The US Food and Drug Administration (FDA) has a long history of using Real-World Evidence (RWE) in the postmarket phase of a new drug. The FDA uses RWE to monitor and track adverse events caused by drugs after the approval, in order to make regulatory decisions or develop guidelines for clinical practice.
In recent years RWE and Real-World Data (RWD) have been playing an increasing role in healthcare, driven by an increased demand for more efficient and faster development of medical products. The FDA has therefore opened up to Real-World Evidence to speed up drug development. In the United States, the 21st Century Cures Act, passed in 2016, modified the FDA Drug approval process by easing the requirements to help accelerate new medical product development. The Act placed a specific focus on RWE to modernize clinical trial designs and support regulatory decision-making processes. Two years later the FDA published a detailed framework for FDA’s Real-Word Evidence Program.
“FDA will work with its stakeholders to understand how RWE can best be used to increase the efficiency of clinical research and answer questions that may not have been answered in the trials that led to the drug approval, for example how a drug works in populations that weren’t studied prior to approval” declared Janet Woodcock, Director of the Center for Drug Evaluation and Research.
How RWE can help clinical research
Technological developments like the Internet of Things, Artificial Intelligence and Machine Learning allow healthcare professionals to collect large amounts of data using computers, smartphones, or wearable devices. Analyzing these data can improve how clinical trials are conducted and help researchers observe product effectiveness.
To give a few examples, RWE can help generate hypotheses for testing, assess trial feasibility, widen the geographical area to include patient minorities, identify patient characteristics, track patients outcomes and collect data in real-time. Real-World Evidence is also one of the strategies to implement a patient-centric approach and actively engage patients during all the phases of clinical trials.
Generate RWE to improve clinical trials
Patchai is a Saas solution to connect patients and healthcare professionals during clinical trials and standard care routines. Patchai platform allows to collect Real-World Data and generate Real-World Evidence in real-time, while improving patient experience and increasing adherence to therapy.
Learn more about how Patchai is working to help CROs and Pharma companies to implement RWE in clinical trials and standard care.
Patchai develops intelligent digital health engagement solutions for decentralized clinical studies. The company has received funding under the Smart&Start Italia program. The funding supported the company to develop its clinical research and standard care platforms and to internalize core functions (IT, business development, marketing&sales, medical affairs, clinical operations, human resources). The company will continue to advance the predictive capabilities of the CO-PRO® technology and the IoT integration of its products.