The workshop will include a series of moderated discussions that focus on issues of measuring trial outcomes from available data sources, potential randomization strategies, specific ePCT design considerations, and unique challenges associated with ePCTs. Panel discussions will utilize case examples from the Collaboratory repertoire and beyond to illustrate how clinical investigators and biostatisticians work to address research questions posed by specific trials.
The Workshop Website provides information on meeting logistics, agenda, and registration. There is also an option to attend the workshop remotely via the NIH Videoconference Center, and those details are also available at the Workshop Website.
Christine M. Hildebrand, PA-C
Clinical Operations Lead
Amici Clinical Research
Chief Operating Officer
Population Health Research Institute
David Braley Research Institute
Improving Qualification of Investigators: Recommendations from the Clinical Trials Transformation Initiative
CTTI; Investigator qualifications; Investigator training; Site team training; Good clinical practice; Clinical trials
There is little evidence that good clinical practice (GCP) training alone sufficiently qualifies investigators in the conduct of clinical trials. What is needed is a targeted and risk-based approach to educating clinical trial investigators and their delegates in GCP principles.
A culture shift is needed that eliminates the distinction between “qualification” and “preparation” and moves toward investigators and their delegates assuming greater ownership of training and documenting evidence of their qualification.
CTTI recommendations outline how to confirm that site teams are qualified while also reducing inefficiencies in training and increasing preparation for successful study execution.
Investigators and site teams come to the table with different levels of research experience, training, and credentials. How can we effectively address gaps in skills and knowledge of GCP principles?
With respect to pragmatic trials conducted within healthcare systems, are there approaches to site monitoring that address issues related to turnover of PIs and clinical and research staff?
Greater ownership of GCP training and qualification by investigators and delegates can lead to active remediation of deficiencies at the clinical site.
CTTI recommendations are meant to be adaptable to the protocol, even when conducted in a real-world clinical setting using electronic health records.
The National Institutes of Health (NIH) Office of Disease Prevention (ODP) needs your help to enhance the quality of research supported by the NIH. The ODP is building a directory of experts in research methods and study designs that can help NIH Scientific Review Officers identify the most appropriate reviewers for NIH research applications. Adding your name and expertise to the directory is easy – simply share your methodological and content area expertise by filling out the ODP’s Prevention Research Expertise Survey (PRES).
The survey covers 7 areas related (but not limited) to prevention research:
Study Design Topics
The PRES takes approximately 15-25 minutes and is strictly voluntary. Based on your skill set and interest, NIH or Department of Health and Human Services (HHS) staff may invite you to serve as a peer reviewer for research applications, or you may be asked to sit on a panel, committee, or workgroup; or to speak at a seminar or workshop. Your responses and information will not be shared with anyone outside of HHS.
The ODP believes the participation of highly qualified methods experts will enhance the quality of peer review; improve the rigor, reproducibility, and impact of research supported by the NIH; and ultimately lead to stronger clinical practice, health policy, and community health programs.
The ODP is the lead office at the NIH responsible for assessing, facilitating, and stimulating research in disease prevention and disseminating the results of this research to improve public health. For more information about the ODP and its work, visit the ODP website.
Thank you in advance for taking the survey – your participation helps improve the rigor, impact, and value of research supported by the NIH.
A tool used to rate how the design of a pragmatic clinical trial will influence the real-world applicability of its results can also be used in real time to assess the impact of changes in trial implementation, a recent study published in Trials found.
When designing a pragmatic trial to test the effectiveness of an intervention under “real-world” conditions, researchers use the Pragmatic Explanatory Continuum Indicator Summary-2 (PRECIS-2) to assess how a variety of design features may affect the applicability of trial results for the intended users. A pragmatic trial differs from a traditional “explanatory” trial, which tests the efficacy of an intervention under ideal conditions. PRECIS-2 rates design features on a scale from “explanatory” to “pragmatic” within several domains. The end users of trial results, such as health care systems, may need the results to be more or less “pragmatic” on the explanatory–pragmatic spectrum in order to implement the intervention in their own care delivery settings.
In a novel effort, researchers with the Pragmatic Trial of Video Education in Nursing Homes (PROVEN) used PRECIS-2 during the conduct of the trial to assess the effects of midtrial changes in implementation. PROVEN, an ongoing NIH Collaboratory Demonstration Project, is a pragmatic, cluster randomized trial evaluating the effectiveness of video-assisted decision support tools for advance care planning in nursing homes.
In the initial design of PROVEN, design features in the implementation-focused domains of PRECIS-2 were relatively pragmatic, especially in the domain measuring flexibility in the delivery of the intervention. As the trial progressed, adaptations in implementation that were necessary to address challenges in monitoring and protocol adherence led to more explanatory approaches. The investigators concluded that some pragmatic trials, such as those conducted in complex health care systems like nursing homes, “may benefit from a more dynamic approach to implementation which allows for fluidity between pragmatic and explanatory features.” PRECIS-2 can be useful in evaluating the impact of midtrial adaptations with these dynamic approaches to trial implementation.
PROVEN is one of the first large-scale pragmatic trials to be conducted in nursing homes. Learn more about PRECIS-2 in the Living Textbook.
On June 4, the National Institutes of Health (NIH) released its first Strategic Plan for Data Science. The plan outlines steps the agency will take to modernize research data infrastructure and resources and to maximize the value of data generated by NIH-supported research.
Data science challenges for NIH have evolved and grown rapidly since the launch of the Big Data to Knowledge (BD2K) program in 2014. The most pressing challenges include the growing costs of data management, limited interconnectivity and interoperability among data resources, and a lack of generalizable tools to transform, analyze, and otherwise support the usability of data for researchers, institutions, industry, and the public.
The goals of the NIH Strategic Plan for Data Science are to:
support an efficient, effective data infrastructure by optimizing data storage, security, and interoperability;
modernize data resources by improving data repositories, supporting storage and sharing of individual data sets, and integrating clinical and observational data;
develop and disseminate both generalizable and specialized tools for data management, analytics, and visualization;
enhance workforce development for data science by expanding NIH’s internal data science workforce and supporting expansion of the national research workforce, and by engaging a broader community of experts and the general public in developing best practices; and
enact policies that promote stewardship and sustainability of data science resources.
As part of the implementation of the strategic plan, the NIH will hire a chief data strategist. For information about the position, see the job announcement.
Seeking to advance the study and practice of engagement in health research, the Patient-Centered Outcomes Research Institute (PCORI) recently launched the Engagement in Health Research Literature Explorer. Locating relevant research articles about engagement can be challenging because of a lack of standard terminology. The new tool searches a curated database of peer-reviewed literature on engagement. Articles are included in the database if they describe engagement experiences, report research findings on engagement practices, or present theories, concepts, or views on engagement. The database is updated monthly and is one way PCORI is helping to promote meaningful involvement of patients, caregivers, clinicians, and other healthcare stakeholders throughout the research process.
The National Institutes of Health (NIH) Office of Extramural Research has released new clinical trial requirements for grant applications and contract proposals due on or after January 25, 2018. In anticipation of these new requirements, the NIH modified the Application Guide and the Review Criteria to address methodological problems common to many clinical trials. As group- or cluster-randomization designs are increasingly common in both basic and applied research, the new Application Guide includes links to the new Research Methods Resources website, which provides resources for investigators considering these group- or cluster-randomized designs, including lists of NIH webinars, key references, and statements to help investigators prepare sound applications and avoid methodological pitfalls.
As part of their ongoing effort to improve the speed and efficiency of conducting clinical trials, the NIH-FDA Joint Leadership Council has created a draft clinical trial protocol template. The template contains instructional and sample text intended to assist NIH-funded investigators in writing protocols for phase 2 or 3 clinical trials that require Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications. Feedback is sought from investigators, investigator-sponsors, institutional review board members, and other stakeholders involved in protocol development and review.
Our goal is to provide an organized way for creative investigators to describe their plans so that others can understand them. – Dr. Pamela McInnes, NIH
Details on the rationale and development of the protocol template are on these blog posts: