Research studies trials

Comprehensive federal laws, regulations, and guidelines help protect people who participate in research studies (called clinical trials). The U.S. Food and Drug Administration (FDA) regulates all gene therapy products in the United States and oversees research in this area. Researchers who wish to test an approach in a clinical trial must first obtain permission from the FDA. The FDA has the authority to reject or suspend clinical trials that are suspected of being unsafe for participants. 

An Institutional Review Board (IRB) and an Institutional Biosafety Committee (IBC) must approve each gene therapy clinical trial before it can be carried out. An IRB is a committee of scientific and medical advisors and consumers that reviews all research within an institution. An IBC is a group that reviews and approves an institution s potentially hazardous research studies. Multiple levels of evaluation and oversight ensure that safety concerns are a top priority in the planning and carrying out of gene therapy research. 

Hundreds of research studies (clinical trials) are under way to test gene therapy as a treatment for genetic conditions, cancer, and HIV/AIDS. If you are interested in participating in a clinical trial, talk with your doctor or a genetics professional about how to participate. 

Clinical trial A research study that tests how well new medical treatments or other interventions work in people. Each study is designed to test new methods of screening, prevention, diagnosis, or treatment of a disease. [NIH]... 

The Canadian Task Force categorized the quality of evidence based on the type of research study. The quality of evidence was organized into three classes Class I evidence comes from procedures having at least one randomized controlled study to support them. Class II is divided into three subclasses, where II-l involves a well-designed controlled study without randomization. Class II-2 evidence comes from well-designed cohort or case-control studies, preferably carried out at more than one research setting. Class II-3 involves uncontrolled research with dramatic results (e.g., penicillin trials in the 1940s). Class III evidence includes the opinions of experts and authorities in the field based on clinical... 

This chapter is written primarily as a guide to running trials with new chemical entities during drug development. The principles described are also directly relevant to all other trials such as those comparing two or more licensed treatments (which may themselves be combinations) and research studies initiated and conducted in academic institutions without any support from the Pharmaceutical Industry. There will be some differences of detail in those other circumstances. 

Fundamental distrust of the industry s ethics. The public realisation that research studies have been withheld from public view, or released in partial (and misleading) form, has created enormous pressures for industry to make information on all trials available via the internet. The delays in relabelling products, the precipitous withdrawal of widely marketed drugs and the failure to identify safety risks before approval (even when it was not scientifically possible to do so) gives support to the canard that companies put profits before people. And prosecutions of major companies for... 

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) of the U.S. National Institutes of Health at http //www.niaaa.nih.gov/ is a good source of background information and news about current clinical trials and research studies, as well as access to various databases and treatment referrals. 

Clinical trials Research studies that involve patients. 

Abbreviations CA, carotid atherosclerosis CPIHD, Caerphilly Prospective Ischemic Heart Disease EVCS, Elderly Vitamin C Status IWHS-D, Lowa Women s Health Study MGH, Mortality in a Geriatric Hospital MRCT Medical Research Council Trial NAHNES I, National Health and Nutrition Examination Survey PSCHD, Prospective Study of vitamin C in Coronary Heart Disease SOP Supplementation... 

I 59 Fletcher AE, Breeze E, Shetty PS. Antioxidant vitamins and mortality in older persons finding from the nutrition add-on study to the Medical Research Council Trial of Assessment and Management of Older People in the Community. Am J Clin Nutr 2003 78 999-1010. 

There are two components to evidence-based medicine and two related sets of responsibilities. The first component is clinical research. Clinical research is a scientific endeavor that provides evidence concerning potential therapeutic interventions. This book has focused on one particular therapeutic intervention, drug therapy. Once clinical trials have been conducted, the evidence obtained is published in clinical communications in journals. Everyone involved in clinical research has the responsibility to provide the best possible evidence in this manner. As noted throughout the book, this includes all aspects of clinical research study design, experimental methodology and clinical operations, analysis and interpretation, and also accurate and complete representation of study findings in clinical communications as discussed in Section 13.6. 

Specific medical claims cannot be made for essential oils or aromatherapy products if such were made, the products would need a product licence. The licence is only granted after an exhaustive series of laboratory and clinical trials to prove safety and efficacy. The issues surrounding research and trials on the use of essential oils in clinical situations are still contentious, but there are increasing numbers of scientific studies and papers in reputable journals. 

Outsourcing is now a common practice of almost all pharmaceutical companies. For example, the use of CSOs to support some aspect of clinical trial research has grown from approximately 30% of the clinical studies conducted in 1993 to over 60% in 1997. The processes that a client uses to select a CSO and how a client interacts with the CSO ensure contracted research studies are monitored appropriately and completed on time and within budget. 

The identification and selection process is only the first step. The second aspect involves monitoring the CSOs to ensure that the research studies are conducted according to the research protocol, that the results are obtained using appropriate techniques and procedures, and that the data generated are correctly recorded and documented in the study report. Many clients hire firms, such as other CSOs or consultants, to monitor outsourced research studies, particularly clinical trials and manufacturing projects. In doing so, the clients should use the same techniques to select and evaluate the monitors as they use to identify a CSO. Monitoring studies at CSOs should include but are not be limited to ... 

In addition, NCCAM plans to support a contract for the development and production of research grade cranberry (Vaccinium macrocarpon) products and placebos for use in clinical studies. There is evidence from small clinical trials suggesting that cranberry may relieve symptoms of urinary tract infection (UTI) and may reduce the need for antibiotics in treating such infections (23). The products developed under the contract will be evaluated in basic and clinical research studies on the role of cranberry in the prevention and treatment of UTIs and other conditions for which there is credible evidence of efficacy. 

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