Dataset Information

Practical and conceptual issues of clinical trial registration for Brazilian researchers.

ABSTRACT:

Context and objective

Clinical trial registration is a prerequisite for publication in respected scientific journals. Recent Brazilian regulations also require registration of some clinical trials in the Brazilian Clinical Trials Registry (ReBEC) but there is little information available about practical issues involved in the registration process. This article discusses the importance of clinical trial registration and the practical issues involved in this process.

Design and setting

Descriptive study conducted by researchers within a postgraduate program at a public university in São Paulo, Brazil.

Methods

Information was obtained from clinical trial registry platforms, article reference lists and websites (last search: September 2014) on the following topics: definition of a clinical trial, history, purpose and importance of registry platforms, the information that should be registered and the registration process.

Results

Clinical trial registration aims to avoid publication bias and is required by Brazilian journals indexed in LILACS and SciELO and by journals affiliated to the International Committee of Medical Journal Editors (ICMJE). Recent Brazilian regulations require that all clinical trials (phases I to IV) involving new drugs to be marketed in this country must be registered in ReBEC. The pros and cons of using different clinical trial registration platforms are discussed.

Conclusions

Clinical trial registration is important and various mechanisms to enforce its implementation now exist. Researchers should take into account national regulations and publication requirements when choosing the platform on which they will register their trial.

SUBMITTER: Freitas CG

PROVIDER: S-EPMC10496585 | biostudies-literature | 2016 Jan-Feb

REPOSITORIES: biostudies-literature

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Publications

Practical and conceptual issues of clinical trial registration for Brazilian researchers.

Freitas Carolina Gomes CG Pesavento Thomas Fernando Coelho TF Pedrosa Maurício Reis MR Riera Rachel R Torloni Maria Regina MR

Sao Paulo medical journal = Revista paulista de medicina 20150821 1

<h4>Context and objective</h4>Clinical trial registration is a prerequisite for publication in respected scientific journals. Recent Brazilian regulations also require registration of some clinical trials in the Brazilian Clinical Trials Registry (ReBEC) but there is little information available about practical issues involved in the registration process. This article discusses the importance of clinical trial registration and the practical issues involved in this process.<h4>Design and setting< ...[more]

PMID: 26313113

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Project description:BackgroundAlthough protocol registration of systematic reviews/meta-analysis (SR/MA) is still not mandatory, it is highly recommended that authors publish their SR/MA protocols prior to submitting their manuscripts for publication as recommended by the Cochrane guidelines for conducting SR/MAs. our aim was to assess the awareness, obstacles, and opinions of SR/MA authors about the protocol registration process.MethodsA cross-sectional survey study included the authors who published SR/MAs during the period from 2010 to 2016, and they were contacted for participation in our survey study. They were identified through the literature search of SR/MAs in Scopus database. An online questionnaire was sent to each participant via e-mail after receiving their approval to join the study. We have sent 6650 emails and received 275 responses.ResultsA total of 270 authors responses were complete and included in the final analysis. Our results has shown that PROSPERO was the most common database used for protocol registration (71.3%). The registration-to-acceptance time interval in PROSPERO was less than 1 month (99.1%). Almost half of the authors (44.2%) did not register their protocols prior to publishing their SR/MAs and according to their opinion that the other authors lack knowledge of protocol importance and mandance to be registered, was the most commonly reported reason (44.9%). A significant percenatge of respondents (37.4%) believed that people would steal their ideas from protocol databases, while only 5.3% reported that their SR/MA had been stolen. However, the majority (72.9%) of participants have agreed that protocol registries play a role in preventing unnecessary duplication of reviews. Finally, 37.4% of participants agree that SR/MA protocol registration should be mandatory.ConclusionAbout half of the participants believes that the main reason for not registering protocols, is that the other authors lack knowledge concerning obligation and importance to register the SR/MA protocols in advance. Therefore, tools should be available to mandate protocol registration of any SRs beforehand and increasing awareness about the benefits of protocol registration among researchers.

Project description:IntroductionPractical social media recommendations are needed to facilitate greater engagement in dementia prevention research. Alongside relevant experts, our aim was to develop a set of consensus recommendations that reflect the values and priorities of prospective participants to guide social media use.MethodsWe conducted a three-round, modified Delphi consisting of three online surveys and three conferences calls. The diverse, international Delphi panel comprised 16 experts with lived (n = 10) and professional (n = 6) experiences. Consensus was defined a priori as ≥ 70% agreement.ResultsTwenty-six items achieved consensus. Two items reached consensus in round 1: ethical considerations of closed social media groups (88%) and of social media users sharing prevention content with connections who are not on social media (79%). Nine items reached consensus in round 2, related to misinformation (79%), stigma (93%), and other key aspects of social media communication. After revisions, 15 items reached consensus in the final round. These items included: identifying when researchers ought to engage, managing closed social media groups, rankings of short form content, prioritizing lay summaries and multimedia resources, and rankings of preferred language. One item about the language of prevention for audiences living with dementia did not reach consensus. Final consensus items formed the new set of recommendations, which we organized into seven social media use cases. These use cases include setting up a social media page or community, handling online misinformation, actively challenging stigma, handling difficult online interactions, introducing new research to the public, help with study recruitment, and the language of prevention when writing posts.DiscussionThese consensus recommendations can help dementia prevention researchers harness social media use for the purposes of public engagement and uphold the norms and values specific to the dementia research and broader communities.HighlightsWe created social media recommendations with research and community experts.Recommendations cover key ethical considerations for dementia prevention research.Areas include misinformation, stigma, information updates, and preferred language.Full consensus recommendations are organized into seven social media use cases.

Dataset Information

Practical and conceptual issues of clinical trial registration for Brazilian researchers.

Context and objective

Design and setting

Methods

Results

Conclusions

Publications

Practical and conceptual issues of clinical trial registration for Brazilian researchers.

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