Institutional Scientific Review of Cancer Clinical Research Protocols: A Unique Requirement That Affects Activation Timelines

Ning, Ning; Yan, Jingsheng; Dietrich, Martin; Xie, Xian Jin; Gerber, David E.

doi:10.1200/jop.2017.024299

Cited by 7 publications

(5 citation statements)

References 21 publications

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“…In particular, research to identify and intervene on racial, ethnic, and other disparities in COVID-19 outcomes is sorely needed. 36 In addition, as precedents in cancer 14 and other areas of clinical research show, 15 the need to consolidate and prioritize research is not limited to pandemics. Our criteria add to existing guidance, which tends to focus narrowly on scientific merit rather than criteria designed to ensure fairness and justice.…”

Section: Resultsmentioning

confidence: 99%

“…As with other forms of research review, some might object that the process we propose will inevitably delay the initiation of some clinical trials. 14 In our experience, an efficient committee that meets regularly—and, critically, whose discussions are guided by criteria such as those offered here—can make sound decisions within days (or shorter). In the long run, this prioritization process can save time and resources by ensuring that a comprehensive portfolio of high-quality, feasible COVID-19 research is conducted.…”

Section: The Oversight Processmentioning

confidence: 90%

“…12,13 Especially in a pandemic, this approach will almost certainly fail to achieve optimal results. Although there have been some efforts to respond to priority-setting challenges, such as the review committees required by comprehensive cancer centers funded by the National Cancer Institute 14 and similar committees tasked with prioritizing which trials the institution will field in certain other disease areas, 15 these are rare outside oncology.…”

Section: Introductionmentioning

confidence: 99%

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An ethics framework for consolidating and prioritizing COVID-19 clinical trials

Meyer

Gelinas²,

Bierer

et al. 2021

Clinical Trials

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Given the dearth of established safe and effective interventions to respond to COVID-19, there is an urgent ethical imperative to conduct meaningful clinical research. The good news is that interventions to be tested are not in short supply. Unfortunately, the human and material resources needed to conduct these trials are finite. It is essential that trials be robust and meet enrollment targets and that lower-quality studies not be permitted to displace higher-quality studies, delaying answers to critical questions. Yet, with few exceptions, existing research review bodies and processes are not designed to ensure these conditions are satisfied. To meet this challenge, we offer guidance for research institutions about how to ethically consolidate and prioritize COVID-19 clinical trials, while recognizing that consolidation and prioritization should also take place upstream (among manufacturers and funders) and at a higher level (e.g. nationally). In our proposed three-stage process, trials must first meet threshold criteria. Those that do are evaluated in a second stage to determine whether the institution has sufficient capacity to support all proposed trials. If it does not, the third stage entails evaluating studies against two additional sets of comparative prioritization criteria: those specific to the study and those that aim to advance diversification of an institution’s research portfolio. To implement these criteria fairly, we propose that research institutions form COVID-19 research prioritization committees. We briefly discuss some important attributes of these committees, drawing on the authors’ experiences at our respective institutions. Although we focus on clinical trials of COVID-19 therapeutics, our guidance should prove useful for other kinds of COVID-19 research, as well as non-pandemic research, which can raise similar challenges due to the scarcity of research resources.

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Section: Resultsmentioning

confidence: 99%

Section: The Oversight Processmentioning

confidence: 90%

Section: Introductionmentioning

confidence: 99%

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An ethics framework for consolidating and prioritizing COVID-19 clinical trials

Meyer

Gelinas²,

Bierer

et al. 2021

Clinical Trials

View full text Add to dashboard Cite

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“…Industry performs scientific design reviews; it may or may not be coincidental that industryfunded trials were more likely to be informative during COVID than those trials funded by others [18]. The cancer clinical research community-influenced by the US government-has adopted the post-funding scientific review of trial designs, but no other research community has followed [19]. An Alzheimer's disease consortium stated "Although there is scant literature on this topic, design flaws that could have been corrected before trial initiation via scientific review are common."…”

Section: Scientific Design Reviewmentioning

confidence: 99%

<strong>A Maturity Model for the Scientific Review of Clinical Trial Designs and Their Informativeness </strong>

Dolley¹,

Norman²,

McNair³

et al. 2023

Preprint

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Many clinical trials end uninformatively. Informativeness, in the context of clinical trials, defines whether a study’s results definitively answer its research questions with meaningful next steps. One subset of these trials are those focused on global health set in low-resource settings. Global health clinical trials benefitting people in low-resource settings are funded primarily by a limited number of large foundations, pharmaceutical firms (“industry”), and national governments. While clinical trial protocols are required to go through reviews in regulatory and ethical domains, outside of industry-funded trials, funders rarely require focused scientific design reviews. There are no documented standards and processes, or even best practices, for funders to perform scientific reviews after the funding commitment. Considering the investment in and standardization of ethical and regulatory reviews, and the prevalence of studies ending without clarity or never finishing, it may be that scientific reviews of trial designs with a focus on informativeness offer the best chance for improved outcomes and return on investments in clinical trials. A maturity model is a helpful tool for knowledge transfer to help grow capabilities in a new area, or for those looking to perform a self-assessment in an existing area. Such a model is offered for scientific design reviews of clinical trial protocols: a valuable and often-neglected governance step for funders or sponsors, among others. This maturity model includes 11 process areas and 5 maturity levels. Each of the 55 process area levels is populated with descriptions on a continuum toward an optimal state to improve trial protocols in the area of risk of failure. This tool allows for prescriptive guidance on next investments to improve attributes of post-funding reviews of trials, with a focus on informativeness.

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“…This scienti c review focuses on many aspects including scienti c merit, objectives, design, study population, outcomes and endpoint de nition, statistical analysis, sample size, and data monitoring. A distinct scienti c review stage for protocols is also common among cancer trials sponsored by US academic cancer centers (12,13).…”

Section: Introductionmentioning

confidence: 99%

Scientific Review of Protocols to Enhance Informativeness of Global Health Clinical Trials

Burford,

Norman,

Dolley

2024

Preprint

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Background Trial informativeness describes the likelihood of a clinical trial to have a meaningful impact on clinical practice, research or policy decisions. A dedicated scientific review process for protocols at the post-funding stage is not common, yet is an opportunity to enhance trial informativeness. The Bill and Melinda Gates Foundation (BMGF), as one of the largest non-industry funders of clinical trials in the world, created a group called Design, Analyze, Communicate (DAC). DAC began expert scientific reviews of a sample of grantees’ trial protocols in 2019. We categorized and quantified areas of scientific review feedback provided for 52 clinical trial protocols submitted to DAC over a 3-year period. Knowledge of feedback themes offers insight into potential areas of trial design weakness, which may be helpful in considering the types of support best offered in the early stages of trial design for global health clinical trials. Methods We conducted a retrospective analysis of protocol review feedback provided by DAC to grantees. Protocols were submitted to BMGF between 2020–2022. A qualitative content analysis was conducted by developing a codebook of clinical trial methodology topics and subtopics, and systematically coding free-text review feedback. Manual text classification of individual feedback statements enabled quantification and frequency analysis of review feedback. Results A total of 1537 individual recommendations were made across all 52 protocols. The median number of recommendations per protocol was 28 (range: 13 to 52), covering a wide range of issues related to clinical trial design, implementation, analysis, and impact. Nearly half of all recommendations (47%) were characterized by the review team as high priority. The areas with the highest frequency of recommendations were Statistics and Data Analysis, Trial Procedures, and Intervention/Dose. Conclusions This study provides a taxonomy of scientific review feedback topic areas that can be used to categorize clinical trial design topics. The high number of recommendations per protocol review across several distinct topic areas highlights the need for a scientific review to enhance informativeness of global health clinical trials. This review must take place prior to trial initiation and review teams should include statistical and trial design expertise with additional expertise tailored to trial/intervention type and phase.

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Institutional Scientific Review of Cancer Clinical Research Protocols: A Unique Requirement That Affects Activation Timelines

Abstract: NCI-mandated institutional scientific review of oncology clinical trials contributes substantially to protocol activation timelines. Further evaluation of this process and the value added to research quality is warranted.

Cited by 7 publications

References 21 publications

An ethics framework for consolidating and prioritizing COVID-19 clinical trials

An ethics framework for consolidating and prioritizing COVID-19 clinical trials

<strong>A Maturity Model for the Scientific Review of Clinical Trial Designs and Their Informativeness </strong>

Scientific Review of Protocols to Enhance Informativeness of Global Health Clinical Trials

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