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Tuesday 23 August 2016

Clinical trials are a type of research study to explore whether a medical treatment, drug, strategy or device is safe and effective for human use. The purpose of clinical trials is research, so the studies follow strict scientific standards. These standards protect patients and help produce reliable study results.

Clinical trials are research studies that aim to determine whether a medical strategy, treatment or device is safe for use or consumption by humans. These studies may also present which medical approaches prove most effective for specific conditions or groups of people and, as a result, add to medical knowledge.
Clinical trials provide the most reliable data to assist in health care decision-making and guidelines.1

To ensure participant safety, clinical trials commence with small groups initially to examine whether a new method causes any harm or unsatisfactory side effects. Often a technique that is successful in a laboratory or animals may not be a success in humans.

Here are some key points about clinical trials. More detail and supporting information is in the main article.
  • Clinical trials are research studies that aim to determine whether a medical strategy, treatment or device is safe for use or consumption by humans.
  • To ensure participant safety, clinical trials commence with small groups initially, to examine whether a new method causes any harm or unsatisfactory side effects.
  • Clinical trials can be separated into the following types: treatment, prevention, diagnostic, screening, supportive care, health services research and basic science.
  • Clinical trials are important to investigate if a new approach works effectively in humans and is safe. Also, to find out what treatments work most successfully for particular illnesses.
  • A clinical trial research team may consist of doctors, nurses, social workers, health care professionals, scientists, data managers and clinical trial coordinators.
  • Designs of clinical trials can be either "observational" or "experimental" and include study types including cohort, case control, systematic review and randomized controlled trials.
  • Clinical drug trials are divided into 4 phases to examine the safety of a new drug and compare it to existing treatments.
  • To participate in a clinical trial, possible subjects have to meet eligibility criteria which define who is suitable to take part.
  • There may be both risk and benefit to subjects of a clinical trial. Participants must read and sign the "informed consent" document before inclusion in a trial.
  • Risks to clinical trial participants are controlled and monitored. However, some risks may be unavoidable due to the nature of medical research studies.
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