Frequently Asked Questions

A clinical trial is a research study that tests the efficacy and safety of new medical interventions to improve health outcomes and bring new medications and procedures to market. Clinical trials are tightly controlled and progress through phases (from Phase I to IV) to test the safety, dosage, efficacy, and long-term effects of medications or treatments before they are approved for wider distribution.

All clinical trials have unique inclusion and exclusion criteria that are based on a variety of demographic and health information. This means to join a study you need to be a certain age, gender, ethnicity, type and stage of disease, weight, etc. A member of the Antivirals and Vaccine Research Program team can go through the study’s criteria with you to help you understand if you are eligible for a certain trial. If you are not eligible for one clinical trial, there may be others that are the right fit for your circumstances.

By joining a clinical trial, you can help researchers advance scientific knowledge and contribute to future treatments. In addition, clinical trials offer participants the chance to access cutting edge investigational healthcare that is not yet on the market, meaning participants can be some of the first patients to benefit from new treatments.

The commitment depends on the study that you join. Most studies last 1 to 2 years, with some requiring monthly visits while others require less frequent appointments.

Given the nature of clinical trials, even if extensive measures have been put in place to protect the safety of patients, there are some risks associated with joining that vary depending on the protocol. Any known risks will be clearly explained to you during the screening process. Before joining a study, every participant will be given informed consent paperwork that walks you through possible risks and the requirements of participation so that you can feel confident joining a trial.

Potential participants will talk with an Antivirals and Vaccine Research Program staff member to discuss their eligibility for the currently enrolling clinical trials. During this discussion, the staff member will give you a general outline of the research study as well as any requirements of participants and potential risks.

Appointments may take place at various locations across Yale’s campus or even remotely via the phone. Participants typically have their appointments at the Antivirals and Vaccine Research Program offices at 135 College Street in New Haven. If your appointment is at 135 College Street, when you arrive, security or a member of our team will let you into the building and bring you up to the offices.

Our office is located at 135 College Street, New Haven, CT 06510, between George Street and North Frontage Road/MLK Jr. Blvd. Parking is provided in a surface lot behind the building (see photo).

You can also reach our offices by train and bus. Metro-North and Shoreline East train services can be taken to either Union Station or New Haven State-Street; both are about a 15-minute walk to our offices. A free Yale shuttle bus runs from Union Station to 60 College Street. Many of the New Haven area public buses stop at the New Haven Green as well, which is a short walk to our offices.

In some studies, some participants may be given placebos, which do not contain any known active ingredients. Placebos are often given during blinded trials, meaning the participants do not know whether they are receiving the treatment or placebo. This is done to determine the physiological effect (physical effect) of a drug vs. the psychological expectation. It is important to note that placebos are never given if it would mean putting participants at risk by denying them appropriate treatment. During screening, you will find out if the trial you are looking to join has a placebo.

Yes, participation in clinical trials is entirely at will, meaning that a participant can always withdraw from a clinical trial at any time for any reason. However, any data collected during your participation in the study up until you withdraw will still be considered in the study. If you choose to withdraw from a study, your care will not be impacted and your relationship with your medical care team will not change.

Most of the studies cover the cost of the intervention (the medication). Most studies also provide stipends to help offset the costs associated with coming in for routine appointments, such as for your time and travel expenses, although these stipends may not cover all expenses incurred.

After the conclusion of a clinical trial, you will continue receiving care from your primary care team. Depending on the study and the sponsor, some participants may be eligible to continue receiving the trial treatment after the conclusion of the initial trial period.

Many structures are in place to ensure that your data and privacy are protected during and after your participation. In the US, the Health Insurance Portability and Accountability Act, or HIPAA, governs patient protected health information (PHI) and ensures that there are technical safeguards to protect patient data and confidentiality. HIPAA also regulates the ways in which researchers and institutions can share and disclose your data. HIPAA protects all your identifiable health information, including your name, social security number, address, test results, billing details, and more. As a participant in a trial, you can always ask to clarify how the study will protect this information.

Yes, in most cases you can continue seeing your regular doctor for your routine medical needs that are not related to the study. It is important to share, both with your primary care team and the study team, your medical history and the fact that you are participating in a trial so that everyone can be up to date on your overall care. The program team will be focused on providing your study-related medical care, while you remain under the care of your regular doctors for all other concerns. Your participation in a research study will not affect your relationships with any providers.

The study team may be able to provide you with transportation at no cost to you.

Since most clinical trials are multi-center ones, the study team will make every effort to find a center that is closer to your new location so that you can continue your study visits at the new center seamlessly.