Frequently Asked Questions

A clinical trial is a research study in which both healthy subjects and/or subjects with a specific diagnosis receive investigational treatments over a period of time. Treatment is given under the supervision of a physician (investigator) and other research professionals. Pharmaceutical and biotechnology companies carefully select qualified sites that have the appropriate staff, skills, and resources available to safely administer these treatments and determine the benefit of these investigational drugs.

Clinical trials are conducted in phases I, II, III, and IV. Phases I and II trials usually require a small population of patients, whereas the later phases involve a larger number of patients. Some clinical trials may include the use of some FDA-approved drugs to compare the effectiveness of the investigational drug in relation to those already approved and available to you through your insurance carriers.

Clinical trials have helped in the advancement of medicine. This process allows us to find and cure many diseases and illnesses and improve treatment options for patients with chronic illnesses. All approved medications have gone through this process. These trials are conducted to determine the efficacy of these drugs, possible side effects, and long-term effects of use.

All clinical trials have guidelines, i.e., inclusion criteria (must meet all) and exclusion criteria (can’t meet any), that each participant must meet to qualify for the study. Some of the factors that may determine your eligibility include (and are not limited to) your age, gender, type, stage, severity of disease, previous treatment, other and past medical history, and mental status.

Remember, the accuracy of the information provided to the research staff is very important as it is used to determine if all inclusion criteria are met and all exclusion criteria are not met. These criteria are used to identify appropriate candidates, promote participant safety, and ensure that the researcher, the pharmaceutical company sponsoring these trials, learns and collects the necessary findings.

Benefits

• Free treatment, labs, and office visits

• A more extensive workup and personalized treatment plan

• Helping the research community and other patients like yourself gain a chance to more treatment options

• The ability to receive first-line treatment that may potentially improve your disease

• Patient stipend

Risks

• Possible lack of benefit or improvement

• Possibilities of experiencing side effects

• There is a chance of receiving a placebo instead of the actual study drug

• Despite any risk or benefit that may be experienced during participation in a clinical trial, there is an institutional review board (IRB) in place, which ensures safety.

As a participant in a clinical trial:

• Be compliant with the study visit schedule

• Consult with staff prior to any medication changes

• Take all medications as instructed

Inform research staff about any changes in your health or new symptoms experienced after starting any investigational product.

After completion of the trial, subjects have several options:

Option A – Open label/Long-term extension:

During this period, the placebo component is usually removed, and subjects are granted the opportunity to receive the investigational product after completing the trial.

Option B – Enroll in another clinical trial

Option C – Continue with the standard of care

The benefit from the investigational drug, this can only be offered to you for treatment once the trial is completed, once it is FDA-approved.