Year in Review 2014: R&D
2014 buzzed with discussion on how to make clinical trials more patient centric. We tried to identify key obstacles to patient enrollment and suggested practical solutions on how to overcome them. We also looked at technologies that will revolutionize R&D and celebrated medical breakthroughs.
Ben Adams speaks to Andrew Hessel about his radical approach to drug discovery. Hessel proposes that his “Pink Army,” a company that works as a cooperative, will change the face of pharma. “Where they create drugs for thousands or millions of people, I do it for one person. Where they charge money for their medicines, I give it away for free. Where they have shareholders, I have an open co-operative. And where it takes 15 years and over US$1.5 billion to create, I want to make my treatments in a few weeks for a few thousand dollars,” he tells eyeforpharma.
Nagaraja Srivatsan reflects on how to make clinical trials patient-friendly. Having identified the lack of personal connection to the trial as one of the main obstacles to patient enrollment and retention, Srivatsan proposes “code halos,” which are the field of digital information that surrounds a person, from which significant clinical value can be derived and measured. Using the B.J.Fogg’s Behavior Change Model as a framework for interpreting the data, the right engagement mechanisms to keep patients motivated and drive compliance and adherence, can be triggered.
Deirdre Coleman speaks to Koen Andries, VP Scientific Fellow in Research and Development at Janssen, who with his team developed a new antibiotic, bedaquiline, for the treatment of multi-drug resistant tuberculosis. The drug is now having a dramatic impact on people in developing countries where tuberculosis still rules. “I’ve seen [the devastation] in the eyes of patients and it’s very hard. We never realize what happens in the developing countries until we actually go there and witness it ourselves,” Andries says.
Scott Connor writes that in clinical trials “true patient centricity requires a multilevel process that combines good data with sophisticated analytics to help sponsors make fact-based decisions in planning and implementing more effective and cost-efficient enrollment and retention strategies". He provides pointers on how to put data to work, including how to involve patients in pre-protocol design, protocol feasibility, and site selection. “The data exists. The analytical capability exists. When fully armed, any sponsor can effectively plan and implement a highly successful enrollment and retention strategy with the patient at the center,” Connor concludes.
Two perspectives on patient centricity. Paul Ivsin sits down with Abbe Steel, CEO of HealthiVibe which focuses on bringing together patient input into the earliest stages of trial design through focus groups and patient surveys, and Casey Quinlan, co-founder of Patients for Clinical Research, which aims to be a force in patient education in engagement for clinical trials. Both speakers express cautious optimism, admitting that pharma hasn't made “substantial changes,” but that they have nonetheless achieved “pockets of success.”
Is patient centricity a fad, asks Paul Ivsin. It doesn’t matter if it is, he writes, as “patient centricity is an important objective and anything that enables [the industry] to get closer to that objective is helpful.” The current enthusiasm for patient engagement is likely to lead to more support and resources to make clinical trials a reality, and even if the fad passes, those resources will still be greater than if there had never been a fad.
Zuzanna Fimińska speaks to Don Wetherhold, CEO Aprecia Pharmaceuticals, about the opportunities and challenges associated with 3D printing of drugs. According to some visionaries, in the future, doctors will no longer write prescriptions, but will provide patients with algorithms that will allow them to print their own medication at home, making any drug cost-effective. Wetherhold believes that 3D printing will “help enable specialized approaches for delivering certain molecules or therapies, or both, offering ‘best fit’ solutions for patients whose needs are not fully met by other technologies.”
Although an astonishing 1.6 million new cancer cases were diagnosed in 2012 alone, only 15% of cancer patients are aware of opportunities to participate in research, and out of those, only 25% report participating in a trial, which amounts to 3% of all adult cancer patients. Those figures are shocking given that 40% of the U.S. pharma industry’s collective clinical trial budget is allocated to recruitment. In this article, Zuzanna Fimińska explores the key barriers preventing patients from trial participation, and identifies five steps to boosting enrollment.
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