Abstract
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.
Highlights
Randomised controlled trials are considered the ‘gold standard’ in medical research for comparing the safety and effectiveness of novel interventions as they minimise bias compared to other empirical study designs, delivering a high level of evidence [1,2]
Resources were deemed eligible for inclusion if they contained: (1) guidance and/or a checklist, which is (2) pathology-related, with (3) content relevant to clinical trial protocols or could influence a clinical trial protocol design from a pathology perspective
The recommendation statements from the individual guidance resources were coded into themes that best describe the nature and type of recommendations offering best practice guidance at various stages of the clinical trial process
Summary
Randomised controlled trials are considered the ‘gold standard’ in medical research for comparing the safety and effectiveness of novel interventions as they minimise bias compared to other empirical study designs, delivering a high level of evidence [1,2]. Planned clinical trials result in misleading findings from suboptimal trial execution and analysis, wasting resources and potentially harming patients [4] Such issues can be mitigated by methodologically rigorous clinical trial protocols to facilitate the design, conduct, analysis, and reporting of reliable clinical trials [3,4,5]. For this reason, the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 Statement was developed to provide standardised guidance for inclusion of key methodological components in clinical trial protocols [6]. These standards do not include guidance specific to pathology input in clinical trials
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