decentralized trials

The Continuing Rise of Decentralized Clinical Trials

Technology plays an ever-growing role in clinical research. This includes everything from the adoption of electronic trial master files to the proliferation of virtual clinical trials.

It’s the latter trend that holds special promise in the realm of clinical research.

As more and more trials are conducted remotely, new opportunities arise. New patients can be recruited, for example, and new ways of generating and sharing data become available.

The COVID-19 pandemic has given the field a nudge in that direction, to be sure, but decentralized clinical research has long been on the horizon.

Here’s a glimpse of where the field stands today, and where it’s headed.

Clinical Research Has Been Speeding Toward Decentralization
In early 2020, as the COVID-19 pandemic was just beginning to take shape, clinical research as an industry was learning how to navigate the confluence of a couple of important trends.

First, the world had seen pharma’s R&D pipeline making its shift away from big, blockbuster products. Instead, smaller companies were increasingly exploring niche and next-gen therapies, Almac’s Abi Pesun writes at Applied Clinical Trials.

Pesun notes how there has been a clear uptick “in the number of rare and orphan diseases under investigation” in recent years.

“To meet these growing demands, trials are becoming faster, decentralized and virtual,” she writes.

That’s partly due to the diminishing ROI sponsors have seen over the last decade. That’s because drug development is simply much more expensive than it was just 10 years ago, Ed Miseta at Clinical Leader writes. “According to estimates from Deloitte, the cost of bringing an asset to market in 2019 was 67 percent higher than in 2010. Additionally, since 2010, sales per asset have been cut in half.”

Decentralized trials, fully remote trials and even hybrid-remote trials were already creating economic efficiencies to help compensate.

Then came COVID-19.

The pandemic brought new financial stress to all industries. The quarantines and social distancing measures adopted around the world created major problems for clinical trial directors, too. Patients were afraid to travel to trial sites or to get too close to researchers.

This accelerated industry-wide adoptions of remote clinical trials, and the technologies needed to make that kind of research possible. And this shift seems poised to continue.

“Based on conversations we’ve had with biopharma companies, a hybrid-approach with virtual and on-site capabilities will endure going forward,” Andrew Hedin, Sanjay Patil and Chuka Esiobu write at the Bessemer Venture Partners blog.

“Beyond the obvious short-term benefits of limiting the risk of COVID-19 exposure for trial participants, reducing the frequency of site visits can have long-term benefits around convenience and alleviating safety concerns, particularly for patients from vulnerable clinical populations. And for pharma, this ultimately means a broader patient pool to enroll in their trials.”


Technology and the Promise of Remote Trials
Looking even further out, there exists a world in which all clinical research is done fully remote (i.e. no hybrid, no on-site capabilities needed). With slashed overhead costs, ROI on niche therapies goes up.

The benefits go beyond the economic realms, too. “The broad introduction of siteless trials would have the potential to increase patient participation, reduce clinical development cycle times, and enhance the industry’s ability to bring medicines to patients in a more expeditious manner,” says Robert Goldman, head of global clinical research and medical affairs at Sunovion Pharmaceuticals.

This would make research much more comfortable and convenient for patients, too. As Ben Faircloth and Andre Valente at L.E.K. Consultants point out, each patient’s home would have sufficient infrastructure for research. At-home nurse visits would be enough to examine and monitor a patient, and any drugs or materials needed could be shipped to the person’s address.

“Fundamentally, this new model will evolve as a direct consequence of the current outbreak and the urgent need to eliminate patient touch points wherever possible,” Faircloth and Valente note, though they concede that some patients would still need to visit a hospital or clinic in certain kinds of trials.

Remote Trials Need Reliable Data and Capable Analytics
The reality outlined above is built upon a robust infrastructure in which data can be generated, captured, collected and analyzed.

Let’s start with analytics capabilities. As Georgia Tech researcher O. T. Inan, et al. write in npj Digital Medicine, tools like machine learning and artificial intelligence can be useful in some of the following tasks:

Matching the right participants to the right studies.
Extracting digital data and turning those into real insights.
Interpreting what researchers find in their trials.
In other words, they provide a pathway from data to meaningful knowledge.

But analytics are only as good as the data they work from. This is where precise data-collection tools come in. Wearables appear to be a good fit for clinical data collection — so long as the medical world can agree on clinical endpoints, Geoffrey Gill at Shimmer Research, Inc. tells Outsourcing-Pharma.

“If we cannot agree on whether someone is getting better or worse and how to measure it, it is difficult to see how we can make decisions on how to treat a patient,” Gill says.

“… The reason that this is such a challenge is that we are measuring things like activity and gait that have never been measured continuously before. Today, almost all wearable devices rely on their own proprietary algorithms to arrive at these measures.”

That’s a solvable problem, though. After all, there have already been famous cases in which trials have relied on data from consumer devices like iPhones.

Zarqa Ali, a doctor in the department of dermatology at Bispebjerg Hospital in Copenhagen, is the first author on a paper that explores the use of wearables in dermatology. Ali et al. cite a GlaxoSmithKline study from 2016 that tracked rheumatoid arthritis symptoms in 300 patients via each person’s iPhone sensors.

The technology, then, is more or less available. It’s just a matter of refining the tech we have today for clinical-grade data analytics.


The Factors That Limit Faster Tech Adoption
Tech refinement isn’t the only thing that stands between the current moment and fully remote clinical trials. All of the individual people working in the industry have some catching up to do, as well.

This is something that requires “organizational commitment,” writes Clinical Performance Partners, Inc. President Beth Harper, who provides examples of some of the very human questions that must be addressed.

“How much time is site staff investing in training subjects on various mobile devices?” she writes. “How are we enabling them to be effective troubleshooters when the subjects have issues? What type of compensation is appropriate to accommodate these and other factors? We need more collaboration between all stakeholders as new technology is introduced to help ease this burden.”

Beyond training and collaboration, the industry needs to create and define new roles in this tech-driven context, Harper writes.

This is no small challenge. Just think about what kind of work would be needed to fold a blockchain-based tool into a clinical tech stack. In theory, a distributed ledger like a blockchain could help solve the problem of data errors, Khalifa University researchers Ilhaam Omar, et al. write, by:

Offering traceability features into each drug’s (or each resource material’s) life cycle.
Helping guarantee protocol compliance through third-party verification.
Making all data management more transparent.
But all of those benefits come with a steep learning curve. Whole teams need to learn how blockchain ledgers work before any of this is possible.

Even telemedicine faces a similar challenge. For all of the promise of patient centricity that telemedicine promises, still “it may be time-consuming and burdensome to set a novel infrastructure and to get sites and patients used to the new system or device to enable remote data collection,” notes Dimitri Talantov, senior medical director at Janssen Clinical Innovation.

This is not a critique of the hesitation that researchers, care providers, sponsors and everyone else in the field might feel about rolling out new technologies. After all, the goal of clinical research is better health outcomes and better therapies for patients. Caution and regulation are important guardrails on the path toward those goals.

Data security, too, remains a major hurdle, Joseph Constance at TrialSiteNews writes. As potentially useful as smartphones can be for data collection, that process needs to be made safe and HIPAA-compliant, for example.

Clinical researchers do not and should not embrace innovative technologies for their own sake. Still, economic and pandemic pressures make a compelling case for decentralized clinical trials, or at least a more hybridized model of off-site and on-site research methods.

Expect to see the tools and the software in this field evolve in response to those pressures.

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