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As per available reports about 10 relevant Journals and more than 20 upcoming international Conferences are presently dedicated exclusively to Clinical trials and about 236 articles have been published on Clinical trials.
Clinical trials are prospective biomedical or behavioral research studies on human subjects that are designed to answer specific questions about biomedical 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. It includes topics like Pre-Clinical Research and Conducts of Clinical Trials, Innovations in Clinical Trials, Clinical Study Designs, Clinical Trials Supplies.
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Scope and Importance:
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. 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.
Clinical trials often involve healthy subjects with no pre-existing medical conditions but sometimes pertain to patients with specific health conditions who seek otherwise unavailable treatments. In early phases, participants are healthy volunteers who receive financial incentives. During dosing periods, study subjects typically remain under supervision for one to 40 nights.
Usually pilot experiments are conducted to gain insights for design of the clinical trial to follow.
In medical jargon, effectiveness is how well a treatment works in practice and efficacy is how well it works in a clinical trial.
In the US, the elderly constitute only 14% of the population, while they consume over one-third of drugs. Seniors are often excluded from trials because their greater health issues and drug use complicate data interpretation. Women, children and people with unrelated medical conditions are also frequently excluded.
The sponsor designs the trial in coordination with a panel of expert clinical investigators, including what alternative/existing treatments to compare to the new agent and what type(s) of patients might benefit. If the sponsor cannot obtain enough subjects at one location, investigators at other locations are recruited to join the study.
During the trial, investigators: recruit patients with the predetermined characteristics, administer the treatment(s) and collect data on the patients' health for a defined time period.
Subjects are volunteers who are not paid for participating.
Data include measurements such as vital signs, concentration of the study drug in the blood and/or tissues, changes to symptoms and whether health outcomes. The researchers send the data to the trial sponsor, who then analyzes the pooled data using statistical tests.
Examples of clinical trial goals include assessing the safety and (relative) effectiveness of a medication or device:
While most clinical trials test one alternative to the novel intervention, some expand to three or four.
The Clinical Trial Support Services is in the growth stage of its economic life cycle, characterized by an increasing number of enterprises, moderate technological change, increasing application of services to growing markets and strong revenue growth. Over the past five years, the industry has experienced growth despite fluctuations in private and public spending following the onset of the recession and subsequent recovery. More recently, the industry has become increasingly dependent on private enterprise investment in clinical trials and associated support services following government austerity measures, which were exacerbated by the 2013 government sequester.
Relevant Societies & Associations
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This page was last updated on 12th Sep, 2015
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