understanding fda expectations

Evolving Needs for CROs: Understanding FDA Expectations

The global contract research organization services market is set to reach $90,926.3 million in 2026, up from $38,396.4 million in 2018, exhibiting a compound annual growth rate of 9.9 percent, according to Fortune Business Insights.

It’s clear that outsourcing clinical trials continues among sponsor organizations. Still, that doesn’t mean there isn’t room for improvement — according to outgoing Food and Drug Association commissioner Scott Gottlieb.

In this post, we look at the challenges Gottlieb set for CROs, what his successor expects from them and how they can evolve to fulfill these demands.

Who is Scott Gottlieb?

Gottlieb, who assumed the lead role in 2017, was “the modernizing FDA commissioner,” says healthcare journalist Ben Adams at FierceBiotech. The physician served as deputy commissioner for medical and scientific affairs during the George W. Bush administration.

Throughout his two year tenure, Gottlieb showed commitment to speeding the delivery of drugs to patients, writes Dominic Tyer at Pharmaphorum. He also “worked to make generic drugs more accessible, lower the prices of branded medicines and speed the development of digital health tools and products.”

Who is Ned Sharpless?

The acting head of the FDA, Ned Sharpless, has suspended his work as head of the National Cancer Institute. Before his role there, he ran the Lineberger Comprehensive Cancer Center at the University of North Carolina and has also co-founded biotech companies for developing cancer drugs and blood tests, explains Jill Wechsler at Pharmaceutical Executive.

“The appointment won praise on all sides, as Sharpless is a respected cancer researcher and well-acquainted with FDA operations and challenges,” she writes.

Outgoing Commissioner’s Criticism of CROs

Outgoing FDA Commissioner Gottlieb has criticized sponsors and CROs of being slow to embrace innovation, resulting in more expensive and less effective clinical trials. Industry players have not been collaborative due to research organizations and sponsors’ legacy business models, he adds. Gottlieb wants a research market driven by new approaches to make it more agile, explains global biopharma industry reporter Nick Paul Taylor.

The outgoing head issued guidance as to how clinical trials should be run and regulated, employing mobile technologies, master protocols and new endpoints. However, he acknowledges the many challenges CROs face, including technical struggles involved in research. But he believes that new incentives to encourage collaboration and data sharing will be effective.

Gottlieb referred to the words of Janet Woodcock, director of the Center for Drug Evaluation and Research: “We must bridge clinical research and healthcare or the entire enterprise is going to fall down. There is just no choice.”

Taylor says that this means CROs will need to use technology to integrate clinical trials into routine healthcare.

What Gottlieb Started Before His Departure

With some trials costing as much as $22 million to produce a drug, Gottlieb committed to bringing down the cost of conducting studies. His aim was to democratize the playing field for those conducting trials, writes medical research reporter Jeannie Baumann.

Gottlieb said this could happen by extending study sites beyond hospitals and universities to smaller sites such as community health centers. The result would be improved patient access to trials.

He also wanted changes to the way CROs approach quality control, which is costly and does not substantively improve the integrity of data. Additionally, the added quality control layer CROs currently employ makes the task of moving trials to smaller community health centers much more challenging, reports Baumann.

Not everyone thinks the criticism is fair. Matt Feldman of the Association of Clinical Research Organizations told Baumann that CROs have already done much to democratize clinical trials. They’ve embraced digital solutions, shifted study locations and tried to improve patient access to trials.


Acting Head to Follow Same Path

Acting FDA commissioner Ned Sharpless has his predecessor’s nod of approval to take on the role full-time, says FierceMedTech associate editor Conor Hale. Gottlieb has recommended Sharpless be named commissioner, tweeting “Ned is a friend to FDA, a great public health champion, a dedicated physician, and will be warmly welcomed into his new role. FDA will benefit greatly from his leadership.”

Sharpless says he will continue the journey that Gottlieb set the agency upon and he won’t be treating his role as temporary or part-time, writes Ben Adams, senior editor at FierceBiotech. He plans to increase competition, lower the cost of prescription drugs and improve generic drugs and biosimilars programs.

CROs are Data Aggregators of RWE

Integrating clinical trial research with routine healthcare is the goal, but the route to achieve it requires effective analysis of real-world evidence (RWE). And acting commissioner of the FDA Ned Sharpless wants more real-world evidence.

This means CROs have to become highly adept at data gathering, aggregation and analysis, says reporter Jacob Bell at BioPharma Dive.

Just contrast the clinical trial of today with one two decades ago. A typical phase III trial in the past would produce around 3 million data points; today, that number sits closer to one million data points per patient per day, Bell explains. Combining this data with RWE from  electronic health records, for instance, can be highly valuable.

After all, this data holds sway over drug approvals, payer decision-making and label expansions, Bell argues. It was EHR data, for example, that helped Pfizer secure approval for Ibrance, its breast cancer therapy.

CROs Need to Change Their Business Models

The models that CROs and sponsor companies use are not adaptive enough to embrace the disruption that innovations can bring. So they need to change. John Carroll, founder of Endpoints News, says Gottlieb’s call for action and change is aimed at making research and development better, cheaper and more efficient.

Gottlieb’s guidance with respect to streamlining research is to use computerized systems for greater oversight, and he advises recruiting patients with challenging conditions so trials better reflect real world conditions.

CROs-Business Models

CROs Can Make Trials More Efficient

Trials are expensive so processes CROs can implement to lower costs will be valuable to patients and the broader research community. Part of that is greater digitization, according to Barbara Kunz, CEO of the Drug Information Association.

That means maximizing data but also creating portals or hubs of engagement so patients could find out more about their conditions, prospective treatments and where to find them.

CROs Collaborate for Better Data Frameworks

A consortium of CROs has joined forced under the name of Align Clinical CRO to promote the use of open source standards to handle data. The first standard is the Operational Data Exchange, which aims to improve the sharing of operational data between sponsors and CROs.

The current data sharing models require sophisticated IT teams working with operations and quality teams, and business analysts, which makes it complicated, explains Brett Husselton, SVP, commercial strategy at UBC and a founding member of Align Clinical CRO. Then there’s also the time sponsors devote to inputting and integrating operational data in their internal systems.

A common data framework, Husselton says, will define the attributes of data, its operational value and other variables to be translatable across platforms. Expect a shared market vocabulary for use across the industry and streamlined data sharing process for improved drug development.

Strike Up Better Partnerships

By 2020, around 75 percent of clinical trials will be outsourced to CROs. The most prudent course of action for these organizations is to create a strong strategic partnership with sponsor organizations rather than a transactional one, explain management consultants Jeffrey S. Handen, Ph.D. and Daniel W. Patrick.

There are many factors behind developing this relationship. CROs can start by defining key assumptions of projections such as sales, expenses and patient enrollment. They can also be clear about their own responsibilities and those of the sponsor, agreeing to useful key performance indicators and metrics and sharing under and overruns of expenses and revenues.

Sharing risk is another effective agreement for research partnerships to thrive. This means that CROs and sponsors set mutual timelines and pursue common goals, as expected, but also share risk to ensure both parties are suitably incentivized, says Krista Armstrong, senior vice president and head of neurosciences at Premier Research.

The agreement would help contracting parties to work together to reduce time and find innovative solutions to make the process more efficient, just as Gottlieb set out to achieve and Sharpless continues to look for.

Armstrong says risk does not mean penalties. She argues that sponsors would unlikely fine research partners for failings. Instead, there’d be incentives for better performance and faster delivery.

Gottlieb won the respect of the industry during his short tenure as FDA head. He applied pressure on CROs and sponsors to make trials cheaper and more efficient. His successor, Sharpless, looks to be continuing along the path set out for him.

Of course, CROs can do more to streamline existing processes and should look for ways to improve operations. But the FDA and broader industry should not lose sight of the good work these research organizations have already done such as creating better digital solutions, tapping into broader research populations and delivering services that sponsor companies can seldom do alone.

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