ClinSearch - Clinical Research

1. What is a Clinical Trial/Study?
This is a research study in human volunteers to answer specific health questions. It is the best way to evaluate drugs effectiveness and safely under a controlled environment.

2. How does a drug get approved by the FDA?
D rug Companies must spend a Considerable amount of money and time evaluation new drugs on at least 2,500 people. New drugs must be proven safe and more effective than a placebo. (Sugar Pill)

3. Why participate?
This gives patients patients a chance to take a more active role in their own health care. Gain access to new treatment before they are widely available. Help others with same medical problems all at no cost to patient or Insurance Company.

4. What is informed consent?
This is the process designed to give volunteers the information they need before participating in a study. Patients can ask as many questions as they want until they feel more comfortable with their decision. Even after they join a study they have the right to drop out at any time of their choosing.

5. What happens during a study?
This varies dependent on the type of study. But may include lab work, physical exam, EKG, Osteoporosis Scan, Cardiac Scans, Endoscopy all at no charge to patient. Symptoms, lab and response to treatment are monitored very carefully.

6. What are risks and benefits?
Risk -- Possible unknown side effects. New drugs may not be effective. Studies require more time than the usual office visits.
Benefit -- Gain access to new treatment, medication, lab work, EKG, scopes, etc. all at no cost. Help new drugs get approved by the FDA.

7. What are the different phases of a Drug Study?

In Phase 2 Studies -- Drugs are given to healthy patients (usually 100-300 people) to see if effective and safe compared to placebo.
In Phase 3 Studies -- Drugs are given to larger groups (1,000-3,000 people) to confirm effectiveness and monitor side effects compared to placebo or other known treatments.
In Phase 4 Post Marketing Studies -- (after Drug approved and on the market) evaluate long term safety and effectiveness.

8. How is clinical research different from being a guinea pig?
A guinea pig has no choice, but our patients can chose not to enter the study or at any time discontinue the study. Many studies often prescribe medication to be taken if the symptoms persist.