CLINICAL TRIALS

A clinical trial is a medical study that is designed to answer questions about the safety and efficacy of potential medications. All investigational medications or treatments must be studied before they can be approved for use in patients and potentially made available to the public.

It is important to test medications in the people they are meant to help. It is important that research includes a variety of people, because different people may respond differently to the investigational medication.

Clinical trials have 4 phases. In phase 1, the investigational medication is evaluated in a small group of people for the first time to gather information on its safety, dosing, and side effects. In phase 2, the investigational medication is evaluated in a larger group of people to see if it is effective and to better understand its safety. If the investigational medication reaches phase 3, it is given to a large group of people to evaluate its efficacy, compare it to commonly used medications (known as standard of care) or placebo, and collect information about its safety. Phase 4 occurs after a medication has been approved by a country's regulatory medical authorities to gather more information on the medication's effects and side effects in the real world.

Participant safety and welfare is always the most important consideration for any clinical trial. As a result, trials are highly regulated with safeguards put in place by both the trial sponsor, Janssen Research & Development, and by the Institutional Review Board (IRB) or Independent Ethics Committee (IEC).

An IRB or IEC is a group of people whose job, along with the sponsor, is to protect the rights, safety, and well-being of the people involved in clinical trials. An IRB/IEC consists of 5 or more members. It is made up of doctors, researchers, and non-scientific members; some of the non-scientific members must be people who have never worked as a healthcare professional or clinical researcher or been involved in the management of clinical research. Only members who are impartial, i.e., are independent of the sponsor of the clinical trial and the investigator, can provide opinion or vote on any trial-related matters.

IRB/IEC members represent diverse experience, perspectives, and expertise. They review research activities to ensure that the trial design and activities are ethical and that the rights of participants are protected.

The IRB/IEC reviews the trial's documentation to:

• Assess whether the trial benefits outweigh the trial risks
• Understand all procedures that will be undertaken to reduce risks
• Make sure that participant-facing items, such as the informed consent form, state all the potential risks and benefits in a way that can be easily understood

All trial-required visits, tests, and medications will be provided at no cost to participants, and reimbursement may be available for expenses required by the trial visits such as local travel, meals, and parking. However, participants will not be paid for taking part in this trial. They will also not be reimbursed for other medical care or current medication(s) needed to support their daily healthcare routines.

Yes, most trials will allow for flexibility in appointment times to accommodate work schedules, work commitment letters to provide to employers, and reimbursement for expenses directly related to the trial visits such as local travel, meals, and parking. You are also encouraged to call your trial physician and trial staff team at any time you have any questions during the trial.

The final results of the trial are not known or shared with anyone involved in the trial until all data has been gathered and fully analyzed.

When the trial is over, the sponsor will seek to publish the results (in a scientific journal, for example). Trial results will also be posted on ClinicalTrials.gov after all trial participants have completed the trial and trial data has been analyzed. Your identity will remain confidential. Only overall summary data results from participants will be publicly shared. Research results will never contain your name and will never publicly report your individual data.

If the data shows positive results, the results may be submitted to regulatory authorities like the U.S. Food and Drug Administration (FDA) for potential approval for use.

Clinical trials are designed in specific ways to test the investigational medication for safety and efficacy. One or more of the answers that you provided were outside of the guidelines for the trial. This does not mean you will not qualify for different trials.