Targeted therapy: a potential oversight in trial protocol

Moorthy, Thurai

doi:10.1016/s1470-2045(18)30575-8

Cited by 2 publications

(3 citation statements)

References 6 publications

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“…Of the 40 guidance resources included [7,9,[34][35][36][37][38][39][40][41][42][65][66][67][68][69][70][71], around half (n = 21, 53%) offered recommendations pertaining to all aspects of pathology input within clinical trials (patient selection, risk stratification, and outcome assessment) [7,9,11,13,17,20,[26][27][28][29][30]35,36,38,41,42,65,[67][68][69][70]. Seven (17%) of the included guidance resources contained explicit recommendations [7,18,31,39,41,66,71], 24 (60%) contained implicit recommendations [9,11-16,19,22-25,27-30, 34-37,42,67,69,70], and the remaining 9 (23%) offered a combination of explicit and implicit recommendations [17,…”

Section: Characteristics Of Guidance Resourcesmentioning

confidence: 99%

“…Best practice recommendation statements that contributed to the recurring themes were gathered and synthesised from 22 of the guidance resources [7,9,11,13,17,19,22,24,[27][28][29][30]32,35,38,39,41,66,67,[69][70][71] using the JBI meta-aggregation approach (see supplementary material, Table S4). The GRADE-CERQual evidence profile (see supplementary material, Table S5) shows the CERQual assessment details, with reasons for reaching the judgements, for each of the four GRADE-CERQual components.…”

Section: Synthesis Of Recommendationsmentioning

confidence: 99%

See 1 more Smart Citation

Recommendations for cellular and molecular pathology input into clinical trials: a systematic review and meta‐aggregation

Lim

Gurusamy

O’Connor³

et al. 2021

The Journal of Pathology CR

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The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 Statement was developed to provide guidance for inclusion of key methodological components in clinical trial protocols. However, these standards do not include guidance specific to pathology input in clinical trials. This systematic review aims to synthesise existing recommendations specific to pathology practice in clinical trials for implementation in trial protocol design. Articles were identified from database searches and deemed eligible for inclusion if they contained: (1) guidance and/or a checklist, which was (2) pathology-related, with (3) content relevant to clinical trial protocols or could influence a clinical trial protocol design from a pathology perspective and (4) were published in 1996 or later. The quality of individual papers was assessed using the AGREE-GRS (Appraisal of Guidelines for REsearch & Evaluation -Global Rating Scale) tool, and the confidence in cumulative evidence was evaluated using the GRADE-CERQual (Grading of Recommendations Assessment, Development and Evaluation-Confidence in Evidence from Reviews of Qualitative research) approach. Extracted recommendations were synthesised using the best fit framework method, which includes thematic analysis followed by a meta-aggregative approach to synthesis within the framework. Of the 10 184 records screened and 199 full-text articles reviewed, only 40 guidance resources met the eligibility criteria for inclusion. Recommendations extracted from 22 guidance documents were generalisable enough for data synthesis. Seven recommendation statements were synthesised as follows: (1) multidisciplinary collaboration in trial design with early involvement of pathologists, particularly with respect to the use of biospecimens and associated biomarker/analytical assays and in the evaluation of pathology-related parameters; (2) funding and training for personnel undertaking trial work; (3) selection of an accredited laboratory with suitable facilities to undertake scheduled work; (4) quality assurance of pathology-related parameters; (5) transparent reporting of pathology-related parameters; (6) policies regarding informatics and tracking biospecimens across trial sites; and (7) informed consent for specimen collection and retention for future research.

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Section: Characteristics Of Guidance Resourcesmentioning

confidence: 99%

Section: Synthesis Of Recommendationsmentioning

confidence: 99%

Recommendations for cellular and molecular pathology input into clinical trials: a systematic review and meta‐aggregation

Lim

Gurusamy

O’Connor³

et al. 2021

The Journal of Pathology CR

View full text Add to dashboard Cite

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“…A potential false negative could lead to grouping patients with somatic mutations with patients who are supposed to have only wild type. A recent publication highlights oversight in clinical trials where the evaluation of detection methods of specific mutations is not well defined, hence the results and conclusion of the trial may stand for re-scrutiny [5]. e. Method comparison.…”

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confidence: 99%

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2019

Journal of Cancer Research and Therapeutic Oncology

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Targeted therapy: a potential oversight in trial protocol

Cited by 2 publications

References 6 publications

Recommendations for cellular and molecular pathology input into clinical trials: a systematic review and meta‐aggregation

Recommendations for cellular and molecular pathology input into clinical trials: a systematic review and meta‐aggregation

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