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Clinical Trials In India
Clinical trials in India refers to clinical research in India in which researchers test drugs and other treatments on research participants. NDCTR 2019 and section 3.7.1 to 3.7.3 of ICMR guidelines requires that all researchers conducting a clinical trial must publicly document it in the Clinical Trials Registry - India. Various government agencies and laws regulate clinical trials. The Drugs Controller General of India grants approval for clinical trials and is the top level authority which specifically oversees clinical trials. The Drugs Controller is a part of the Central Drugs Standard Control Organisation and answers to that organization. Both of those organizations answer the Ministry of Health and Family Welfare as the highest level government agency overseeing everything related to medicine and health. The Indian Council of Medical Research governs the professional and ethical behavior of the doctors and scientists. The Pharmacovigilance Program of India tracks reports of ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Research
Clinical research is a branch of healthcare science that determines the safety and effectiveness ( efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. Clinical research is different from clinical practice. In clinical practice established treatments are used, while in clinical research evidence is collected to establish a treatment. Overview The term "clinical research" refers to the entire bibliography of a drug/device/biologic, in fact any test article from its inception in the lab to its introduction to the consumer market and beyond. Once the promising candidate or the molecule is identified in the lab, it is subjected to pre-clinical studies or animal studies where different aspects of the test article (including its safety toxicity if applicable and efficacy, if possible at this early stage) are studied. In the United State ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Central Drugs Standard Control Organization
The Central Drugs Standard Control Organisation (CDSCO) is India's national regulatory body for cosmetics , pharmaceuticals and medical devices. It serves a similar function to the European Medicines Agency of the European Union, the PMDA of Japan, the Food and Drug Administration (FDA) of the United States, and the Medicines and Healthcare products Regulatory Agency of the United Kingdom, and the National Medical Products Administration (NMPA) of China. The Indian government has announced its plan to bring all medical devices, including implants and contraceptives under a review of the Central Drugs and Standard Control Organisation (CDSCO). Within the CDSCO, the Drug Controller General of India (DCGI) regulates pharmaceutical and medical devices and is positioning within the Ministry of Health and Family Welfare. The DCGI is advised by the Drug Technical Advisory Board (DTAB) and the Drug Consultative Committee (DCC). Divided into zonal offices, each one carries out pr ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Patient-reported Outcomes
A patient-reported outcome (PRO) is a health outcome directly reported by the patient who experienced it. It stands in contrast to an outcome reported by someone else, such as a physician-reported outcome, a nurse-reported outcome, and so on. PRO methods, such as questionnaires, are used in clinical trials or other clinical settings, to help better understand a treatment's efficacy or effectiveness. The use of digitized PROs, or electronic patient-reported outcomes (ePROs), is on the rise in today's health research setting. Terminology PROs should not be confused with PCOs, or ''patient-centered outcomes''. The latter implies the use of a questionnaire covering issues and concerns that are specific to a patient. Instead, ''patient-reported'' outcomes refers to reporting situations in which only the patient provides information related to a specific treatment or condition; this information may or may not be of concern to the patient. Further, PROs should not be confused with P ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Good Clinical Practice
Good clinical practice (GCP) is an international quality standard, which governments can then transpose into regulations for clinical trials involving human subjects. GCP follows the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and enforces tight guidelines on ethical aspects of clinical research. High standards are required in terms of comprehensive documentation for the clinical protocol, record keeping, training, and facilities, including computers and software. Quality assurance and inspections ensure that these standards are achieved. GCP aims to ensure that the studies are scientifically authentic and that the clinical properties of the investigational product are properly documented. GCP guidelines include protection of human rights for the subjects and volunteers in a clinical trial. It also provides assurance of the safety and efficacy of the newly developed compounds. GCP guidelines include standards on how ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Type I And Type II Errors
In statistical hypothesis testing, a type I error is the mistaken rejection of an actually true null hypothesis (also known as a "false positive" finding or conclusion; example: "an innocent person is convicted"), while a type II error is the failure to reject a null hypothesis that is actually false (also known as a "false negative" finding or conclusion; example: "a guilty person is not convicted"). Much of statistical theory revolves around the minimization of one or both of these errors, though the complete elimination of either is a statistical impossibility if the outcome is not determined by a known, observable causal process. By selecting a low threshold (cut-off) value and modifying the alpha (α) level, the quality of the hypothesis test can be increased. The knowledge of type I errors and type II errors is widely used in medical science, biometrics and computer science. Intuitively, type I errors can be thought of as errors of ''commission'', i.e. the researcher unlu ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Translational Health Science And Technology Institute
Translational Health Science and Technology Institute (THSTI) is a society registered under the Societies Registration Act XXI of 1860. It is also an autonomous institute of the Department of Biotechnology, Ministry of Science and Technology, Government of India. It was set up in 2009 at Gurgaon and is now located in NCR Biotech Science Cluster, Faridabad along with the Regional Center for Biotechnology, Advanced Technology Platforms Center, Small Animal Facility, and Bio-incubator. Envisioned by former secretary of DBT, M. K. Bhan, the centre was created to enable faster transition of lab research to market. Pramod Garg is the executive director of THSTI. THSTI has six intramural centers namely Vaccine & Infectious Disease Research Centre (VIDRC), Pediatric Biology Centre (PBC), Centre for Bio-design & Diagnostics (CBD), Centre for Human Microbial Ecology (CHME), Policy Centre for Biomedical Research (PCBR), and Drug Discovery Research Centre (DDRC). Vaccine & Infectious Dis ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Human Challenge Studies
A human challenge study, also called a challenge trial or controlled human infection model (CHIM), is a type of clinical trial for a vaccine or other pharmaceutical involving the intentional exposure of the test subject to the condition tested. Human challenge studies may be ethically controversial because they involve exposing test subjects to dangers beyond those posed by potential side effects of the substance being tested. During the mid 20th and 21st century, the number of human challenge studies has been increasing. A challenge study to test promising vaccines for prevention of COVID-19 was under consideration during 2020 by several vaccine developers, including the World Health Organization (WHO), and was approved in the UK in 2021. Over the second half of the 20th and the 21st centuries, vaccines for some 15 major pathogens have been fast-tracked in human challenge studies – involving about 30,000 participants – while contributing toward vaccine development to pr ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
West Bengal National University Of Juridical Sciences
The West Bengal National University of Juridical Sciences (WBNUJS or NUJS) is a premier public law school in India, also known as Columbia of East, and is an elite National Law University located in Bidhannagar, Kolkata, West Bengal, India. In 2021, it was ranked fourth among law colleges in India by National Institutional Ranking Framework and second by ''India Today''. It comes under the exclusive chancellorship and purview of the Chief Justice of India. The university was one of the first law universities to offer a five-year integrated B.A. LLB (Hons.) degree program, and an LLM program. Admission to the B.A. LLB degree program is through the Common Law Admission Test, a highly competitive, nationwide entrance examination, held jointly by the national law schools. NUJS also offers MPhil, Ph.D., and diplomas in business laws and other programs, in addition to a number of online courses that attract students from 17 countries across the world. History NUJS was establish ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Fundamental Rights In India
The Fundamental Rights in India enshrined in the III (Article 12-32) of the Constitution of India guarantee civil liberties such that all Indians can lead their lives in peace and harmony as citizens of India. These rights are known as "fundamental" as they are most essential for all-round development i.e., material,intellectual, moral and spiritual and protected by fundamental law of the land i.e. constitution. These include individual rights common to most liberal democracies, such as equality before law, freedom of speech and expression, freedom of association and peaceful assembly, freedom to practice religion, and the right to constitutional remedies for the protection of civil rights by means of writs such as habeas corpus. Violations of these rights result in punishments as prescribed in the Indian Penal Code, subject to discretion of the judiciary. The Fundamental Rights are defined as basic human freedoms which every Indian citizen has the right to enjoy for ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Constitution Of India
The Constitution of India (IAST: ) is the supreme law of India. The document lays down the framework that demarcates fundamental political code, structure, procedures, powers, and duties of government institutions and sets out fundamental rights, directive principles, and the duties of citizens. It is the longest written national constitution in the world. It imparts constitutional supremacy (not parliamentary supremacy, since it was created by a constituent assembly rather than Parliament) and was adopted by its people with a declaration in its preamble. Parliament cannot override the constitution. It was adopted by the Constituent Assembly of India on 26 November 1949 and became effective on 26 January 1950. The constitution replaced the Government of India Act 1935 as the country's fundamental governing document, and the Dominion of India became the Republic of India. To ensure constitutional autochthony, its framers repealed prior acts of the British parliam ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Ethics Committee
An ethics committee is a body responsible for ensuring that medical experimentation and human subject research are carried out in an ethical manner in accordance with national and international law. Specific regions An ethics committee in the European Union is a body responsible for oversight of medical or human research studies in EU member states. Local terms for a European ethics committee include: * A Research Ethics Committee (REC) in the United Kingdom * A Medical Research Ethics Committee (MREC) in the Netherlands. * A Comité de Protection des Personnes (CPP) in France. In the United States, an ethics committee is usually known as an institutional review board (IRB) or research ethics board (REB) and is dedicated to overseeing the rights and well-being of research subjects participating in scientific studies in the US. Similarly in Canada, the committee is called a Research Ethics Board (REB). In Australia, an ethics committee in medical research refers to a Human R ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Phases Of Clinical Research
The phases of clinical research are the stages in which scientists conduct experiments with a health intervention to obtain sufficient evidence for a process considered effective as a medical treatment. For drug development, the clinical phases start with testing for safety in a few human subjects, then expand to many study participants (potentially tens of thousands) to determine if the treatment is effective. Clinical research is conducted on drug candidates, vaccine candidates, new medical devices, and new diagnostic assays. Summary Clinical trials testing potential medical products are commonly classified into four phases. The drug development process will normally proceed through all four phases over many years. If the drug successfully passes through Phases I, II, and III, it will usually be approved by the national regulatory authority for use in the general population. Phase IV trials are 'post-marketing' or 'surveillance' studies conducted to monitor safety over sever ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
