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For example, a suboptimal control arm or limited access to best care upon progression may skew the trial results toward a benefit in the experimental arm. Beyond the fact that such limitations do not prevent drugs reaching the market, other assessment tools, such as those developed by professional societies\u2014ESMO\u2010MCBS and ASCO Value Framework\u2014do not integrate these important shortcomings.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We propose creating a novel framework with the scope of assessing registration cancer clinical trials in haematology and oncology (randomized or single arm)\u2014that is trials leading to a marketing authorization. The main steps of the methods are (1) assembling a scientific board; (2) defining the scope, goal and methods through pre\u2010specified, pre\u2010registered and protocolized methodology; (3) preregistration of the protocol; (4) conducting a scoping review of limitations and biases affecting oncology trials and assessing existing scores or methods; (5) developing a list of features to be included and assessed within the framework; (6) assessing each feature through a questionnaire sent to highly cited haematologists and oncologists involved in clinical trials; and (7) finalizing the first version of framework.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Not applicable.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Our proposal emerged in response to the lack of consideration for key limitations in current trial assessments. The goal is to create a framework specifically designed to assess single trials leading to marketing authorization in the field of oncology and haematogy.<\/jats:p><\/jats:sec>","DOI":"10.1111\/eci.14267","type":"journal-article","created":{"date-parts":[[2024,6,27]],"date-time":"2024-06-27T12:55:12Z","timestamp":1719492912000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["A novel framework to assess haematology and oncology registration trials: The <scp>THEOREMM<\/scp> project"],"prefix":"10.1111","volume":"54","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6936-5783","authenticated-orcid":false,"given":"Timoth\u00e9e","family":"Olivier","sequence":"first","affiliation":[{"name":"Department of Oncology Geneva University Hospital  Geneva Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7876-3978","authenticated-orcid":false,"given":"Alyson","family":"Haslam","sequence":"additional","affiliation":[{"name":"Department of Epidemiology and Biostatistics University of California San Francisco  San Francisco California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Patricia","family":"Burke","sequence":"additional","affiliation":[{"name":"Patient  Liverpool UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5263-6241","authenticated-orcid":false,"given":"Isabelle","family":"Boutron","sequence":"additional","affiliation":[{"name":"Universit\u00e9 Paris Cit\u00e9 and Universit\u00e9 Sorbonne Paris Nord, Inserm, INRAe, Centre for Research in Epidemiology and Statistics (CRESS)  Paris France"},{"name":"Centre d'\u00c9pid\u00e9miologie Clinique H\u00f4pital H\u00f4tel Dieu  Paris France"},{"name":"Cochrane France  Paris France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3760-3801","authenticated-orcid":false,"given":"Florian","family":"Naudet","sequence":"additional","affiliation":[{"name":"Inserm, CIC 1414 (Centre d'Investigation Clinique de Rennes) Rennes 1 University  Rennes France"},{"name":"Inserm, Irset (Institut de recherche en sant\u00e9, environnement et travail) Rennes 1 University  Rennes France"},{"name":"Institut Universitaire de France  Paris France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3118-6859","authenticated-orcid":false,"given":"John P. 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