FAQ

Almost anyone can participate in a clinical trial. You can participate in clinical trials to advance medical research—regardless of your age, health, ethnicity or background. There is no insurance required, nor any proof of legal status or citizenship.

Many trials are for healthy volunteers. These include most vaccine trials. Others are looking for people with specific illnesses or medical conditions, such a type 2 diabetes. These potentially offer participants the chance at access to new investigational therapies, well before they are approved for the general public.

Clinical research volunteers are paving the way by contributing in trials to help bring novel medicines to the US and the world.

Yes. Every study is a little bit different.

 

Most trials offer compensation for your time and effort, which could be anywhere from a few hundred to a thousand dollars or more.

The compensation you receive is approved by an independent ethics board, and is relative to what is required of you in that trial—including the length and number of study visits. The compensation is detailed in the informed consent document you will receive at your first study visit.

When you speak with our Patient Enrollment Specialists, please feel free to discuss the compensation with them. We appreciate the sacrifice of your time and effort entailed in study participation, and want to be upfront with you about compensation.

It varies by study. Studies typically require you to come to the clinic a few times, complete e-diaries, and/or speak with clinicians on the phone. The majority of our trials are conducted in outpatient clinics—that means that no overnight stay is needed for most of the studies. Most visits are similar to what you would experience at your regular care visits to your doctor, such as a physical exam, vitals, medical history, blood/urine sample.

It varies by study. The ethics and laws that govern medical practice also apply to clinical studies, and we adhere to these strict standards. However, studies, by nature, involve investigational products that might be ineffective or cause side effects.

 

Clinical studies are overseen by the U.S. Food and Drug Administration (FDA). Clinical studies also follow strict protocols that we adhere to, and they are reviewed by Institutional Review Boards (IRBs)—a board of highly qualified individuals who are dedicated to ensuring patients’ rights are protected.

Each participant goes through an informed consent process that explains in detail each step of the trial. Our team will help clarify information regarding the specific medicine that is being studied, the number of required doctor or clinic visits, potential side effects and many other aspects of the study and your participation. You are encouraged to ask any and all questions throughout the process.

Each clinical trial is provided with a protocol – which are the guidelines for a study. There are trials that seek patients with a specific medical condition and others that seek healthy participants. Each study is different. The protocol provides inclusion and exclusion criteria depending on various factors that allow us to determine your eligibility or ineligibility for a specific trial.

Pharmaceutical companies, various health organizations, and federal agencies fund clinical trials.

No. Clinical trials are funded by various organizations or federal agencies. These sponsors cover the costs of the trial.

It is important to ask questions. Our team is there to provide the information and care you need, so please do not hesitate to ask any questions regarding the study. A few common questions are:

  • Who is my main point of contact?
  • How long will this study last?
  • What is the purpose of the study?
  • Has this study drug been tested before?
  • Why do we believe this treatment would be effective?
  • What kinds of tests and treatments are involved?
  • Will this trial affect my day-to-day activities?

Yes. A patient has the right to choose to leave a clinical trial at any time and for whatever reason. We ask that you let our clinical staff know that you are withdrawing.

This varies by study. When patients are notified whether they received the placebo, we refer to this as “breaking the blind.” Not all studies break the blind. If the criteria allow, you will be notified once the study has reached completion.

Yes. All medical records and research materials that might identify you are held confidential in accordance with the law, and are never sold or shared with third parties.

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