Understanding Trials
Clinical Trials
Learn about clinical trials and how they impact MDS care. Explore their purpose, process, and potential benefits to make informed decisions about your treatment.
What is a Clinical Trial?
A clinical trial is a research study that tests new medical treatments, such as drugs, medical devices, or procedures, to see if they are safe and work well in people. Clinical trials can explore new ways to prevent, detect, or treat disease.
Each clinical trial follows a specific plan, called a protocol, which outlines the study's objectives, methods, statistics, and organization. This protocol is essential as it ensures the trial is conducted consistently and rigorously, allowing researchers to reliably collect data, answer specific questions, and validate results from earlier laboratory and preclinical studies.
What is a Preclinical Study?
Preclinical studies, also called preclinical research, are the first steps taken to examine new drugs and treatments before they are tested on people. These studies are usually done in laboratories, where scientists use cells, tissues, and animals to collect early data on the safety and effectiveness of treatments.
During preclinical studies, researchers work out the best amount and way to give the treatment and look for any possible toxicities. This early research is very important because it helps provide the information needed to decide if the treatment is ready for clinical trials with human participants.
Find Clinical Trials for MDS
SparkCures offers a user-friendly platform where patients can search for trials, learn about eligibility criteria, and connect with trial sites.
Phases of a Clinical Trial
Clinical trials are conducted in distinct phases, with each phase designed to answer a different research question about the new treatment, such as how it works, its safety, effectiveness, and how it compares with existing treatments.
Phase I - Safety
In Phase I trials, a new treatment is given to human volunteers for the first time, with only a small number of people receiving it. The focus is to determine the safety and optimal dosage of the treatment. Researchers observe how the body reacts to the drug, noting any side effects.
Phase II – Safety, dosing & efficacy
Phase II trials involve a larger group of participants to further assess the safety and explore the effectiveness of the treatment. Phase II trials aim to determine if the drug works as intended for a specific condition and gathers more data on optimal dosages and potential side effects.
Phase III – Confirming safety & efficacy
Conducted with an even larger group of participants, this phase compares the new treatment to existing standard treatments. It confirms the new treatment's effectiveness, monitors side effects, and collects information that will allow the treatment to be used safely.
Phase IV – post-marketing safety and efficacy
Phase IV trials, also called post-marketing surveillance, happen after a treatment has been approved and released on the market. These trials collect additional data on the treatment's long-term effectiveness, benefits, and any rare or long-term side effects. This phase helps ensure ongoing safety and efficacy monitoring of the treatment.
