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Abstract

Defining a clinical trial registration and results disclosure (CTR/RD) business process is challenged by a dynamic set of expectations to be met. External stakeholder groups have differing expectations of and uses for disclosed information about clinical trials. Regulations in the United States and internationally continue to evolve and emerge. A growing number of portals offering varying information about the same studies have a profound effect on the volume of work and create pressure to keep information across portals consistent. This article focuses on the challenges of changing and improving CTR/RD database processes in response to new expectations, new regulations, and imperatives for increased efficiency. Some keys for success are offered.

Keywords

Key Words Clinical trial registry Clinical trial results Clinical trial disclosure Business process

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References

World Health Organization International Clinical Trials Registry Platform. http://www.who.int/ictrp/en/. Accessed December 8, 2009.

World Medical Association Declaration of Helsinki. Ethical principles for medical research involving human subjects. http://www.wma.net/en/30publications/10policies/b3/index.html. Accessed December 8, 2009.

International Committee of Medical Journal Editors. Uniform requirements for manuscripts submitted to biomedical journals: publishing and editorial issues related to publication in biomedical journals: obligation to register clinical trials. http://www.icmje.org/publishing_10register.html. Accessed December 8, 2009.

US Food and Drug Administration. Food and Drug Administration Modernization Act, Section 113. 42 U.S.C. § 282(j). Enacted November 21, 1997.

Food and Drug Administration Amendments Act of 2007. Public Law 110–85. Enacted September 27, 2007.

ClinicalTrials.gov. Protocol Data Element Definitions. Draft, August 20, 2008. http://prsinfoxlinicaltrials.gov/definitions.html. Accessed December 8, 2009.

ClinicalTrials.gov. Elaboration of definitions of responsible party and applicable clinical trial. Draft, March 9, 2009. http://prsinfo.clinicaltrials.gov/ElaborationsOnDefinitions.pdf. Accessed December 8, 2009.

European Commission. Communication from the Commission: guidance on the information concerning paediatric clinical trials to be entered into the EU Database on Clinical Trials (EudraCT) and on the information to be made public by the European Medicines Agency (EMEA), in accordance with Article 41 of Regulation (EC) No 1901/2006. http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-10/2009_c28_01/2009_c28_01_en.pdf. Accessed December 8, 2009.

Revised PhRMA Principles on the conduct of clinical trials. http://www.phrma.org/files/042009_Clinical%20Trial%20Principles_FINAL.pdf. Accessed December 8, 2009.

10.

WHO. International Clinical Trials Registry Platform, Universal Trial Number. http://www.who.int/ictrp/unambiguous_identification/utn/en/index.html. Accessed December 8, 2009.

11.

WHO. International Clinical Trials Registry Platform, Trial Registration Data Sets. http://www.who.int/ictrp/network/trds/en/index.html. Accessed December 8, 2009.

12.

Health Level 7. http://www.hl7.org/index.cfm. Accessed December 8, 2009.

Clinical Trial Registration and Results Disclosure: Business Process Considerations

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