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Clinical Study is also called as clinical trials. Clinical trials are prospective biomedical or behavioral research studies on human subjects that are designed to answer specific questions about biomedical or behavioral interventions (novel vaccines, drugs, treatments, functional foods, dietary supplements, devices or new ways of using known interventions), generating safety and efficacy data. They are conducted only after satisfactory information has been gathered that satisfies health authority/ethics committee approval in the country where approval of the therapy is sought. Depending on product type and development stage, investigators initially enroll volunteers and/or patients into small pilot studies, and subsequently conduct progressively larger scale comparative studies. As positive safety and efficacy data are gathered, the number of patients typically increases. Clinical trials can vary in size, and can involve a single research entity in one country or multiple entities in multiple countries.
A full series of trials may cost hundreds of millions of dollars. The burden of paying is usually borne by the sponsor, which may be a governmental organization or a pharmaceutical, biotechnology or medical device company. When the required support exceeds the sponsor's capacity, the trial may be managed by an outsourced partner, such as a contract research organization or an academic clinical trials unit. Trials to evaluate the effectiveness and safety of medications or medical devices by monitoring their effects on large groups of people.
Clinical research trials may be conducted by government health agencies such as NIH, researchers affiliated with a hospital or university medical program, independent researchers, or private industry. Usually volunteers are recruited, although in some cases research subjects may be paid. Subjects are generally divided into two or more groups, including a control group that does not receive the experimental treatment, receives a placebo (inactive substance) instead, or receives a tried-and-true therapy for comparison purposes.Typically, government agencies approve or disapprove new treatments based on clinical trial results. While important and highly effective in preventing obviously harmful treatments from coming to market, clinical research trials are not always perfect in discovering all side effects, particularly effects associated with long-term use and interactions between experimental drugs and other medications.
For some patients, clinical research trials represent an avenue for receiving promising new therapies that would not otherwise be available. Patients with difficult to treat or currently "incurable" diseases, such as AIDS or certain types of cancer, may want to pursue participation in clinical research trials if standard therapies are not effective. Clinical research trials are sometimes lifesaving.
There are four possible outcomes from a clinical trial:
Positive trial -- The clinical trial shows that the new treatment has a large beneficial effect and is superior to standard treatment.
Non-inferior trial -- The clinical trial shows that that the new treatment is equivalent to standard treatment. Also called a non-inferiority trial.
Inconclusive trial -- The clinical trial shows that the new treatment is neither clearly superior nor clearly inferior to standard treatment.
Negative trial -- The clinical trial shows that a new treatment is inferior to standard treatment.
OMICS International Organizes 300+ conferences, 500+workshops and 200+symposiums on Clinical, Medicine, Pharma and Science & Technology every year across USA, Europe, Asia, Middle East, Australia and UK with support from 1000 more scientific societies and Publishes 500 open access journals which contains over 30000 eminent personalities, reputed scientists as editorial board members. All the OMICS International Conferences held in USA have tended to the most recent and the most important issues that the mankind is standing up to at present. Amid the year 2014-2015, OMICS International have planned International Conferences on Bio-differing qualities and supportable vitality, Diabetes, Oral Health, Epidemiology, Endocrinology, Lasers, Optics & Photonics, Materials Science & Engineering, Forensic Research & Technology, Pharmaceutical Regulatory Affairs to a ton of other topical meetings that talk about the issues basically.
Socities :
SOCRA The Society of Clinical Research Associates.
Phase I and IIa Clinical Trials Conference
Indian Society for Clinical Research
International Association of Clinical Research Nurses
New Zealand Association of Clinical Research Conference
Society for Clinical Trials (SCT)
Association of Clinical Research Professionals
Central Society for Clinical and Translational Research
Australian Society for Medical Research (ASMR)
American Association for Cancer Research
Companies:
Quintiles
Covance
PPD
Kendle
Ikon
ABC Laboratories
Abingdon Life Sciences
Parexel international.
Accell Clinical Research
Accium Biosciences
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This page was last updated on December 22, 2024
