Right now, there are over 300,000 clinical studies in progress all over the world.2
For each clinical research study, researchers develop factors that allow someone to participate in the study called eligibility criteria. These include age, gender, previous treatment history and other medical information. It is important to test medications and medical products in the people they are meant to help, and to conduct research in diverse populations because different people may respond differently to treatments.
Janssen is committed to improving diversity and inclusion while valuing each participant’s contribution to clinical research studies. By including all diverse populations in clinical studies, Janssen can help determine if investigational medications will be safe and effective for as many people as possible, helping to create a better future for patients. Learn more at ResearchIncludesMe.com.
Participant safety and welfare is always the most important aspect of any study. As a result, studies are highly regulated with safeguards in place by both the study sponsor, Janssen Research & Development and by the Human Research Ethics Committee (HREC). The study sponsor is involved in the development of research protocols, participant informed consent forms and the review of related study materials. The sponsor follows a thorough process to ensure all study related materials are compliant with local laws of the country in which they are used in. The HREC’s involvement is to assure that appropriate steps are taken to protect the rights and welfare of participants in the research. To accomplish this purpose, HRECs use a group process to review research protocols and related materials to ensure protection of the rights and welfare of study participants.4
Study clinics will follow recommended local and federal clinical COVID-19 guidelines.
All study-required visits, tests and medications will be provided at no cost to participants, and reimbursement may be available for expenses directly related to the study visits such as local travel, meals and parking. However, participants will not be paid for taking part in this study and will not be reimbursed for other medical care or current medication(s) needed to support daily healthcare routines.
When the study is over, the sponsor may seek to publish the results (in a scientific journal, for example). Study results will also be posted on ClinicalTrials.gov after all study participants have completed the study and study data has been analysed. 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 at the end of the study, the data shows positive results, the results may be submitted for approval to the U.S. Food and Drug Administration (FDA). If the FDA approves the application, the medication will become available for doctors in the US to prescribe to their appropriate patients.
Research studies are designed in specific ways to test the investigational medication for safety and effectiveness. One or more of the answers that you provided were outside of the guidelines for one of the studies. This does not mean you will not qualify for different research studies.