Governance
The board, the assessment committee, the secretariat and the external reviewer register, and how a document passes between them.
§1Bodies
Table 1. The bodies of the Institute.
| Body | Members | Function |
|---|---|---|
| Board of Trustees | 8 | Holds the Institute’s governance, finances and conflicts regime. Does not participate in certainty ratings. |
| Assessment Committee | 11 | Ratifies every certainty rating the Institute publishes. Chaired independently of the Board. |
| Secretariat | 10 | Drafts and maintains the document set, runs the comment-period process and manages the evidence log. |
| External reviewers | 60 | Review draft assessments before ratification. Standing reviewers review every document in their domain. |
| Specialist advisers | 12 | Advise on individual assessments within a defined domain. |
| Comment-period correspondents | 70 | Have made at least one formal submission to a public comment period. |
| Submitted-evidence contributors | 36 | Have submitted third-party test data to the Institute’s evidence log. |
The assessment committee ratifies every certainty rating the Institute publishes and is chaired independently of the board. No document is published before ratification.
§2The path a document follows
- Scoping. The secretariat registers a question or a document scope. For a synthesis this is protocol registration and it precedes the search.
- Drafting. The secretariat prepares the draft against the house standards. Extraction and certainty assessment are performed independently in duplicate with disagreement resolved by a third member.
- External review. Standing reviewers in the relevant domain review the draft. Reviewers are named in the register against their domain rather than against individual documents, for the reason recorded on the register policy disposition page.
- Public comment. Where the document is a methodology, a standard, a rubric, a synthesis or a monograph entering the set, it is released for public comment. Every submission is answered and given a disposition.
- Disposition. Amendments arising are applied and each is made traceable to a numbered submission.
- Ratification. The assessment committee ratifies the document and the cycle in which it does so is recorded on the document.
- Review. Every document carries a next-review date. A document past that date without a new version is flagged in the registry.
§3Principals
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Board of TrusteesChair, Board of Trusteessince 2023
A clinical pharmacologist whose career was spent in regulatory assessment and in the methodology of benefit–risk evaluation. She chaired a national medicines committee for nine years and has written extensively on the problem of assessing…
Emeritus Professor of Clinical… -
Board of TrusteesDeputy Chair, Board of Trusteessince 2023
A public-health physician with a background in evidence appraisal for population-level commissioning. Her contribution to the Institute's framework is the requirement that every assessment state the population in which the estimate was…
Consultant in Public Health Medicine -
Board of TrusteesTrustee, Chair of the Audit and Conflicts Committeesince 2023
A lawyer whose practice concerned regulatory and research-integrity matters. He designed the Institute's conflicts-of-interest regime, including the rule that a declared interest in a compound removes a reviewer from the assessment of that…
Former Chair, national research-integrit… -
Board of TrusteesTrustee, Chair of the Analytical Standards Committeesince 2023
An analytical chemist who spent two decades developing and validating stability-indicating methods for peptide and protein products. She is the principal author of the Institute's COA minimum data standard and of the position, unusual in…
Independent consultant; formerly Head… -
Board of TrusteesTrusteesince 2024
A pharmacist and clinical pharmacologist whose research concerns medication safety in populations obtaining medicines outside regulated supply. He argued successfully that the Institute should publish supplier dossiers rather than decline…
Associate Professor of Pharmacy Practice -
Board of TrusteesTrusteesince 2024
A hepatologist whose clinical research concerns metabolic dysfunction-associated steatotic liver disease and the reliability of histological endpoints. She led the Institute's decision to record, for every histological endpoint it…
Professor of Hepatology -
Board of TrusteesTrustee, Honorary Treasurersince 2023
Responsible for the Institute's finances and for the sponsorship-disclosure architecture. She established the rule that no sponsor may exceed twenty per cent of annual income and that any sponsor whose contribution would breach that…
Chartered accountant; charity finance… -
Board of TrusteesTrustee, Patient and Public Involvement leadsince 2024
Responsible for ensuring that the Institute's comment periods are genuinely open to people who use the compounds it assesses, rather than only to professionals. She has argued, against some internal resistance, that a submission from a…
Consultant Physician in Metabolic… -
Assessment CommitteeChair, Assessment Committeesince 2023
Chairs the committee that ratifies every certainty rating the Institute publishes. Her methodological position, applied consistently across the monograph series, is that an active-controlled non-inferiority result and a placebo-controlled…
Professor of Diabetes and Endocrinology -
Assessment CommitteeDeputy Chair, Assessment Committeesince 2023
Chairs assessments from which the Committee Chair is recused, which in practice means the entire incretin series. His contribution is the Institute's treatment of trials stopped early for efficacy: they are extracted in full, and a note…
Consultant Cardiologist; Reader in… -
Assessment CommitteeLead Statistician, Assessment Committeesince 2023
Responsible for every effect estimate and confidence interval the Institute reproduces, and for the rule that an estimate is reported on the scale on which it was measured before any standardisation. She insisted that the Institute publish…
Senior Statistician, independent -
Assessment CommitteeAssessment Committee member, clinical pharmacologysince 2023
Responsible for the pharmacokinetic sections of the monograph series, including the decision to record explicitly where a parameter has not been characterised in humans rather than importing an animal value. He has objected in writing to…
Clinical Pharmacologist, teaching… -
Assessment CommitteeAssessment Committee member, safetysince 2024
Responsible for adverse-event extraction and for the Institute's convention that an incidence figure is reported with the trial, dose and duration from which it comes, never as a bare percentage. She also authored the position that a…
Consultant in Pharmacovigilance -
Assessment CommitteeAssessment Committee member, chemistrysince 2023
Responsible for the identification sections of the monograph series. Her rule, applied throughout, is that where a structure has not been published the monograph says "not disclosed" rather than reproducing an unsourced sequence from a…
Professor of Medicinal Chemistry -
Assessment CommitteeAssessment Committee member, analytical standardssince 2024
Contributes the analytical-characterisation sections of the monographs and reviews every submitted third-party report for method adequacy. She identified the systematic problem, recorded across several monographs, that very short polar…
Analytical Scientist, accredited… -
Assessment CommitteeAssessment Committee member, nephrologysince 2024
Responsible for renal assessments, including the Institute's convention of reporting annual eGFR slope alongside any composite kidney endpoint on the ground that slope is less vulnerable to competing-risk distortion in populations with…
Consultant Nephrologist -
Assessment CommitteeAssessment Committee member, neuropsychiatric outcomessince 2025
Responsible for assessments in the neuropsychiatric indications, including the addiction and cognition groups. She authored the Institute's distinction between a low certainty rating arising from an absence of studies and one arising from…
Consultant Psychiatrist -
Assessment CommitteeAssessment Committee member, respiratory and sleepsince 2025
Responsible for the sleep-apnoea assessments and for the observation, recorded in several documents, that centrally scored polysomnographic endpoints support a higher certainty rating than symptom-only respiratory endpoints in trials where…
Consultant in Respiratory and Sleep… -
Assessment CommitteeAssessment Committee member, methodssince 2024
Responsible for the search strategies underlying the synthesis series and for the requirement that every synthesis publish its search strings, database coverage and screening decisions in full, so that a reader can reconstruct the included…
Senior Research Fellow, evidence… -
SecretariatDirector of the Institutesince 2023
Responsible for the Institute's output as a whole and for the quarterly assessment cycle. She holds the final editorial decision on register language, and has consistently required that where the Institute does not know something the…
Compound Evidence Institute -
SecretariatHead of Secretariatsince 2023
Manages the comment-period process, including the drafting of secretariat responses and the disposition of every submission. The convention that a submission is answered on its substance regardless of the submitter's standing, and that a…
Compound Evidence Institute -
SecretariatHead of Evidence Managementsince 2023
Maintains the reference library and the submitted-evidence log, and is responsible for the rule that a reference the Institute cannot verify against a primary record is either excluded or marked as unverified.
Compound Evidence Institute -
SecretariatHead of Analytical Assessmentsince 2024
Leads the methods series and the review of submitted third-party test data. He compiled the finding, reported across the supplier dossiers, that counter-ion and water determination are absent from essentially the whole of this supply…
Compound Evidence Institute -
SecretariatSenior Assessment Officer, monographssince 2024
Drafts monographs in the incretin and amylin series and maintains the per-indication evidence extracts.
Compound Evidence Institute
The full register, 207 entries.