Clinical research is a vital driver of medical progress. Yet, many people are unaware of the essential role of institutional review boards (IRBs) in protecting clinical trial participants by ensuring compliance with human subject protection requirements. With more than three decades of experience, Advarra is dedicated to advancing clinical research by providing expert oversight. As a trusted partner in supporting the advancement of life-changing therapies, Advarra prioritizes transparency, compliance with regulatory requirements and guidance, integrity, and participant safety in every trial. The company’s rigorous review process, conducted by professionals—physicians, clinicians, therapeutic area experts, pharmacologists, and others—with deep expertise across various scientific disciplines, as well as non-scientists who provide ethical balance and participant advocacy, ensures that trials meet regulatory requirements and the highest ethical standards and minimize risks to study participants
What is Clinical Research?
Clinical research tests new treatments and therapies to determine their safety, effectiveness, and potential to improve health outcomes. It is the foundation of medical innovation. Advancement in treatment of diseases—from cancer to diabetes to rare diseases—have all come about because of clinical trials. Clinical trials progress through several phases:
- In Phase I, the focus is on testing the safety, dosage, and side effects, rather than effectiveness of a new treatment in a small group of participants.
- Phase II further assesses safety, investigates whether the new treatment is effective, and determines the optimal dose.
- Phase III involves more significant groups of participants to confirm the new treatment’s effectiveness, monitoring long-term safety, and comparing it to existing therapies.
Participants in clinical trials bravely volunteer to help test new treatments, contributing to scientific advances that ultimately stand to benefit society. This process ensures that new therapies meet the U.S. Food & Drug Administration’s standard for safety and efficacy. A critical part of clinical trials is to learn and confirm scientific assumptions, and to incorporate learnings to enhance the study protocols for the sake of safety, efficacy and efficiency to introduce products to patients in need.
The Vital Role of Institutional Review Boards (IRBs)
As set forth in the federal regulations that govern the conduct of clinical trials, an IRB is an independent group of experts, including scientists and non-scientists, that reviews clinical trial proposals to ensure they meet ethical standards that are designed to protect participants’ rights. The role of the IRB is crucial in examining clinical trial designs to make sure the research complies with regulatory requirements and is ethically appropriate, informed consent procedures are thorough, clear, and transparent and that patient recruitment materials are accurate and not misleading. The IRB achieves its mission through a comprehensive and thoughtful review of study-related information/documentation (e.g., protocol, investigational product information, informed consent form(s), other participant facing materials). This process better enables investigators and participants to engage in a discussion that empowers participants to fully understand the nature and potential risks and benefits of the trial, before agreeing to participate. The role of the IRB is to review the study documentation and Investigator qualifications, collect safety reports, and evaluate requests for modifications to the study. The IRB does not monitor patients nor advise the sponsor on the design of the study. Moreover, the IRB does not evaluate patients for inclusion or exclusion in a given clinical trial; such determinations are made by the investigators responsible for the conduct of each study. Advarra’s IRB is highly experienced and works diligently to provide expert oversight, ensuring that every clinical trial adheres to the highest ethical standards and is compliant with applicable regulations.
The Impact of Clinical Research: Empowering Participants and Advancing Medicine
The existence of clinical trials is the reason why many life-saving treatment options are available today. For example, these trials may help to advance cancer treatments and chronic disease management medicines and potentially offer patients access to cutting-edge therapies that may not yet be available through conventional medical channels.
The Future of Clinical Research
Advarra recognizes that clinical research is an essential component of medical progress, and we remain dedicated to upholding the highest standards of ethics, integrity, and regulatory compliance.
Through expert oversight, Advarra works hand-in-glove with the most experienced researchers in the United States and Canada to advance new scientific discoveries. By remaining at the forefront of clinical research, Advarra is helping scientists and industry leaders bring new treatments to market and into the hands of patients who need them.