Data Sharing Statements for Clinical Trials: a Requirement of the International Committee of Medical Journal Editors / Declaración sobre compartir datos: un requerimiento del Comité Internacional de Editores de Revistas Médicas

El Comité Internacional de Editores de Revista Médicas (ICMJE) ha tomado la posición que el compartir los datos generados por los ensayos clínicos es una obligación ética, por cuanto los participantes en esos estudios se colocaron en riesgo al aceptar su inclusión. En esta editorial el ICMJE expresa que requerirá desde Julio 2018 que los manuscritos enviados a sus revistas deben incluir una declaración sobre compartir datos. A su vez, los ensayos clínicos que comiencen a enrolar pacientes a partir de Enero 2019, deben incluir un plan sobre compartir datos en el registro de tales ensayos. Se dan en esta declaración cuatro ejemplos de declaraciones sobre compartir datos, referidos a qué datos se compartirán, cuándo estarán disponibles y qué criterios de acceso se establecerán. El ICMJE visualiza un futuro cercano en el cual el compartir los datos será la norma, con el fin de maximizar el conocimiento ganado por los esfuerzos y sacrificios de los participantes.

Data Sharing: A New Editorial Initiative of the International Committee of Medical Journal Editors. Implications for the Editors´ Network / Compartilhamento de dados: Nova Iniciativa Editorial do Comitê Internacional de Editores de Revistas Médicas. Implicações para a Rede de Editores

Abstract The International Committee of Medical Journal Editors (ICMJE) provides recommendations to improve the editorial standards and scientific quality of biomedical journals. These recommendations range from uniform technical requirements to more complex and elusive editorial issues including ethical aspects of the scientific process. Recently, registration of clinical trials, conflicts of interest disclosure, and new criteria for authorship - emphasizing the importance of responsibility and accountability-, have been proposed. Last year, a new editorial initiative to foster sharing of clinical trial data was launched. This review discusses this novel initiative with the aim of increasing awareness among readers, investigators, authors and editors belonging to the Editors´ Network of the European Society of Cardiology.

Resumo O Comitê Internacional de Editores de Revistas Médicas (ICMJE) fornece recomendações para aprimorar o padrão editorial e a qualidade científica das revistas biomédicas. Tais recomendações variam desde requisitos técnicos de uniformização até assuntos editoriais mais complexos e elusivos, como os aspectos éticos do processo científico. Recentemente, foram propostos registro de ensaios clínicos, divulgação de conflitos de interesse e novos critérios de autoria, enfatizando a importância da responsabilidade e da responsabilização. No último ano, lançou-se uma nova iniciativa editorial para fomentar o compartilhamento dos dados de ensaios clínicos. Esta revisão discute essa nova iniciativa visando a aumentar a conscientização de leitores, investigadores, autores e editores filiados à Rede de Editores da Sociedade Europeia de Cardiologia.

Quality and completeness of data documentation in an investigator-initiated trial versus an industry-sponsored trial.

Literature on the quality and completeness of data and documentation in investigator-initiated research studies is scarce. We carried out a study to compare the quality of data and documentation in an investigator-initiated trial (IIT) with those in an industry-sponsored study. We retrospectively studied the archived data pertaining to 42 patients enrolled in two trials, 14 patients in an industry-sponsored study and 28 randomly selected patients from an IIT. Trial-related documents were examined and scored for the completeness of the acquisition of data and for storage as per a pre-formulated checklist. Weighted scores were given for each point on the checklist proportional to its relative importance in the data documentation process. A global score and sub-scores for specific modules were given for each subject. The scores in the two studies were compared using the Mann Whitney U test. The total score for general documents was similar in the IIT (14/14, 100%) and the sponsored study (24/25, 96%). The mean summary global score obtained for study-specific documents (maximum possible score, 32) in the IIT (27.1; 95% CI 26.4-27.8) was also not significantly different from that in the sponsored study (27.9; 95% CI 26.7-29.1; p=0.1291). Thus, investigatorinitiated studies carried out by independent researchers in highvolume academic centres, even without active data monitoring and formal audits, appear to adhere to the high standards laid out in the International Conference on Harmonisation-Good Clinical Practices guidelines, ensuring accuracy and completeness in data documentation and archival.