Clinical trials registry
A clinical trials registry, sometimes abbreviated as a CTR, is an official platform and catalog for registering a clinical trial. Some countries require clinical trials being conducted in that country to be registered, other do not require it, but often strongly encourage it. ClinicalTrials.gov, run by the United States National Library of Medicine (NLM) was the first online registry for clinical trials and is the largest and most widely used today.
Clinical trials are conducted to allow safety and efficacy data to be collected for health interventions (e.g., drugs, diagnostics, devices, therapy protocols). The goal of a clinical trials registry is to provide increased transparency and access to clinical trials, made available to the public. Clinical trials registries are often searchable (for example, trials can be searchable by disease/indication, drug, location, etc.). Trials are registered by the pharmaceutical, biotech or medical device company (Sponsor) or by the hospital or foundation which is sponsoring the study, or by another organization, such as a contract research organization (CRO) which is running the study.
There has been a push from governments and international organizations, especially since 2005, to make clinical trial information more widely available and to standardize registries and processes of registering. The World Health Organization is working toward "achieving consensus on both the minimal and the optimal operating standards for trial registration".
- 1 International participation
- 2 Number of registered studies per registry
- 3 Clinical trial registries by country
- 4 Other Registries
- 5 References
The International Committee of Medical Journal Editors (ICMJE) decided that from July 1, 2005 no trials will be considered for publication unless they are included on a clinical trials registry. The World Health Organization has begun the push for clinical trial registration with the initiation of the International Clinical Trials Registry Platform. There has also been action from the pharmaceutical industry, which released plans to make clinical trial data more transparent and publicly available. Released in October 2008, the revised Declaration of Helsinki, states that "Every clinical trial must be registered in a publicly accessible database before recruitment of the first subject."
The World Health Organization maintains an international registry at http://apps.who.int/trialsearch/. WHO states that the international registry's mission is "to ensure that a complete view of research is accessible to all those involved in health care decision making. This will improve research transparency and will ultimately strengthen the validity and value of the scientific evidence base."
The ISRCTN is a numerical system for uniquely identifying clinical trials worldwide. Its website is http://isrctn.org/. It is run as a non-profit organization and lists all trials registered with it. The ISRCTN maintains the clinical trial database controlled-trials.com.
Since 2007, the International Committee of Medical Journal Editors ICMJE accepts all primary registries in the WHO network in addition to clinicaltrials.gov. The complete list is as follows:
- Australia and New Zealand's (ANZCTR) (http://www.anzctr.org.au)
- Brazilian Clinical Trials Registry (ReBec) (http://www.ensaiosclinicos.gov.br)
- Chinese Clinical Trial Registry (ChiCTR) (http://www.chictr.org)
- Clinical Research Information Service (CRiS), Republic of Korea (http://cris.cdc.go.kr)
- Clinical Trials Registry - India (CTRI) (http://ctri.nic.in)
- Cuban Public Registry of Clinical Trials(RPCEC) (http://registroclinico.sld.cu)
- EU Clinical Trials Register (EU-CTR) (https://www.clinicaltrialsregister.eu/)
- German Clinical Trials Register (DRKS) (http://www.drks.de)
- Iranian Registry of Clinical Trials (IRCT) (http://www.irct.ir/)
- Japan's UMIN-CTR (http://umin.ac.jp)
- Thai Clinical Trials Registry (www.clinicaltrials.in.th)
- The Netherlands' Trialregister.nl
- The United States' ClinicalTrials.gov
- The International ISRCTN.org
- Pan African Clinical Trial Registry (PACTR) (http://www.pactr.org/)
- Sri Lanka Clinical Trials Registry (SLCTR) (http://www.slctr.lk/)
Number of registered studies per registry
Worldwide, there is growing number of registries. A 2013 study identified the following top five registries (numbers updated as of August 2013):
|3.||Japan registries trwork (JPRN)||12,728|
|5.||Australia and New Zealand (ANZCTR)||8,216|
Clinical trial registries by country
The Pan-African clinical trials registry (PACTR) is available at pactr.org. It is funded by the European and Developing Countries Clinical Trials Partnership (EDCTP) and operates out of the South African Cochrane Centre (Cochrane Collaboration) based at the South African Medical Research Council. PACTR's remit ensures that it can register all clinical trials that are conducted on the continent in all disease areas. PACTR is a primary member of the WHO's International Clinical Trials Registry Platform (ICTRP), and thus contributes data to the central search portal hosted by ICTRP.
Australia and New Zealand
Registering trials with the ANZCTR is voluntary. It is publicly owned and managed by a non-profit organization and is funded by an enabling grant from Australia's National Health and Medical Research Council (NHMRC). The registry is in English.
Brazil has a registry (the Registro Brasileiro de Ensaios Clínicos, abbreviated ReBEC) at: ensaiosclinicos.gov.br. ReBEC is a project of the Brazilian Ministry of Health, The Panamerican Health Organization (PAHO) and The Oswaldo Cruz Foundation (FIOCRUZ).
The Canadian Institutes of Health Research (CIHR) participates with the ISRCTN.
EudraCT is a non-public database of all drug trials in the European Community (EC) from May 1, 2004 onwards. Its website is eudract.ema.europa.eu. In March 2011, EUCTR was launched, which is the public version of EudraCT including phase II to IV trials plus all pediatric trials.
Germany's clinical trials registry, the DRKS, is available at www.drks.de. The DRKS is an open access, free of charge online register for clinical trials and is available both in English and German. DRKS is part of the ICTRP network at WHO. The DRKS works with two partner registries in Germany, DeReG - German Registry for Somatic Gene-Transfer Trials and Clinical Trial Registry of the University Medical Center Freiburg.
Italy's The Portal of the Clinical Research with Medicines of the Italian Medicines Agency (AIFA) is a public source of information about the clinical trials with medicines conducted in Italy, the regulations and the ethical principles ruling the research, as well as the initiatives that AIFA promotes in the field of research. Unfortunately the portal has not been working since January 2013, for technical reasons; although it was expected to restart soon, an operational date has not yet been posted so far (July 2013).
Japan has three registries that work as a network known as the Japan Primary Registries Network (JPRN). Its search portal is hosted by the Japanese National Institute of Public Health. While the search portal is only available in Japanese, the three registries' sites are also available in English:
- University Hospital Medical Information Network (UMIN CTR)
- Japan Pharmaceutical Information Center - Clinical Trials Information (JapicCTI)
- Japan Medical Association - Center for Clinical Trials (JMACCT CTR)
The Netherlands registry participates with WHO and its website is trialregister.nl. While the "About" sections of the website are only available in the Dutch language, clinical trial data are available in English.
South Africa’s Department of Health announced in November 2005, that clinical trials conducted in the country must be submitted to the South African National Clinical Trials Register. Its site is located at: sanctr.gov. Clinical trial guidelines for South Africa are available at the Department of Health's official site.
South Korea's registry is Clinical Research Information Service (CRiS) and available at http://ncrc.cdc.go.kr/cris/index.jsp. It is managed by the Korea Centers for Disease Control and Prevention and funded by South Korea's Ministry of Health and Welfare.
Clinicaltrials.gov is the largest clinical trials registry and holds about 150,000 trials from more than 175 countries. Clinical trials conducted in the United States are required to be registered in the registry.
The registry traces back to the Health Omnibus Programs Extension Act of 1988 (HOPE or Public Law 100-607) which mandated the development of a database of AIDS Clinical Trials Information System. It would later be expanded under the Food and Drug Modernization Act of 1997 (FDAMA or Public Act 105-115). The registry is run by the United States National Library of Medicine (NLM).
Clinical trial registries are also set up and managed by governmental organizations, non-governmental organizations, universities, as well as commercial and nonprofit entities. This includes pharmaceutical companies, international organizations, and health organizations. A list is available at http://www.circare.org/registries.htm.
ClinicalStudyResults is an online database of clinical trials maintainted by PhRMA; available at http://www.clinicalstudyresults.org/ http://www.clinicalstudyresults.org/.
ClinicalTrialSearch.org is an open source semantic database of Clinical Trials. A list is available at http://www.clinicaltrialsearch.org/.
Pharmaceutical industry initiative
The IFPMA Clinical Trials Portal is a major pharmaceutical industry initiative designed to increase the transparency of clinical trials by providing a convenient "one-stop-shop" for published clinical trial information. It helps to fulfill the commitment made by the research-based pharmaceutical industry in its Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases. It is available here.
- Huser, V.; Cimino, J. J. (2013). "Evaluating adherence to the International Committee of Medical Journal Editors' policy of mandatory, timely clinical trial registration". Journal of the American Medical Informatics Association 20 (e1): e169–74. doi:10.1136/amiajnl-2012-001501. PMID 23396544.