Clinical trial is a Research study to determine the effectiveness and safety of a new drug, vaccine, device or a new approach to treat or prevent a medical condition. Before a medication is approved, it goes through FDA mandated 3 rigorous study phases. Phase I is study on a very small group of healthy volunteers to determine the safety of the study medication. Phase II is study on volunteers with appropriate medical condition to determine the safety and effectiveness of different dosages of the medication. Phase III is a study on over hundred volunteers with appropriate medical condition to test the efficacy and safety of the pre-determined dosages. The two phases may compare the efficacy against a placebo, which is an inert medication. After FDA approves the medication, it is further tested on few hundred to over thousand volunteers with appropriate medical condition to determine the safety and effectiveness in Phase IV study.

You get access to new medications, vaccines and devices that is not available to general population. You get to understand your disease well as you work closely with health care professionals who manage your medical condition. During the study you may get free medical care including labs, ekgs and other study related workup. You get an opportunity to help in the advancement of medical science by contributing to the development of new medications that may one day be approved to help people with different medical conditions. After all, someone volunteered in the past to help study the medication that you may be taking today.

Informed Consent is a document that gives you complete information about the clinical trial that you can review prior to participation. It is mandated by the FDA and other regulatory bodies. It explains the visit details and may include visit schedule and procedures to be done at these visits. It provides phone numbers and other contact details of the study staff. You may take the consent documents home and discuss with your family and your treating physicians prior to signing up for the study.

The study is free to all volunteers. You do not need health Insurance to participate. All qualified participants are reimbursed for their time and travel.

Like any approved medication, No study medication with potential benefits to you can be without risks of side effects or adverse reactions. The study medication may not be effective to you or you may receive placebo (inert pill) with no effect at all (if there is a placebo comparator). All protocols for the study are approved by the FDA and we strictly adhere to their guidelines. During the study your health is monitored closely. Before any drug is tested in humans, it is thoroughly tested in animals for safety.

Your participation in a trial is completely voluntary. You may choose not to participate in the study or can withdraw from the study any time with no negative implications. If you are a patient of any of the physicians working on the study, it will not affect your relationship with the physician and they will continue to take care of you as before your participation in the study.

You will be required to return the study product as soon as the study is over. Remember that these may not be FDA approved medications. In rare circumstances patients are allowed to continue these products if there is no approved cure for the medical condition (for which the medication is being tested) and has been shown to benefit the patient’s life threatening condition.