Clinical trials have been transformed over the last year as a result of the pandemic, with many traditional processes taking on new formats to increase clinical development efficiencies. Technology and digital modernization of clinical trials, as well as advanced therapies and personalized medicine, and the transition to decentralized clinical trials resulting from the pandemic, are key areas driving clinical trials today. Additionally, the increasing number of drugs in various phases of development, along with growing R&D expenditure, are driving outsourcing in the clinical trial space.

Murray Aitken, Executive Director, IQVIA Institute for Human Data Science discusses key market trends, post-pandemic opportunities, and driving efficiencies in today’s complex trials.

Contract Pharma: What are the key market trends driving opportunities and outsourcing?

Murray Aitken: COVID-19 really pushed the industry to take a closer look at the changing landscape and how we can continue clinical development with more efficiency without compromising data quality or safety. Several key drivers of change, include:
 
Patient-centric decentralized clinical trial design: We used to bring the patient to the trial. Now, the idea is to design trials that fit into patients’ lives seamlessly and reduces burdens placed on them and sites to improve patient engagement. We are seeing a dramatic ramp-up in decentralized trial elements whether it be telehealth technologies and virtual oversight models to assist sites and engage with patients or home health visits to perform lab work, infusions and other home care needs. And, patients are simply more engaged and savvy about managing their own healthcare. The use of social media and technology-enabled referrals is increasing patient awareness, access, recruitment, and participation at a time when it’s needed most.

·       Remote trial execution: As digitization is occurring at a rapid pace, so does the use of remote capabilities throughout the entirety of a trial from start-up to clinical monitoring and data review. It is important that CROs and sponsors avoid increased burden on sites and patients when designing such models.
 
Additionally, it is critical to recognize that disparities seen in COVID-19 research highlighted the industry’s increasing focus on ensuring underrepresented communities, including communities of color, are sufficiently represented in clinical trials. Through education and awareness, these communities can have access to treatment options that currently are not available to them. It is vital for CROs to help sponsors modulate trial enrollment and prioritize engagement among disproportionately affected populations in clinical development.
 
CP: What are the current market challenges?

MA: In response to the pandemic last year, sponsors, sites, CROs and regulatory agencies made decisions and rapidly shifted gears to re-start or keep trials on track. Then, in going through the ebbs and flows of the pandemic, the industry adjusted strategies to ensure trials catch-up to, meet, or exceed intended goals for drug development. Now, in some cases, there will still be catching up in trial programs and adjustments in term of how everyone works. The challenge is to continue maintaining data integrity within trials, while protecting the safety of patients, HCPs, and colleagues.
 
We have also yet to see how the so-called backlog of patients – people who missed routine check-ups, screenings and diagnosis visits during 2020 – will be cleared this year and beyond. In particular, we think about how many patients will present with more advanced disease than usual, and how that will impact the flow of patients into clinical trials. Typical patient journeys, which should always include clinical research as a care option, are being re-mapped as a consequence of the pandemic.
 
Health delivery systems, including investigator sites, are also facing immediate challenges due to the disruption to their business models caused by the pandemic.  How they manage through these challenges now, more than a year of disruption, will also have an impact on clinical trial activity for the remainder of this year and beyond.
 
CP: What do you anticipate for clinical development post pandemic?

MA: The pandemic has helped push for a united urgency in the industry to accelerate trial design and execution and related timelines and ensure burdens placed on patients and sites are reduced as we look to bring therapies to market quicker and with more quality for patients in need. It has also highlighted what can be done when stakeholders collaborate in pursuit of a common goal, when technologies are fully embraced, and when flexibility, speed and agility are top priorities.  Learning from the pandemic, we see a shift in what is expected from the industry moving forward:
 
·       Greater acceptance of patient-centric trial elements. Seeing how research was sustained through pandemic-related shutdowns and site closures via decentralized trial solutions, sponsors will consider how virtual they can go with their trials to best meet the needs within their therapeutic areas of focus.

·       Need for transparency and collaboration. In the fight against COVID-19, siloed information such as study protocols were available to all, creating a level of transparency for study teams, sponsors and most importantly, patients that we have never seen before. Also, we experienced collaborations between private sector pharmaceutical companies and governmental agencies to meet public health needs around the pandemic. It is something that can trickle into other therapeutic areas as well.

·       Focus on underrepresented communities in research. Disparities among COVID-19 research heightened the industry’s increasing understanding of the true need to ensure underrepresented communities are sufficiently represented in clinical trials. Though the industry is moving at a rapid pace, we are seeing sponsors deliberately slow enrollment in trials to better ensure representation of diverse communities.
 
Beyond the pandemic’s effects, we also see the surge of innovative science, particularly in oncology, rare diseases, and neuroscience, driving significant increases in the number of candidate drugs for clinical development. For example, in our IQVIA Institute report on R&D trends, we show that oncology clinical trial starts in 2020 were up 60% over the level in 2015. We have also seen a record inflow of venture capital funding for life sciences companies up 50% in 2020 compared to 2019, and increased funding of R&D by large pharma companies. These are very positive trends for advancing healthcare and patients that do require new approaches to trial design and execution that can accommodate this swelling of the clinical development pipeline – by sponsors, sites, regulators and CROs. 
 
CP: What capabilities are needed for today’s complex clinical trials?

MA: CROs have to be agile, adaptable and scalable in services and capabilities to help sponsors effectively navigate through the complex clinical development landscape.
 
Tech-enabled services and capabilities such as artificial intelligence (AI), machine learning, decentralized trials, telehealth, direct-to-patient models and remote monitoring not only kept trials moving during the pandemic, but in some cases, accelerated timelines while maintaining data quality and patient safety. While integration and use of these elements increases, it is equally important for CROs to provide related expertise to ensure the industry’s high quality data standard is maintained, if not elevated, while updating ecosystems in trial design and execution. All the while, CROs also have to ensure burdens on patients and their loved ones and study teams are reduced in the process.
 
CP: What’s critical to driving efficiency?

MA: Disruptive technologies such as AI are helping to resolving challenges inherent to the clinical trial process. Embracing intelligent, intuitive technologies, sponsors and CROs are able to better orchestrate outcomes that help get much-needed treatments to patients faster with heightened productivity and efficiency. The seamless integration of systems and data and interoperability is replacing disparate point solutions.
 
Sponsors and service providers are working to evaluate the implications of these opportunities, both in terms of the technologies themselves, but more importantly, how to integrate and normalize the data from these sources such that valuable insights are fully visible and can be obtained to support more streamlined decision making and effective process improvement.
 
Additionally, process automation through AI is helping to eliminate repetitive tasks and reduce administrative burden to free staff for higher-level responsibilities, including spending more time with patients. This type of productivity could impact every phase of the clinical trial process.

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Murray Aitken is the executive director of the IQVIA Institute for Human Data Science. Mr. Aitken is a renowned expert on the challenges facing the global healthcare industry, and the prospects for improving patient outcomes through managing costs and maximizing access through Human Data Science. Throughout his 15-year tenure at IQVIA, Mr. Aitken has served in various roles responsible for healthcare insights, corporate strategy, and consulting. Prior to his time at IQVIA, Mr. Aitken was a partner at McKinsey & Company in New Jersey and Los Angeles in the U.S. and in Seoul, South Korea, covering a broad range of industries, including life sciences and consumer goods.