What are clinical Trials

Medical studies that are conducted to search for cures of various medical symptoms and diseases are called Clinical Trials. Clinical trials involve subjects participating in these research studies. Clinical trials look at

  • Preventing disease – using drugs, vitamins, foods to reduce risk
  • Treatments – new drugs or combinations of drugs; new ways of giving treatment, new types of treatment
  • Diagnosing disease – new tests or scans
  • Controlling symptoms – new drugs or complementary therapies
  • A Clinical study is conducted to determine:
  • Safety and efficacy of a new drug
  • Safety and efficacy of a different dose of drug
  • Safety and efficacy of an already marketed drug to treat a different indication/symptom
  • Whether Device A is better at treating a patient versus Device B

Types of studies

Phase I

Phase 1 studies assess the safety of a drug or device. This primary stage of testing usually includes a small number of healthy volunteers (20 to 100), who are generally compensated for participation in the study. This stage can take months to complete sometimes. The study is constructed to determine the effects of the drug or device on humans including how it is consumed, metabolized, and discharged. This stage also explores the side effects that occur as dosage levels are deviated. About 70% of experimental drugs pass in this is stage of testing.

Phase II

These studies test the productivity of a drug or device. This second stage of testing can last from several months to two years, and involves up to several hundred patients. Most studies of this stage are randomized trials where one group of patients receives the experimental drug, while a second “control” group receives a standard treatment or placebo. Neither the patients nor the researchers know who has received the experimental drug because these studies are often blinded. This allows investigators to support the pharmaceutical company and the FDA with comparative information about the relative safety and effectiveness of the new drug. About one-third of experimental drugs successfully complete both Phase I and Phase II studies.

Phase III

These studies involve randomized and blind testing in numbers from 100 to 1000. This large-scale stage of testing, supplies the pharmaceutical company and the FDA with a more absolute explanation of the performance of the drug or device, the benefits and the extent of possible adverse reactions. In this stage of testing 70% to 90% of drugs that enter successfully complete this phase of testing. Once this stage is complete, a pharmaceutical company can request FDA approval for marketing the drug.

Phase IV

These studies, often called Post Marketing Surveillance Trials, are conducted after a drug or device has been approved for consumer sale. Pharmaceutical companies have several objectives at this stage:

– – To analyze drug with other drugs already in the market

— To supervise a drug’s long-term productivity and impact on a patient’s quality of life; and

— To conclude the cost-effectiveness of a drug therapy relative to other traditional and new therapies.

— This stage studies can result in a drug or device being taken off the market or restrictions of use could be placed on the product depending on the findings in the study.

The U.S National Institute of Health organized trials in to 5 different categories

Prevention Trials

Looks for better way to prevent disease in people who have never had the disease or to prevent the disease from returning

Screening Trials

Test the best way to detect certain diseases or health conditions.

Diagnostic Trials

Conducted to find better tests or procedures for diagnosing a particular disease or medical condition

Treatment Trials

Test experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.

Quality of Life Trials

Explore ways to improve comfort and quality of life for patients with chronic illness

Patients benefit from availability of new treatment options and free medical care. Study patients can qualify for compensation for their time and travel.

Additional the patient to gain more knowledge about their disease and to meet others with the same condition through our workshops and support groups.

A patient may had a troubled history on finding care for their disease or condition. Through a physician’s study, patients can be introduced to treatments that may be more effective than the standard approach. Patients will receive close monitoring by physicians and other health professionals.

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