What is quality? For Patricia Leuchten, CEO of The Avoca Group, and the members of its Quality Consortium, quality can be a platform for innovation and change. And the way forward for clinical research innovation is by breaking down the silos, taking advantage of advancing technology and building bridges to patients. And that is how Leuchten set the stage for Day 2 of The Avoca Group Quality Consortium Summit 2014.
The Consortium is sponsored by Eli Lilly and Pfizer, and features 23 other sponsors, as well as 11 CROs as members. Day 1 of the Summit was a members-only event, Day 2 on May 7, was open to all, offering ideas that captured Leuchten’s three pillars addressed in the opening.
Quality by Design
Quality by Design (QbD) started the breaking down silos aspect with presentations by Janis Hall, Senior Consultant at The Avoca Group who presented survey data on the use and understanding of QbD among its members. Coleen Glessner, VP, Head of Clinical Trial Process and Quality at Pfizer, shared her professional road to quality and her explanation that QbD is to plan, control, and improve clinical trials. Following that, panelists discussed QbD, with a lot of focus on protocol design and development, and changing the paradigm to eliminate amendments and address complexity upfront.
Another presentation offered a peek into the changing world of healthcare providers and how that is changing clinical trials, both from a physician and patient standpoint. Specifically, Jennifer Byrne, CEO of PMG Research, noted how more and more physician investigators belong to larger medical practices and patients go into larger systems rather than single practice offices. She said that investigators may not be able to go to pharma-sponsored investigator meetings like they did before when they were in their own practice because now they have their own boss.
PMG Research partnered with Wilmington Health, a large integrated multi-specialty medical group practice in Southeastern North Carolina, to bring clinical trials to its patients. The partnership began only in October 2013, but early data presented by Wilmington Health’s CEO, Jeff James, showed that its patients in clinical trials have higher satisfaction scores with the group vs. patients in the general population, and that patients in clinical trials have lower per patient costs vs. other patients. Another stat showed that diabetic patients in clinical trials had higher control of their glycemic numbers at 89.1% vs. 79.4%. While James didn’t have data to understand why this is, he says that clinical research is becoming a significant strategic plan for the group.
Patients Like Me
Jamie Heywood is founder of Patients Like Me, a website he conceived after his first stint on Match.com in 2005, as well as extensive experiences and research dealing with his brother’s diagnosis and subsequent death from ALS. The website was designed to give patients in depth information on outcomes, treatments, and studies that they can use to make more effective decisions on managing their illness, as well as share their information and get or provide support to others.
In the website, patients can chart their health, medical history, quality of life, and using that data, Heywood presented how he and his colleagues could predict a current ALS trial wasn’t going to meet its endpoints criteria. You can read about how they used their data to achieve the results in this BMJ article.
Using a linear drawing, Heywood described the life or health of a patient. In one very tiny sliver of their health span would be a patient participating in a clinical trial. But Heywood maintains that industry treats the patient like the clinical trial is all that matters. “Do you ask them about their life?” he asked this audience of industry professionals. He says that industry should partner with patients, and respect them. Heywood believes that advancing technology, coupled with a focus on the patient, healthcare is changing to a holistic health span. And that span is or includes integrated, discovery, validation and care.
Heywood acknowledged the industry fears of regulators that could de-rail an approval or even patients that could compromise trials via social networks or even the current state of compassionate use. However, he believes that more can be done to achieve goals for all the parties involved.
The BMJ article that Heywood and his colleagues authored summed it best when they wrote “we propose forging a new social contract that maximizes both scientific discovery and patient autonomy, setting the stage for better trials with more engaged participants. Together we can develop rigorous new methods to include patients in selecting therapies, protocol design, recruitment, feedback, lay summaries, publications, and assessment of value.”