Mimi Traylor-Knowles co-wrote this blog post with Maria Whitman.
Thomas Edison said: “There is a way to do it better. Find it.” Real-world evidence is a tool to help us do just that.
The theme at this year’s American Society of Clinical Oncology (ASCO) 2017 Annual Meeting (ASCO) was "Making a Difference in Cancer Care With YOU," which highlights the importance of everyone's involvement in improving care for patients with cancer. This theme also reminds us that improving care is part innovation and part application of what we have to do better.
At ASCO, I sat down with Dr. Yousuf Zafar, associate professor of medicine and public policy at Duke University, to talk about real-world evidence. We agree that real-world evidence is a critical tool to help deliver better, individualized care to patients. However, unlocking its potential requires each and every stakeholder to play a specific role:
- Patients: According to Dr. Zafar, “The largest impact patients can have is their voice.” The focus on patient-centric care is growing, and new data released at ASCO proves that listening to the patient’s voice can result in real benefits to the patient’s survival. A new study conducted at the University of North Carolina and reported at ASCO’s plenary session shows that patients who had access to a web-based portal where they could report their symptoms extended their survival by five months over patients who didn’t have access. When we compare this to improvements achieved by some novel therapeutic interventions alone, there’s no question of the value of the metrics and data generated with and by patients.
- Providers: Providers play a unique role as a source of data collection, ultimately influencing the quality and quantity of information available. Dr. Zafar has recognized an increasing requirement to thoughtfully and rigorously design and collect data points that will capture the most important metrics for patient care. This isn’t an easy task considering the additional burden that it may place on practices and their staff, but it’s an important step forward.
- Payers: Zafar notes that payers have an important role now due to the amount of information at their disposal. If payers can compliantly share information with other stakeholders in the ecosystem, they have a strong opportunity to improve the depth and quality of available data. Payers are armed with data on therapy type, patient response and cost, which are important pieces of data to consider when evaluating which cancer therapy should be provided to a particular patient.
- Regulatory agencies: Zafar encourages regulatory agencies to feel empowered to consider real-world evidence in their approval decision-making process, and presentations at ASCO indicated that this was in the works. A presentation by Dr. Sean Khozin, senior medical officer at the Food & Drug Administration, acknowledges that the current clinical trial model is stuck in the past. The FDA is actively working on using real-world evidence from electronic health record systems to help guide regulatory decisions.
- Pharmaceutical manufacturers: Zafar believes that manufacturers have a particularly special role in the process since they’re ultimately responsible for the data that gets the drug approved. However, while manufacturers pursue their foundational trial data, Dr. Zafar encourages them to use “outside-the-box thinking” and seek out new partnerships and collaborations to continuously generate data for an agent outside of the randomized trial setting.
While each stakeholder has a role, Dr. Zafar acknowledges that progress will only be achieved with partnerships—and progress isn’t that far off, either. Dr. Zafar notes that the technology is already here. We just have to unlock its power by generating high-quality data. In five years, he envisions that we’ll have moved beyond why real-world evidence is important and the basics of collection and coordination, and we’ll be discussing how to do it best. How do we get there? It starts with you.