Clinical trial
hideIn clinical trials are conducted to allow safety and efficacy data to be collected for new drugs or devices. These trials can only take place once satisfactory information has been gathered on the quality of the product and its non-clinical safety, and Health Authority/Ethics Committee approval is granted in the country where the trial is taking place.
Depending on the type of product and the stage of its development, investigators enroll healthy volunteers and/or patients into small pilot studies initially, followed by larger scale studies in patients that often compare the new product with the currently prescribed treatment. As positive safety and efficacy data are gathered, the number of patients is typically increased. Clinical trials can vary in size from a single center in one country to multicenter trials in multiple countries.
Due to the sizable cost a full series of clinical trials may incur, the burden of paying for all the necessary people and services is usually borne by the sponsor who may be the pharmaceutical or biotechnology company that developed the agent under study. Since the diversity of roles may exceed resources of the sponsor, often a clinical trial is managed by an outsourced partner such as a contract research organization
For more information about Clinical trial, read the full article at
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News tagged with clinical trials
Motivational 'women-only' cardiac rehab improves symptoms of depression
Nov 17, 2009 |
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Depressive symptoms improved among women with coronary heart disease who participated in a motivationally-enhanced cardiac rehabilitation program exclusively for women, according to research presented at the American Heart ...
Viagra for women? Drug developed as antidepressant effective in treating low libido
Medicine & Health / Medications
Nov 16, 2009 |
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The drug flibanserin, which was originally created as an antidepressant, is effective in treating women with low libido, pooled results from three separate clinical trials have found.
Client-directed therapy technique drastically reduces divorce/separation rates
Medicine & Health / Psychology & Psychiatry
Nov 13, 2009 |
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Using four simple questions to generate client-directed feedback can greatly increase the chances that struggling couples will stay together, according to a recently published study.
New evidence that dark chocolate helps ease emotional stress
Nov 11, 2009 |
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The "chocolate cure" for emotional stress is getting new support from a clinical trial published online in ACS' Journal of Proteome Research.
Researchers mobilizing global resources to test new treatments for severe H1N1 infection
Nov 11, 2009 |
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An important, ground-breaking initiative is unfolding in the global critical care community in response to the H1N1 pandemic.
Drug shrinks lung cancer tumors in mice
Nov 10, 2009 |
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(PhysOrg.com) -- A potential new drug for lung cancer has eliminated tumours in 50% of mice in a new study published today in the journal Cancer Research. In the animals, the drug also stopped lung cancer ...
Stem cells restore mobility in neck-injured rats (w/ Video)
Nov 10, 2009 |
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(PhysOrg.com) -- The first human embryonic stem cell treatment approved by the FDA for human testing has been shown to restore limb function in rats with neck spinal cord injuries - a finding that could expand the clinical ...
Say yes to a clinical trial; it may be good for your health
Oct 30, 2009 |
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Patients with chronic heart failure who agree to take part in clinical trials have a better prognosis than those who do not, according to a study reported in the November European Journal of Heart Failure.(1) The finding, say th ...
Swine flu vaccine must be free and safe for high uptake
Oct 28, 2009 |
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Almost half of adults surveyed in Summer 2009 in Hong Kong (45%) say they would take up free swine flu vaccination. However, this figure drops to around 1 in 7 (15%) if the price they have to pay for the vaccine reaches $HK200 ...
Recommended treatment for heart failure often underused
Oct 20, 2009 |
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Less than one-third of patients hospitalized for heart failure and participating in a quality improvement registry received a guideline-recommended treatment of heart failure, aldosterone antagonist therapy, according to ...
Centralized Review Process Markedly Expedites Approval of Cancer Clinical Trials
Oct 19, 2009 |
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(PhysOrg.com) -- A Central Institutional Review Board (CIRB) for cancer clinical trials that was created by the National Cancer Institute (NCI), part of the National Institutes of Health, in 2001 helps trials start more quickly ...
Designing drugs and their antidotes together improves patient care
Oct 04, 2009 |
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Imagine a surgical patient on a blood-thinning drug who starts bleeding more than expected, and an antidote that works immediately - because the blood thinner and antidote were designed to work together. Researchers at Duke ...
As swine flu intensifies, US rolls out first vaccine doses
Oct 04, 2009 |
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US health authorities are hoping to contain what they say is an intensifying swine flu pandemic with a massive A(H1N1) vaccination campaign that begins this Tuesday.
3 Questions: AIDS researchers on new vaccine results
Medicine & Health / HIV & AIDS
Sep 29, 2009 |
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(PhysOrg.com) -- On Thursday, an international research team reported that a new AIDS vaccine tested in more than 16,000 volunteers in Thailand protected a small but significant minority against infection. The ...
Considering usual medical care in clinical trial design
Sep 29, 2009 |
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In this week's PLoS Medicine, Liza Dawson (National Institutes of Health) and colleagues discuss the scientific and ethical issues associated with choosing clinical trial designs when there is no consensus on what consti ...
