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Clinical trial

Types of Clinical Trials: – Observational studies involve observing subjects and measuring outcomes. – Interventional studies involve giving experimental treatments to compare outcomes. – Prevention […]

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Types of Clinical Trials:
– Observational studies involve observing subjects and measuring outcomes.
– Interventional studies involve giving experimental treatments to compare outcomes.
– Prevention trials aim to prevent diseases in individuals.
– Diagnostic trials seek better tests for diagnosing diseases.
– Quality of life trials aim to improve comfort for those with chronic illnesses.
– Prevention trials aim to prevent diseases.
– Screening trials identify diseases or health conditions.
– Diagnostic trials find better tests for diagnosing diseases.
– Treatment trials test new drugs or approaches.
– Genetic trials assess the prediction accuracy of genetic disorders.

Phases of Clinical Trials:
– Phase 0 focuses on pharmacodynamics and pharmacokinetics in humans.
– Phase I screens for safety in a small group of people.
– Phase II establishes preliminary efficacy of the drug in a treatment group.
– Phase III provides final confirmation of safety and efficacy.
– Phase IV conducts safety studies post-marketing.

Trial Design:
– Randomized Controlled Trials assign subjects randomly to receive study treatment or a placebo.
– Observational Studies provide less compelling evidence compared to randomized controlled trials.
– Active Control Studies are conducted to address ethical concerns of giving placebos to patients.
– Master Protocol tests multiple experimental treatments in a single trial.
– Clinical Trial Protocol defines and manages the trial and ensures safety and health of trial subjects.

Patient and Public Involvement:
– Patient and public involvement (PPI) allows collaboration in clinical research.
– PPI enhances research quality and relevance.
– Public involvement brings diverse perspectives to research.
– PPI ensures research is accessible and relevant to specific communities.
– Public contributors help in presenting research in clear language.

History and Evolution of Clinical Trials:
– Lady Mary Wortley Montagu, Edward Jenner, James Lind, John Woodall, John Haygarth, and Sir William Gull were early contributors.
– May 20 is celebrated as Clinical Trials Day in honor of James Lind’s research.
– Sir Geoffrey Marshall, Sir Austin Bradford Hill, and Sir Ronald A. Fisher made significant contributions.
– The British Medical Research Council recognized the importance of clinical trials in the 1930s.
– International Clinical Trials Day is celebrated on May 20.

Clinical trial (Wikipedia)

Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. Clinical trials generate data on dosage, safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial—their approval does not mean the therapy is 'safe' or effective, only that the trial may be conducted.

A clinical trial participant receives an injection.

Depending on product type and development stage, investigators initially enroll volunteers or patients into small pilot studies, and subsequently conduct progressively larger scale comparative studies. Clinical trials can vary in size and cost, and they can involve a single research center or multiple centers, in one country or in multiple countries. Clinical study design aims to ensure the scientific validity and reproducibility of the results.

Costs for clinical trials can range into the billions of dollars per approved drug, and the complete trial process to approval may require 7–15 years. The sponsor may be a governmental organization or a pharmaceutical, biotechnology or medical-device company. Certain functions necessary to the trial, such as monitoring and lab work, may be managed by an outsourced partner, such as a contract research organization or a central laboratory. Only 10 percent of all drugs started in human clinical trials become approved drugs.

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