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A randomized controlled trial is a type of scientific experiment that aims to reduce certain sources of bias when testing the effectiveness of new treatments; this is accomplished by randomly allocating subjects to two or more groups, treating them differently, and then comparing them with respect to a measured response. One group—the experimental group—receives the intervention being assessed, while the other—usually called the control group—receives an alternative treatment, such as a placebo or no intervention. The groups are monitored under conditions of the trial design to determine the effectiveness of the experimental intervention, and efficacy is assessed in comparison to the control. There may be more than one treatment group or more than one control group.
Clinical trials are experiments or observations done in clinical research. Such prospective biomedical or behavioral research studies on human participants are 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 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.
Colchicine is a medication used to treat gout and Behçet's disease. In gout, it is less preferred to NSAIDs or steroids. Other uses include the prevention of pericarditis and familial Mediterranean fever. It is taken by mouth.
An orphan drug is a pharmaceutical agent developed to treat medical conditions which, because they are so rare, would not be profitable to produce without government assistance. The conditions are referred to as orphan diseases.
The pharmaceutical industry discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as medications to be administered to patients, with the aim to cure them, vaccinate them, or alleviate the symptoms. Pharmaceutical companies may deal in generic or brand medications and medical devices. They are subject to a variety of laws and regulations that govern the patenting, testing, safety, efficacy and marketing of drugs.
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Oseltamivir, sold under the brand name Tamiflu, is an antiviral medication used to treat and prevent influenza A and influenza B (flu). Many medical organizations recommend it in people who have complications or are at high risk of complications within 48 hours of first symptoms of infection. They recommend it to prevent infection in those at high risk, but not the general population. The Centers for Disease Control and Prevention (CDC) recommends that clinicians use their discretion to treat those at lower risk who present within 48 hours of first symptoms of infection. It is taken by mouth, either as a pill or liquid.
Alosetron, sold under the brand name Lotronex among others, is a 5-HT3 antagonist used for the management of severe diarrhea-predominant irritable bowel syndrome (IBS) in women only.
The regulation of therapeutic goods, defined as drugs and therapeutic devices, varies by jurisdiction. In some countries, such as the United States, they are regulated at the national level by a single agency. In other jurisdictions they are regulated at the state level, or at both state and national levels by various bodies, as in Australia.
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Dabigatran, sold under the brand name Pradaxa among others, is an anticoagulant used to treat and prevent blood clots and to prevent stroke in people with atrial fibrillation. Specifically it is used to prevent blood clots following hip or knee replacement and in those with a history of prior clots. It is used as an alternative to warfarin and does not require monitoring by blood tests. It is taken by mouth.
Nancy Fern Olivieri is a prominent Toronto haematologist and researcher with an interest in the treatment of haemoglobinopathies. She is best known for a protracted struggle with the Hospital for Sick Children and the pharmaceutical company Apotex about the drug deferiprone.
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The following outline is provided as an overview of and topical guide to clinical research:
The National Center for Health Research is a Washington, D.C.-based non-profit organization founded in 1999. It uses objective, research-based information to encourage new, more effective programs and policies that promote the health and safety of women, children, and families. The center educates patients, consumers, and health professionals through its articles, trainings, and media, and educates policymakers and analysts about the latest research at briefings, hearings, and meetings. The President of the National Center is Diana Zuckerman. The primary program is The Cancer Prevention and Treatment Fund, which has an online health hotline and provides free, research-based information and services to patients and their families.
AllTrials is a project advocating that clinical research adopt the principles of open research. The project summarizes itself as "All trials registered, all results reported": that is, all clinical trials should be listed in a clinical trials registry, and their results should always be shared as open data.
Study 329 was a clinical trial conducted in North America from 1994 to 1998 to study the efficacy of paroxetine, an SSRI anti-depressant, in treating 12- to 18-year-olds diagnosed with major depressive disorder. Led by Martin Keller, then professor of psychiatry at Brown University, and funded by the British pharmaceutical company SmithKline Beecham—known since 2000 as GlaxoSmithKline (GSK)—the study compared paroxetine with imipramine, a tricyclic antidepressant, and placebo. SmithKline Beecham had released paroxetine in 1991, marketing it as Paxil in North America and Seroxat in the UK. The drug attracted sales of $11.7 billion in the United States alone from 1997 to 2006, including $2.12 billion in 2002, the year before it lost its patent.
Kay Dickersin is an academic who trained first in cell biology and subsequently epidemiology. She went on to a career studying factors that influence research integrity, in particular publication bias and outcome reporting bias. She is retired Professor Emerita in the Department of Epidemiology at Johns Hopkins Bloomberg School of Public Health where she was Director of the Center for Clinical Trials and Evidence Synthesis there. She was also Director of the US Cochrane Center and the US Satellite of the Cochrane Eyes and Vision Group within the Cochrane Collaboration. Dickersin received multiple awards for her research.
Swasthya Adhikar Manch v. Union of India was a 2013 court case in which Swasthya Adhikar Manch requested additional government regulation in the management of clinical trials. The court found in favor of that organization and ordered regulation.
References
- ↑ Balestra, Giulietta Luul; Dasgupta, Jashodhara; Sandhya, Yatirajula Kanaka; Mannell, Jenevieve (2 December 2018). "Developing political capabilities with Community-Based Monitoring for health accountability: The case of the Mahila Swasthya Adhikar Manch". Global Public Health. 13 (12): 1853–1864. doi:10.1080/17441692.2018.1464586.
- ↑ GOI Monitor Desk (3 January 2015). "Pharma companies don't want any regulation". Goi Monitor.
- ↑ Shelar, Jyoti (2 June 2018). "After a lull of five years, clinical trials on the rise in India". The Hindu.
- ↑ Kay, M. (3 July 2014). "Indian Supreme Court demands clarity on clinical trial approvals". BMJ. 349 (jul03 13): g4383–g4383. doi:10.1136/bmj.g4383.
- ↑ Bagcchi, S. (4 October 2013). "Indian Supreme Court halts approval of new clinical trials until regulatory framework is set up". BMJ. 347 (oct04 2): f5996–f5996. doi:10.1136/bmj.f5996.
- ↑ Srinivasan, Sandhya (17 April 2016). "Trials and tribulations". Himal Southasian .
- ↑ Datta, PT Jyothi (17 January 2020). "It has been a defining decade for clinical trials". Business Line .