Clinical trials registry
Encyclopedia
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".
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 "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:
(EDCTP) and works with the Cochrane Collaboration
. It works with the countries of Botswana, Burkina Faso, Cameroon, Ethiopia, Gabon, Gambia, Ghana, Kenya, Malawi, Mali, Mozambique, Nigeria, Rwanda, Senegal, South Africa, Tanzania, Uganda, Zambia, and Zimbabwe.
and New Zealand
share a registry. The ANZCTR is located at: anzctr.org.au.
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.
's clinical trial registry is called ChiCTR and its website is chictr.org. It is available both in Chinese (Mandarin) and English.
ChiCTR was established in October 2005, one week after India's registry was established and it participates in the World Health Organization
’s International Clinical Trials Registry Platform.
'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..
's clinical trials registry, CTRI, was established in October 2005 and registration became mandatory in June 2009. Its website is ctri.in.
CTRI is in English and it participates in the World Health Organization
’s International Clinical Trials Registry Platform.
's registry, the IRCT, is available at irct.ir. It is run and funded by the Iranian Ministry of Health and Medical Education.
'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.
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:
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.
’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.
'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.
are registered on clinicaltrials.gov.
Clinicaltrials.gov is the largest clinical trials registry and holds over 114,000 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).
ClinicalStudyResults is an online database of clinical trials maintainted by PhRMA; available at http://www.clinicalstudyresults.org/.
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.
Clinical trial
Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...
. 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
ClinicalTrials.gov
ClinicalTrials.gov is a registry of clinical trials. It is run by the United States National Library of Medicine at the National Institutes of Health, and is the largest clinical trials database, currently holding registrations from over 93,000 trials from more than 170 countries in the...
, run by the United States National Library of Medicine
United States National Library of Medicine
The United States National Library of Medicine , operated by the United States federal government, is the world's largest medical library. Located in Bethesda, Maryland, the NLM is a division of the National Institutes of Health...
(NLM) was the first online registry for clinical trials and is the largest and most widely used today.
Clinical trials
Clinical trial
Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...
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
Contract research organization
A contract research organization, also called a clinical research organization, is a service organization that provides support to the pharmaceutical and biotechnology industries in the form of outsourced pharmaceutical research services...
(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
World Health Organization
The World Health Organization is a specialized agency of the United Nations that acts as a coordinating authority on international public health. Established on 7 April 1948, with headquarters in Geneva, Switzerland, the agency inherited the mandate and resources of its predecessor, the Health...
is working toward "achieving consensus on both the minimal and the optimal operating standards for trial registration".
International participation
The International Committee of Medical Journal Editors (ICMJE) decided that from July 1st, 2005 no trials will be considered for publication unless they are included on a clinical trials registry. The World Health OrganizationWorld Health Organization
The World Health Organization is a specialized agency of the United Nations that acts as a coordinating authority on international public health. Established on 7 April 1948, with headquarters in Geneva, Switzerland, the agency inherited the mandate and resources of its predecessor, the Health...
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
Declaration of Helsinki
The Declaration of Helsinki is a set of ethical principles regarding human experimentation developed for the medical community by the World Medical Association . It is widely regarded as the cornerstone document of human research ethics...
, 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 "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)
- The Netherlands' Trialregister.nl
- The United States' ClinicalTrials.govClinicalTrials.govClinicalTrials.gov is a registry of clinical trials. It is run by the United States National Library of Medicine at the National Institutes of Health, and is the largest clinical trials database, currently holding registrations from over 93,000 trials from more than 170 countries in the...
- The International ISRCTN.org
- Pan African Clinical Trial Registry (PACTR) (http://www.pactr.org/)
- Sri Lanka Clinical Trials Registry (SLCTR) (http://www.slctr.lk/)
Africa
The Pan-African clinical trials registry (PACTR) is available at pactr.org. It is funded by the European and Developing Countries Clinical Trials PartnershipEuropean and Developing Countries Clinical Trials Partnership
The European and Developing Countries Clinical Trials Partnership or EDCTP is a partnership between the European Union , Norway, Switzerland and developing countries and other donors, as well as the pharmaceutical industry, to enable clinical trials and the development of new medicines and vaccines...
(EDCTP) and works with the Cochrane Collaboration
Cochrane Collaboration
The Cochrane Collaboration is a group of over 28,000 volunteers in more than 100 countries who review the effects of health care interventions tested in biomedical randomized controlled trials. A few more recent reviews have also studied the results of non-randomized, observational studies...
. It works with the countries of Botswana, Burkina Faso, Cameroon, Ethiopia, Gabon, Gambia, Ghana, Kenya, Malawi, Mali, Mozambique, Nigeria, Rwanda, Senegal, South Africa, Tanzania, Uganda, Zambia, and Zimbabwe.
Australia and New Zealand
The countries of AustraliaAustralia
Australia , officially the Commonwealth of Australia, is a country in the Southern Hemisphere comprising the mainland of the Australian continent, the island of Tasmania, and numerous smaller islands in the Indian and Pacific Oceans. It is the world's sixth-largest country by total area...
and New Zealand
New Zealand
New Zealand is an island country in the south-western Pacific Ocean comprising two main landmasses and numerous smaller islands. The country is situated some east of Australia across the Tasman Sea, and roughly south of the Pacific island nations of New Caledonia, Fiji, and Tonga...
share a registry. The ANZCTR is located at: anzctr.org.au.
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
National Health and Medical Research Council
The National Health and Medical Research Council is Australia's peak funding body for medical research, with a budget of roughly 700 million dollars a year...
(NHMRC). The registry is in English.
China
ChinaChina
Chinese civilization may refer to:* China for more general discussion of the country.* Chinese culture* Greater China, the transnational community of ethnic Chinese.* History of China* Sinosphere, the area historically affected by Chinese culture...
's clinical trial registry is called ChiCTR and its website is chictr.org. It is available both in Chinese (Mandarin) and English.
ChiCTR was established in October 2005, one week after India's registry was established and it participates in the World Health Organization
World Health Organization
The World Health Organization is a specialized agency of the United Nations that acts as a coordinating authority on international public health. Established on 7 April 1948, with headquarters in Geneva, Switzerland, the agency inherited the mandate and resources of its predecessor, the Health...
’s International Clinical Trials Registry Platform.
Europe
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
GermanyGermany
Germany , officially the Federal Republic of Germany , is a federal parliamentary republic in Europe. The country consists of 16 states while the capital and largest city is Berlin. Germany covers an area of 357,021 km2 and has a largely temperate seasonal climate...
'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..
India
IndiaIndia
India , officially the Republic of India , is a country in South Asia. It is the seventh-largest country by geographical area, the second-most populous country with over 1.2 billion people, and the most populous democracy in the world...
's clinical trials registry, CTRI, was established in October 2005 and registration became mandatory in June 2009. Its website is ctri.in.
CTRI is in English and it participates in the World Health Organization
World Health Organization
The World Health Organization is a specialized agency of the United Nations that acts as a coordinating authority on international public health. Established on 7 April 1948, with headquarters in Geneva, Switzerland, the agency inherited the mandate and resources of its predecessor, the Health...
’s International Clinical Trials Registry Platform.
Iran
IranIran
Iran , officially the Islamic Republic of Iran , is a country in Southern and Western Asia. The name "Iran" has been in use natively since the Sassanian era and came into use internationally in 1935, before which the country was known to the Western world as Persia...
's registry, the IRCT, is available at irct.ir. It is run and funded by the Iranian Ministry of Health and Medical Education.
Italy
ItalyItaly
Italy , officially the Italian Republic languages]] under the European Charter for Regional or Minority Languages. In each of these, Italy's official name is as follows:;;;;;;;;), is a unitary parliamentary republic in South-Central Europe. To the north it borders France, Switzerland, Austria and...
'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.
Japan
JapanJapan
Japan is an island nation in East Asia. Located in the Pacific Ocean, it lies to the east of the Sea of Japan, China, North Korea, South Korea and Russia, stretching from the Sea of Okhotsk in the north to the East China Sea and Taiwan in the south...
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)
Netherlands
The NetherlandsNetherlands
The Netherlands is a constituent country of the Kingdom of the Netherlands, located mainly in North-West Europe and with several islands in the Caribbean. Mainland Netherlands borders the North Sea to the north and west, Belgium to the south, and Germany to the east, and shares maritime borders...
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
South AfricaSouth Africa
The Republic of South Africa is a country in southern Africa. Located at the southern tip of Africa, it is divided into nine provinces, with of coastline on the Atlantic and Indian oceans...
’s Department of Health
Department of Health (South Africa)
The Department of Health is the executive department of the South African government which is assigned to health matters....
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
South KoreaSouth Korea
The Republic of Korea , , is a sovereign state in East Asia, located on the southern portion of the Korean Peninsula. It is neighbored by the People's Republic of China to the west, Japan to the east, North Korea to the north, and the East China Sea and Republic of China to the south...
'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.
Sri Lanka
The Sri Lanka Clinical Trials Registry (SLCTR) is available at slctr.lk. It is funded by the Sri Lanka Medical Association and managed by the Sri Lanka Clinical Trials Registry Committee.United States
Clinical trials in the USUnited States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
are registered on clinicaltrials.gov.
Clinicaltrials.gov is the largest clinical trials registry and holds over 114,000 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
United States National Library of Medicine
The United States National Library of Medicine , operated by the United States federal government, is the world's largest medical library. Located in Bethesda, Maryland, the NLM is a division of the National Institutes of Health...
(NLM).
Other Registries
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/.
Pharmaceutical industry initiative
The IFPMA Clinical Trials PortalIFPMA Clinical Trials Portal
The ' 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...
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.