Clinical trials data bank

The results of clinical trials conducted under an IND have traditionally been regarded as confidential business information that FDA was prohibited from releasing to the public under the Freedom of Information Act and that the publication of which was determined solely by the drug sponsor. The Food and Drug Administration Modernization Act of 1997 established a clinical trial data bank for drugs for serious or life-threatening disease and required the inclusion of information on all effectiveness trials for these drugs. As a result of widespread concern about the lack of public availability of information about all clinical trials and their results, individual companies and the Pharmaceutical Research and Manufacturers of America have... 

Clinical Trials Data Bank We have established a clinical trials data bank to collect information on your clinical trials protocols. Please list your protocols for serious and life-threatening conditions [Food and Drug Administration Modernization Act of 1997 section 113]. When finalized, you should list your protocols in accordance with our Draft Guidance for Industry—Information Program on Clinical Trials for Serious or Life-Threatening Diseases Implementation Plan, June 2001. 

Form 3674 Certification of Compliance with Requirements of Clinical-Trails.gov Data Bank completed (if clinical trials have been conducted)... 

HIPAA requirements for subject privacy is increasing the amount of documentation needed for the initiation of a trial. Besides the requirement for informed consent, which has evolved from the Declaration of Helsinki, there is now an additional need for authorization from the subject for release of the individually identifiable health information that the drug sponsor must enter into the data bank for statistical analysis to comply with requirements necessary for new product approvals. However, HIPAA does not include data needed for adverse experience reporting assessments for clinical trials. 

For many years, the registration in a public data bank of aU clinical trials — from start to completion and reporting of results — has seemed a quixotic quest of some academic researchers, medical-journal editors, and librarians. Within the past two months, however, a constellation of events and developments has broadened this effort and captured the... 

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