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Update on Registration of Clinical Trials in ClinicalTrials.gov

2009; Elsevier BV; Volume: 136; Issue: 1 Linguagem: Inglês

10.1378/chest.09-1219

1931-3543

Tony Tse, Rebecca Williams, Deborah A. Zarin,

Pharmaceutical industry and healthcare

This brief note is an update to the "Medical Writing Tip of the Month" article on clinical trial registration in CHEST. Zarin and Keselman, 2007 Zarin DA Keselman A Registering a clinical trial in ClinicalTrials. gov. Chest. 2007; 131: 909-912 Abstract Full Text Full Text PDF PubMed Scopus (73) Google Scholar ClinicalTrials.gov (http://clinicaltrials.gov/), which currently contains > 73,000 registered trials, is operated by the National Institutes of Health. Although ClinicalTrials.gov continues to support a wide range of trial registration policies, including that of the International Committee of Medical Journal Editors (ICMJE), 2 Laine C De Angelis C Delamothe T et al. Clinical trial registration: looking back and moving ahead. Ann Intern Med. 2007; 147: 275-277 Crossref PubMed Scopus (48) Google Scholar we want to call your attention to a new US law. On September 27, 2007, Congress enacted the Food and Drug Administration Amendments Act (FDAAA) [United States Public Law 110-85], which expands the legal requirements for registration beyond previous US law and mandates results reporting. 3 Tse T Zarin DA Clinical trial registration and results reporting: ClinicalTrials.gov and FDAAA. FDLI Update. 2009; 1: 18-22 Google Scholar Violations are subject to penalties. While the information presented previously on how to register at ClinicalTrials.gov continues to apply, we briefly describe changes to the registration requirements under FDAAA (see http://prsinfo.clinicaltrials.gov/fdaaa.html for more information). Reporting results at ClinicalTrials.gov is addressed in the companion "Medical Writing Tip of the Month" article in this issue of CHEST. 4 Tse T Williams RJ Zarin DA Reporting "basic results" in ClinicalTrials.gov. Chest. 2009; 136: 295-303 Abstract Full Text Full Text PDF PubMed Scopus (110) Google Scholar The Role of Conflict of Interest in Reporting of Scientific InformationCHESTVol. 136Issue 1PreviewWe have come to appreciate that scientific misconduct is often not intuitively obvious to those who perpetrate it. Therefore, this commentary has been written to review what we know about the role of conflict of interest (COI) in the reporting of scientific information and to challenge those of us in educator roles to do a better job in mentoring our trainees, junior faculty, and associates on what is right and wrong; what is ethical and unethical. The review addresses the following questions: (1) Why has the public trust in the clinical research industry been eroded? (2) How often is the ethical concept of equipoise violated in industry-sponsored randomized controlled clinical trials? (3) How often are negative trials underreported and favorable trials selectively or redundantly over-reported in industry-sponsored randomized controlled clinical trials? (4) What is being done to restore the public trust? While there are multiple strategies to mitigate COI in the reporting of scientific information, we have come to appreciate that the disclosure of potential conflicts of interest is not enough. Full-Text PDF Reporting "Basic Results" in ClinicalTrials.govCHESTVol. 136Issue 1PreviewGrowing awareness of selective publication of research studies ("publication bias") and the selective reporting of outcomes in publications ("outcome reporting bias"),1 has led policymakers to call for increased "clinical trial transparency" through the public disclosure of key information about clinical trials.2 A US federal law3 enacted in 2007 mandates registration and results reporting for certain clinical trials of drugs, biological products, and devices, regardless of study funding source, at ClinicalTrials.gov , an online registry and results database operated by the National Library of Medicine of the National Institutes of Health (NIH). Full-Text PDF