The International Clinical Trials Registry Platform (ICTRP) is a platform for the registration of clinical trials operated by the World Health Organization. [1]
The ICTRP combines data from multiple cooperating clinical trials registries to generate a global view of clinical trials worldwide, with a search portal that allows access to the entire dataset. [2] [3] It requires a minimum standard set of database fields, the WHO Trial Registration Data Set, to be present for a trial to be registered. [4] All entries are given a Universal Trial Number (UTN) that identifies them uniquely. [5]
The organization has sought to assist various national governments in establishing their own clinical trials databases. [6]
It combines data from the following primary registries and data providers: [7] [8]
The International Classification of Diseases (ICD) is a globally used medical classification used in epidemiology, health management and for clinical purposes. The ICD is maintained by the World Health Organization (WHO), which is the directing and coordinating authority for health within the United Nations System. The ICD is originally designed as a health care classification system, providing a system of diagnostic codes for classifying diseases, including nuanced classifications of a wide variety of signs, symptoms, abnormal findings, complaints, social circumstances, and external causes of injury or disease. This system is designed to map health conditions to corresponding generic categories together with specific variations, assigning for these a designated code, up to six characters long. Thus, major categories are designed to include a set of similar diseases.
The Cochrane Library is a collection of databases in medicine and other healthcare specialties provided by Cochrane and other organizations. At its core is the collection of Cochrane Reviews, a database of systematic reviews and meta-analyses that summarize and interpret the results of medical research. The Cochrane Library aims to make the results of well-conducted clinical trials readily available and is a key resource in evidence-based medicine.
Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments and known interventions that warrant further study and comparison. Clinical trials generate data on dosage, safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial—their approval does not mean the therapy is 'safe' or effective, only that the trial may be conducted.
Health care, or healthcare, is the improvement of health via the prevention, diagnosis, treatment, amelioration or cure of disease, illness, injury, and other physical and mental impairments in people. Health care is delivered by health professionals and allied health fields. Medicine, dentistry, pharmacy, midwifery, nursing, optometry, audiology, psychology, occupational therapy, physical therapy, athletic training, and other health professions all constitute health care. The term includes work done in providing primary care, secondary care, tertiary care, and public health.
.eu is the country code top-level domain (ccTLD) for the European Union (EU). Launched on 7 December 2005, the domain is available for any person, company or organization based in the European Union. This was extended to the European Economic Area in 2014, after the regulation was incorporated into the EEA Agreement, and hence is also available for any person, company or organization based in Iceland, Liechtenstein and Norway. The TLD is administered by EURid, a consortium originally consisting of the national ccTLD registry operators of Belgium, Sweden, and Italy, joined later by the national registry operator of the Czech Republic. Trademark owners were able to submit registrations through a sunrise period, in an effort to prevent cybersquatting. Full registration started on 7 April 2006.
Health informatics combines communications, information technology (IT), and health care to enhance patient care and is at the forefront of the medical technological revolution. It can be viewed as a branch of engineering and applied science.
The Principles of Good Laboratory Practice (GLP) establish rules and criteria for a quality system that oversees the organizational processes and conditions in which non-clinical health and environmental safety studies are planned, conducted, monitored, recorded, reported, and archived. These principles apply to the non-clinical safety testing of substances found in various products to ensure the quality and integrity of the safety data submitted to regulatory authorities globally.
.me is the Internet country code top-level domain (ccTLD) for Montenegro.
Ocrelizumab, sold under the brand name Ocrevus, is a medication used for the treatment of multiple sclerosis. It is a humanized anti-CD20 monoclonal antibody. It targets CD20 marker on B lymphocytes and is an immunosuppressive drug. Ocrelizumab binds to an epitope that overlaps with the epitope to which rituximab binds. It is administered by intravenous infusion. The fixed-dose combination ocrelizumab/hyaluronidase is administered by subcutaneous injection.
Orphanet is an organisation and knowledge base dedicated to rare diseases as well as corresponding diagnosis, orphan drugs, clinical trials and expert networks.
ClinicalTrials.gov is a registry of clinical trials. It is run by the United States National Library of Medicine (NLM) at the National Institutes of Health, and holds registrations from over 444,000 trials from 221 countries.
Patient participation is a trend that arose in answer to medical paternalism. Informed consent is a process where patients make decisions informed by the advice of medical professionals.
Healthcare CRM, also known as Healthcare Relationship Management, is a broadly used term for a Customer relationship management system, or CRM, used in healthcare.
Real world data (RWD) in medicine is data derived from a number of sources that are associated with outcomes in a heterogeneous patient population in real-world settings, including but not limited to electronic health records, health insurance claims and patient surveys. While no universal definition of real world data exists, researchers typically understand RWD as distinct from data sourced from randomized clinical trials.
Preregistration is the practice of registering the hypotheses, methods, or analyses of a scientific study before it is conducted. Clinical trial registration is similar, although it may not require the registration of a study's analysis protocol. Finally, registered reports include the peer review and in principle acceptance of a study protocol prior to data collection.
The Solidarity trial for treatments is a multinational Phase III-IV clinical trial organized by the World Health Organization (WHO) and partners to compare four untested treatments for hospitalized people with severe COVID-19 illness. The trial was announced 18 March 2020, and as of 6 August 2021, 12,000 patients in 30 countries had been recruited to participate in the trial.
Clinical Trials Registry – India (CTRI) is the government of India's official clinical trial registry. The National Institute of Medical Statistics of the Indian Council of Medical Research established the CTRI on 20 July 2007. Since 2009 the Central Drugs Standard Control Organisation has mandated that anyone conducting clinical trials in India must preregister before enrolling any research participants.
The European Union Clinical Trials Regulation is the legislation relating to the conduct of clinical trials of investigational medicinal products within the European Union. The regulations repealed the previous legislation, namely the clinical trials directive and came into force on 31 January 2022.
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