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Clinical Trials and What You Should Know

Clinical Trials and What You Should Know

Clinical trials are how researchers test new investigational medicines or treatments before they are widely available to patients.  People like you participate in clinical trials every day. Some because they have limited treatment options and others because they know someone with an untreatable condition. Whatever the reason, these individuals are all contributing their time to help expand treatments in the future.

The goal of a clinical trial is to collect information on the safety and efficacy effectiveness of a drug. Every new drug or treatment must complete the clinical trial process before being submitted for Food and Drug Administration (FDA) approval.  By participating in the clinical development, you are gaining access and contributing to potential new therapeutics and technologies not yet available in the market. You are supporting medical and scientific progress and success, which may be of great benefit to those affected.

Let’s take a closer look…

What is a Clinical Trial?

Clinical trials are how researchers test new investigational medicines or treatments before they are widely available to patients. Clinical trials are conducted in phases.  

The decision to join a clinical trial is a personal decision. We encourage you to consult with your doctor, talk to your family, and ask questions.

There are three to four phases that must be completed before a new medication or treatment is approved by the FDA and each phase has a specific purpose.

    • Phase 1 is tested on a small group of usually healthy study participants to test safety and dosage limitations. 
    • Phase 2 involves a larger group of study participants and seeks to determine if a drug is effective in people with specific medical conditions. Safety and side-effects are monitored, and this phase may extend for several years. 
    • Phase 3 involves an even greater amount of study participants and continues to gather information on safety and effectiveness. If the results of Phase 3 are positive, the study treatment will be submitted for approval to the FDA. 
    • Phase 4 studies are conducted if additional research questions need to be answered. Phase 4 studies are conducted after FDA approval when the treatment is already available to the public. This phase tests the long-term effectiveness and side effects of the new treatment over a large population in real life scenarios.

Every clinical trial is guided by a study protocol (plan) that is reviewed for safety and designed to answer specific research questions.

When you are offered an opportunity to join a trial, the purpose of the study, tests and procedures conducted, and medications you will be taking will be clearly explained. Potential benefits and risks will also be explained by clinical research staff before you consent to participate in any trial.

ProSciento’s team of experts manages clinical research studies domestically and internationally. If you’d like to learn more about clinical research studies, or what we do, please call [#]. Once you get on a call with our trained healthcare team, we can answer any questions and/or concerns you may have.

Whatever your motivation for joining a clinical trial, you can be confident that you are in great company! Most drugs available in the market today were only made possible by study participants.

Conclusion

Clinical trial researchers partner with study participants to help advance science in the treatment of diseases.

Before enrolling in a study, we encourage you to talk to your family and consult with your doctor about any questions you may have. When you’re ready, one of our highly trained team members will guide you through the process every step of the way. We have English and Spanish-speaking team members ready to help you and answer any questions or concerns you may have.

Is this a treatment program?

By participating in the clinical development, you are gaining access and contributing to new therapeutics and technologies not yet available in the market. You are supporting medical and scientific progress and success, which may be of great benefit to those affected.

Are visiting hours allowed?

Due to the current state of affairs with COVID-19, once you are enrolled in a study and check-in for our overnight stays, visiting hours will be limited to protect the safety of our staff and other study participants.

Do you have other locations for screening visits or clinical studies?

Generally, all screenings and study visits will take place at our Chula Vista facility. We may ask you to get some lab work and procedures done at other off-site locations, but this varies largely on the study. Our study participant recruiters can provide you with more information during your call.

As a global clinical research organization, ProSciento also manages clinical research studies in locations throughout the US, Canada, Europe and Asia-Pacific. If interested in clinical studies outside of Southern California, including NASH PASS® studies , please email participants@nashpass.com.

How do I receive my stipend for participation?

You may receive a stipend for participating in a study. The stipend amount will depend on the length of the study, number of study visits, and additional factors. Your stipend will be available to you via a prepaid debit card that you will receive after you are enrolled in a study.

In many cases, if an individual is eligible to participate in a study, travel expenses are covered in the stipend you will receive for the screening visit. Our study participant recruiters can provide you with more information during your call.

Is participating in a study safe?

Our highly qualified medical and support staff undergo extensive training to minimize risks for study participants. You can be assured that the following safeguards are in place:

  • We have been conducting clinical research studies for over 16 years.
  • We are compliant with Good Clinical Practice (GCP) that provides public assurance that the rights, safety, and well-being of study participants involved in research are protected.
  • Monitoring of all studies by Institutional Review Boards (IRB) that ensure ethical standards and rights of study participants are maintained for each clinical trial.
  • Emergency control systems at our facility and emergency training of our staff involved in the study.