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Abstract

Clinical trial disclosure has received much international attention. The US Congress has enacted the Food and Drug Administration Amendments Act of 2007 (FDAAA), also known as Public Law 110-85. Section 801 of FDAAA requires public registration of new or ongoing clinical trials and disclosure of results for completed clinical trials on the public database ClinicalTrials.gov. FDAAA has provisions for proof of compliance and authorizes penalties for noncompliance; several phases will be implemented over 3 years and completed by 2010.

In the European Union (EU), the European Parliament enacted the Clinical Trials Directive (Directive 2001/20/EC of April 4, 2001), which governs public access to information on clinical trials in the European Community. Article 11 of the Clinical Trials Directive, enforced by the European Medicines Agency (EMEA), deals with the exchange of information among the EU member states. In some cases, it also deals with the countries of the European Economic Area. The directive is accompanied by two regulations; one refers to clinical trials in general, and the other applies specifically to trials in the pediatric population. These regulations describe how some of the protocol and results information in the EudraCT database at EMEA will be automatically released to the public through the EudraPharm database. The public release is planned for 2010 and 2011.

Requirements for clinical trials disclosure have also been established at the national level in several countries. A summary is presented here of the key global requirements for public disclosure of clinical trial information on drugs, biologics, and medical devices, with a brief overview on the position of various stakeholders involved in this important and evolving topic.

Keywords

Clinicaltrials.gov EMEA EudraPharm EudraCT FDA Amendments Act of 2007 WHO

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References

Laine

Horton

De Angelis

Clinical trial registration: looking back and moving ahead (editorial). JAMA. 2007;(June 4):E1-E2.

Damle

Lurie

Wolfe

. A policy study of clinical trial registries and results databases (HRG publication #1819). Public Citizens Health Research Group. 2007. http://www.citizen.org/documents/1819.pdf. Accessed June 13, 2009.

Ghersi

Clarke

Berlin

Reporting the findings of clinical trials: a discussion paper. Bull World Health Org. 2008; Article DOI:10.2471/08.053769: http://www.who.int/bulletin/volumes/86/08–053769.pdf. Accessed June 13, 2009.

Zarin

Tse

Medicine: moving toward transparency of clinical trials. Science. 2008;319: 1340–1342.

Wood

AJJ

. Progress and deficiencies in the registration of clinical trials. N Engl J Med. 2009;360: 824–830.

US Food and Drug Administration. FDAAA, US Public Law No. 110–85 § 801. 2007. http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_public_laws&docid=f:publ085.110.pdf. Accessed June 13, 2009.

European Commission. Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the member states relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Off J Eur Commun. 2001;L 121:34–41.

European Commission. Communication from the commission regarding the guideline on the data fields contained in the clinical trials database provided for in Article 11 of Directive 2001/20/EC to be included in the database on medicinal products provided for in Article 57 of Regulation (EC) No 726/2004 (2008/C 168/02). Off J Eur Union. 2008;51:3–4.

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. Off J Eur Union. 2009;C 28:1–4.

10.

US Food and Drug Administration. Food and Drug Administration Modernization Act (FDAMA). http://www.fda.gov/cdrh/modact97.pdf. 1997;Section 113, information program on clinical trials for serious or life-threatening diseases, Food and Drug Administration Modernization Act of 1997; Public Law 105–115, 105th Congress. http://www.fda.gov/downloads/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDAMA/FullTextofFDAMAlaw/UCM089145.pdf. 1997;Section 113, information program on clinical trials for serious or life-threatening diseases, Food and Drug Administration Modernization Act of 1997; Public Law 105–115, 105th Congress. http://www.fda.gov/downloads/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDAMA/FullTextofFDAMAlaw/UCM089145.pdf. Accessed June 13, 2009.

11.

Karst

. FDA clarifies that FDAAA clinical trial certification requirement applies to IND submissions; questions remain about ANDA bioequivalence study registration. FDA Law Blog, Hyman, Phelps & McNamara, 2008. http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2008/09/fda-clarifies-t.html. Accessed June 13, 2009.

12.

Covington

Food and Drug Administration Amendment Act of 2007. Food and Drug E-Alert 9–10-2007.

13.

Wager

FDAAA legislation: global implications for clinical trial reporting and publication planning. Keyword Pharma. 2008;(November): 3–13.

14.

Porter

. A new era: clinical trial results open to the public. Regul Focus. 2008;(October):36–41.

15.

Ramaswamy

Championing integrity in pharmaceutical publishing. www.scripnews.com 2008;(July 16):24–25.

16.

US Food and Drug Administration. Certification of complicance (form FDA 3674). 2008. http://www.fda.gov/opacom/morechoices/fdaforms/FDA-3674.pdf. Accessed June 13, 2009.

17.

European Commission. List of fields to be made public from EudraCT for paediatric clinical trials in accordance with Article 41 of Regulation (EC) no 1901/2006 and its implementing guideline 2009/C 28/01. ENTR/F/2/SF/jr D (2009) 3698 2009.

18.

European Commission. List of fields contained in the “EudraCT” clinical trials database to be made public, in accordance with Article 57(2) of Regulation (EC) no 726/2004 and its implementing guideline 2008/C168/02. ENTR/F/2/SF D (2009) 3687 2009.

19.

Verband forschender Arzneimittelhersteller e.V. (VFA, German Association of Research-Based Pharmaceutical Companies). Strict rules for publication of post-marketing surveillance studies. VFA 2007. http://www.vfa.de/en/articles/art-2007–11-002.html. Accessed June 13, 2009.

20.

Zarin

Ide

Tse

Harlan

West

Lindberg

. Issues in the registration of clinical trials. JAMA. 2007;297: 2112–2120.

21.

Groves

Mandatory disclosure of trial results for drugs and devices. BMJ. 2008;336:170.

22.

Sim

Chan

Gulmezoglu

Evans

Pang

Clinical trial registration: transparency is the watchword. Lancet 2006;367: 1631–1633.

23.

Horton

Trial registers: protecting patients, advancing trust. Lancet. 2006;367: 1633–1635.

24.

Hirsch

Trial registration and results disclosure: impact of US legislation on sponsors, investigators, and medical journal editors. Curr Med Res Opin. 2008;24: 1683–1689.

25.

Thomas

Tesch

Clinical trial disclosure: the ongoing debate on public registers for clinical trials. Write Stuff. 2007;16: 67–72.

26.

Thomas

Tesch

Clinical trial disclosure—focusing on results. Write Stuff. 2008;17: 70–73.

27.

Viereck

Boudes

An analysis of current pharmaceutical industry practices for making clinical trial results publicly accessible. Contemp Clin Trials. 2009;30: 293–299.

Clinical Trial Disclosure: Global Overview and Implications of New Laws and Guidelines

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