Literature DB >> 26242226

The evolution in registration of clinical trials: a chronicle of the historical calls and current initiatives promoting transparency.

Claudia Pansieri1, Chiara Pandolfini1, Maurizio Bonati2.   

Abstract

PURPOSE: Quality of care is strongly influenced by evidence-based medicine, a large part of which is based on results obtained from clinical trials. If trials are conducted in secret, patient safety is at risk. Several mandates-legal, editorial, financial, and ethical-have tried to influence the disclosure of clinical trials, first by encouraging registration in publicly accessible registers and, second, by calling for the publication of results. Not all these initiatives have reached high rates of compliance, but the succession of national and international events over a few years gave an important boost to information disclosure. This article provides a chronicle of the succession of the events, from the historical calls to the recent EMA policy and WHO statement, and public consultations requested by the NIH, and the HHS, which will inevitably change the international panorama. The path of these new policies is moving towards more supervised clinical research. Individual scientific institutions can also contribute, at the local level, to such an ethical endeavor as is improving research transparency, by disclosing information on the trials coordinated by their own researchers.
RESULTS: The way is long and complex, but, if everyone contributes there could be a prompt, worldwide diffusion of the findings of clinical trials, and therefore a more possible evidenced-based medicine.

Entities:  

Keywords:  Clinical trials as topic/legislation and jurisprudence; Government regulation; Publication bias; Registries

Mesh:

Year:  2015        PMID: 26242226     DOI: 10.1007/s00228-015-1897-9

Source DB:  PubMed          Journal:  Eur J Clin Pharmacol        ISSN: 0031-6970            Impact factor:   2.953


  48 in total

Review 1.  Principles for international registration of protocol information and results from human trials of health related interventions: Ottawa statement (part 1).

Authors:  Karmela Krleza-Jerić; An-Wen Chan; Kay Dickersin; Ida Sim; Jeremy Grimshaw; Christian Gluud
Journal:  BMJ       Date:  2005-04-23

2.  EMA's transparency seems to be opaque.

Authors:  Rita Banzi; Vittorio Bertele'; Silvio Garattini
Journal:  Lancet       Date:  2014-11-21       Impact factor: 79.321

3.  Sharing and reporting the results of clinical trials.

Authors:  Kathy L Hudson; Francis S Collins
Journal:  JAMA       Date:  2015-01-27       Impact factor: 56.272

4.  SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials.

Authors:  An-Wen Chan; Jennifer M Tetzlaff; Peter C Gøtzsche; Douglas G Altman; Howard Mann; Jesse A Berlin; Kay Dickersin; Asbjørn Hróbjartsson; Kenneth F Schulz; Wendy R Parulekar; Karmela Krleza-Jeric; Andreas Laupacis; David Moher
Journal:  BMJ       Date:  2013-01-08

5.  European Ombudsman ramps up action against European Medicines Agency over data transparency plans.

Authors:  Ingrid Torjesen
Journal:  BMJ       Date:  2014-06-05

6.  The proposed rule for U.S. clinical trial registration and results submission.

Authors:  Deborah A Zarin; Tony Tse; Jerry Sheehan
Journal:  N Engl J Med       Date:  2014-12-24       Impact factor: 91.245

7.  Comparison of protocols and registry entries to published reports for randomised controlled trials.

Authors:  Kerry Dwan; Douglas G Altman; Lynne Cresswell; Michaela Blundell; Carrol L Gamble; Paula R Williamson
Journal:  Cochrane Database Syst Rev       Date:  2011-01-19

8.  SPIRIT 2013 statement: defining standard protocol items for clinical trials.

Authors:  An-Wen Chan; Jennifer M Tetzlaff; Douglas G Altman; Andreas Laupacis; Peter C Gøtzsche; Karmela Krleža-Jerić; Asbjørn Hróbjartsson; Howard Mann; Kay Dickersin; Jesse A Berlin; Caroline J Doré; Wendy R Parulekar; William S M Summerskill; Trish Groves; Kenneth F Schulz; Harold C Sox; Frank W Rockhold; Drummond Rennie; David Moher
Journal:  Ann Intern Med       Date:  2013-02-05       Impact factor: 25.391

9.  The imperative to share clinical study reports: recommendations from the Tamiflu experience.

Authors:  Peter Doshi; Tom Jefferson; Chris Del Mar
Journal:  PLoS Med       Date:  2012-04-10       Impact factor: 11.069

10.  Open clinical trial data for all? A view from regulators.

Authors:  Hans-Georg Eichler; Eric Abadie; Alasdair Breckenridge; Hubert Leufkens; Guido Rasi
Journal:  PLoS Med       Date:  2012-04-10       Impact factor: 11.069

View more
  4 in total

1.  Factors associated with reporting results for pulmonary clinical trials in ClinicalTrials.gov.

Authors:  Isaretta L Riley; L Ebony Boulware; Jie-Lena Sun; Karen Chiswell; Loretta G Que; Monica Kraft; Jamie L Todd; Scott M Palmer; Monique L Anderson
Journal:  Clin Trials       Date:  2017-11-10       Impact factor: 2.486

2.  Clinical trial registries: more international, converging efforts are needed.

Authors:  Claudia Pansieri; Chiara Pandolfini; Maurizio Bonati
Journal:  Trials       Date:  2017-02-27       Impact factor: 2.279

3.  The relationship between endorsing reporting guidelines or trial registration and the impact factor or total citations in surgical journals.

Authors:  Jing Zhou; Jianqiang Li; Jingao Zhang; Bo Geng; Yao Chen; Xiaobin Zhou
Journal:  PeerJ       Date:  2022-01-25       Impact factor: 2.984

4.  Transparency in ovarian cancer clinical trial results: ClinicalTrials.gov versus PubMed, Embase and Google scholar.

Authors:  Anna Roberto; Silvia Radrezza; Paola Mosconi
Journal:  J Ovarian Res       Date:  2018-04-10       Impact factor: 4.234

  4 in total

北京卡尤迪生物科技股份有限公司 © 2022-2023.