Learn About Clinical Trials

A clinical trial, also known as a research study, is voluntary research conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, and other therapies, or new ways of using existing treatments.

Clinical trials are critical for advancing medical science, improving patient care, and developing new and effective treatments that can potentially save lives and enhance patient quality of life. All drugs must go through the clinical trial process before being approved as safe and effective for use.

Clinical trials are typically conducted in 4 phases:

1

Evaluates the safety, dosing, and side effects of an investigational drug. It usually involves a small group of participants.

2

Further investigates safety and effectiveness in a larger group of people.

3

Confirms an investigational drug's effectiveness, monitors side effects, and compares it to placebo (inactive study drug) or an existing treatment. This usually involves participation on a large scale, including multiple study locations and centers.

4

Once a drug is approved, it is evaluated in a real-world setting and monitored for long-term safety, effectiveness, and potential side effects.

The Importance of Diversity

We are committed to inclusivity and diversity in our research because we understand that, in order to develop potential treatment options for people of different backgrounds, we need to ensure that our clinical trials are representative of the patient population we aim to serve.

What to Expect as a Participant

It's important to understand the process of a clinical trial in order to decide if participation is the best option for you. Here are some things you can expect when participating in a clinical trial.

Prescreening

The study team will review your health to make sure you meet the eligibility criteria of the clinical trial.

Informed Consent

The study team will discuss with you the entire process of the clinical trial, as well as the goals, risks, and benefits. They will provide you with a document called the Informed Consent Form (ICF) that outlines everything the team discusses in detail. You will have the opportunity to review the document and ask any questions you may have before signing the ICF.

Participation in any clinical trial is completely voluntary, and you may stop participation at any time.

Screening

After signing the ICF, the study team will fully review your medical history, perform exams and tests (if necessary), and determine whether you qualify to participate in the clinical trial.

Participation

What actually happens during a clinical trial varies depending on the trial. You will know exactly what will occur well in advance, and it will be fully outlined for you in the ICF. Some things that may occur include:

Keeping a diary
Providing blood or urine samples
Filling out surveys
Attending phone or in-person visits

Follow-up

After the treatment portion of the trial is completed, you may be required to come in for a visit so the study team can review your overall health and document any changes that have occurred. This will also be outlined in the ICF prior to you joining the clinical trial.

What to Expect as a Care Partner

Care partners play an extremely important role in supporting a patient in their clinical trial participation. You may be asked to contribute in multiple ways to help your loved one during the process.

Emotional support and advocacy

Your biggest role as a care partner is often to provide the encouragement and reassurance that your loved one may need while participating in a clinical trial. In addition, you’re also their biggest advocate to ensure that their needs and concerns are met during the trial.

Transportation and accompaniment

As a care partner, you may be asked to drive your loved one to and from study visits. You may also be called upon to accompany your loved one during the visit to help answer questions and provide overall support.

Medication management

Depending on the trial and health of your loved one, you may be needed to dispense and/or monitor medication as required in the trial. It is critical that any treatment regimens are followed as closely as possible to the trial requirements.

Observation and reporting

Care partners may be in the best position to monitor and observe the effect of any investigational treatment. It may be your responsibility to look for side effects, track symptoms or adverse events, and communicate back to the study team. Doing so can help the success of your loved one in their participation, as well as the overall outcome of the clinical trial.