In the push for innovation, regulators are ahead of the curve as pharma and CROs lag behind

By Melissa Fassbender contact

- Last updated on GMT

(Image: Getty/patpitchaya)
(Image: Getty/patpitchaya)

Related tags: Clinical trials, CRO, Drug development

As regulators work to advance the modern clinical trial, the risk-averse clinical research industry is falling behind in the race to bring new therapies to patients, says an industry expert, echoing the former FDA commissioner’s calls for innovation.

Hugh Levaux is celebrating 20 years in the industry this year, having begun his career in 1999 as a health economist at Quintiles, now Iqvia. Over this time, the biggest change has come from outside the industry with the advent of cloud-based services, which allow once fundamentally incompatible systems to connect, said Levaux, who is now the CEO and founder of Protocol First.

“The world is so hungry for data that software developers around the world have figured out ways to connect and bridge these worlds … And let machines do things that human beings have a very hard time doing,”​ said Levaux – which is where Protocol First comes in.

The company’s EHR-to-EDC application, Clinical Pipe (CP), is a “system-agnostic connector” linking electronic health record (EHR) systems, like Epic and Cerner, to electronic data capture (EDC) systems, such as Medidata Rave or Oracle InForm.

The company also has a proprietary eClinical platform, P1 EDC, which is focused on complex oncology trials, and is live at several major cancer centers as part of the Leukemia and Lymphoma Society’s Beat AML Master Trial​, for which Syneos Health is a contract research organization (CRO) partner. P1 EDC uses a proprietary electronic protocol (eProtocol) format to model any trial design, such as basket, master, platform, and umbrella.

While most of the company’s business is in the oncology space, Levaux expects it to percolate to other therapeutic areas, with demand being driven by the adoption of EHR across the industry – a trend two decades in the making.

EHR transformation and adoption

“There’s no question that the push of the prior administration of incentives for the adoption of EHR has made a big difference,”​ said Levaux, noting that the federal government invested billions of dollars as part of this.

There also has been what he called a “very measured approach”​ to getting hospital networks to update their technology. “So we essentially hopped on the bandwagon that essentially the taxpayer has been supporting,”​ Levaux said.

In parallel, changes in medicine and increasing complexity have morphed EHRs – which were originally developed as a billing system – to a clinical-decision support tool. Still, Levaux described the regulatory environment and the compliance environment as “a jumbled mess.”

“It’s already hard enough on the clinical research side of things to be FDA compliant and meet all those regulations,”​ he added. “But when you do EHR to EDC, now you have two sets of standards, now you have HIPPA for health care and Part 11 for FDA, and security obligation that are much stricter.”

This creates a “regulatory wall”​ that for many organizations, is very difficult to climb – a challenge Protocol First aims to ease. For example, health systems have very strict requirements when it comes to encryption, key rotation, data segmentation per region, so Clinical Pipe has incorporated these requirements so that both sponsors and research sites know that they meet all regulatory requirements.  

“We have a technology revolution that our grandchildren will know about … And it has barely touched clinical research,”​ added Levaux, speaking to the lack of innovation among EDC companies, which he said have not fundamentally changed their platforms over the last 20 years.

A 'continued reluctance to adopt innovative approaches'

In a change to business as usual, regulators are actually ahead of the software manufacturers and users, said Levaux.

The Office of the National Coordinator for Health Information Technology (ONC) – the division inside the US Department of Health and Human Services in charge of supporting interoperable, private and secure nationwide health information technology (IT) systems – is leading adoption of the latest technology, security, and encryption standards, he said.

The US Food and Drug Administration (FDA) likewise in July 2018 published​ a guidance which Levaux explained: “very clearly delineates how you get data from EHR into research databases.”

Additionally, prior to his departure in April, former FDA Commissioner Scott Gottlieb released a statement​ on new strategies to modernize clinical trials, including the use of master trials, incorporating EHR data, and advancing monitoring capabilities.

“Unfortunately, we’ve seen a continued reluctance to adopt innovative approaches among sponsors and clinical research organizations,” ​Gottlieb said, adding that in some cases the business models of these companies aren’t “compatible with the kind of positive but disruptive changes that certain innovations can enable.”

Gottlieb called on industry and academia to invest in and leverage these approaches “and develop new incentives that reward collaboration and data sharing across the clinical research enterprise.”

The FDA has caught up, but companies aren’t willing to take risks on the operational side of the business, said Levaux.

“It’s the pharmaceutical companies that are not really adopting [new approaches] … And that’s a big change,”​ Levaux added, citing the history of eSource or ePro, and the push from technology providers and pharma for clarification from regulators.

“I think the regulators on both sides of the chasm between health care and research are ahead of the curve. And yes, pharma and CROs are behind,”​ he added. “And in my mind, they will adapt, or they will eventually be left behind … Because, ultimately, patients need these innovative treatments faster.”

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