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Do variations in allocation concealment methods influence the effects found in intervention reviews?

Naing C, Hasan SS, Aung K

J Evid Based Med, 2011 Nov;4(4):255-8.
PMID: 23672756 DOI: 10.1111/j.1756-5391.2011.01156.x

(i) To explore any discrepancies in intervention effects between a set of Cochrane reviews that includes trials with liberal criteria and a set with restrictive criteria in which trials with liberal design have been removed from the review, and (ii) to suggest ways to improve the quality of evidence.

Matched MeSH terms: Clinical Trials as Topic/methods*
Good clinical practice

Merican I

Med J Malaysia, 2000 Aug;55 Suppl B:35-7.
PMID: 11125519
Matched MeSH terms: Clinical Trials as Topic/methods
Patient and public involvement in the design of clinical trials: An overview of systematic reviews

Price A, Albarqouni L, Kirkpatrick J, Clarke M, Liew SM, Roberts N, et al.

J Eval Clin Pract, 2018 02;24(1):240-253.
PMID: 29076631 DOI: 10.1111/jep.12805

BACKGROUND: Funders encourage lay-volunteer inclusion in research. There are controversy and resistance, given concerns of role confusion, exploratory methods, and limited evidence about what value lay-volunteers bring to research. This overview explores these areas.
METHODS: Eleven databases were searched without date or language restrictions for systematic reviews of public and patient involvement (PPI) in clinical trials design. This systematic overview of PPI included 27 reviews from which areas of good and bad practice were identified. Strengths, weaknesses, opportunities, and threats of PPI were explored through use of meta-narrative analysis.
RESULTS: Inclusion criteria were met by 27 reviews ranging in quality from high (n = 7), medium (n = 14) to low (n = 6) reviews. Reviews were assessed using CERQUAL NICE, CASP for qualitative research and CASP for systematic reviews. Four reviews report risk of bias. Public involvement roles were primarily in agenda setting, steering committees, ethical review, protocol development, and piloting. Research summaries, follow-up, and dissemination contained PPI, with lesser involvement in data collection, analysis, or manuscript authoring. Trialists report difficulty in finding, retaining, and reimbursing volunteers. Respectful inclusion, role recognition, mutual flexibility, advance planning, and sound methods were reported as facilitating public involvement in research. Public involvement was reported to have increased the quantity and quality of patient relevant priorities and outcomes, enrollment, funding, design, implementation, and dissemination. Challenges identified include lack of clarity within common language, roles, and research boundaries, while logistical needs include extra time, training, and funding. Researchers report struggling to report involvement and avoid tokenism.
CONCLUSIONS: Involving patients and the public in clinical trials design can be beneficial but requires resources, preparation, training, flexibility, and time. Issues to address include reporting deficits for risk of bias, study quality, and conflicts of interests. We need to address these tensions and improve dissemination strategies to increase PPI and health literacy.

Matched MeSH terms: Clinical Trials as Topic/methods*
Fulltext Real-world effectiveness of BNT162b2 mRNA vaccine: a meta-analysis of large observational studies

Kow CS, Hasan SS

Inflammopharmacology, 2021 Aug;29(4):1075-1090.
PMID: 34241782 DOI: 10.1007/s10787-021-00839-2

This paper aims to summarize through meta-analyses the overall vaccine effectiveness of the BNT162b2 mRNA vaccine from observational studies. A systematic literature search with no language restriction was performed in electronic databases to identify eligible observational studies which reported the adjusted effectiveness of the BNT162b2 mRNA vaccine to prevent RT-PCR confirmed COVID-19. Meta-analyses with the random-effects model were used to calculate the pooled hazard ratio (HR) and pooled incidence rate ratio (IRR) at 95% confidence intervals, and the vaccine effectiveness was indicated as (pooled HR - 1)/HR or (pooled IRR - 1)/IRR. Nineteen studies were included for this meta-analysis. The meta-analysis revealed significant protective effect against RT-PCR confirmed COVID-19 ≥ 14 days after the first dose, with vaccine effectiveness of 53% (95% confidence interval 32-68%), and ≥ 7 days after the second dose, with vaccine effectiveness of 95% (95% confidence interval: 96-97%). Despite its effectiveness, reporting vaccine safety data by relevant stakeholders should be encouraged as BNT162b2 mRNA is a new vaccine that has not gained full approval. There have been limited data about vaccine effectiveness among immunocompromised patients; thus, the vaccine should be used cautiously in this patient population.

Matched MeSH terms: Pragmatic Clinical Trials as Topic/methods*
Recommendations for improving clinical trial design to facilitate the study of youth-onset type 2 diabetes

Jalaludin MY, Barrientos-Pérez M, Hafez M, Lynch J, Shehadeh N, Turan S, et al.

Clin Trials, 2020 02;17(1):87-98.
PMID: 31450961 DOI: 10.1177/1740774519870190

BACKGROUND: The prevalence of type 2 diabetes is increasing in youths and differs from adult-onset type 2 diabetes in its characteristics and progression. Currently, only two drugs are approved for youth-onset type 2 diabetes and many patients are not meeting glycemic targets. Clearly, there is an urgent need to complete clinical trials in youths with type 2 diabetes to increase the therapeutic choice for these patients. However, factors such as limited patient numbers, unwillingness of patients to participate in trials, failure to meet strict inclusion and exclusion criteria, and poor clinic attendance have limited the size and number of trials in this complicated patient demographic.
RECOMMENDATIONS: This is a narrative opinion piece on the design of clinical trials in youth-onset type 2 diabetes prepared by researchers who undertake this type of study in different countries. The review addresses possible ways to enhance trial designs in youth-onset type 2 diabetes to meet regulatory requirements, while minimizing the barriers to patients' participation. The definition of adolescence, recruitment of sufficient patient numbers, increasing flexibility in selection criteria, improving convenience of trial visits, requirements of a control group, possible endpoints, and trial compliance are all considered. The authors recommend allowing extrapolation from adult data, using multiple interventional arms within future trials, broadening inclusion criteria, and focusing on endpoints beyond glucose control, among others, in order to improve the successful completion of more trials in this population.
CONCLUSIONS: Improvements in trial design will enable better recruitment and retention and thereby more evidence for treatment outcomes for youth-onset type 2 diabetes.

Matched MeSH terms: Clinical Trials as Topic/methods*
Proceedings of OMERACT 10, the International Consensus Conference on Outcome Measures in Rheumatology Clinical Trials. May 4-8, 2010. Kota Kinabalu, Borneo

J Rheumatol, 2011 Jul;38(7):1448-518.
PMID: 22263235
Matched MeSH terms: Clinical Trials as Topic/methods*
Fulltext Development of standard clinical endpoints for use in dengue interventional trials

Tomashek KM, Wills B, See Lum LC, Thomas L, Durbin A, Leo YS, et al.

PLoS Negl Trop Dis, 2018 10;12(10):e0006497.
PMID: 30286085 DOI: 10.1371/journal.pntd.0006497

Dengue is a major public health problem worldwide. Although several drug candidates have been evaluated in randomized controlled trials, none has been effective and at present, early recognition of severe dengue and timely supportive care are used to reduce mortality. While the first dengue vaccine was recently licensed, and several other candidates are in late stage clinical trials, future decisions regarding widespread deployment of vaccines and/or therapeutics will require evidence of product safety, efficacy and effectiveness. Standard, quantifiable clinical endpoints are needed to ensure reproducibility and comparability of research findings. To address this need, we established a working group of dengue researchers and public health specialists to develop standardized endpoints and work towards consensus opinion on those endpoints. After discussion at two working group meetings and presentations at international conferences, a Delphi methodology-based query was used to finalize and operationalize the clinical endpoints. Participants were asked to select the best endpoints from proposed definitions or offer revised/new definitions, and to indicate whether contributing items should be designated as optional or required. After the third round of inquiry, 70% or greater agreement was reached on moderate and severe plasma leakage, moderate and severe bleeding, acute hepatitis and acute liver failure, and moderate and severe neurologic disease. There was less agreement regarding moderate and severe thrombocytopenia and moderate and severe myocarditis. Notably, 68% of participants agreed that a 50,000 to 20,000 mm3 platelet range be used to define moderate thrombocytopenia; however, they remained divided on whether a rapid decreasing trend or one platelet count should be case defining. While at least 70% agreement was reached on most endpoints, the process identified areas for further evaluation and standardization within the context of ongoing clinical studies. These endpoints can be used to harmonize data collection and improve comparability between dengue clinical trials.

Matched MeSH terms: Clinical Trials as Topic/methods*