:p> <ns3:bold>Discussion: </ns3:bold>This study will identify variation between outcomes suggested in EMA and FDA regulatory guidance relative to outcomes included in published COS for research, thus demonstrating the degree of representation of COS in regulatory guidance and vice versa. If the findings of this study reveal a lack of concordance between COS and regulatory guidance overall or for particular disease areas, we will invite feedback from FDA and EMA and will seek to highlight where findings support the recommendations towards using well-developed COS or will make recommendations to COS developers on outcomes of importance to these key regulators.</ns3:p>

Item Type: Article
Uncontrolled Keywords: 4203 Health Services and Systems, 32 Biomedical and Clinical Sciences, 42 Health Sciences, Generic health relevance
Divisions: Faculty of Health and Life Sciences
Faculty of Health and Life Sciences > Institute of Population Health
Depositing User: Symplectic Admin
Date Deposited: 30 Jun 2021 14:38
Last Modified: 21 Jun 2024 04:35
DOI: 10.12688/hrbopenres.13139.1
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