About Clinical Trials
What Are Clinical Trials?
A clinical trial (also known as a clinical study) involving an investigational drug is designed to learn more about a drug’s ability to safely and effectively treat a specific disease or condition. Regulatory agencies and health authorities use the results of clinical trials to decide if an investigational drug should be approved and made more broadly available to patients and physicians.1
Informed Consent
Informed consent occurs before you participate to make sure you understand the study, have all your questions properly answered, and learn about your rights as a study participant. This process helps you decide whether you want to become involved.2
Remember, you can quit any clinical trial at any time and for any reason. That includes the SOL study, even after signing the Informed Consent Form.2
Safety of Clinical Trials
Clinical trials are conducted by trained medical professionals who monitor the health of participants throughout the study.3 Every clinical trial in the U.S. is reviewed by the U.S. Food and Drug Administration (FDA), and an Institutional Review Board (IRB) or Ethics Committee (EC), which helps ensure that the study is conducted properly and that the rights of study participants are protected.4
A clinical trial is not the same as medical care from your regular physician and should not replace medical advice from a physician about any condition.5 You are not guaranteed to receive benefits from participating in a clinical trial.2,5
Are you interested in joining the SOL study?
Learn more about an investigational treatment for wet AMD being evaluated in this clinical trial.
REFERENCES: 1. U.S. Food & Drug Administration. Development & approval process: drugs. Updated August 8, 2022. Accessed July 23, 2024. https://www.fda.gov/drugs/development-approval-process-drugs. 2. U.S. Food & Drug Administration. Informed consent for clinical trials. Updated January 4, 2018. Accessed July 23, 2024. https://www.fda.gov/patients/clinical-trials-what-patients-need-know/informed-consent-clinical-trials. 3. U.S. Food & Drug Administration. Basics about clinical trials. Updated May 8, 2023. Accessed July 23, 2024. https://www.fda.gov/patients/clinical-trials-what-patients-need-know/basics-about-clinical-trials. 4. U.S. Food & Drug Administration. Institutional review boards (IRBs) and protection of human subjects in clinical trials. Updated September 11, 2019. Accessed July 23, 2024. https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/institutional-review-boards-irbs-and-protection-human-subjects-clinical-trials. 5. U.S. Food & Drug Administration. Clinical research versus medical treatment. Updated March 22, 2018. Accessed July 23, 2024. https://www.fda.gov/patients/clinical-trials-what-patients-need-know/clinical-research-versus-medical-treatment.