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Clinical Study is also called as clinical trials. Clinical Trials are prospective bio medical or behavioral research studies on human subjects that are designed to answer specific questions about bio medical 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.
Scope & Importance
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.
Japan captured 1.2% of global market share during this period (representing relative market growth of 33.6%). The growth of the Japanese market does not come as a total surprise to us since we identified Japan as a country with one of the largest gaps between share of global BPCT sites and biopharma significance indicator in a previous study.
North America saw a continued loss of global market share of BPCT Phase II-III sites. At 2.6% it lost the largest market share among global regions over the period. However, with 43.8% of total global market share, North America still remains the global market leader by a wide margin.
Germany lost 0.4% of global market share with a relative market decline of 6.6%. But with 5.5% of global market share it still ranks #2 behind the US.
France lost 0.6% of global market share with a relative market decline of 16.5%. With just 3.2% of the global market share its rank fell two places to #5.
Spain gained 0.1% of global market share with a relative market growth of 4.9%. With 2.9% of global market share it maintained its #6 ranking.
UK was a top gainer in Western Europe and one of the fastest growing countries globally. It gained 0.4% of global market share on a strong 15.4% relative market growth and jumped global ranks from 10 to 7.
Italy traded global ranks with the UK, falling from 7 to 10 globally on 0.1% loss of global market share and a relative market decline of 5.3%.
Belgium was the only other Western European country in the global top 20. With a 1.4% loss of the market share, it fell from 13 to 15 globally, overtaken by a more rapidly growing China and Hungary.
Australia & New Zealand gained 0.3% of the global BPCT Phase II-III market share to a total of 2.1%, with a strong relative market growth of 15%. Next to Japan, Australia and New Zealand were top gainers among developed BPCT countries.
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This page was last updated on 14th Sep, 2015
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