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1.
Trials ; 20(1): 169, 2019 Mar 15.
Artículo en Inglés | MEDLINE | ID: mdl-30876434

RESUMEN

BACKGROUND: Data repositories have the potential to play an important role in the effective and safe sharing of individual-participant data (IPD) from clinical studies. We analysed the current landscape of data repositories to create a detailed description of available repositories and assess their suitability for hosting data from clinical studies, from the perspective of the clinical researcher. METHODS: We assessed repositories that enable storage, sharing, discoverability, re-use of the IPD and associated documents from clinical studies using a pre-defined set of 34 items and publicly available information from April to June 2018. For this purpose, we developed an indicator set to capture the maturity of the repositories' procedures and their suitability for the hosting of IPD. The indicators cover guidelines for data upload and data de-identification, data quality controls, contracts for upload and storage, flexibility of access, application of identifiers, availability of metadata, and long-term preservation. RESULTS: We analysed 25 repositories, from an initial set of 55 identified as possibly relevant. Half of the included repositories were generic, i.e. not limited to a specific disease or clinical area and 13 were launched in the last 8 years. The sample was extremely heterogeneous and included repositories developed by research funders, infrastructures, universities, and editors. All but three repositories do not apply a fee for uploading, storage or access to data. None of the repositories completely demonstrated all the items included in the indicator set, but three repositories (Dryad, Drum, EASY) met - fully or partially - all items. Flexibility of data-access modalities appears to be limited, being lacking in half of the repositories. CONCLUSIONS: Our evaluation, though often hampered by the lack of sufficient information, can help researchers to find a suitable repository for their datasets. Some repositories are more mature because of their support for clinical dataset preparation, contractual agreements, metadata and identifiers, different modalities of access, and long-term preservation of data. Further work is now required to achieve a more robust and accurate system for evaluation, which in turn may encourage the sharing of clinical study data. TRIAL REGISTRATION: Study protocol available at https://zenodo.org/record/1438261#.W64kW9Egrcs .


Asunto(s)
Acceso a la Información , Macrodatos , Estudios Clínicos como Asunto , Recolección de Datos/métodos , Minería de Datos/métodos , Bases de Datos Factuales , Difusión de la Información/métodos , Humanos , Metadatos
2.
BMJ Open ; 9(2): e024863, 2019 02 19.
Artículo en Inglés | MEDLINE | ID: mdl-30782920

RESUMEN

OBJECTIVES: To gather knowledge on the current debate, opinions and attitudes of Italian patient and citizen groups on individual participant data (IPD) sharing from clinical studies. DESIGN: Cross-sectional online survey. SETTING AND PARTICIPANTS: A 22-item online questionnaire was sent by email to 2003 contacts of patient and citizen groups in Italy. We received 311 responses, checked for duplicate respondents (16); 295 single groups responded, 280 providing questionnaires eligible for analysis (response rate 15%). Ninety (32.1%) dealt with oncology and palliative care, 175 (46.2%) operated locally or regionally and 136 (48.6%) were involved in clinical research. OUTCOME MEASURE: Data on Italian patient and citizen groups' self-reported knowledge, attitudes and opinions on IPD sharing, mechanisms for IPD access, advantages and risks. RESULTS: Half the respondents (144 out of 280, 51%) had some knowledge about the IPD sharing debate, and 60 (42%) stated they had an official position (35 in favour, 19 in favour with restrictions, 2 against, 1 neither for nor against, 3 missing). Nineteen discussed the topic encouraged by this survey; 39% approved broad access by researchers and other professions and identified information to participants, data de-identification, secure archives, access agreements and sanctions for misuse as important aspects of IPD sharing models. Respondents highlighted re-identification, privacy and re-use of data for purposes that participants do not agree on, as main risks, advancement of innovation and reducing waste in research as main advantages. Around half believed IPD sharing would not discourage study participation. CONCLUSIONS: Half the respondents were aware of the debate. Those who had an official position were mainly in favour of IPD sharing. Many supported broad access, asking for conditions important for building trust in entities that handle IPD sharing.Although limited by the low response rate, these findings reinforce the demand for reliable and transparent processes where accountabilities are clear.


Asunto(s)
Ensayos Clínicos como Asunto , Difusión de la Información , Participación del Paciente , Recolección de Datos , Conocimientos, Actitudes y Práctica en Salud , Humanos , Internet , Italia , Autoinforme , Encuestas y Cuestionarios
3.
Biochem Med (Zagreb) ; 28(1): 010201, 2018 Feb 15.
Artículo en Inglés | MEDLINE | ID: mdl-29472799

RESUMEN

Introduction: The aim of the IMPACT (IMProving Access to Clinical Trial data) Observatory is to assess the transformation of clinical trials (CT) related to the evolution of sharing of CT data. The objective of this study is to establish a baseline for monitoring CT data sharing by the Observatory. Materials and methods: In this scoping review we searched for publications that address sharing, dissemination, transparency or reuse of CT data published prior to December 31st 2000. Two authors screened titles and abstracts of 1204 records received by Medline searches and added 47 publications from direct discovery. Four researchers extracted, coded, and analyzed the predefined information from 102 selected papers. Results: We found a growing recognition of the importance of data sharing prior to 2001. However, there were numerous obstacles including the ambiguity of the concept of data sharing, the absence of specific terminology and the lack of an "open" culture. By the end of 2000, data, metadata, and evidence based medicine were defined. Data sharing, registries, databases and re-analyses of individual patient data (IPD) emerged. The use of systematic reviews and IPD meta-analysis in decision making was promoted. Most arguments for broader data sharing came from oncology, paediatrics, rare diseases, AIDS, pregnancy, perinatal medicine, and media reporting related scandals. Conclusions: Our findings indicate that the year 2000 could be used as a baseline for monitoring the evolution of CT data sharing as basic prerequisites were set in place, including greater understanding that CT data sharing is essential for decision making and the advancements of the Internet.


Asunto(s)
Bases de Datos Factuales , Ensayos Clínicos como Asunto , Humanos , Difusión de la Información , Sistema de Registros
4.
BMJ Open ; 7(12): e018647, 2017 Dec 14.
Artículo en Inglés | MEDLINE | ID: mdl-29247106

RESUMEN

OBJECTIVES: We examined major issues associated with sharing of individual clinical trial data and developed a consensus document on providing access to individual participant data from clinical trials, using a broad interdisciplinary approach. DESIGN AND METHODS: This was a consensus-building process among the members of a multistakeholder task force, involving a wide range of experts (researchers, patient representatives, methodologists, information technology experts, and representatives from funders, infrastructures and standards development organisations). An independent facilitator supported the process using the nominal group technique. The consensus was reached in a series of three workshops held over 1 year, supported by exchange of documents and teleconferences within focused subgroups when needed. This work was set within the Horizon 2020-funded project CORBEL (Coordinated Research Infrastructures Building Enduring Life-science Services) and coordinated by the European Clinical Research Infrastructure Network. Thus, the focus was on non-commercial trials and the perspective mainly European. OUTCOME: We developed principles and practical recommendations on how to share data from clinical trials. RESULTS: The task force reached consensus on 10 principles and 50 recommendations, representing the fundamental requirements of any framework used for the sharing of clinical trials data. The document covers the following main areas: making data sharing a reality (eg, cultural change, academic incentives, funding), consent for data sharing, protection of trial participants (eg, de-identification), data standards, rights, types and management of access (eg, data request and access models), data management and repositories, discoverability, and metadata. CONCLUSIONS: The adoption of the recommendations in this document would help to promote and support data sharing and reuse among researchers, adequately inform trial participants and protect their rights, and provide effective and efficient systems for preparing, storing and accessing data. The recommendations now need to be implemented and tested in practice. Further work needs to be done to integrate these proposals with those from other geographical areas and other academic domains.


Asunto(s)
Investigación Biomédica/normas , Ensayos Clínicos como Asunto , Consenso , Difusión de la Información/métodos , Comités Consultivos , Humanos
5.
Biochem Med (Zagreb) ; 26(3): 308-307, 2016 Oct 15.
Artículo en Inglés | MEDLINE | ID: mdl-27812300

RESUMEN

INTRODUCTION: The opening of research data is emerging thanks to the increasing possibilities of digital technology. The opening of clinical trial (CT) data is a part of this process, expected to have positive scientific, ethical, health, and economic impacts thus contributing to research integrity. The January 2016 proposal by the International Council of Medical Journal Editors triggered ample discussion about CT data sharing and reconfirmed the need for an ongoing assessment of its dynamics. The IMProving Access to Clinical Trials data (IMPACT) Observatory aims to play such a role, and assess the data sharing culture, policies, and practices of key players, the impact of their interventions on CTs, and contribute to a transformation of research. The objective of this paper is to present the IMPACT Observatory as well as share some of its preliminary findings. MATERIALS AND METHODS: Methods include a scoping study of research, surveys, interviews, and an environmental scan of research data repositories. RESULTS: Our preliminary findings indicate that although opening of CT data has not yet been achieved, its evolution is encouraging. Initiatives by key players contribute to increasing of CT data sharing, and many barriers are shrinking or disappearing. CONCLUSIONS: The major barrier is the lack of data sharing standards, from preparing data for public sharing to its curatorship, findability and access. However, experiences accumulated by sharing CT data according to "upon request" or "open" mechanisms could inform the development of such standards. The Vivli, CORBEL-ECRIN and Open Trials projects are currently working in this direction.


Asunto(s)
Ensayos Clínicos como Asunto , Difusión de la Información , Servicios de Información , Medicina Basada en la Evidencia , Humanos
6.
Mater Sociomed ; 28(1): 74-6, 2016 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-27047274

RESUMEN

The first BH Cochrane Symposium was held on 12 October 2015 in Sarajevo, Bosnia and Herzegovina (BH), organized by the Agency for Quality and Accreditation in Healthcare in Federation of BH (AKAZ) and Medical Faculty University of Sarajevo. A group of ten national and international experts presented the Cochrane organization and systematic reviews, as well as the IMPACT Observatory, development of guidelines in BH, and the role of AKAZ. Examples of the development and use of Cochrane reviews in evidence informed decision making in health as well as research integrity were presented and discussed. Major BH decision makers and interested professionals from all over BH participated in a symposium and its lively discussion, especially from the perspective of Cochrane and its activities in BH, and the collaboration with the Croatian Cochrane. It can be expected that this symposium will inspire further growth of participation and use of Cochrane in BH and increase the awareness of various aspects of evidence informed medicine and research integrity.

7.
Rev Panam Salud Publica ; 38(6),dic. 2015
Artículo en Inglés | PAHO-IRIS | ID: phr-18567

RESUMEN

El protocolo de un ensayo clínico es la base para planificar, ejecutar, publicar y evaluar el ensayo. Sin embargo, los protocolos y las guías que existen para su elaboración varían enormemente en cuanto a su calidad y contenido. En este artículo se describe la elaboración sistemática y el alcance de la Declaración SPIRIT 2013 (denominada así por la sigla en inglés de Standard Protocol items: Recommendations for Interventional Trials o Elementos estándares de un protocolo: recomendaciones para los ensayos de intervención), una guía en la que se establecen los contenidos mínimos que debe tener el protocolo de un ensayo clínico. La lista de comprobación de la declaración SPIRIT, que consta de 33 elementos, se aplica a los protocolos de todos los ensayos clínicos y se centra más en el contenido que en el formato. En esta lista se recomienda hacer una descripción completa de lo que se ha planificado, aunque no se establece cómo diseñar o ejecutar un ensayo. Al brindar orientación sobre los contenidos fundamentales, las recomendaciones SPIRIT procuran facilitar la redacción de protocolos de alta calidad. El cumplimiento de las recomendaciones SPIRIT debería mejorar la transparencia y la exhaustividad de los protocolos de los ensayos en beneficio de los investigadores, los participantes, los pacientes, los patrocinadores, los financiadores, los comités de ética de la investigación o las juntas de revisión institucionales, los revisores, las revistas biomédicas, los registros de ensayos, los formuladores de políticas, los organismos reguladores y otras partes interesadas clave.


The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol. The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.


Asunto(s)
Ensayos Clínicos como Asunto , Ensayos Clínicos como Asunto , Protocolos Clínicos , Protocolos Clínicos
8.
BMJ ; 346: e7586, 2013 Jan 08.
Artículo en Inglés | MEDLINE | ID: mdl-23303884

RESUMEN

High quality protocols facilitate proper conduct, reporting, and external review of clinical trials. However, the completeness of trial protocols is often inadequate. To help improve the content and quality of protocols, an international group of stakeholders developed the SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials). The SPIRIT Statement provides guidance in the form of a checklist of recommended items to include in a clinical trial protocol. This SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations. For each checklist item, we provide a rationale and detailed description; a model example from an actual protocol; and relevant references supporting its importance. We strongly recommend that this explanatory paper be used in conjunction with the SPIRIT Statement. A website of resources is also available (www.spirit-statement.org). The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement, should help with the drafting of trial protocols. Complete documentation of key trial elements can facilitate transparency and protocol review for the benefit of all stakeholders.


Asunto(s)
Protocolos Clínicos/normas , Ensayos Clínicos como Asunto/métodos , Guías de Práctica Clínica como Asunto , Lista de Verificación , Comités de Monitoreo de Datos de Ensayos Clínicos , Ensayos Clínicos como Asunto/normas , Ensayos Clínicos como Asunto/estadística & datos numéricos , Seguridad Computacional , Recolección de Datos/métodos , Ética Médica , Humanos , Auditoría Médica , Selección de Paciente , Rol Profesional , Control de Calidad , Distribución Aleatoria , Proyectos de Investigación , Investigadores , Apoyo a la Investigación como Asunto , Tamaño de la Muestra , Responsabilidad Social , Estadística como Asunto , Factores de Tiempo , Resultado del Tratamiento
9.
Ann Intern Med ; 158(3): 200-7, 2013 Feb 05.
Artículo en Inglés | MEDLINE | ID: mdl-23295957

RESUMEN

The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol.The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.


Asunto(s)
Protocolos Clínicos/normas , Ensayos Clínicos como Asunto/métodos , Ensayos Clínicos como Asunto/normas , Lista de Verificación , Humanos
10.
Rev Panam Salud Publica ; 30(1): 87-96, 2011 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-22159656

RESUMEN

The objective of this article is to propose a roadmap toward transparency of clinical trials in the Americas by their prospective registration and results disclosure. This will broaden access to more complete and accurate data and facilitate evidence-informed decision-making and participation in research. Consequently, it should have a positive impact on people's health and should promote trust in health research. Existing initiatives were identified, registration of trials was analyzed following the World Health Organization (WHO) standards on trial registration, and a roadmap is proposed to address the gaps in advancing transparency. The analysis shows that, in spite of numerous regional and country initiatives, clinical trials taking place in nonEnglish-speaking parts of the Americas are underregistered. A roadmap is proposed to enhance research governance and good research practice by improving the transparency of clinical trials. The proposed roadmap includes strategies for implementing WHO international standards for trial registration, for developing international standards of public disclosure of trial results, and for a potential role of the Pan American Health Organization.


Asunto(s)
Ensayos Clínicos como Asunto/métodos , Revelación , Sistemas de Registro de Reacción Adversa a Medicamentos , Américas , Ensayos Clínicos como Asunto/ética , Ensayos Clínicos como Asunto/normas , Recolección de Datos , Revelación/ética , Revelación/normas , Registros Electrónicos de Salud , Humanos , Difusión de la Información/ética , Consentimiento Informado , Cooperación Internacional , Estudios Multicéntricos como Asunto/ética , Estudios Multicéntricos como Asunto/métodos , Estudios Multicéntricos como Asunto/normas , Selección de Paciente , Proyectos de Investigación/normas , Resultado del Tratamiento , Revelación de la Verdad , Organización Mundial de la Salud
11.
PLoS One ; 5(8): e12484, 2010 Aug 31.
Artículo en Inglés | MEDLINE | ID: mdl-20824212

RESUMEN

BACKGROUND: Although randomized clinical trials (RCTs) are considered the gold standard of evidence, their reporting is often suboptimal. Trial registries have the potential to contribute important methodologic information for critical appraisal of study results. METHODS AND FINDINGS: The objective of the study was to evaluate the reporting of key methodologic study characteristics in trial registries. We identified a random sample (n = 265) of actively recruiting RCTs using the World Health Organization International Clinical Trials Registry Platform (ICTRP) search portal in 2008. We assessed the reporting of relevant domains from the Cochrane Collaboration's 'Risk of bias' tool and other key methodological aspects. Our primary outcomes were the proportion of registry records with adequate reporting of random sequence generation, allocation concealment, blinding, and trial outcomes. Two reviewers independently assessed each record. Weighted overall proportions in the ICTRP search portal for adequate reporting of sequence generation, allocation concealment, blinding (including and excluding open label RCT) and primary outcomes were 5.7% (95% CI 3.0-8.4%), 1.4% (0-2.8%), 41% (35-47%), 8.4% (4.1-13%), and 66% (60-72%), respectively. The proportion of adequately reported RCTs was higher for registries that used specific methodological fields for describing methods of randomization and allocation concealment compared to registries that did not. Concerning other key methodological aspects, weighted overall proportions of RCTs with adequately reported items were as follows: eligibility criteria (81%), secondary outcomes (46%), harm (5%) follow-up duration (62%), description of the interventions (53%) and sample size calculation (1%). CONCLUSIONS: Trial registries currently contain limited methodologic information about registered RCTs. In order to permit adequate critical appraisal of trial results reported in journals and registries, trial registries should consider requesting details on key RCT methods to complement journal publications. Full protocols remain the most comprehensive source of methodologic information and should be made publicly available.


Asunto(s)
Almacenamiento y Recuperación de la Información/métodos , Sistema de Registros , Proyectos de Investigación/normas , Organización Mundial de la Salud , Humanos , Control de Calidad , Ensayos Clínicos Controlados Aleatorios como Asunto/normas
13.
Trials ; 10: 56, 2009 Jul 22.
Artículo en Inglés | MEDLINE | ID: mdl-19624821

RESUMEN

BACKGROUND: Since September 2005 the International Committee of Medical Journal Editors has required that trials be registered in accordance with the World Health Organization (WHO) minimum dataset, in order to be considered for publication. The objective is to evaluate registries' and individual trial records' compliance with the 2006 version of the WHO minimum data set. METHODS: A retrospective evaluation of 21 online clinical trial registries (international, national, specialty, pharmaceutical industry and local) from April 2005 to February 2007 and a cross-sectional evaluation of a stratified random sample of 610 trial records from the 21 registries. RESULTS: Among 11 registries that provided guidelines for registration, the median compliance with the WHO criteria were 14 out of 20 items (range 6 to 20). In the period April 2005-February 2007, six registries increased their compliance by six data items, on average. None of the local registry websites published guidelines on the trial data items required for registration. Slightly more than half (330/610; 54.1%, 95% CI 50.1% - 58.1%) of trial records completed the contact details criteria while 29.7% (181/610, 95% CI 26.1% - 33.5%) completed the key clinical and methodological data fields. CONCLUSION: While the launch of the WHO minimum data set seemed to positively influence registries with better standardisation of approaches, individual registry entries are largely incomplete. Initiatives to ensure quality assurance of registries and trial data should be encouraged. Peer reviewers and editors should scrutinise clinical trial registration records to ensure consistency with WHO's core content requirements when considering trial-related publications.


Asunto(s)
Ensayos Clínicos como Asunto , Adhesión a Directriz , Sistema de Registros , Organización Mundial de la Salud , Estudios Transversales , Humanos , Estudios Retrospectivos
15.
J Med Internet Res ; 11(1): e8, 2009 Mar 09.
Artículo en Inglés | MEDLINE | ID: mdl-19275984

RESUMEN

BACKGROUND: Electronic data capture (EDC) tools provide automated support for data collection, reporting, query resolution, randomization, and validation, among other features, for clinical trials. There is a trend toward greater adoption of EDC tools in clinical trials, but there is also uncertainty about how many trials are actually using this technology in practice. A systematic review of EDC adoption surveys conducted up to 2007 concluded that only 20% of trials are using EDC systems, but previous surveys had weaknesses. OBJECTIVES: Our primary objective was to estimate the proportion of phase II/III/IV Canadian clinical trials that used an EDC system in 2006 and 2007. The secondary objectives were to investigate the factors that can have an impact on adoption and to develop a scale to assess the extent of sophistication of EDC systems. METHODS: We conducted a Web survey to estimate the proportion of trials that were using an EDC system. The survey was sent to the Canadian site coordinators for 331 trials. We also developed and validated a scale using Guttman scaling to assess the extent of sophistication of EDC systems. Trials using EDC were compared by the level of sophistication of their systems. RESULTS: We had a 78.2% response rate (259/331) for the survey. It is estimated that 41% (95% CI 37.5%-44%) of clinical trials were using an EDC system. Trials funded by academic institutions, government, and foundations were less likely to use an EDC system compared to those sponsored by industry. Also, larger trials tended to be more likely to adopt EDC. The EDC sophistication scale had six levels and a coefficient of reproducibility of 0.901 (P< .001) and a coefficient of scalability of 0.79. There was no difference in sophistication based on the funding source, but pediatric trials were likely to use a more sophisticated EDC system. CONCLUSION: The adoption of EDC systems in clinical trials in Canada is higher than the literature indicated: a large proportion of clinical trials in Canada use some form of automated data capture system. To inform future adoption, research should gather stronger evidence on the costs and benefits of using different EDC systems.


Asunto(s)
Ensayos Clínicos como Asunto/estadística & datos numéricos , Electrónica , Encuestas Epidemiológicas , Estadística como Asunto , Adulto , Canadá , Niño , Ensayos Clínicos como Asunto/clasificación , Ensayos Clínicos como Asunto/normas , Interpretación Estadística de Datos , Correo Electrónico , Humanos , Industrias , Edición , Tamaño de la Muestra , Enseñanza
17.
Trials ; 8: 30, 2007 Oct 23.
Artículo en Inglés | MEDLINE | ID: mdl-17956618

RESUMEN

INTRODUCTION: Despite intense interest in trial registration, there is a wide gap between theoretical postulates on trial registration and its implementation worldwide. OBJECTIVE: We aimed to evaluate trialists views about current international guidelines on trial registration, including the World Health Organization's (WHO) International Clinical Trials Registry Platform (ICTRP) policies and the Ottawa Statement, as well as their intention to register any future clinical trials they conduct. METHODS: We identified all 40,158 PUBMED-indexed clinical trials published from May 2005 to May 2006 using an advanced search strategy. From a random sample of 500 confirmed clinical trials, corresponding authors with e-mail contact addresses were surveyed. RESULTS: A total of 275 (60%) questionnaires from 45 countries were completed. 31% of the respondents had received only nonindustry funding during the past ten years, while 5% and 61% had received only industry or mixed funding respectively. Approximately two third of participants supported registration of all 20 WHO Data Set items, and endorsed the Ottawa Statement part 1 and part 2. Delayed public disclosure of some essential data in instances where they may be considered sensitive for competitive commercial reasons was supported by 30% of the participants, whereas immediate disclosure was supported by 53%. Only 21% of participants had registered all of their ongoing trials since 2005, while 47% stated that they would provide the 20 WHO Data Set items to a publicly accessible register for all their future clinical trials; a significantly higher proportion of participants who received only nonindustry funding (62%) was found among those who would always provide the 20 WHO items for future trials, compared to 42% of participants who received mixed or only industry funding. Among those who were undecided about endorsing registration. One third of participants expressed a lack of sufficient knowledge as the primary reason. CONCLUSION: Although disagreement was apparent on certain issues, our findings illustrate that trial registration is gradually becoming part of the current research paradigm internationally. Our results also suggest that researchers require more knowledge to inform their decision to comply with the International standards at this early stage of voluntary trial registration.

18.
BMJ ; 335(7621): 624-5, 2007 Sep 29.
Artículo en Inglés | MEDLINE | ID: mdl-17901471
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