Different individuals may respond to medication in different ways. ![]() Our phase IV clinical studies alone cannot establish cause-effect relationship. WARNING: Please DO NOT STOP MEDICATIONS without first consulting a physician since doing so could be hazardous to your health.ĭISCLAIMER: All material available on is for informational purposes only, and is not a substitute for medical advice, diagnosis, or treatment provided by a qualified healthcare provider. Our analysis results are available to researchers, health care professionals, patients ( testimonials), and software developers ( open API). Results of our real-world drug study have been referenced on 700+ medical publications, including The Lancet, Mayo Clinic Proceedings, and Nature. We study millions of patients and 5,000 more each day. With real-world medical big data and proven AI/ML algorithms, eHealthMe provides a platform for everyone to access and run their own phase IV clinical trials. You can discuss the study with your doctor, to ensure that all drug risks and benefits are fully discussed and understood.ĮHealthMe: the source of phase IV clinical trials The FDA has started to use real-world data to monitor postmarket safety and adverse events, and payers to support value-based payment program. The 21st Century Cures Act, passed in 2016, places additional focus on the use of real-world data to support regulatory decision making. These programs potentially contribute to the variability of the quantity and quality of evidence supporting recent drug approvals.Īll these suggest an ongoing need for continued evaluation of therapeutic safety and efficacy after drug approvals. When the drugs are approved and released in the market to a much bigger and ever-changing public, it is not uncommon for drugs to behave differently in the real world than in (phase I-III) clinical trials.ĭuring the past 30 years, special regulatory programs are available to the FDA including Fast Track (1988, in statute 1997), Priority Review (1992), Accelerated Approval (1992), and Breakthrough Therapy designation (2012). The guidelines ensure that only a selected set of people are chosen due to time and costs. These clinical trials have guidelines about who can participate. New drugs have to go through a series (phase I-III) of clinical trials before they are approved by the FDA. With real-world big data and AI/ML algorithms, eHealthMe is running millions of phase IV trials and makes the results available to the public. As a result, rare or long-term effects of a drug can be observed in a much larger population of patients and over a much longer period of time in phase IV trials. Phase IV trials are used to detect adverse drug outcomes and monitor drug effectiveness in the real world, as opposed to phase I-III trials that are used under specific guidelines.
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