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
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News tagged with clinical trials
Is it right for drug companies to carry out their own clinical trials?
10 hours ago |
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In BMJ today two experts debate whether the conflict of interest is unacceptable when drug companies carry out clinical trials on their own medicines.
First anti-seizure drug for newborns to be developed
Medicine & Health / Medications
Nov 26, 2009 |
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(PhysOrg.com) -- Researchers at the UCL Institute for Child Health are developing the first anti-seizure drug specifically for newborn babies, with the aim of reducing brain damage.
Search results for clinical trials
Clinical trials launched for treating most aggressive brain tumor with personalized cell vaccines
9 hours ago |
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The University of Navarra Hospital (Spain) has launched a series of clinical trials in order to assess the efficacy of an immunotherapy treatment. This approach involves the application of personalised vaccines —produced ...
New stem cell technology leads to better treatment for complicated bone fractures
13 hours ago |
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A novel technology involving use of stem cells, developed by Hebrew University of Jerusalem researchers, has been applied to provide better and rapid healing for patients suffering from complicated bone fractures.
Over-the-counter eye drops raise concern over antibiotic resistance
Medicine & Health / Medications
Nov 27, 2009 |
3.8 / 5 (4) |
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(PhysOrg.com) -- The use of antibiotic eye drops for conjunctivitis has increased by almost half since they became available over the counter at chemists in 2005, data obtained by Oxford University researchers ...
Research sheds light on workings of anti-cancer drug
Chemistry / Analytical Chemistry
Nov 26, 2009 |
5 / 5 (1) |
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(PhysOrg.com) -- The copper sequestering drug tetrathiomolybdate (TM) has been shown in studies to be effective in the treatment of Wilson disease, a disease caused by an overload of copper, and certain metastatic cancers. ...
Physician-scientist proves stem cells heal lungs of newborn animals
Nov 26, 2009 |
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Dr. Bernard Thébaud lives in two very different worlds. As a specialist in the Stollery Children's Hospital's Neonatal Intensive Care Unit at the Royal Alexandra Hospital, he cares for tiny babies, many of whom struggle ...
Preventing Spread of HIV in Jails: Best Window of Opportunity Early in Incarceration
Medicine & Health / HIV & AIDS
Nov 25, 2009 |
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(PhysOrg.com) -- With World AIDS Day less than a week away, two new studies from Yale School of Medicine show that jail inmates, one of the highest risk groups for AIDS, are far more likely to be tested for ...
Implant-based cancer vaccine is first to eliminate tumors in mice
Nov 25, 2009 |
4.7 / 5 (31) |
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(PhysOrg.com) -- A cancer vaccine carried into the body on a carefully engineered, fingernail-sized implant is the first to successfully eliminate tumors in mammals, scientists report this week in the journal ...
A RANK insider resolving the enigma of the fever chart
Nov 25, 2009 |
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Mammals have evolved a complex system for controlling bone remodeling. Babies require calcium for healthy bones and they obtain it from their mother's milk. Nursing mothers release calcium from their bones. Surprisingly, ...
Tailor-made HIV/AIDS treatment closer to reality
Medicine & Health / HIV & AIDS
Nov 25, 2009 |
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An innovative treatment for HIV patients developed by McGill University Health Centre researchers has passed its first clinical trial with flying colours. The new approach is an immunotherapy customized for each individual ...
Autism treatment: Risky alternative therapies have little basis in science
Nov 24, 2009 |
3 / 5 (2) |
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James Coman's son has an unusual skill. The 7-year-old, his father says, can swallow six pills at once. Diagnosed with autism as a toddler, the Chicago boy had been placed on an intense regimen of supplements and medications ...
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