What are Clinical Trials?

Use this guide to help locate published or unpublished clinical trials in health sciences. For exhaustive searching there is always the possibility of including other databases or searching in other languages and countries of origin.

The resources in this guide may be relevant to both randomized (RCT’s) and non-randomized trials, community trials, and various phases of trials.

Definition of a clinical trial

• “A research activity that involves the administration of a test regimen to humans to evaluate its eficacy and safety.” (Last JM, International Epidemiological Association. A dictionary of epidemiology. i31366284 4th ed. New York: Oxford University Press; 2001)
• See also Bandolier Glossary


Published Trials – Through the UQ Library

Subscription Database Access

You can search for published trials using bibliographic literature databases. The following databases, which may have references to clinical trials, are available via the UQ Library’s Databases page.

Contact Your Liaison Librarian for expert assistance in searching the databases.

Cochrane Collaboration (Organization) Includes Cochrane Central Registrar of Controlled Trials (CENTRAL) CENTRAL is the Cochrane Collaboration's register of controlled trials. The register provides bibliographic information (i.e. abstracts rather than full-text) on over 415,000 reports of trials identified by contributors to the Cochrane Collaboration. CENTRAL provides individual reviewers with easy and reliable access to the maximum possible number of trials relevant to their review topic. Trials are identified from multiple sources, including searches of bibliographic databases, handsearches of many hundreds of journals and conference proceedings, and searches of other trial registers. Since the overriding aim is to create an unbiased source of data for systematic reviews, all known controlled trials are included in CENTRAL irrespective of language of publication or where and when the studies were conducted.

Ovid Medline Combine search with the following terms: Randomized controlled trial.pt or clinical trial.pt. Then combine this last set with your search topic set using and.

PLoS Clinical Trials PLoS Clinical Trials (eISSN 1555-5887) is an international, peer-reviewed, open-access journal published by the Public Library of Science (PLoS). Launched in March 2006.

PubMed From the PubMed Services menu: Choose Clinical Queries. Then select therapy and narrow, specific search.

Biological Abstracts May contain pre-clinical or laboratory trials

Web of Science

EMBASE Drugs & pharmacology

Cinahl

PEDro, the physiotherapy evidence database

UQ Library Catalogue

To learn more about clinical trials you can search the UQ Library catalogue using the Subject Heading “Clinical Trials”.


Trial Registries - Protocols

These registries list protocols of clinical trials. They can be searched to identify trials at various stages from registration of protocol to completion, and which might not necessarily ever be published or indexed in databases.

ClinicalTrials.gov A Service of the US National Institutes of Health. Developed by the National Library of Medicine.	http://clinicaltrials.gov/
International Standard Randomised Controlled Trial Number (ISRCTN) Register	http://www.controlled-trials.com/isrctn/
National Research Register. UK Department of Health	http://www.nrr.nhs.uk
WHO Clinical Trial Search Portal	http://www.who.int/trialsearch/
metaRegister of Controlled Trials (mRCT) Multiple Trial search	http://www.controlled-trials.com/mrct/
Australian Clinical Trials Registry (ACTR) National on-line registry of all types of clinical trials being undertaken in Australia. Funded by National Health and Medical Research Council (NHMRC)	http://www.actr.org.au/
European Register of Clinical Trials in Children DEC-net international register. Openly available.	www.dec-net.org
European Community Clinical Trials database Registration required to access.	http://eudract.emea.eu.int


Sponsored Trial Data Publications

US Food and Drug Administration posts selected review documents for new drug approvals on its Web site.

Pharmaceutical company web sites

GlaxoSmithKline Clinical Trial Register	http://ctr.gsk.co.uk
GSK Register Letter: More on compulsory registration of clinical trials	http://bmj.bmjjournals.com/cgi/content/full/330/7489/479-b
Clinical Study Results The US pharmaceutical industry (PhRMA) repository for controlled clinical trial results	http://www.clinicalstudyresults.org
Centerwatch Clinical Trials Listing Service Thomson's listing of NIH government funded trials protocols	http://www.centerwatch.com/patient/nih/nihcat14.html
Trialscentral Provides links to a large number of US organisations conducting trials, including drug companies and research bodies	http://www.trialscentral.org/AllRegistersByType.aspx


Unpublished Trial Data Publications
• Contact Drug companies & research organisations.
• Search web for 'grey literature'. The search term "grey literature" will lead to sites that collect and make available links to this unpublished material, for example institutional reports, research papers etc.

Patents Applications

The UQ Library can provide help:

• Derwent Innovations Index, (the world's most comprehensive database of patents information) is available via UQ Library's Database page
• The UQ Library has produced a "How-to" guide for finding Patents

Policy Statements and Guidelines for Registration of Trials

Australian Clinical Trials Registry (ACTR) National on-line registry of all types of clinical trials being undertaken in Australia. Funded by National Health and Medical Research Council (NHMRC)	http://www.actr.org.au/
Ottowa Statement on trial registration	http://ottawagroup.ohri.ca/statement.html
Committee of Medical Journal Editors Statement on trials registration	http://content.nejm.org/cgi/content/full/352/23/2436
WHO statement "require registration of all trials whose primary purpose is to affect clinical practice (phase 3 trials)"	http://www.who.int/ictrp/en/
United States Congress (Fair Access to Clinical Trials Act) (currently before Congress 18/10/05)	http://www.house.gov/
CONSORT Statement An important research tool that takes an evidence-based approach to improve the quality of reports of randomized trials. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials.	http://www.consort-statement.org/Statement/revisedstatement.htm
Bmj editorial: Abbasi K. Compulsory registration of clinical trials. BMJ 2004;329: 637-8. (18 September.)[Free Full Text]	http://bmj.bmjjournals.com/cgi/reprint/329/7467/637
European Pharmaceutical Industries. Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases	www.efpia.org/4_pos/sci_regu/Clinicaltrials2005.pdf

Checklists for Reporting of Clinical Trials

CONSORT Statement checklist	http://www.consort-statement.org/Statement/ revisedstatement.htm#checklist
WHO Mexico statement on health research. April 1, 2005 WHO minimal registration data set	http://www.who.int/ictrp/comments1/en/index.html

Validity of Clinical Trials

A number of checklists are available to assist with assessment of validity of clinical trials.

Evidence-based medicine Sackett ... [et al.] Publisher New York, N.Y. Churchill Livingstone, 2000. 2nd ed

R723.5 .E89 2000 Herston Medical, Biol Sciences, PA Hospital, Mater, Bundaberg, Rockhampton, Toowoomba

Registers of Other Study Types

Cochrane Library - Review Protocols	http://www.cochrane.org/reviews/clibintro.htm
BioMed Central Research Protocol Register	http://www.biomedcentral.com/info/authors/protocols
National Research Register All types of medical research in the UK including clinical trials	http://www.nrr.nhs.uk/default.htm

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