Since the onset of the COVID-19 pandemic, we have seen Austrian economist Joseph Schumpeter’s concept of creative destruction come into play often. As the wily virus caused chaos and mayhem to social and economic activity globally and challenged existing models and current systems, it left no one with any option but to adapt and innovate. As a result, we have witnessed businesses and systems replace their long-standing and sometime obsolete practices, products and services with more effective and innovative approaches and offerings to survive and thrive during the pandemic. Decentralisation of clinical trials is a case in point.
Trials and tribulations
An article published online in The Lancet in December 2021 informs that the COVID-19 pandemic affected scientific research worldwide and over 2000 trials registered on ClinicalTrials.gov were stopped. Delays in regulatory approvals, hassles with site set-ups and delegation of responsibilities, limited scope for site visits, lack of participation by health units and clinicians, enrollment of patients for the study, etc were some of the challenges of doing clinical research during the pandemic.
Henry McNamara, Sr VP and GM, Oracle Health Sciences shares his views on this situation and explains, “The COVID-19 pandemic radically changed clinical operations forcing the clinical research community to re-evaluate how to manage clinical trials. In a flash, physical access to patients across the globe became infeasible, causing a significant impact on clinical data collection and patient monitoring.”
“The biggest factor delaying clinical trials today – exacerbated by COVID-19 – is enrollment. It’s difficult to find enough patients to participate in trials. The study found that more than half (51 per cent) of respondents identified longer enrolment timelines as one of the key ramifications of the pandemic. This is partly due to the inconvenience of trial participation for the patient. For instance, some patients may be living away from the site, so in-person visits can be a large inconvenience,” he adds.
These circumstances have paved the way for accelerated adoption of virtual clinical trials (VCTs) worldwide, altering the traditional approaches to clinical trials, probably for ever.
The age of VCTs
A GlobalData report titled ‘Virtual Clinical Trials – Thematic Research’, states, “COVID-19 lockdowns and social distancing measures caused significant disruption to clinical trials and accelerated the use of virtual trials. Companies that had not considered this model before had no option but to rapidly implement new technologies and procedures to maintain business continuity, and many companies will continue to use virtual trials post-pandemic. 67 per cent of the participants cited COVID-19 as the reason they plan to use decentralised clinical trials in the future.”
McNamara shares data from an Oracle-commissioned study by Informa Pharma Intelligence that reveals “76 per cent of respondents accelerated their adoption of decentralised clinical trial methods during the COVID-19 pandemic.” Why? Well, as Sowmya Kaur EVP – Navitas Clinical Research and BU Head Clinical APAC explains, “A virtual clinical trial harnesses the power of technology to improve patient recruitment, retention, collection of data, and analysis. They support efficient trials as they tap into digital technologies, like apps, monitoring devices, and online social engagement platforms to conduct each stage of the clinical trial. This includes enhanced support for recruitment, informed consent, patient counseling, measuring clinical endpoints, and in determining adverse reactions.”
“The advent of digital solutions in clinical trial management and conduct has improved transparency, with an onus on delivering better healthcare. Consumers or patients have access to a wide range of information, and, with this dissemination of information, there is increased expectancy. This has initiated a need for rethinking clinical trials to maximise benefits. There has been a significant shift towards embracing the incredible advantages of data analytics, along with digital models of engagement, to forge clinical trials that cater to the current demands,” opines Kaur. (Check Box: Key steps in a virtual clinical trial)
“Virtual trials ease the patient burden of traveling to sites for multiple visits and tests, remove geographic and logistical constraints to participation, and leverage technology for real-time information access and communication between sites and patients. Investments in technology and remote trials were underway before COVID-19 due to cost and efficiency considerations and the pandemic will only catalyse these developments”, points out Jinu Jose, VP, Head – Sales and Clinical Operations, R&D Solutions, IQVIA India.
Thus, the market outlook for virtual clinical trials is very bright. The global virtual clinical trials market is expected to grow from $ 2,092.67 million in 2020 to $5,521.67 million by the end of 2025, as per a report by ResearchandMarkets.com. Another recent report by ResearchandMarkets.com states that the global eClinical solutions market is expected to grow from $6,784.59 million in 2021 to $14,897.53 million by 2027at a CAGR of 14 per cent.
Clearly, virtual clinical trials are set to increase, but what does this mean for India? Well, industry stakeholders seem to share a positive outlook about India’s potential for growth in this sphere.
Jose informs, “The investments we have seen in building the decentralised trial infrastructure have been unprecedented. These developments, coupled with the introduction of the New Drugs and Clinical Trials Rules, 2019, which was a significant milestone, will encourage more global clinical studies to be conducted in India, thus improving access to treatment for patients.”
He shares, “Given its large population and growing disease burden, unmet medical needs, highly trained, English-speaking healthcare professionals, clinical research professionals, leadership in information technology, advancements in mobile and internet accessibility and burgeoning patient population, India possesses immense potential for conducting global decentralised clinical trials.”
“The growing number of pharma companies in developing Asian countries such as China, India, Taiwan, and Korea has also opened up growth opportunities for the eClinical solutions market in this region,” states Kaur.
Preparing for progress
However, to leverage the advantage and optimise the growth potential, there is a need to put certain measures into place. So, what do the industry experts recommend?
◆Invest in the right technologies: GlobalData’s report titled ‘Virtual Clinical Trials – Thematic Research’ highlights a considerable increase in deal-making activity in the virtual trials space over the past 18 months. Nine M&As linked to virtual trials were witnessed in 2020, instead of one in 2018 and two in 2019, as per the report. In 2021, this segment has seen some major M&As including Thermo Fisher’s acquisition of PPD for $17.4 billion in April 2021 and ICON’s acquisition of PRA Health Sciences for $12 billion in February 2021.
India needs to learn from the global playbook and invest in existing and emerging technologies to build and fortify its position in the virtual clinical trials space.
Industry experts also under-score this fact and elaborate on the importance of emerging technology in this space. McNamara points out, “The ability to do home health, virtual visits, and telemedicine are key to making trials easier for patients, which lessens the enrolment barrier. Whilst the technology has existed, two key barriers have precluded its adoption: state/regulatory support and end-user (physician) acceptance. COVID-19 has broken down these barriers almost overnight, triggering mass relaxation of regulatory hurdles, and likewise immediate realisation by the medical community that video can work, and in many cases, is better than face-to-face interactions.”
Jose adds, “Great advances have been made in AI and Machine Learning (ML), which can be applied to automate many data-heavy processes to lessen the pressure. AI and ML not only process data faster than humans, but they can also point to patterns and trends that humans can’t see. This ideally leads to a more accurate and detailed view of how patients are responding in trials, which can lead to better patient experience, better therapies, and treatments in the long run.”
Kaur weighs in, “The need to invest in digital tools like Artificial intelligence (AI) and Machine Learning (ML) tools is crucial. These tools help ensure clinical trial continuity during and post the pandemic era. Significant strides in incorporating digital health solutions began a few years ago, more as experimental solutions or as support for certain sections of clinical trials. Such investments have paved the way for hybrid clinical trials that are guiding forces for successful and efficiently run clinical trials.”
◆ Adequate regulatory support: Regulatory support and flexibility to accommodate novel approaches and interventions for disease management is crucial. Indian regulators should promote and encourage initiation and conduct of virtual clinical trials in an ethical manner with appropriate processes and policies. Fortunately, industry stakeholders inform that regulatory pathways in India for clinical trials are evolving to keep pace with changing demands.
Jose updates, “Indian clinical trials regulations have evolved over the last few years and introduction of the New Drugs and Clinical Trials Rules, 2019 has been a significant milestone infusing significant interest and confidence in the clinical trials industry. During the pandemic, the clinical trial industry worked very closely with regulators on innovative trial designs, improvised pathways for approvals, and use of digital health platforms in various aspects of the clinical trial continuum. We hope that these will continue beyond the pandemic to sustain the momentum and fast track the clinical trial application review process.”
He further opines, “While these were short-term measures, we are confident that this opens many possibilities to further improve the overall clinical trials process and leverage technology and automation to bring drugs to markets faster while reducing the overall cost of development. Some of the specific areas in virtual trials that require focus from a regulatory perspective include – IMP management, patient consent, use of digital platforms, documentation, and access to data. We also believe that there are significant opportunities for the industry to proactively partner with regulators to drive continued innovations and faster adoption of newer ways of working.”
“In the context of the pandemic, the regulators have been willing and flexible to adopt new technologies and provide quicker approvals. As the pandemic situation spiraled, regulators moved with speed to issue guidance enabling sponsors to introduce new approaches and protocols for clinical trials,’ states Kaur.
◆ Build better security management systems: Jose explains, “Cyber security, privacy and data protection are key tenets of managing a clinical trial. Any service delivery model that has a backbone of data and technology is prone to cyber-attacks and data thefts. The conventional clinical trial processes are largely automated (electronic data capture, trial management, document exchange, IMP management etc.) and while virtual trials introduce a layer of technology, the risk does not significantly rise.”
“While continuing to invest in world-class technology, cyber security and digital capability can help mitigate the risks to a larger extent. We believe that investments in training, education, and increasing awareness of employees and the larger clinical research ecosystem we operate can significantly help better manage these risks,” he adds.
Kaur enlightens, “As clinical trials take a digital approach the complexity grows along with the risk to data integrity. The challenge is the difficulty in securing a clinical trial ecosystem that may involve hundreds of data input points, trial sites, networks and applications, including patient’s own devices like wearables, smart phone apps being on the constant rise.”
She adds, “It is critical when designing a clinical study, to map the data flow, from where the data is generated, how it is stored and how many software systems it flows through. Clear controls need to be in place at the sponsor’s site, at the sponsor’s trial partners to scan for malware and incorporate patch applications as soon as patches become available, and train/inform personnel on how to protect data.”
However, Kaur also informs that increased use of technology is being accompanied by the development of better security management systems. She says, “Industry as well as regulators understand the utmost importance of data protection. The importance of data protection increases as the amount of data created and stored continues to grow at unprecedented rates. There is also little tolerance for downtime that can make it impossible to access important information. There are many storage and management options that can help to restrict access, monitor activity, and respond to threats (e.g.,Data loss prevention, Storage with built-in data protection, Firewalls, Encryption, Endpoint protection etc.,)”
◆ Create a tech-savvy, digitally-skilled workforce: A barrier to progress in virtual trial field is skill-shortage. GlobalData’s State of the Biopharmaceutical Industry 2021 report cites lack of specific skills and talents as the key hurdle barrier to digital transformation initiatives. It is an imperative to recruit and train digital talent on priority to enable utilisation of remote technologies in clinical trials. The industry needs a workforce that is skilled in digital, advanced data analytics and AI/ML to leverage these tech solutions to generate and analyse datasets.
As Jose highlights, “The future of work in our industry will be at the intersection of strong clinical/medical expertise, use of data/analytics and digital platforms to achieve better outcomes for our patients. The foundation skill is and will continue to remain the ability to apply clinical and medical expertise in different contexts in a clinical trial. Data and analytics will be pervasive in our decision making and the use of new technology platforms will drive the future of our work. Therefore, we need to continue to invest in building skills in emerging areas including data, analytics and digital platforms.
He adds, “Remote working lends itself well to the decentralised trial model. Virtual trials will open new opportunities for professionals in the areas of information technology, logistics, patient care (home health nursing/phlebotomy support) and training.”
Kaur emphasises, “Virtual trials mandate the need for a digital-savvy workforce which is required to satisfy patient health and well-being demands, which will be frequently delivered through innovative technology-based applications. The focus for professionals in the industry should be on developing skills in technology like AI, ML, etc., data analytics, governance of data and more.”
On an optimistic note, Kaur shares, “About 50 per cent of workers find themselves as digital natives, with the figure set to rise to 75 per cent by 2025. Within the next few decades, the entire workforce will have grown up under the ubiquitous influence of the Internet and other technologies. Digital natives are already shaping the future of working life: as a new generation enters the workforce, business processes will continue to modernise in view of evolving skill sets.”
VCTs are here to stay
Jose says, “The process, technology and infrastructure supporting virtual trials is evolving. Like with most emerging industry solutions, we do expect that over a period there will be consolidation, standardisation, and greater maturity of the ecosystem supporting virtual trials. In the future, we believe that this will pave the way for not only for reduced R&D costs but also better data quality, access to patients, better diversity, improved protocol adherence, reduce study dropout, faster patient recruitment and reduced cycle times for clinical trials.”
McNamara opines, “Today’s environment has helped push the industry from looking at decentralised trials as a series of pilots to accelerating adoption because they are simply a better way to operate. Organisations have adapted to decentralised trials quickly in the face of the global pandemic, but the industry needs to embrace this change not as situational, but as a permanent evolution. With the right processes and technologies in place, the shift can be advantageous to patients, sites, and sponsors moving forward. Ultimately, decentralised trials will change clinical research forever, driving patient centricity, richer real-world data, and faster development of life-enhancing therapies and treatments.
“Virtual clinical trials enable improving patient-centric experience, offers a cost-effective, and easy to manage solution. All these indicators provide a compelling insight for virtual trials to become the default in the post COVID era,” asserts Kaur.
Thus, the outlook for VCTs is very positive given the myriad advantages they offer over traditional, site-based clinical trials. Therefore, as Kitty Whitney, Director of Thematic Analysis at GlobalData highlights, “While COVID-19 shone a spotlight on virtual trials, data show that the shift towards virtual trials was underway before the pandemic. Companies who are not already integrating virtual components into trials need to adapt their research models to become more patient-centric in order to recruit and retain more participants and improve trial efficiencies overall.”