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Impact of NCI-mandated scientific review on protocol development and content.

ABSTRACT: PURPOSE:The NCI requirement that clinical trials at NCI-designated cancer centers undergo scientific review in addition to Institutional Review Board review is unique among medical specialties. We evaluated the impact of this process on protocol development and content. METHODS:We analyzed cancer clinical trials that underwent full board review by the Harold C. Simmons Cancer Center Protocol Review and Monitoring Committee (PRMC) from January 1, 2009, through June 30, 2013. We analyzed associations between trial characteristics, PRMC decisions, and protocol modifications using Chi-square testing, Fishers exact testing, and logistic regression. RESULTS:A total of 226 trials were analyzed. Of these, 77% were industry-sponsored and 23% were investigator-initiated. Initial PRMC decisions were: approval (40%), provisional approval (52%), deferral (7%), and disapproval (1%). These decisions were associated with study sponsor (P<.001) and phase (P<.001). Ultimately, 97% of industry-sponsored and 90% of investigator-initiated trials were approved (P=.05). Changes were requested for 27% of industry-sponsored trials compared with 54% of investigator-initiated trials (P<.001). Total changes requested (mean, 5.6 vs 2.4; P<.001) and implemented (mean, 4.6 vs 2.1; P=.008) per protocol were significantly greater for investigator-initiated trials. Changes related to study design were more commonly requested (35% vs 13% of trials) and implemented (40% vs 5% of trials) for investigator-initiated trials compared with industry-sponsored trials (P=.03). CONCLUSIONS:NCI-mandated scientific protocol review seems to have a substantial impact on investigator-initiated trials but less effect on industry-sponsored trials. These findings may provide guidance on development and prioritization of institutional protocol review policies.

SUBMITTER: Ning N

PROVIDER: S-EPMC5119526 | biostudies-literature | 2015 Apr

REPOSITORIES: biostudies-literature

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Impact of NCI-mandated scientific review on protocol development and content.

Ning Ning N Yan Jingsheng J Xie Xian-Jin XJ Gerber David E DE

Journal of the National Comprehensive Cancer Network : JNCCN 20150401 4

<h4>Purpose</h4>The NCI requirement that clinical trials at NCI-designated cancer centers undergo scientific review in addition to Institutional Review Board review is unique among medical specialties. We evaluated the impact of this process on protocol development and content.<h4>Methods</h4>We analyzed cancer clinical trials that underwent full board review by the Harold C. Simmons Cancer Center Protocol Review and Monitoring Committee (PRMC) from January 1, 2009, through June 30, 2013. We ana ...[more]

PMID: 25870377

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Project description:EFSA Strategy 2027 outlines the need for fit-for-purpose protocols for EFSA generic scientific assessments to aid in delivering trustworthy scientific advice. This EFSA Scientific Committee guidance document helps address this need by providing a harmonised and flexible framework for developing protocols for EFSA generic assessments. The guidance replaces the 'Draft framework for protocol development for EFSA's scientific assessments' published in 2020. The two main steps in protocol development are described. The first is problem formulation, which illustrates the objectives of the assessment. Here a new approach to translating the mandated Terms of Reference into scientifically answerable assessment questions and sub-questions is proposed: the 'APRIO' paradigm (Agent, Pathway, Receptor, Intervention and Output). Owing to its cross-cutting nature, this paradigm is considered adaptable and broadly applicable within and across the various EFSA domains and, if applied using the definitions given in this guidance, is expected to help harmonise the problem formulation process and outputs and foster consistency in protocol development. APRIO may also overcome the difficulty of implementing some existing frameworks across the multiple EFSA disciplines, e.g. the PICO/PECO approach (Population, Intervention/Exposure, Comparator, Outcome). Therefore, although not mandatory, APRIO is recommended. The second step in protocol development is the specification of the evidence needs and the methods that will be applied for answering the assessment questions and sub-questions, including uncertainty analysis. Five possible approaches to answering individual (sub-)questions are outlined: using evidence from scientific literature and study reports; using data from databases other than bibliographic; using expert judgement informally collected or elicited via semi-formal or formal expert knowledge elicitation processes; using mathematical/statistical models; and - not covered in this guidance - generating empirical evidence ex novo. The guidance is complemented by a standalone 'template' for EFSA protocols that guides the users step by step through the process of planning an EFSA scientific assessment.

Project description:Waste is part of the agenda of the European Environment and Health Process and included among the topics of the Sixth Ministerial Conference on Environment and Health. Disposal and management of hazardous waste are worldwide challenges. We performed a systematic review to evaluate the evidence of the health impact of hazardous waste exposure, applying transparent and a priori defined methods. The following five steps, based on pre-defined systematic criteria, were applied. 1. Specify the research question, in terms of "Population-Exposure-Comparators-Outcomes" (PECO).Populationpeople living near hazardous waste sites; Exposure: exposure to hazardous waste; Comparators: all comparators; Outcomes: all diseases/health disorders. 2. Carry out the literature search, in Medline and EMBASE. 3. Select studies for inclusion: original epidemiological studies, published between 1999 and 2015, on populations residentially exposed to hazardous waste. 4. Assess the quality of selected studies, taking into account study design, exposure and outcome assessment, confounding control. 5. Rate the confidence in the body of evidence for each outcome taking into account the reliability of each study, the strength of the association and concordance of results.Fifty-seven papers of epidemiological investigations on the health status of populations living near hazardous waste sites were selected for the evidence evaluation. The association between 95 health outcomes (diseases and disorders) and residential exposure to hazardous waste sites was evaluated. Health effects of residential hazardous waste exposure, previously partially unrecognized, were highlighted. Sufficient evidence was found of association between exposure to oil industry waste that releases high concentrations of hydrogen sulphide and acute symptoms. The evidence of causal relationship with hazardous waste was defined as limited for: liver, bladder, breast and testis cancers, non-Hodgkin lymphoma, asthma, congenital anomalies overall and anomalies of the neural tube, urogenital, connective and musculoskeletal systems, low birth weight and pre-term birth; evidence was defined as inadequate for the other health outcomes. The results, although not conclusive, provide indications that more effective public health policies on hazardous waste management are urgently needed. International, national and local authorities should oppose and eliminate poor, outdated and illegal practices of waste disposal, including illegal transboundary trade, and increase support regulation and its enforcement.

Project description:IntroductionScientific Initiation (SI) is an educational activity that allows students to begin their scientific training and research under the guidance of an experienced researcher. While several studies have examined students' perceptions of SI, research on the perspective of researchers working in this field is currently lacking. Thus, this study's aim is to describe the protocol design for conducting a systematic review. At the same time, the review aims also to identify factors influencing the work of researchers in SI and explore the motivations leading researchers to engage in research projects within institutions and their respective impacts.Method and analysesLiterature search will be done using the bibliographic databases, including Academic Search Premier, APA PsycNet, CINAHL Plus, ERIC, SocINDEX, Scopus, and Web of Science. The search strategy was guided by the PICo framework (Population, phenomenon of Interest, and Context). The preparation and development of this protocol following guidelines were employed: Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Protocols 2015 (PRISMA-P 2015), Peer Review of Electronic Search Strategies 2015 (PRESS 2015), and PRISMA-Search (PRISMA-S). Original, peer-reviewed articles that examine the factors related to the work of researchers in SI will be included without any language or publication date restrictions. Qualitative, quantitative, and mixed-methods studies will be screened by two independent researchers. The included studies will be analyzed to identify factors, policies, and their impacts obtained analytically. Findings will be objectively categorized and synthetically represented through figures, diagrams, and graphic models. The risk of bias will be assessed using the Critical Appraisal Skills Program (CASP) and the Downs and Black checklists. A third senior reviewer will resolve any discrepancies.DiscussionWe aim to understand the factors that drive researchers to engage in SI research through the dissemination of the findings of this systematic review. This may aid the development of institutional strategies and actions that can support the enhancement of SI programs and encourage greater researcher participation.

Project description:UnlabelledBackgroundAll randomized clinical trials (RCTs) require a protocol; however, numerous studies have highlighted protocol deficiencies. Reporting guidelines may improve the content of research reports and, if developed using robust methods, may increase the utility of reports to stakeholders. The objective of this study was to systematically identify and review RCT protocol guidelines, to assess their characteristics and methods of development, and to compare recommendations.MethodsWe conducted a systematic review of indexed literature (MEDLINE, EMBASE and the Cochrane Methodology Register from inception to September 2010; reference lists; related article features; forward citation searching) and a targeted search of supplementary sources, including a survey of major trial funding agencies in six countries. Records were eligible if they described a content guideline in English or French relevant to RCT protocols. Guidelines were excluded if they specified content for protocols for trials of specific procedures or conditions or were intended to assess trial quality. We extracted guideline characteristics and methods. Content was mapped for a subset of guidelines that described development methods or had institutional endorsement.ResultsForty guidelines published in journals, books and institutional reports were included in the review; seven were specific to RCT protocols. Only eight (20%) described development methods which included informal consensus methods, pilot testing and formal validation; no guideline described all of these methods. No guideline described formal consensus methods or a systematic retrieval of empirical evidence to inform its development. The guidelines included a median of 23 concepts per guideline (interquartile range (IQR) = 14 to 34; range = 7 to 109). Among the subset of guidelines (n = 23) for which content was mapped, approximately 380 concepts were explicitly addressed (median concepts per guideline IQR = 31 (24,80); range = 16 to 150); most concepts were addressed in a minority of guidelines.ConclusionsExisting guidelines for RCT protocol content varied substantially in their recommendations. Few reports described the methods of guideline development, limiting comparisons of guideline validity. Given the importance of protocols to diverse stakeholders, we believe a systematically developed, evidence-informed guideline for clinical trial protocols is needed.

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Impact of NCI-mandated scientific review on protocol development and content.

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Impact of NCI-mandated scientific review on protocol development and content.

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