The clinical research enterprise is “at best the sickliest link” in the chain between patients, the healthcare system, and science that can and should bring cures and better therapies, according to Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research (CDER).

“We have a sicker population, we have expensive new interventions and we have wonderful new science that is begging to get translated and evaluated,” said Woodcock in her keynote address at the recent Bridging Clinical Research and Clinical Health Care conference. “All these forces are coming together and converging on the clinical research enterprise. We must bridge clinical research and healthcare, or the entire enterprise is going to fall down.”

To illustrate how little research is getting translated into new directives for healthcare providers, Woodcock explained that only about 15 percent of professional guidelines for healthcare providers in the U.S. are based on evidence from evaluation of trials or actual data; the rest are based on expert opinion. Innovations abound, she said, but we still lack the means to evaluate their impact, and that is a shortcoming of the clinical research space.

“We keep trying things and changing things, but we aren’t ever really sure whether we’ve gone in the right direction or actually taken a step backward,” Woodcock said. “For new pharmaceuticals, despite the billions of dollars spent developing them, we often lack important information when they come on the market about how they’re going to perform in the real world. And we don’t really have a good way of evaluating how they’re performing in the real world.”

The crux of the problem, she said, is that the goals sought by each sector of the healthcare and clinical research arenas have far more to do with other priorities — such as financial gain, tenure, business goals — than they do the kind of collaborative learning that will bring new cures.

“Currently I think almost all the incentives, financially or otherwise, in this whole vast healthcare ecosystem are aligned against collaborative learning,” she said. Woodcock listed the stakeholders that interact with patients and study subjects, explaining where they err.

For academic clinical researchers, she said, the focus is often primarily on tenure, obtaining grant support and productivity in the clinic. And insurers and payers, while they could benefit from increased knowledge from clinical research about what works best, do not focus on learning. “It’s not their business,” said Woodcock. “It’s not how their incentives are aligned.”

Healthcare providers, meantime, work in a fee-for-service environment that is antithetical to research, adding, though, that she expects large healthcare networks to eventually emerge as entry points for bridging research into healthcare more rapidly.

The medical product industry, she said, is now mired in increased research complexity coupled with an overarching desire to create new revenue streams, and these get in the way of maintaining a pure focus on learning and quickly sharing new information gleaned from research.

So NIH then? Well, no. NIH, said Woodcock, has spent the last 40 to 50 years building up the basic biomedical research enterprise, and now that must be sustained.

“The enterprise is like a hundred and fifty baby birds — it has to be fed,” said Woodcock, mentioning laboratories, thousands of post docs, securing of grants and research centers all across the U.S. “I don’t think you can look to NIH and say they are going to fund this enterprise and bring about these transformations. They have other incentives, other pressures on them,” said Woodcock.

Given all these badly misaligned pressures on the industry’s key stakeholders, Woodcock offered her thoughts on how to proceed in building “a nice, sturdy bridge instead of this very flimsy and teetering bridge.”

1. Put the patient and the treating practitioner in the center of the efforts. “That’s what this enterprise is supposed to be about: people who need treatment,” said Woodcock.
   

   She added that ignoring community physicians and not sharing study results with them is part of the problem, and must stop. “Their marginalization has lead to the fact that most people are not referred into clinical research in any way because their healthcare practitioners are marginalized from this enterprise and don’t want anything to do with it,” she said.

2. Information collection on patients in trials should be well integrated into their overall healthcare. “The clinical research from the trials are often in a different universe that doesn’t hinge on real life, real doctor visits, real patient visits, or patient’s lives,” Woodcock said.
3. The data collected must be robust by design or intent, not by quality control, she said, adding that data produced only to satisfy quality control requirements alienates the whole enterprise from the actual flow of data. The best case scenario: a world in which we verify key elements in integrated fashion into the health record so that we can rely upon those elements, and in a way that no one needs to repeat input efforts, said Woodcock. But we’re not there yet.
4. Currently, consent documents are long and unwieldy. Patients don’t understand them. Most don’t read them. Said Woodcock, we need to figure out how to do consent and randomization seamlessly within a digital environment so that potential subjects are not turned off to research right out of the gate. “It’s a nut that will have to be cracked in order to do more efficient learning in healthcare,” she said.
5. We need rapid knowledge terms, said Woodcock. She pointed to pilot programs, taking small steps, garnering quick feedback and quick confirmation on whether one is on the right path or not, then communicating that to all stakeholders.

Said Woodcock, “People are really eager for answers; They don’t just want to wait ten years to hear: do this. But right now, what do we tell them? ‘Here’s what we found in this study but more research is needed.’ How does that help a practitioner or patient? We need to say, ‘This is what we know now, and if you participate, in one year we’ll know more and we can feed that back to you and to your doctors, and we will build on that so the knowledge we gained from you will count. It will make a difference.’”

If those in clinical research can do that, the rapid knowledge feedback loop will start sustaining itself, she said.