Robert Califf, FDA - Stanford Big Data 2015

TL;DR

The FDA aims to improve the evidentiary basis for medical decision making and decision making about individual health by utilizing big data and advancing innovation.

Transcript

I was here last year in a very different capacity talking about the Google baseline study now I have a somewhat different topic my real job here is really to be a front man for Taha who will be following and showing you some very specific things going on at the FDA and opening up the knowledge base and the treasure chest it really exists inside of ... Read More

Key Insights

• 😷 Good evidence is essential for informed medical decision making and can prevent disputes based on opinions without a factual basis.
• 🧑‍⚕️ The FDA has the complex task of balancing the protection of public health with the advancement of innovation.
• 😃 Big data presents challenges and opportunities for the FDA, including considerations of biomarkers, patient-reported outcomes, and curated data.
• 💁 Patients' involvement in research and control over their health information is increasing.
• 😷 The FDA's role is crucial in assuring the safety and effectiveness of medical technologies.
• 😃 Collaboration between various stakeholders is necessary for successful implementation of big data in healthcare.
• 😃 Responsible use of big data by the FDA can lead to better decisions and improved quality of life for individuals.

Questions & Answers

Q: What is the speaker's main goal at the FDA?

The speaker aims to improve the evidentiary basis for medical decision making and decision making about individual health.

Q: How does the FDA balance its mission to protect public health with its mission to enhance innovation?

The FDA must find the right balance between promoting innovation and minimizing risks to public health when it comes to new technologies and therapies.

Q: What are some key considerations for the FDA regarding big data?

The FDA needs to navigate issues like biomarkers, patient-reported outcomes, and the use of social networking and curated data in the healthcare system while protecting intellectual property.

Q: How does the FDA involve patients in the decision-making process?

Patients are no longer just beneficiaries of medical research but are now active participants in the design, funding, and prioritization of research projects.

Summary & Key Takeaways

• The speaker acknowledges that his ideas and implementation strategies at the FDA are a work in progress, but he aims to improve evidence-based medical decision making.

• The FDA has two missions: protecting public health and advancing public health through innovation, but these missions can sometimes be in conflict with each other.

• Big data and cross-cutting issues like biomarkers, patient-reported outcomes, and social networking are important considerations for the FDA.