What are clinical trials, what should I know and how do I participate?

People of all ages, races and ethnicities—who are either healthy or have pre-existing conditions—participate in clinical trials research all over the world. You can too!

So, what is a clinical study (a.k.a. “clinical trial”)?

Clinical studies are kinds of research that determine if new therapies are safe and effective for treating and preventing diseases and health conditions. Study investigators and teams must follow strict protocol that dictates how the study is executed and how safety measures will be implemented. New therapies studied in protocols include medications, vaccines, medical devices and procedures. Clinical studies provide the scientific backing and real-world evidence needed to get new treatments approved by the FDA and into the hands of patients like you. For example, without the hundreds of thousands of willing participants in clinical studies for COVID-19 treatments and vaccines, pandemic lockdowns could have lasted much longer, and hospitalization and death rates would have been higher. So, by joining a clinical study, you contribute to meaningful changes and a positive impact on our lives.

Should I participate?

This is a decision that is best made with consultation from healthcare professionals, study teams and even the input of your friends and family. Study participation is completely voluntary and can be canceled at any time. Ensure all of your answers about the potential benefits and risks get answered, and thoroughly consider what's involved, including:

• Dosing schedules

• Time commitments

• Travel commitments and accessibility

• Bottom line: consider conversations with your doctors, family and friends before enrolling in a study

What is in place to protect my safety?

Clinical studies follow rigorous standards and are highly regulated by the government to protect participants. Every research proposal must be reviewed and approved by the FDA, as well as an independent Ethics Committee (EC) or Institutional Review Board (IRB) to safeguard the rights and welfare of participants. Often, studies also employ an Independent Data Safety and Monitoring Board to regularly review accumulating data on patients in a trial. Similar to all medical treatments and procedures, clinical studies are not 100% risk-free. However, measures are taken to monitor your rights, safety and wellbeing above all else. Despite these precautions, your condition or health could remain the same, improve or get worse. For this reason, protocol visits and assessments are scheduled regularly to help enable close monitoring and early detection of any potential issues.

How can I participate?

Ask your healthcare provider if there is a clinical study that is right for you. Patient advocacy groups for specific diseases can act as another great resource to learn what studies are being conducted for you and/or your condition.

Ultimately, clinical studies help others while helping you as well. The more research collected, the better scientists, doctors and other healthcare professionals can learn how to treat diseases. At YCO, we value thorough research so we can deliver data-driven results to improve the lives of patients just like you all over the world.

Get in touch with us at yosheclinical.com for information on clinical studies in your area or see clinicaltrials.gov

Additional helpful resources:

US FDA:

Clinical Trials: What Patients Need to Know

https://www.fda.gov/patients/clinical-trials-what-patients-need-know

NIH: What are Clinical Trials

https://www.nia.nih.gov/health/what-are-clinical-trials-and-studies

ClinicalTrials.gov: For Patients and Families

https://clinicaltrials.gov/ct2/help/for-patient

We look forward to learning with you.