Gerard M H Swaen1, Neil Carmichael, John Doe. 1. Epidemiology, Health Services, The Dow Chemical Company, P.O. Box 444, 4530 AK Terneuzen, The Netherlands. gswaen@dow.com
Abstract
OBJECTIVE: To evaluate the need for the creation of a system in which observational epidemiology studies are registered; an Observational Studies Register (OSR). STUDY DESIGN AND SETTING: The current scientific process for observational epidemiology studies is described. Next, a parallel is made with the clinical trials area, where the creation of clinical trial registers has greatly restored and improved their credibility and reliability. Next, the advantages and disadvantages of an OSR are compared. RESULTS: The advantages of an OSR outweigh its disadvantages. CONCLUSION: The creation of an OSR, similar to the existing Clinical Trials Registers, will improve the assessment of publication bias and will provide an opportunity to compare the original study protocol with the results reported in the publication. Reliability, credibility, and transparency of observational epidemiology studies are strengthened by the creation of an OSR. We propose a structured, collaborative, and coordinated approach for observational epidemiology studies that can provide solutions for existing weaknesses and will strengthen credibility and reliability, similar to the approach currently used in clinical trials, where Clinical Trials Registers have played a key role in strengthening their scientific value.
OBJECTIVE: To evaluate the need for the creation of a system in which observational epidemiology studies are registered; an Observational Studies Register (OSR). STUDY DESIGN AND SETTING: The current scientific process for observational epidemiology studies is described. Next, a parallel is made with the clinical trials area, where the creation of clinical trial registers has greatly restored and improved their credibility and reliability. Next, the advantages and disadvantages of an OSR are compared. RESULTS: The advantages of an OSR outweigh its disadvantages. CONCLUSION: The creation of an OSR, similar to the existing Clinical Trials Registers, will improve the assessment of publication bias and will provide an opportunity to compare the original study protocol with the results reported in the publication. Reliability, credibility, and transparency of observational epidemiology studies are strengthened by the creation of an OSR. We propose a structured, collaborative, and coordinated approach for observational epidemiology studies that can provide solutions for existing weaknesses and will strengthen credibility and reliability, similar to the approach currently used in clinical trials, where Clinical Trials Registers have played a key role in strengthening their scientific value.