What are Biomarker-Guided Clinical Trials for Cancer?
What are clinical trials for cancer?
Clinical trials are research studies that explore new ways to prevent, detect, or treat diseases, including cancer. They are essential for advancing medical knowledge and improving patient care. In cancer research, clinical trials often test new treatments like drugs, surgical procedures, or radiation therapy, as well as combinations of existing treatments. Participants or patients in these trials receive interventions according to a research plan or protocol created by investigators. These studies follow strict scientific standards to ensure patient safety and produce reliable results. By participating in clinical trials, patients contribute to the development of new therapies that may benefit future patients.
Phases of clinical trials:
Phase 1: Tests a new treatment’s safety, dosage, and side effects in a small group (generally 20–100 people).
Phase 2: Expands to 100–300 patients to evaluate effectiveness against cancer and further assess safety.
Phase 3: Involves hundreds to thousands of patients to compare the new treatment with standard therapies, confirming efficacy and monitoring side effects.
Phase 4: Conducted after approval to track long-term safety and effectiveness in the general population.
Each phase helps ensure new treatments are safe and effective before widespread use.
What are biomarker-driven clinical trials for cancer?
Biomarker-driven clinical trials are a type of cancer study that uses biological markers, or biomarkers, to guide the selection of therapies. Biomarkers are measurable indicators found in blood, other body fluids, or tumor tissues that can provide information about a person's cancer state or how they might respond to treatment. In cancer, biomarkers can include specific gene mutations, protein expressions, or other molecular changes unique to an individual's tumor.
These trials aim to match patients with treatments that are more likely to be effective based on the specific characteristics of their cancer. For example, a patient whose tumor has a particular genomic mutation might receive a drug specifically targeting that mutation. This approach, often referred to as precision oncology, has the potential to improve treatment outcomes by tailoring therapy to the individual characteristics of each patient's cancer.
Innovative trial designs, such as basket and umbrella trials, have been developed to efficiently study biomarker-driven therapies. Basket trials test the effect of a single drug on a specific mutation across various cancer types, while umbrella trials evaluate multiple treatments for a single type of cancer based on different biomarkers present within that cancer. These designs allow researchers to more effectively assess the efficacy of targeted therapies and accelerate the development of personalized treatment options.
How Navexio can help you navigate clinical trials
Navigating the complex landscape of clinical trials can be challenging for patients and their families. Navexio specializes in cancer navigation and support services, offering personalized guidance to help you find, understand and access appropriate clinical trials. Our team of experienced biomedical scientists and care navigators work closely with you to identify trials that match your specific cancer type and biomarker profile.
We provide comprehensive support throughout the clinical trial process, including:
Education: Helping you understand the purpose, potential benefits, and risks of clinical trials.
Eligibility Assessment: Reviewing your medical history and biomarker information to search and assess suitable trials.
Coordination: Assisting with the logistics of trial screening and enrollment, including communication with trial investigators and coordinators, and scheduling.
Advocacy: Ensuring your questions are answered and your concerns are addressed throughout the trial.
By leveraging our deep knowledge of oncology, molecular biology, and genomics, Navexio is committed to empowering you with the information and support needed to make informed decisions about participating in biomarker-driven clinical trials. Our goal is to leave no stone unturned in the pursuit of the most effective, personalized cancer treatments available.