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Regulatory News | 09 August 2016 | By Michael Mezher
US Food and Drug Administration (FDA) Commissioner Robert Califf is calling on cardiologists to embrace new technologies and data sources, such as genetic sequencing, regenerative medicine, personal electronic devices and social media, in order to improve patient outcomes moving forward.
Califf, himself a renowned cardiologist, makes the call in an editorial published in the August edition of the Journal of the American College of Cardiologists.
"The FDA is responding to this changing world. However, we believe the needed changes must involve not only the FDA but the entire ecosystem of which the FDA is a part. As we work together to shape the future of medicine, cardiovascular specialists will play a special role," Califf writes.
Despite recent advancements in cardiology, which Califf says have resulted in "a nearly 40% reduction in the risk of death from cardiovascular disease," Califf believes the next great strides will come from integrating new technologies into the field.
"We are now entering a new era in medicine that is characterized by dramatic accelerations in biological and information sciences and near-ubiquitous uptake of social media and personal devices," Califf writes. In order to move forward, Califf says that cardiologists must work to combine these new technologies and data sources to steer clinical decision-making.
However, Califf cautions that adopting such new technologies caries an inherent risk if not adequately researched: "The potency and integrated nature of these interventions also increases the potential for harm if they are used inappropriately or if their development plans do not generate the evidence needed to guide practice, tipping the balance of risk and benefit in an unfavorable direction."
Here, Califf says that cardiologists must lean in to new methods of evidence generation, including so-called real-world evidence, which Califf has called FDA's "top programmatic priority."
"The cardiovascular community has been a leader in evidence-based medicine, yet only about 15% of its major practice guideline recommendations are currently supported by high-quality evidence," Califf writes. Going forward, Califf says researchers must leverage new data sources, including electronic health records, social media and data generated by patients' wearable devices.
Califf also urges cardiologists to make better use of phenotyping to inform the development of early stage products: "From the FDA's perspective, better phenotyping would yield much more informative early-phase clinical trials and facilitate the detection of therapeutic benefit and off-target toxicities much earlier in the development process.
"Now, ingenious research and technology development, combined with general advances in biological and information technologies, will further accelerate improvement in outcomes. But if we are to harness these technologies and apply them effectively, our systems for evidence generation and healthcare delivery must continue to improve in concert with drugs, devices, and biological products," Califf concludes.
The Future of Cardiovascular Medicine From the Regulatory Perspective
Tags: Cardiology, Robert Califf