Characteristics of Oncology Clinical Trials

Hirsch, Bradford R.; Califf, Robert M.; Cheng, Steven K.; Tasneem, Asba; Horton, John; Chiswell, Karen; Schulman, Kevin A.; Dilts, David M.; Abernethy, Amy P.

doi:10.1001/jamainternmed.2013.627

Cited by 155 publications

(85 citation statements)

References 34 publications

(45 reference statements)

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“…Bradford et al found that 41.8% of trials were funded primarily by the industry [25], which corresponds with the 51.9% in our study. A reason for concern should be the lack of industrial funding for research beyond forms of systemic therapy.…”

Section: Discussionsupporting

confidence: 84%

Current status and perspectives of interventional clinical trials for glioblastoma – analysis of ClinicalTrials.gov

et al. 2017

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The records of 208.777 (100%) clinical trials registered at ClinicalTrials.gov were downloaded on the 19th of February 2016. Phase II and III trials including patients with glioblastoma were selected for further classification and analysis. Based on the disease settings, trials were classified into three groups: newly diagnosed glioblastoma, recurrent disease and trials with no differentiation according to disease setting. Furthermore, we categorized trials according to the experimental interventions, the primary sponsor, the source of financial support and trial design elements. Trends were evaluated using the autoregressive integrated moving average model. Two hundred sixteen (0.1%) trials were selected for further analysis. Academic centers (investigator initiated trials) were recorded as primary sponsors in 56.9% of trials, followed by industry 25.9%. Industry was the leading source of monetary support for the selected trials in 44.4%, followed by 25% of trials with primarily academic financial support. The number of newly initiated trials between 2005 and 2015 shows a positive trend, mainly through an increase in phase II trials, whereas phase III trials show a negative trend. The vast majority of trials evaluate forms of different systemic treatments (91.2%). In total, one hundred different molecular entities or biologicals were identified. Of those, 60% were involving drugs specifically designed for central nervous system malignancies. Trials that specifically address radiotherapy, surgery, imaging and other therapeutic or diagnostic methods appear to be rare. Current research in glioblastoma is mainly driven or sponsored by industry, academic medical oncologists and neuro-oncologists, with the majority of trials evaluating forms of systemic therapies. Few trials reach phase III. Imaging, radiation therapy and surgical procedures are underrepresented in current trials portfolios. Optimization in research portfolio for glioblastoma is needed.Electronic supplementary materialThe online version of this article (doi:10.1186/s13014-016-0740-5) contains supplementary material, which is available to authorized users.

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Section: Discussionsupporting

confidence: 84%

Current status and perspectives of interventional clinical trials for glioblastoma – analysis of ClinicalTrials.gov

et al. 2017

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“…One such example was a recently published cross-sectional study of oncology research that found that more than 25,000 outcomes had appeared only once or twice in oncology trials [2]. Furthermore, key outcomes may go unreported, and a review of missing data in Cochrane Reviews found that 102/143 (71%) reviews were unable to obtain the findings for key outcomes in the included trials, and 26 (18%) were missing data for more than half the patients on the review's pre-specified primary outcome [3].…”

Section: Introductionmentioning

confidence: 99%

Choosing Important Health Outcomes for Comparative Effectiveness Research: A Systematic Review

et al. 2014

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BackgroundA core outcome set (COS) is a standardised set of outcomes which should be measured and reported, as a minimum, in all effectiveness trials for a specific health area. This will allow results of studies to be compared, contrasted and combined as appropriate, as well as ensuring that all trials contribute usable information. The COMET (Core Outcome Measures for Effectiveness Trials) Initiative aims to support the development, reporting and adoption of COS. Central to this is a publically accessible online resource, populated with all available COS. The aim of the review we report here was to identify studies that sought to determine which outcomes or domains to measure in all clinical trials in a specific condition and to describe the methodological techniques used in these studies.MethodsWe developed a multi-faceted search strategy for electronic databases (MEDLINE, SCOPUS, and Cochrane Methodology Register). We included studies that sought to determine which outcomes/domains to measure in all clinical trials in a specific condition.ResultsA total of 250 reports relating to 198 studies were judged eligible for inclusion in the review. Studies covered various areas of health, most commonly cancer, rheumatology, neurology, heart and circulation, and dentistry and oral health. A variety of methods have been used to develop COS, including semi-structured discussion, unstructured group discussion, the Delphi Technique, Consensus Development Conference, surveys and Nominal Group Technique. The most common groups involved were clinical experts and non-clinical research experts. Thirty-one (16%) studies reported that the public had been involved in the process. The geographic locations of participants were predominantly North America (n = 164; 83%) and Europe (n = 150; 76%).ConclusionsThis systematic review identified many health areas where a COS has been developed, but also highlights important gaps. It is a further step towards a comprehensive, up-to-date database of COS. In addition, it shows the need for methodological guidance, including how to engage key stakeholder groups, particularly members of the public.

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“…Consistent with this view, oncology trials constitute the largest clinical discipline across all ClinicalTrials.gov registrations (11). Likewise, oncology trials comprise the largest subset of ClinicalTrials.gov registrations within Duke Medicine.…”

Section: Protocol Review and Monitoring System (Prms)mentioning

confidence: 89%

ClinicalTrials.gov Reporting: Strategies for Success at an Academic Health Center

O'Reilly

Hassell

Snyder

et al. 2014

Clinical And Translational Science

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The Food and Drug Administration Amendments Act of 2007 (FDAAA 2007, US Public Law 110-98) mandated registration and reporting of results for applicable clinical trials (ACTs). Meeting these registration and results reporting requirements has proven to be a challenge for the academic research community. Duke Medicine has made compliance with registration and results reporting a high priority. In order to create uniformity across a large institution, a written policy was created describing requirements for clinical trials disclosure. Furthermore, a centralized resource group was formed with three full time staff members. The group not only ensures compliance with FDAAA 2007, it also acts as a resource for study teams providing hands-on support, reporting, training and ongoing education. Intensive resourcing for results reporting has been crucial for success. Due to implementation of the institutional policy and creation of centralized resources, compliance with FDAAA 2007 has increased dramatically at Duke Medicine for both registration and results reporting. A consistent centralized approach has enabled success in the face of changing agency rules and new legislation.

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Characteristics of Oncology Clinical Trials

Cited by 155 publications

References 34 publications

Current status and perspectives of interventional clinical trials for glioblastoma – analysis of ClinicalTrials.gov

Current status and perspectives of interventional clinical trials for glioblastoma – analysis of ClinicalTrials.gov

Choosing Important Health Outcomes for Comparative Effectiveness Research: A Systematic Review

ClinicalTrials.gov Reporting: Strategies for Success at an Academic Health Center

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