Dataset Information

Enhancing clinical evidence by proactively building quality into clinical trials.

ABSTRACT:

Background

Stakeholders across the clinical trial enterprise have expressed concern that the current clinical trial enterprise is unsustainable. The cost and complexity of trials have continued to increase, threatening our ability to generate reliable evidence essential for making appropriate decisions concerning the benefits and harms associated with clinical interventions. Overcoming this inefficiency rests on improving protocol design, trial planning, and quality oversight.

Methods

The Clinical Trials Transformation Initiative convened a project to evaluate methods to prospectively build quality into the scientific and operational design of clinical trials ("quality-by-design"), such that trials are feasible to conduct and important errors are prevented rather than remediated. A working group evaluated aspects of trial design and oversight and developed the Clinical Trials Transformation Initiative quality-by-design principles document, outlining a series of factors generally relevant to the reliability of trial conclusions and to patient safety. These principles were then applied and further refined during a series of hands-on workshops to evaluate their utility in facilitating proactive, cross-functional dialogue, and decision-making about trial design and planning. Following these workshops, independent qualitative interviews were conducted with 19 workshop attendees to explore the potential challenges for implementing a quality-by-design approach to clinical trials. The Clinical Trials Transformation Initiative project team subsequently developed recommendations and an online resource guide to support implementation of this approach.

Conclusion

The Clinical Trials Transformation Initiative quality-by-design principles provide a framework for assuring that clinical trials adequately safeguard participants and provide reliable information on which to make decisions on the effects of treatments. The quality-by-design workshops highlighted the value of active discussions incorporating the different perspectives within and external to an organization (e.g. clinical investigators, research site staff, and trial participants) in improving trial design. Workshop participants also recognized the value of focusing oversight on those aspects of the trial where errors would have a major impact on participant safety and reliability of results. Applying the Clinical Trials Transformation Initiative quality-by-design recommendations and principles should enable organizations to prioritize the most critical determinants of a trial's quality, identify non-essential activities that can be eliminated to streamline trial conduct and oversight, and formulate appropriate plans to define, avoid, mitigate, monitor, and address important errors.

SUBMITTER: Meeker-O'Connell A

PROVIDER: S-EPMC4952025 | biostudies-literature | 2016 Aug

REPOSITORIES: biostudies-literature

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Publications

Enhancing clinical evidence by proactively building quality into clinical trials.

Meeker-O'Connell Ann A Glessner Coleen C Behm Mark M Mulinde Jean J Roach Nancy N Sweeney Fergus F Tenaerts Pamela P Landray Martin J MJ

Clinical trials (London, England) 20160420 4

<h4>Background</h4>Stakeholders across the clinical trial enterprise have expressed concern that the current clinical trial enterprise is unsustainable. The cost and complexity of trials have continued to increase, threatening our ability to generate reliable evidence essential for making appropriate decisions concerning the benefits and harms associated with clinical interventions. Overcoming this inefficiency rests on improving protocol design, trial planning, and quality oversight.<h4>Methods ...[more]

PMID: 27098014

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Project description:BackgroundRecently, the quality of clinical trials conducted in China has made considerable progress. However, clinical trials conducted in China still fall below the global average standard. The aim of this systematic review was to assess studies that investigated the quality of clinical trials conducted in China, summarize the issues, and provide suggestions for conducting high-quality clinical trials in China.MethodsWe comprehensively searched studies that investigated the quality of clinical trials conducted in China in the following databases from inception to December 1, 2021: National Knowledge Infrastructure, the Chinese Science and Technology Periodical Database, WanFang Data, China Biology Medicine, PubMed, and Embase. We then analyzed the issues in clinical trial registration, ethics review, implementation, and reporting. SPSS 25.0 software was used for data analysis. The data synthesis was conducted using summary statistics and a narrative format.ResultsA total of 90 studies were analyzed, there were 50 studies with 0-5 citation counts (55.56%), 18 studies with 5-10 citation counts (20%), 9 studies with 10-15 citation counts (10%), and 13 studies with more than 15 citation counts (14.44%). Eight (8.89%) studies were conducted by a supervision department, 38 (42.22%) by organizations with GCP qualification, and 44 (48.89%) by third parties. Additionally, there were some problems in the ethical review process of clinical trials, clinical trial registration process, clinical trial implementation process, and clinical trial reporting process.ConclusionsThe current study shows that the quality problems of clinical trials in China still exist. The reported problems are related to the process of clinical trials, including ethical review, registration, implementation, reporting. Due to the limited quantity and quality of included studies, the conclusions of this study need to be verified by high-quality studies.Review registrationNot registerated in PROSPERO.

Project description:BACKGROUND:With the second largest tuberculosis (TB) burden globally, China is committed to actively engage in international TB clinical trials to contribute to global TB research. However, lack of research capacity among local sites has been identified as a barrier. MAIN TEXT:The China Tuberculosis Clinical Trials Consortium (CTCTC) was initiated by Beijing Chest Hospital with investment from the US National Institutes of Health and technical support from Family Health International 360 in 2013, as a nationwide collaborative clinical trial network to strengthen selected clinical site research capacity and attract TB clinical trials. The program aims to: 1) recruit leading hospitals that care for TB patients; 2) conduct on-site assessment to identify capacity gaps and needs for improvement; 3) design and deliver capacity building activities; 4) attract and deliver high quality results for TB clinical trials. A total of 24 sites have joined CTCTC, covering 20 provinces in China. Twenty-two sites have been accredited by the National Medical Products Administration (NMPA) to be qualified to conduct TB clinical trials. The onsite assessment, extensive trainings among the CTCTC sites and young investigators have resulted in better understanding and improvement of the site capacity in conducting TB clinical trials. The establishment and growth of the CTCTC network has benefited from the good leadership, effective international cooperation and local commitment. Issues in human resources, regulatory environment and sustainability have been challenging the network from continuing growth. Clinical researchers have full-time clinical responsibilities in China and it is thus important to build a cadre of other human resources to assist. The regulatory environment is becoming friendlier in China to introduce international clinical trials to the CTCTC network. CONCLUSIONS:The CTCTC, with mature management structure and sustainable development model, which are distilled five key lessons for other developing countries or investigators of interest. They are the respectively using assessment-based approach to design tailored training package, understanding the availability of clinical researchers, providing solutions to maintain sustainability, understanding local regulatory environments and working with an international organization with local on-site team, respectively. Although, the experiences and capacity of China's TB hospitals in conducting clinical research vary. Considerable efforts to continue building the capacity are still needed, although the gap is smaller for a few top-tier hospitals.

Project description:BackgroundMost researchers in Uzbekistan prefer to publish their reports in journals of their home country. Moreover, the proportion of healthcare practitioners who prefer to use these national sources of information also remains high. However, the quality of publications from national journals, in post-Soviet countries, has not been systematically evaluated until now. The primary objective of this study was to evaluate the quality of randomized controlled trials' (RCTs) reports published in medical journals from Uzbekistan. We supposed that reports had at least minimal quality to contribute to the higher quality of healthcare.MethodsTo evaluate the quality of RCTs, we selected two journals from the list of national medical journals for which background information was provided. We decided to select articles from journals that had the highest subscription rate and were likely to have the highest impact on clinical decisions. The journals were Medical Journal of Uzbekistan and Paediatrics. Only issues published in 2007-2017 were considered for evaluation. Two evaluators independently scored RCTs and controlled clinical trials (CCTs) reported in the journals. The 5-point scale developed by Jadad et al. was used to evaluate the quality of reports. Consensus-based decision was made about the final score of each report.ResultsWe reviewed 1311 studies in the two journals and found 380 clinical trials reports for the final evaluation. Our main finding was that none of the reports received a final score of more than 1, with an absolute agreement between evaluators. A median score of the studied reports was equal to 0, predicting a very low quality of controlled trials reported in the national journals (Wilcoxon signed-rank test p = 1.0; 95% CI = 0-0).ConclusionsWe believe that quality of reports about controlled trials, in Uzbekistan, can be considered insufficient to contribute to the higher quality of care and patients' safety. In the worst case, such condition can cause serious damage to the public health and lead to ineffective use of resources in the country. Therefore, the better reporting and organization of RCTs and CCTs should become a main goal of all stakeholders interested in the effective and safe healthcare in the country.

Dataset Information

Enhancing clinical evidence by proactively building quality into clinical trials.

Background

Methods

Conclusion

Publications

Enhancing clinical evidence by proactively building quality into clinical trials.

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