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4 Lessons Learned and Best Practices
Pages 35-52

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From page 35...
... (Chan) • Funders have opportunities to influence and enable the rigor and reproducibility of studies they fund (e.g., providing feed back on proposals, tools and training, statistical support, and translational expertise; requiring data sharing for milestone payments; providing sufficient funding for data curation and management as well as open-access publication fees)
From page 36...
... The second panel considered lessons learned and best practices for increased transparency from the field clinical research that could be applied to improving transparent reporting of preclinical studies (see Box 4-1 for corresponding workshop session objectives)
From page 37...
... initiative as an example of how guidelines can improve the reporting of clinical trial protocols and drive quality and efficiencies downstream. Geeta Swamy, vice dean for scientific integrity and associate vice president for research at Duke University, offered her perspective on developing a culture of research integrity and accountability at an institution through education, best practices, and scientific and analytical excellence.
From page 38...
... or ethics approval of clinical studies are the result of protocols Allocation concealment 59% Blinding 34% Primary outcomes 25% Power calculation 40% Harms reporting system 41% % with inadequate information FIGURE 4-1 Important information lacking in clinical trial protocols, shown as a percentage of protocols with inadequate information. SOURCES: Chan presentation, September 25, 2019; citing Chan et al., 2004, 2008, 2017; Hróbjartsson et al., 2009; Mhaskar et al., 2012; Pildal et al., 2005; and Scharf and Colevas, 2006.
From page 39...
... . Adhering to reporting guidelines upfront can lead to downstream efficiencies by helping to ensure that clinical trial protocols are complete and of high quality, Chan summarized.
From page 40...
... SEPTRE also includes time-saving features, such as the ability to easily upload protocol information to ClinicalTrials.gov, which Chan said "reduces the registration time from hours to minutes." Another feature is the ability to automatically track protocol amendments and easily carry them through to the next protocol version. THE INSTITUTION'S ROLE IN IMPROVING REPRODUCIBILITY Geeta Swamy, Vice Dean for Scientific Integrity and Associate Vice President for Research, Duke University Although it is always hoped that people know what is right and will ultimately do what is right, things can still go wrong, Swamy said, and the stakes can be high for individuals, researchers, and institutions.
From page 41...
... In its effort to support a culture of research integrity, the Duke Office of Scientific Integrity is focused on five main areas: (1) education and resources to translate the principles of integrity into routine practice; (2)
From page 42...
... Swamy said the intent was to empower investigators with interactive, hands-on learning resources for their trainees rather than "one more electronic module to check a box" for compliance. Best Practice Among the best practices implemented are electronic research notebooks for preclinical research.
From page 43...
... FUNDER/FOUNDATION ROLE IN INFLUENCING AND ENABLING REPRODUCIBILITY Magali Haas, Chief Executive Officer and President, Cohen Veterans Bioscience The mission of Cohen Veterans Bioscience is to accelerate the development of diagnostics and therapeutics for posttraumatic stress disorder (PTSD) and traumatic brain injury, Haas said.7 There are few U.S.
From page 44...
... pproach RAPID Dx NeuroTech Hub PLATFORM Computational Modeling CTN/ Incubator FIGURE 4-3 Cohen Veterans Bioscience platform approach to advancing repro ducible, rigorous, and robust research in the field of traumatic brain injury and posttraumatic stress disorder, engaging strategic partners across industry, aca demia, and foundations. SOURCE: Haas presentation, September 25, 2019.
From page 45...
... The Preclinical Data Forum has also published guidelines and checklists such as a Consensus Preclinical Checklist for information related to the use of rodents in research. Cohen Veterans Bioscience also funded a $10,000 prize, awarded through the Preclinical Data Forum, for the best negative data publication.
From page 46...
... Haas also raised the importance of funding enabling technologies that can be mass produced for use by researchers, as is being done in a consortium with the Wellcome Trust, IMEC, and the Howard Hughes Medical Institute to support a multi-channel "preclinical nanoprobe" to improve quality of the data being collected. BRAIN Commons Cohen Veterans Bioscience is also focused on improving data sharing and openness by sponsoring the BRAIN Commons, a cloud-based platform for data sharing of preclinical, clinical, omics, imaging, neuroimaging, and other data, Haas said.
From page 47...
... There is a variety of reasons for reducing the number of animals used in a study, she said, but it is also important to remember that underpowered studies are often uninterpretable. Chan said the current practice of registration of clinical trials demonstrates the role journals can play in leading change.
From page 48...
... Chan observed that some IRBs require trial registration as a condition for review, and he encouraged IRBs to also recommend adherence to reporting guidelines, such as SPIRIT, to improve the content of submissions. He reiterated that is important to promote reporting guidelines to researchers as beneficial and not burdensome, in that submitting high-quality protocols facilitates more rapid review and leads to fewer queries and requests for revisions.
From page 49...
... Goodman asked how protocol review could be made a routine part of funding decisions, and how adherence to proposed protocols might be monitored after grants are awarded. Swamy noted that there are new requirements for the Human Subjects and Clinical Trials Information Form to be submitted to NIH with proposal and grant applications.
From page 50...
... Common Data Elements Stuart Hoffman, scientific program manager for the Department of Veterans Affairs' Office of Research and Development, shared his experience with the development of common data elements for traumatic brain injury and noted the challenges of coming to consensus on those ele
From page 51...
... She agreed that development of common data elements for preclinical research will be challenging, and noted that NIH has assembled a preclinical common data elements working group. The extent to which the common data elements are adopted depends on incentives and enforcement ("carrots and sticks")


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