This Is Part-2 of a Series. Click here to read the first part: The Top 5 Sources of Pharma Data In the U.S.
I don’t think everyone in the pharma industry is aware of just how much clinical trial data is out there for free, ready for the taking. If there is information you need related to clinical research, it likely lies in one of the millions of trial records that exist in our list of the top free sources of pharma data. And not just trial-specific data such as eligibility criteria or results. When we group together data of this volume from all over the globe we can extrapolate insights about every aspect of the industry. Think sponsor activity, therapeutic area popularity, global recruiting, operational expense predictions – the list goes on.
In the past, industry professionals have started a research process with “is this data available?”. With the volume of data at our fingertips in 2017 the question has changed to “Where is this data?” followed up by “How do I leverage it?”
At BrackenData, we focus on solving the latter questions for teams. After all, it’s great to know that almost a quarter-million trial records exist on ClinicalTrials.gov, but it takes thousands of hours to meaningfully visualize this information and categorize it for the different needs of clinical operations, commercial planning, or sales teams.
This post is the second installment of our Top Free Sources of Pharma Data series. The goal of this series is to help you and your team address the first question: "Where is this data?" Part-1 focused on databases maintained by US-government organizations. In this post, we look at the six biggest clinical trial registries outside the US. Read along as we cover, in order of database size:
- EudraCT / EudraPharm (EU)
- UMIN Clinical Trials Registry (Japan)
- ANZCTR (Australia / New Zealand)
- ISRCTN Registry (UK)
- ChiCTR (China)
- CTRI (India)
EudraCT / EudraPharm
EudraCT Website: https://eudract.ema.europa.eu/
EudraPharm Website: http://www.eudrapharm.eu
About the Data: Records on 50,232 clinical trials taking place within the EU as of February 1st 2016. EudraCT is the repository for clinical trial applications and results submissions. EudraPharm is the public repository for drug product, trial sponsor, and clinical trial information. We’ve grouped the two together because they split the functions that are usually present in a single trial registry. Also “EudraCT” is the blanket industry term even though “EudraPharm” is sometimes what users are referring to.
Maintained By: European Medicines Agency (EMA)
Backstory: Of these two data sources, EudraCT, which stands for European Union Drug Regulating Authorities Clinical Trials, came first. It launched on May 1st 2004, and contains data on all EU regulated clinical trials since that date. The date of commencement for EudraPharm isn’t published online
More Information: Though EudraCT can be difficult to work with it’s an important registry because the vast majority of pharma companies conduct research in Europe, and/or intend their products to be commercialized there. EudraCT is the second largest individual clinical trial registry in the world.
While most clinical trial registries have been designed to allow patients and physicians to find clinical trials trial sites that are recruiting by condition and geography, this isn't the case with EudraCT. It's closed to the general public. You must be approved by the EMA to get a EudraCT account, which requires proof of the intention to submit a trial application or trial results. In other words, only investigators and collaborators get an account. EudraPharm is more comparable to ClinicalTrials.gov, which publicizes approved information on products, and sponsors. EudraPharm is also a source of veterinary product data and is available in 24 languages.
UMIN Clinical Trials Registry aka UMIN-CTR (Japan)
About the Data: 26,731 records of Japanese clinical trials.
Maintained by: University Hospital Medical Information Network (UMIN) Center
Backstory: Japan has three clinical trial registries that work together as a network. The other two are Japan Pharmaceutical Information Center – Clinical Trials Information (JapicCTI) and Japan Medical Association – Center for Clinical Trials (JMACCT CTR). Together all three form the Japan Registries Network (JPRN), however, UMIN-CTR is the only Japanese registry recognized as a primary registry within the WHO network. This is important because a trial needs to be registered in the WHO network to be a listed source for any International Committee of Medical Journal Editors (ICMJE) approved publications.
More Information: JPRN does have its own website, http://rctportal.niph.go.jp/, maintained by Japan’s National Institute of Public Health (NIPH), which aggregates the data from the three Japanese networks. Japan is the second largest market for pharmaceutical and biotechnology products, making up about 10% of global industry sales. Therefore pharma and pharma services companies should pay close attention to Japanese clinical trial activity. JPRN is the most exhaustive source for researching Japanese clinical trial information but know for the purposes of publishing medical literature that not everything in there is ICMJE approved. Also, while UMIN-CTR is available in both English and Japanese, JPRN is only available in Japanese.
ANZCTR (Australia / New Zealand)
About the Data: 19,762 records of clinical trials based in Australia and/or New Zealand.
Maintained by: ANZCTR is a publicly owned and managed by NHMRC Clinical Trials Centre, University of Sydney, a not-for-profit organization.
Backstory: There isn’t an established date listed for ANZCTR but the website does state that it was one of the first three registries as a WHO ICTRP primary registry back in 2007.
More Information: The website lists the Australian government’s National Health and Medical Research Council and the NCRIS (National Research Infrastructure for Australia) as major funders. Though it is the fourth largest clinical trial registry in the world and a WHO approved database, registering trials on ANZCTR is not actually mandatory for Australian trial investigators.
ISRCTN Registry (UK)
About the Data: 15,715 trial records for clinical trials registered within the UK
Maintained by: “Curated by a team of expert editors” with major support by BioMed Central.
Backstory: ISRCTN registry was launched in 2000. In 2014 it was the fourth largest registry in the world, but has since fallen to fifth place.
More Information: We expect the ISRCTN’s rank in the list of world registries by volume of trial records to continue falling over the coming years. Even though it is one of five registries to have over 15,000 trials on file, it’s growth rate is the smallest on our list. It registers an average of 982 trials per year, a volume ClinicalTrials.gov adds to its database in two weeks. This low growth rate is likely because trial registration isn’t mandatory. Instead, it takes the approach of being a user-friendly option for patients to find trials, and for investigators to get their work found.
About the Data: 11,136 records of clinical trials based in China.
Maintained by: Chinese Clinical Trial Registry
Backstory: According to the website “Chinese Clinical Trial Registry (ChiCTR) assigned to be the representative registry of China to join WHO ICTRP in 2007."
More Information: This website was established one week after India’s national clinical trial registry, which is next on this list. Information on the website is available in both English and Mandarin. The non-profit organization by the same name who maintains the site and database posts content on the website to educate the public about clinical trial fundamentals and clinical trial registration. Users can filter their search by 6 fields. An interactive banner at the top shares interesting visuals about the database such as a breakdown of funding types or ethics committee approvals. More than 25% of the trials in the database are sponsored by West China Hospital of Sichuan University.
Clinical Trials Registry India
About the Data: 8,407 records of clinical trials held in India.
Maintained by: India’s National Institute of Medical Statistics (ICMR)
Backstory: According to the website “The Clinical Trials Registry- India (CTRI), hosted at the ICMR's National Institute of Medical Statistics (http://nims-icmr.nic.in), is a free and online public record system for registration of clinical trials being conducted in India that was launched on 20th July 2007 (www.ctri.nic.in). Initiated as a voluntary measure, since 15th June 2009, trial registration in the CTRI has been made mandatory by the Drugs Controller General (India) (DCGI) (www.cdsco.nic.in). Moreover, Editors of Biomedical Journals of 11 major journals of India declared that only registered trials would be considered for publication”.
More Information: The CTRI registration process requires an investigator to disclose all sponsors, interventions, and patient populations before enrolling the first patient. Submissions must also go through an ethics review board before being approved. India currently represents 20% of global generic drug exports by volume, and is expected to be the third largest market for all pharma products by 2020 (source). That means if you’re in the pharma ecosystem, pay attention to India, and be familiar with what’s inside CTRI.