scholarly journals The contribution and attitudes of research ethics committees to complete registration and non-selective reporting of clinical trials: A European survey

2016 ◽  
Vol 12 (3) ◽  
pp. 123-136 ◽  
Author(s):  
Daniel Strech ◽  
Jasper Littmann ◽  
Keyword(s):  
Clinical Trials ◽  
Research Ethics ◽  
Time Lag ◽  
Ethics Committees ◽  
Trial Registration ◽  
Selective Reporting ◽  
Positive Trial ◽  
Research Ethics Committees ◽  
Publication Rates ◽  
Study Results

Background: For many years, studies have shown that the results of clinical trials are often published or reported selectively with a statistically significant bias in favour of positive trial results. Trial registration as a precondition for publication had only limited effects on current practice. Results of trials which were approved by research ethics committees (RECs) are often published only partially, with a substantial time lag or not at all. This study examined existing procedures of RECs in the European Union to monitor and prevent incomplete registration of trials and selective reporting of trial results. It further investigated opinions of REC members about the need to update current legislation on this matter. Methods: Web-based survey on members of RECs in 22 European countries. Results: Over 90 percent of respondents agreed that the incomplete publication of trial results had a strong or somewhat negative impact on public health and on healthcare professionals’ trust in the validity of clinical research, yet only 30 percent reported that their REC had some (often unsystematic) mechanism in place to check that findings of approved studies are published in some form. Less than 10 percent stated that their REC has further specific procedures in place to prevent or minimize selective reporting of study results. Respondents stated variously that their REC did not have the resources to follow up on this matter. Conclusions: The existing legislation to regulate trial registration and encourage complete publication of trial results leaves room for improvement. REC members welcome guidelines to adequately address both problems. The new Regulation EU No. 536/2014 as well as the FDA Amendment Act from 2007 require the reporting of summary results within 1 year after study end. As recent reviews demonstrated, without any systematic approach to monitor the adherence to these regulations, publication rates remain rather low.

scholarly journals Registration audit of clinical trials given a favourable opinion by UK research ethics committees

BMJ Open ◽  
2019 ◽  
Vol 9 (2) ◽  
pp. e026840 ◽  
Author(s):  
Carla Denneny ◽  
Sue Bourne ◽  
Simon E Kolstoe
Keyword(s):  
Clinical Trials ◽  
Research Ethics ◽  
Ethics Committees ◽  
Ethics Committee ◽  
Trial Registration ◽  
Research Ethics Committees ◽  
The European Union ◽  
Clinical Trial Registration ◽  
Research Ethics Committee ◽  
The Uk

ObjectiveTo determine levels of public registration for a cohort of clinical trials reviewed and given a favourable opinion by research ethics committees in the United Kingdom.Study designAudit of records.SettingClinical trials receiving a favourable ethics opinion between 1 January 2016 and 30 June 2016.Main outcome measuresCorrelation between trials on the UK research ethics committee database and any primary registry entry on the WHO International Clinical Trials Registry Platform or clinicaltrials.gov as of 29 August 2017 (14 to 20 months after the favourable ethics committee opinion).ResultsOver the study period 1014 trials received a favourable ethics opinion, with 397 (39%) registered on the European Union Drug Regulating Authorities Clinical Trials database, and 18 with an agreed clinical trial registration deferral. Excluding these trials, the total number subsequently requiring registration was 599, and of these 405 (40% of total) were found to be registered. Follow-up with the 194 investigators or sponsors of trials not found to be registered produced 121 responses with a further 10 (1%) trials having already registered, 55 commitments to register and a variety of other responses. The overall registration rate was therefore 80%.ConclusionsDespite researchers and sponsors being reminded that registration of clinical trials is a condition of the research ethics committee (REC) favourable opinion, one-fifth of clinical trials either had not been registered, or their registration could not easily be found, 14 to 20 months after receiving the favourable opinion letter. The methodology trialled here proved effective, and although there are positive indications of a culture change towards greater registration, our results show that more still needs to be done to increase trial registration.

scholarly journals Prospective Trial Registration and Publication Rates of Randomized Clinical Trials in Digital Health: A Cross Sectional Analysis of Global Trial Registries

2019 ◽  
Author(s):  
Mustafa Al-Durra ◽  
Robert P. Nolan ◽  
Emily Seto ◽  
Joseph A. Cafazzo
Keyword(s):  
Clinical Trials ◽  
Digital Health ◽  
Prospective Trial ◽  
Trial Registration ◽  
Reporting Bias ◽  
Selective Reporting ◽  
Funding Sources ◽  
Publication Rates ◽  
Selective Reporting Bias ◽  
The U.S

AbstractRegistration of clinical trials was introduced to mitigate the risk of publication and selective reporting bias in the realm of clinical research. The prevalence of publication and selective reporting bias in trial results has been evidenced through scientific research. This bias may compromise the ethical and methodological conduct in the design, implementation and dissemination of evidence-based healthcare interventions. Principal investigators of digital health trials may be overwhelmed with challenges that are unique to digital health research, such as the usability of the intervention under test, participant recruitment, and retention challenges that may contribute to non-publication rate and prospective trial registration. Our primary research objective was to examine the prevalence of prospective registration and publication rates in digital health trials. We included 417 trials that enrolled participants in 2012 and were registered in any of the seventeen WHO registries. The prospective registration and publication rates were at (38.4%) and (65.5%) respectively. We identified a statistically significant (P<.001) “Selective Registration Bias” with 95.7% of trials published within a year after registration, were registered retrospectively. We reported a statistically significant relationship (P=.003) between prospective registration and funding sources, with industry-funded trials having the lowest compliance with prospective registration at (14.3%). The lowest non-publication rates were in the Middle East (26.7%) and Europe (28%), and the highest were in Asia (56.5%) and the U.S. (42.5%). We found statistically significant differences (P<.001) between trial location and funding sources with the highest percentage of industry funded trials in Asia (17.3%) and the U.S. (3.3%).

The Development and Validation of a Guide for Peruvian Research Ethics Committees to Assist in the Review of Ethical-Scientific Aspects of Clinical Trials

2012 ◽  
pp. 97-114 ◽  
Author(s):  
Susy Olave Quispe ◽  
Duilio Fuentes Delgado ◽  
Gabriela Minaya Martínez ◽  
Rosa Surco Ibarra ◽  
Martín Yagui Moscoso ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Research Ethics ◽  
Ethics Committees ◽  
Research Ethics Committees ◽  
Development And Validation

scholarly journals Perspectives of non-specialists on the potential to serve as ethics committee members

2019 ◽  
Vol 47 (5) ◽  
pp. 1868-1876
Author(s):  
Chikako Kane ◽  
Kenshi Takechi ◽  
Masayuki Chuma ◽  
Hiroshi Nokihara ◽  
Tomoko Takagai ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Research Ethics ◽  
Ethics Committees ◽  
Research Review ◽  
Research Ethics Committees ◽  
Review Committee ◽  
Future Studies ◽  
Detailed Explanation ◽  
Key Issues

Objective In Japan, under the new Clinical Trials Act pertaining to investigator-initiated clinical trials that came into effect on 1 April 2018, review boards should review proposed clinical trials while considering written opinions from specialists. Additionally, involvement of non-specialists is mandatory, and attention is being placed on their effective contributions. This study was performed to determine representative key issues with which to promote these contributions. Methods This qualitative study was conducted in 2018 using a focus group interview of six non-specialists regarding perspectives on clinical research itself and research ethics committees. Results For perspectives on clinical research itself, 33 codes were established and sorted into 2 categories and 6 subcategories relating to ambivalence toward clinical research. For perspectives on research ethics committees, 54 codes were established and sorted into 3 categories and 10 subcategories relating to the theme “knowledge and an environment that promotes non-specialist members’ participation.” One notable result was the willingness of participants to obtain details about a study should they be selected. Conclusions The results suggest that detailed explanation of a particular study would encourage non-specialist members to participate in a clinical research review committee. Education aimed at non-specialist participation should therefore be considered in future studies.

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