Year in Review 2015: Clinical
Here are the top clinical articles of 2015.
Industry leaders have been walking the patient-centric talk in 2015 in order to bring much needed change to the process of conducting clinical trials. Here are some of the innovative efforts aimed at reducing costs and putting the patient at the center of the trials process.
Melva Covington, Senior Scientist in Global R&D at Sanofi, shares some strategies with eyeforpharma readers on how to produce clinical trial data more representative of real-world diversity. Such strategies include, but are not limited to, partnerships with advocacy groups, payers, scientists and government agencies. Covington says, “Every engagement we do with our patients and communities enable us to look at rich information and understand the diversity of the populations we are querying.” She also stresses that in any clinical trial, it’s not just about ethnic diversity - but also gender and geographical diversity.
Covington’s concerns about reaching all segments of the population for recruitment, as well as engaging with each patient’s experiences before, during and after trial participation, are echoed by Paul Ivsin. Ivsin points out that the danger of engaging with patients online (e-patients) is that these participants don’t necessarily represent the true diversity of patients. Consequently, pharma needs to find ways to engage all participants. Indeed, although e-patients are becoming “active chronicler[s], providing a vividly 3-dimensional portrait of their condition and its impact on their life,” a study on US e-patients has revealed them to be younger, wealthier, better educated, and less ethnically diverse than the general population.
One option for enhancing patient engagement in clinical trials is through the ‘Twittersphere.’ This is certainly what Carmen Gonzalez, Communication Project Manager at Health Services Advisory Group, Inc., has found. She told eyeforpharma, “By engaging patient advocates directly, you respect their prominence in the public sphere and let them make the call if they deem your client's research worthy of circulation. That respect creates goodwill.” In addition, patient education through approved tweets can go a long way in building a culture of trust, and, to prevent patients feeling forgotten after a trial, easily understandable results can be tweeted - keeping participants in the loop and reinforcing that trust.
Trust can be further reinforced by standardizing the patient feedback approach. Dr Stephanie Manson, GSK’s Value Evidence Leader, believes the problem with pharma trying to be more patient-centric is “the lack of a unified approach.” GSK's Clinical Trial Patient Feedback Questionnaire, which stemmed from informal discussions with a kidney cancer patient, was developed to address this by successfully engaging patients with the clinical trial process. This innovative approach to unifying patient feedback was shortlisted in the ‘Most Valuable Patient’ Initiative category at eyeforpharma’s Barcelona Awards.
One of the factors leading to failures and costly trials is a lack of high-quality data necessary to make crucial decisions at various stages of the drug development process. Bartley O’Connor, Director of PatientPharma collaborated with pharma to conduct a pilot project where patients recorded short videos about how they are feeling. These videos were then sent to their medical teams using an app on a mobile device, enabling real-time feedback about the patient experience through words and images. A simple and direct solution, it allows a two-way flow of information between the medical team and patients.
In eyeforpharma’s whitepaper, Patient-Centred Clinical Trial: A New Paradigm, Organization Management Consultant Joyce Avedisian and 100 senior clinical leaders explored the patient’s central role in clinical trials. The aim was to gain insight into how interactions with patients should be taking place. This article touches on some of the key findings within this thought paper, with a specific focus on putting patients at the center of clinical trials by aligning the heart, head, and hands within the research sponsor’s organization and among all key stakeholders.
Is there a better way to carry out clinical trials? Dr Andree Bates of Eularis believes so and provides insights into how better trials can be achieved. The key message within this article is that if companies could weave trials into development more, they would be “far more successful in their efficacy results and outcomes for patients – and profits.” Given the current length, cost, and inefficiency of clinical trials, Bates argues for utilizing trials more as part of the research process.
Efforts by companies to tackle the rising costs of clinical research led to the establishment of common clinical quality standards across the industry. It also led to the formulation of a framework for risk-based monitoring via TransCelerate, a non-profit organization that collaborates with pharma companies, research organizations, health authorities, and academia with the common goal of improving clinical trials. Dr Jeffrey Kasher, who was instrumental in getting TransCelerate off the ground, talks about his continuing drive towards establishing common standards through technology in his current position as Director of DrugDev.
Moses Zonana, CEO of CleverCap , talks about the CleverCap adherence platform, which provides accurate recording of multiple data points to identify a patient’s level of adherence, critical dosing, and timing. With half of new drug compounds failing to demonstrate efficacy, pharma need to take into account that non-adherence to medication –found in 43% to 78% of trial participants - is often causing drugs to fail at the therapeutic trial level. Could CleverCap be a solution?
“We know we need to engage with patient groups early and often - so it is really about starting off a relationship, and you have to look at this relationship being long-term,” says Dr Jeff Sherman, Chief Medical Officer and Executive Vice President at Horizon Pharma. In this article, Sherman makes the symbiotic relationship clear: the industry needs patients in order to bring drugs to market and we, as patients, need those drugs - if not now, perhaps at some point in the future. Therefore, the focus of pharma teams during the clinical trial process should be on creating an experience that is as patient-friendly and healthcare-professional-friendly as possible.
Sonal Singh, Assistant Professor of Medicine, Health Policy, and Management, and International Health at John Hopkins University, provides actionable advice on how to conduct trials in a timelier fashion. The coordination of trials, appropriate funding, and the use of technology in addition to methods for patient engagement in designing trial endpoints are aspects to be considered in cutting clinical trial times. In particular, technology allows clinical operations teams to analyze, visualize, and share data, resulting in time savings of around 30% compared to paper-based methods.
Dr Anne Beal, Chief Patient Officer for Sanofi, emphasizes the importance to research of input from patients, the topic of eyeforpharma’s whitepaper, ‘Clinical Trials: How Bringing Patients to the Centre Can Cut Costs and Deliver Better Outcomes.’ Beal believes the patient is the core of business and all activities should be centered around patient needs. With this in mind, the future of patient-centric clinical trials is explored, including the challenges and the role of technology in facilitating such trials.
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