Registration Of Clinical Trial : Advantages, Disadvantages, And Consumer Perspective

1633 Words7 Pages
Registration of Clinical Trial: Advantages, Disadvantages Industrial, and Consumer Perspective Introduction Registration of clinical trials has been a controversial issue for years. According to ICMJE, a clinical trial is any research project that prospectively allocates people or a group of individuals to intervention, with or without concurrent comparison or control groups, to study the cause and effect relationship between a health related, intervention and a health outcome. Health-related interventions are those used in the modification of biomedical or health-related outcomes such as drugs, surgical procedures, devices, behavioral treatments, educational programs, dietary interventions, quality improvement interventions, and the…show more content…
The project intends to take the lead in setting international norms and standards for trial registration and reporting (World Health Organization). Additional the International Committee of Medical Journal Editors (ICMJE) made an announcement of a tough stance on trial registration. One regulation being that after 1 July 2005 trials that begin enrollment of patients must register in a public trials registry at or before the onset of enrollment to be considered for publication in those journals. Trials that began patient enrollment on or before 1 July 2005 must register before 13 September 2005 to be considered for publication Importance The need for trial registration received a lot of acknowledgment for years. However, it was not until in 2004 when the revelation that trial data on the harms of specific serotonin reuptake inhibitors in children went undisclosed that its urgency became especially evident. Legal action by the Attorney General of New York 's upon GlaxoSmithKline and the decision of medical journal editors not to publish any trial unless it is has been registered put emphasis on the importance of registering trials (Dyer). Considering that transparency in research and knowledge, sharing is now widely seen as a precondition for the success of the health research enterprise makes trial registries a valuable tool to help achieve this transparency. In the same way, advances in technology made research methodology evolve so are the Internet in making
Get Access