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Panel Detail

Pulling back the curtain on clinical trials data

Monday, November 17, 2014
9:15 AM - 10:10 AM


Gregory Curt, Chairman, Life Sciences Consortium, CEO Roundtable on Cancer; Executive Director, US Medical Affairs, AstraZeneca
Craig Lipset, Head, Clinical Innovation, Worldwide Research & Development, Pfizer Inc.
Joseph Ross, Assistant Professor, General Internal Medicine, Yale University School of Medicine
Katherine Wilemon, Founder and CEO, FH Foundation


Jonathan Simons, President and CEO, Prostate Cancer Foundation

In the United States, companies are scrambling to set policies about reporting and sharing data from clinical trials, and they are also working in earnest to share data in ways that can benefit them all. During a Partnering for Cures panel, "Pulling back the curtain on clinical trials data," a group of experts representing a variety of stakeholders in the medical research system gathered to talk about the challenges of making the most of these data. Describing the current state of data in the clinical trial realm, Gregory Curt of the CEO Roundtable on Cancer and AstraZeneca said, "We spend hundreds of millions of dollars on clinical trials around the world and then lock the data in a tomb, while all the while patients think that this data is being used."

Curt went on to say that academia and pharma often blame each other for this problem, but both parties have a responsibility to improve. Joseph Ross of Yale University School of Medicine agreed, saying that "even in NIH-sponsored studies, only two-thirds of clinical trials are published."

The panelists discussed ways in which data can be harnessed from the "tomb" and be put to use for the benefit of patients. A consensus of panelists agreed that, as a starting point, both academia and industry need to responsibly share and analyze data generated from clinical trials. As an example, Curt cited Project Data Sphere, which is a platform to share, integrate, and analyze oncology trial datasets to revolutionize cancer research.

Katherine Wilemon of FH Foundation described her goal of raising awareness of familial hypercholesterolemia (FH) through education and research. She faced the challenge of having little data from which to draw conclusions, and she saw an opportunity to create a registry for people with FH. She explained that a unique aspect of this registry is that it has two portals to enter data and view content – a patient portal and an institutional review board portal. She created the registry in this fashion because she wanted to make sure that the patient's voice is heard and not just an object being reported on.

These projects and others led by large pharmaceutical companies are a step in the right direction to sharing and using data in innovative ways. "The real lesson to be learned is that there is a lot of data out there that can really inform clinical practice," said Ross.

In closing, the moderator, Jonathan Simons of the Prostate Cancer Foundation, challenged the panelists to prescribe solutions that would improve use of clinical trial data. Many panelists focused on improving informed consent of patient data. Wilemon noted that 'it is difficult for patients to do a risk analysis for sharing data,' and others agreed that there need to be better tools available to help patients weigh decisions around sharing personal data.

Craig Lipset of Pfizer added that "90 percent of patients with access and control of their data want to share it." A way of allowing them to share data with not only one provider or in one clinical trial is through global consent, which gives permission for data to be used in more than one registry.

This idea and the others offered throughout the panel may have the potential to disrupt how we both collect and share data in research today. As we continue to build systems that are able to capture data more efficiently and quickly, the amount of data that we have to inform clinical practice will continue to grow, and solutions for sharing and analyzing it will be of increasing importance.