Despite roadblocks, demand for innovative treatments persists: IQVIA

Outsourcing-Pharma (OSP) chatted with Costa Panagos (CP) president of R&D operations with IQVIA, about the developments with the most significant impact on the clinical research field in 2020, and the trends most likely to drive industry evolution in the coming year.

OSP: What do you think were the biggest stories in clinical research and drug development this year?​

CP: In response to the pandemic, sponsors, sites, clinical research organizations (CROs) and regulatory agencies made decisions and rapidly shifted gears to re-start or keep trials on track; now, in going through the ebbs and flows of the pandemic, the industry is adjusting to ensure trials either catch-up to, meet, or exceed intended goals for drug development. The industry worked hard to safeguard that research continued, we maintained data integrity within trials, and we protected the safety of patients, HCPs, and colleagues above all else.

Decentralized, patient-centric solutions, including virtual trials, gave sponsors a much-needed lifeline during this global crisis. The decades-old traditional clinical trials model requiring patients go to the trial’s brick-and-mortar site is evolving by adding virtual services such as digital patient engagement, remote provision of IP and clinical assessment, and remote site and data monitoring.

All of our ongoing trials were screened through a risk-based assessment of new challenges caused by the pandemic, and potential strategies available to mitigate risks of missed visits, delayed or missed IP provision, losing patients from follow-up, etc. Many trials, from March onward, have benefited from these approaches, keeping their personnel and patients safe, and ensuring the database will ultimately yield clear results.

We are augmenting sites’ ability to recruit with the use of real-world evidence of patients in or local to their practice, as well as increasing patient awareness through social media and technology-enabled referral processes. Telehealth technologies and virtual oversight models assist the sites and engage with the patients throughout a trial. In some cases, patients may only need to visit a trial site for complex medical procedures or infusions.

CROs access, curate and integrate data coming from patients through mobile sources and connected devices (e.g. wearables, phones) and even unstructured sources (e.g. eDiaries). For years, nearly all the data collected during a clinical trial came from Electronic Data Capture (EDC) form.

But today, in some cases, only 20-30% of the patient primary source data comes from the EDC itself, with much of the data coming from other sources, including third party vendors, connected devices, and wearables. Part of that adjustment for sponsors and CROs is synchronizing data in this new ecosystem, ensuring we maintain our industry’s high-quality data management standard when augmenting datasets with new technology capabilities.

As digitization continues to accelerate, so does the deployment of remote capabilities throughout the lifecycle of a trial from start-up to clinical monitoring and data review. In fact, at the height of the pandemic, our on-site visits shifted almost completely to remote monitoring. We were able to make this pivot quite quickly due to the lessons learned from our risk-based monitoring (RBM) portfolio in terms of managing site risks using data and predictive analytics.

When it comes to leveraging these remote tactics in the future, the challenging part will be effectively designing technology-driven, hybrid and virtual trial models to decrease the burden for sites and patients.

OSP: In what ways did IQVIA rise up and provide clients with ways to meet the challenges of the year?​

CP: Realizing trial needs are evolving, we have looked at every aspect, from novel protocol design to patient recruitment strategies, regulatory reviews, clinical processes, supply chain, technologies and tools to determine how we can support sponsors in their individual efforts to continue clinical development and ultimately, improve patient health. Without compromising data quality or safety, we continue to mobilize our transformation in human data science and technology in an agile manner to help our sponsors navigate this dynamic environment.

Artificial intelligence (AI), machine learning, decentralized trials, telehealth, and direct-to-patient models are not only keeping trials moving, but in some cases, accelerating timelines even during a pandemic. We bring trials directly to patients whenever possible to keep patients safe, to decrease trial burden, and to help strengthen their engagement.

Our IQVIA Study Hub cloud platform allows patients and study teams to securely connect in a televisit. Patients can also upload medical history and report outcomes from connected devices (e.g., tablet, smartphone, wearable devices).

Through internal capabilities and our network of mobile research nurses, IQVIA offers at-home support by trained nurses and phlebotomists. This means lab tests, infusions, or anything that requires a healthcare professional can safely and effectively be performed right in the patient’s home.

If COVID-19 cases resurge in parts of the world, we can predict and address in real-time changes to site accessibility. Remote monitoring solutions enable us to monitor safety trends across sites, participants or regions, and adjust swiftly; our Data Science analytics teams have adapted AI models that assess the dynamic infection rates by country to predict the pandemic impact on sites and what related actions we need to deploy to ensure trial continuity.

In contrast, where sites are open but don’t have the capacity to support their ongoing trials, we offer On-Site Support Services (OSS) such as study coordinators and nurse trialists to augment site study activities (e.g. site activation, patient recruitment, etc.), ensuring we achieve enrollment goals and meet study timelines.

OSP: As we get ready to tear the last page off our desk calendars, what should sites, sponsors and pharma firms do or consider if they want to be ready for what’s ahead in the next calendar year?​

CP: Scientific innovation has exploded in recent years and is having a major impact in how we, as an industry, design and execute trials. Specialized skills are needed to successfully design and execute trials and while sponsors may work on several types of trials per year, CROs work on several hundred—providing expertise, scalable processes and technologies. As the landscape grows more complex and trial costs surge, sponsors are seeing the value in functional service provision (FSP) partnerships to help increase trial efficiencies and make better use of resources.

Additionally, what data and technology a sponsor wishes to own and develop versus what it needs to integrate, curate, and/or outsource is an important question contemplated from all angles of the industry. Most sponsors now see a comprehensive technology and data strategy as a core element of their wider business planning.

As patient-centric data capture and secondary (real world) data sources evolve quickly and drive demand for related capabilities, the increasing need for diverse data integration, master data management, and more complex technology and cloud infrastructure will be areas where sponsors may seek support

As tech-enabled modalities become a staple in clinical development, the seamless integration of systems and data through interoperability will replace disparate point solutions and help reduce labor-intensive work for sponsors and site teams alike.

OSP: Do you have anything to add about lessons learned in 2020, or what’s ahead in 2021?​

CP: This year has only emphasized that despite roadblocks, no matter the scale, the demand for innovative treatments won’t change. It will only increase. But we will stay resilient and meet the demand in new and exciting ways.

Sponsors should continue to consider how to reduce burden and better engage sites and patients using new technologies to understand what works best for them and improves their clinical research experience. The thoughtful deployment of technology can provide a real opportunity to increase participation and streamline the execution process which helps sites, patients and the wider industry.

Looking ahead, 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 insights can be obtained to further support more streamlined decision making and effective process improvement.

Additionally, patient-centric trial designs will continue to become more of the norm in this increasingly digital world. This may necessitate the industry rethink the skillsets needed to support this model as not just clinical expertise is required, but also potentially technical, data-driven, and diagnostic specialties to handle these new complexities.

And finally, across IQVIA R&D Solutions, we are conducting research organized and led by hundreds of project managers. A core responsibility of our PMs is to anticipate, de-risk, and lead multi-function, multi-vendor teams through challenges; very few of them would have predicted what 2020 would bring in terms of enormous, unanticipated obstacles.

Project managers have had to re-assess risk across every function and site they depend on, relying on deep knowledge of trial methodology and operational strategy, as well as the new technology and disease-specific impacts thrown at them. The year has emphasized how important an investment we make in the key leaders driving these cross-functional teams, ensuring we draw on the wisdom within the organization as we navigate uncharted waters.