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
Vitamin D levels associated with survival in lymphoma patients
Dec 05, 2009 |
4.7 / 5 (3) |
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A new study has found that the amount of vitamin D in patients being treated for diffuse large B-cell lymphoma was strongly associated with cancer progression and overall survival. The results will be presented at the annual ...
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Validity of cost-effectiveness models based on randomized clinical trials
10 hours ago |
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Cost-effectiveness studies are widely used to guide prescribing policy in many countries, as part of health technology assessment programmes. However, a new study published this week in PLoS Medicine by Tjeerd-Pieter van St ...
Autologous stem cell transplantation for soft tissue sarcoma: insufficient research into therapy
2 hours ago |
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Due to a lack of suitable studies, it is unclear whether patients with soft tissue sarcoma can benefit from autologous haematopoietic stem cell transplantation. With this type of therapy, some of the patient's own (autologous) ...
Second-line CML drugs evoke faster response than front-line therapy
Dec 07, 2009 |
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Two medications approved as treatment for drug-resistant chronic myeloid leukemia continue to provide patients with quicker, better responses as a first treatment than the existing front-line drug, researchers at The University ...
Multiple myeloma patients experience high response rate with new 3-drug combination
Dec 06, 2009 |
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A new three-drug combination has shown in a phase 1/2 clinical trial that it is a "highly effective regimen" in the treatment of patients newly diagnosed with multiple myeloma, a cancer of white blood cells in bone marrow, ...
Improving the odds:A new method for bone marrow transplantation
Dec 07, 2009 |
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Although bone marrow transplants have long been standard for acute leukemia, current treatments still rely on exact matches between donor and patient. Now, scientists at the University of Perugia, Italy, and the Weizmann ...
Dutch PhD develops fast method for preparing flu vaccine
23 hours ago |
5 / 5 (1) |
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(PhysOrg.com) -- A shortage of flu vaccines may soon become a thing of the past. Researcher Manon Cox has designed an alternative process for producing large quantities of safe and effective vaccines at twice to four times ...
Higher risk for heart disease and diabetes associated with androgen deprivation therapy
21 hours ago |
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Men of all ages treated for prostate cancer with androgen deprivation therapy, specifically with gonadotropin-releasing hormone agonists (GnRH), have an increased risk of diabetes and cardiovascular disease, according to ...
Antidepressant Can Change Patient's Personality
Medicine & Health / Psychology & Psychiatry
Dec 07, 2009 |
4.3 / 5 (12) |
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(PhysOrg.com) -- The nation is still debating the effects of antidepressant medications on brain chemistry almost 20 years after publication of the best-seller "Listening to Prozac." Though selective serotonin reuptake inhibitors ...
HIV-related memory loss linked to Alzheimer's protein
Medicine & Health / Neuroscience
22 hours ago |
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More than half of HIV patients experience memory problems and other cognitive impairments as they age, and doctors know little about the underlying causes. New research from Washington University School of Medicine in St. ...
Researchers restore some function to cells from cystic fibrosis patients
Dec 06, 2009 |
5 / 5 (1) |
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In an encouraging new development, a team led by Scripps Research Institute scientists has restored partial function to lung cells collected from patients with cystic fibrosis. While there is still much work to be done before ...
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