In a bid to ease the burden on patients and boost the notoriously low levels of recruitment and retention in clinical trials, sponsors are turning towards virtual clinical trials.
The shift in direction has also meant that CROs have had to look for ways to adapt to new market demands. Here we look at the overview of virtual trials, the CRO market and how outsourced partners are refocusing their expertise to remain valuable to sponsors.
The Future Is Virtual — Mostly
A 2019 survey from The Avoca Group focuses on the relationship between sponsors and their service provider partners and, in particular, CROs’ perspectives on technology in trials. Despite the optimism of what technology can enable such as a future of wearable devices and virtual trials, Ed Miseta at Clinical Leader says the current reality is low adoption of tech solutions.
Referring to the survey, Miseta explains:
- 31 percent of sponsors and 24 percent of service providers have collected patient data through wearables and sensors;
- Only 25 percent for sponsors and 14 percent for providers have used virtual or siteless trials.
Yet there is an excitement and expressed commitment to using more tech in future trials, with 65 percent of providers planning to use wearables and sensors in the future and 71 percent using virtual and site-less trials.
Miseta says the responses show that CROs intend to continue supporting sponsors even as virtual trials become more common.
Perhaps one reason for the slow adoption of virtual trials is that they are not well-suited to all investigative studies. Jimmy El Hokayem, Ph.D., head of Biorasi’s Neurology and Regenerative Medicine Center of Excellence, says virtual trials — while presenting many benefits — are limited to trials that do not require in-hospital supervision or equipment, for example.
There’s a trend for 100 percent virtual trials, but this is not possible, says Mark Hanley, CEO at VirTrial. Echoing Hokayem’s sentiments, Hanley says only a small number of studies can be wholly virtual in their protocol. Patients not only have to learn to use technology but also tend to favor human-to-human relationships. Hanley sees virtual trials adapting to hybrid trials based on necessity.
Challenges With Virtual Trials
Virtual trials are aimed at being more patient-centric, removing the need for patients to travel to sites. But not everyone is convinced virtual is a panacea for clinical research. Some patients struggle with the additional responsibilities that virtual trials can bring, writes clinical project management consultant Shanique Smythe.
Patients must receive the investigational product at their homes, complete study assessments, and troubleshoot equipment or technology problems. This could be overly burdensome for patients that lack technological awareness.
Smythe says sponsors and CROs will need to train patients in proper use of study equipment and completion of assessments. Training should be web-based and approved by an institutional review board or independent ethics committee. A CRO can help sponsors resolve patient issues, particularly if the sponsor opts for a completely virtual trial without any central site.
The Outsourcing Market Is Booming
Regardless of the current and predicted future use of virtual trials, the outsourcing clinical trial services is a market that continues to grow. Despite stories of job losses for those working in pharma such as sales reps, scientists and manufacturers, hires for CROs and contract manufacturing organizations (CMOs) continue to rise, according to John Ebeid, senior vice president at Randstad Life Sciences.
Ebeid explains that the rise is due to CROs needing personnel power to accommodate the new programs, projects and partnerships with pharma.
Statistics from Frost & Sullivan shows the global CRO market is set to grow at a compound annual growth rate of 7.9 percent to reach $71.7 billion by 2024. One of the reasons for the boom is that sponsors need external expertise to meet the demand for new therapies and specialty trials, says Kamaljit Behera, program lead in Life Sciences IT at global growth consulting and research firm Frost & Sullivan.
The move towards virtual trials also demands that CROs adapt their business models. “In the future, more than competing for customers, it is critical for CROs to identify and establish partnerships with the right stakeholders to complement capabilities in evolving digitally-led patient-centric clinical trial designs,” Behera explains.
Focus points for CROs to grow or partner include integrative technology such as AI and blockchain, virtual clinical trials and specialist vendor collaborations. Many CROs are investing heavily in this transformation to be digital providers, says Wendi Lau, vice president of operational improvement at Astellas Pharmaceuticals. She notes that it’s too soon to tell whether companies are better served by investing in developing their own new capabilities or partnering with specialist tech providers.
Collaboration Is Required
Clinical trial recruitment challenges have been documented extensively. Around 80 percent of trials don’t meet enrolment deadlines, while 37 percent of sites miss their targets and 10 percent won’t even recruit a single patient. The lack of patient-centricity has been a problem but Frost & Sullivan partner Reenita Das writes that the cost and time burdens are reshaping how pharma delivers trials.
The solution is wearable devices and mHealth smartphone apps to support either completely virtual trials or hybrid models in which patients receive most of their care digitally. Consequently, data collection and analysis become major considerations for sponsors and their CRO partners. Combining trial data with real-world evidence has become a vital element in clinical research.
Das says the clinical trials IT solutions market is booming. Patient recruitment, engagement and retention will change under the virtual trial model.
Traditional clinical trial businesses such as site management organizations and patient recruitment organizations will need to evolve their business models either through skills acquisition or collaboration with new IT players such as wearable device manufacturers, data aggregators and mHealth platform providers.
Indeed, this shift in requirements has already resulted in the emergence of new companies such as Science 37, which engages and monitors patients in virtual trials. Consultant Nimita Limaye, Ph.D. says Science 37 combines a proprietary cloud-based mobile platform, telemedicine technology, wireless devices, decentralized physician networks, and in-house experienced clinical study staff to help sponsors conduct virtual trials.
CROs Must Maximize Data
The most significant shift for CROs is that they started out as “bodies for hire” but have now become aggregators of data, explains Dawn Anderson, managing director life sciences at Deloitte.
Through wearables and RWE, a typical phase III trial conducted now yields more than a million data points per patient daily, compared with three million data points during an entire trial conducted 20 years ago, she adds. CROs, therefore, need to master data – collected through virtual trials and RWE — to support sponsors’ attempts at drug approval, payer decision-making and label expansions.
This requires an evolution by CROs in order to remain relevant in the new clinical research marketplace. Anderson points to new players such as Google, Apple, Verilys, and Amazon with access to huge amounts of data, as possibly being “new players” in the future.
The Evolution of the CRO
Data expertise will grow in importance for CROs that manage all types of trials — specifically so for virtual trials. Therefore, CROs need to adapt to become digital leaders, writes Dr. Monica Tocchi, founder and chief medical officer at clinical trial services and electronic data capture solutions provider Meditrial Europe.
CROs should be investing in new IT infrastructure and dedicated solutions to support sponsors with integrated and affordable digital tools.
“In my personal experience, customers of Meditrial CRO demand not only the key strategic guidance for their new technologies, but also an ability of their CRO partner to confront their evolving business needs through collaboration with regulators, leading physicians, researchers, academia, entrepreneurs and investors. New skills and resources are required to CROs in order to claim ‘full-service offering’ in today’s healthcare ecosystem,” Tocchi says.
CROs have long been adapting processes to provide a more patient-centric offering that is flexible to both patients and sponsors’ needs. As virtual trials become more prevalent, CROs will need to become even more adept at handling large amounts of data. Far from being extra hands on deck, CROs should be experts in data aggregation.
Whether the best option to achieve these desired capabilities comes through upskilling, reskilling or collaboration with additional tech vendors remains to be seen. What is certain is the CRO role is changing and data expertise is at the heart of this shift.