Best practice for analysis of shared clinical trial data.
BMC Med Res Methodol
; 16 Suppl 1: 76, 2016 Jul 08.
Article
en En
| MEDLINE
| ID: mdl-27410240
ABSTRACT
BACKGROUND:
Greater transparency, including sharing of patient-level data for further research, is an increasingly important topic for organisations who sponsor, fund and conduct clinical trials. This is a major paradigm shift with the aim of maximising the value of patient-level data from clinical trials for the benefit of future patients and society. We consider the analysis of shared clinical trial data in three broad categories (1) reanalysis - further investigation of the efficacy and safety of the randomized intervention, (2) meta-analysis, and (3) supplemental analysis for a research question that is not directly assessing the randomized intervention.DISCUSSION:
In order to support appropriate interpretation and limit the risk of misleading findings, analysis of shared clinical trial data should have a pre-specified analysis plan. However, it is not generally possible to limit bias and control multiplicity to the extent that is possible in the original trial design, conduct and analysis, and this should be acknowledged and taken into account when interpreting results. We highlight a number of areas where specific considerations arise in planning, conducting, interpreting and reporting analyses of shared clinical trial data. A key issue is that that these analyses essentially share many of the limitations of any post hoc analyses beyond the original specified analyses. The use of individual patient data in meta-analysis can provide increased precision and reduce bias. Supplemental analyses are subject to many of the same issues that arise in broader epidemiological analyses. Specific discussion topics are addressed within each of these areas. Increased provision of patient-level data from industry and academic-led clinical trials for secondary research can benefit future patients and society. Responsible data sharing, including transparency of the research objectives, analysis plans and of the results will support appropriate interpretation and help to address the risk of misleading results and avoid unfounded health scares.
Texto completo:
1
Base de datos:
MEDLINE
Asunto principal:
Ensayos Clínicos como Asunto
/
Difusión de la Información
Tipo de estudio:
Clinical_trials
/
Guideline
/
Systematic_reviews
Límite:
Humans
Idioma:
En
Revista:
BMC Med Res Methodol
Asunto de la revista:
MEDICINA
Año:
2016
Tipo del documento:
Article
País de afiliación:
Reino Unido