Clinical research a ‘sickly link’ in health care enterprise: CDER director

Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA) has been talking about collaboration for a long time, she said during her keynote presentation at the inaugural Bridging Clinical Research and Health Care Collaborative.

“We have made some progress, but I am here to say we must bridge clinical research and health care or the entire enterprise is going to fall down,”​ she added. “There is just no choice.”​

Health care demands and costs are rising; there are expensive new interventions and “wonderful new science,”​ said Woodcock. “All these forces are coming together and converging on the clinical research enterprise, which is at best a sickly link in this chain,”​ she explained.

In the US, only about 15% of guideline recommendations are based on evidence from trials or actual data, she explained. While “innovation abounds”​ the industry lacks the means to evaluate its effectiveness.

“We keep trying things and changing things, but we aren’t ever really sure whether we’ve gone in the right direction or taken a step backward,”​ Woodcock said. This, despite billions of dollars spent in development.

Currently, almost all the incentives in the whole enterprise – financially or otherwise – are aligned against collaborative learning, she explained. As part of this, Woodcock said fewer people are going into clinical research as a profession and that clinical researchers themselves are “under assault.”​

The industry needs people who are willing to “go beyond the basic job description”​ to work in “the space left open by these huge incentives that exist,” ​Woodcock said.

“That’s always who brings about change – It’s not the people who are right in the center doing well by the structure that currently exists and profiting personally from the existing enterprise, because they don’t see the problem,”​ she added.

This “open space”​ will allow motived people to collaborate and create a new set of research methods, which Woodcock said could revolutionize the creation of medical knowledge.

“We are at a crossroads and have been for a few years,”​ said Badhri Srinivasan, head of global development operations at Novartis.

While there have been “massive advances in research”​ and there are “massive”​ patient needs “the bridge in the middle still has not been built – and we need to build that bridge,”​ he said.

Srinivasan said his biggest fear is that the industry will think small, about the problems of tomorrow rather than long term – “Not thinking about how to land a rocket vertically, but how to build a rocket cheaply,” ​he explained.

Designing the bridge between clinical research and health care​

In building a bridge “to this new state,”​ Woodcock said an essential feature will be to “put the patient and the treating practitioner in the center of its efforts.”​

Patients and community practitioners have been marginalized by increasingly complicated science and the industrialization of clinical trials. Moving forward, Woodcock stressed that these providers must be brought back into the enterprise.

“The marginalization of community physicians must stop,”​ she said. “Those are the people delivering health care.”​

As Woodcock explained, this marginalization has led to the fact the patients in the US are not referred to clinical research.

“Two percent or less of the eligible population in the US participate in clinical trials,”​ Srinivasan added, and between 50 and 80% of patients do not get recommended.

“We need to democratize clinical trials,”​ he said. “We have treated this whole transaction as a business-to-business transaction, we need to change it to a business-to-consumer transaction.”​

Also as part of the bridge, Woodcock said the industry must integrate information collection into the workflow – “It can’t be a separate activity,”​ she explained.

“Data collected must be robust, but it must be robust by design, by intent – not quality control,”​ said Woodcock.

“Whatever changes that we try to make in this bridge, whatever struts or elements we try to put to reinforce this bridge, one of the most important things is not only putting patient and practitioners at the center, but feeding that information back to them…making them full participants in this clinical research enterprise,”​ she added.