What is a clinical Trial?

A clinical trial is a research study in human volunteers to answer specific health questions. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people, and ways to improve health. Observational trials, another kind of clinical trial, addresses health issues in large groups of people or populations in natural settings.

Why Participate?

  • Patients can play an active role in their own healthcare.
  • Gain access to new research treatments before they are widely available.
  • Obtain expert medical care at leading health care facilities / seek the opinion of specialists during their participation in a clinical trial.
  • Help others by contributing to medical research.

How Do I Know If I Qualify?

Each clinical trial has specific requirements for age, sex and the medical condition being studied. The company sponsoring the study will set the guidelines. Some information may be obtained through an initial phone contact. At that time, if you meet eligibility for study entry, the next step would be a screening visit, where specific tests (usually a physical exam, lab work and sometimes x-rays are performed). The physician conducting the study, called the Principal Investigator (PI), or Sub-Investigator will then determine if the study is right for you.

What are the Phases of Drug Development?

Clinical trials assess the safety and effectiveness of drugs. Some trials test entirely new drugs. Others evaluate whether older drugs should have their recommended dosages adjusted, or if they can be used to fight different diseases.

  • Phase I trials assess whether a given drug can be consumed safely by humans.
  • Phase II ** trials determine if a drug is effective for its stated purpose.
  • Phase III ** trials take drugs that show promising results in Phase II, and administer them to larger numbers of people to confirm the results.
  • Phase IV, or post marketing trials, are also done on brand name medication for various reasons. Additional info on clinical trials may be found at www.clinicaltrials.org or www.clinicaltrials.gov.

** In Phase II and III trials study medications are
frequently compared to a placebo or a drug of a
similar compound.