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The Importance of Clinical Trials |
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As a clinical trial management service provider to the pharmaceutical, biotechnology, Medical Device industries and to Academia/Government. |
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| Author: Nidesh Khatri |
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What is a clinical trial?
Among many definitions of clinical trials, generally they are considered to be biomedical or health-related research studies in human beings that follow a pre-defined protocol. Clinical Trials include Interventional Studies and Observational Studies both.
Interventional Studies are those in which the research subjects are assigned by the investigator to a treatment or other intervention, and their outcomes are measured.
Whereas Observational studies are those in which individuals are observed and the investigators measure their outcomes.
Why should we participate in a clinical trial?
Participants in clinical trials can benefit as they can know more about their own health, can gain access to better health care and new research treatments at the earliest.
Who are permitted to participate in a clinical trial?
The clinical trials have guidelines about who can participate. Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results. The factors that allow someone to participate in a clinical trial are called "inclusion criteria" and those that disallow someone from participating are called "exclusion criteria".
Factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions play a role in deciding before permitting a candidate to participate in a clinical trial.
What takes place during a clinical trial?
The process of clinical trial depends on the type of trial being conducted. There are doctors, nurses, social workers and health care professionals in the Clinical Trial team. The team checks the clinical trial participant at the beginning and gives specific instructions. They then monitor the participant carefully during the entire trial process. Importantly they stay in touch with the participant after the trial is over.
What are the Benefits of participating in Clinical Trial?
Clinical trials that are well-designed and well-executed are the best approach for eligible participants to:
Participant gets a chance to play an active role in own health care.
Gain access to new research treatments before they are widely available.
Obtain expert medical care at leading health care facilities during the trial.
Helping others by contributing to medical research.
What are the Risks Involving Clinical Trials?
Clinical Trial may have unpleasant, serious or even life-threatening side effects to experimental treatment.
The experimental treatment may not be effective for the participant.
The protocol may require more of their time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements.
Thus, Clinical trial investigators play a crucial role in the development of new medicines and with the ever-expanding number of clinical trials.
About Author
Nidesh Khatri is Director - B.D. with Med Devices Lifesciences Pvt. Ltd.; Visit the site http://www.meddevices.net/ for more information about Clinical Trials.
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