With the COVID-19 pandemic throwing a number of challenges in the path of new and ongoing clinical trials, sites and sponsors are seeking ways to keep their research going while keeping patient burden and experience top of mind. Patricia Salter (senior director of operational transformation and performance, research and development solutions with IQVIA) took the time to discuss the company’s growing decentralized clinical trial offerings, and how such technology is transforming research.
OSP: Could you please share an overview of IQVIA’s development and evolution of decentralized clinical trial solutions? Please feel free to talk about how your work and solutions in this area evolved before and after COVID-19’s arrival.
PS: In 2018, IQVIA Virtual Trials was launched, offering the first adaptable and scalable decentralized clinical trials (DCT) offering from a traditional contract research organization. Our focus was clear: deliver studies directly to patients wherever they are, as 100% remote studies or as hybrids blending patient-centric approaches with traditional site-based elements.
We knew that doing so would expand our geographic reach to help identify and engage with the right patients and that it would improve patient engagement and reduce study drop-out by making participation more convenient through fewer site visits. We could achieve this by strategically selecting the right decentralized approaches for the study protocol and population such as telemedicine, home health or phlebotomy services, direct-to-patient drug delivery and connected devices.
As with many technological innovations, the pharmaceutical industry was initially slow to embrace the DCT concept. But COVID-19 accelerated interest in the use of these tools as a way to keep trials running through the pandemic.
It was an unexpected shift, but it has helped many sponsors and sites see the value of decentralization for clinical research and identify where and when decentralized trial elements may bring permanent benefits to clinical research, even after the pandemic is over.
Our experience with over 60 trials – including global COVID-19 vaccine and therapy studies – demonstrated that hybrid approaches are the most commonly used by leveraging televisits, remote monitoring and other DCT tools in combination with traditional on-site study activities. We believe this approach will remain after the COVID-19 pandemic, especially now that sites, sponsors and patients have experienced the benefits of DCT approaches.
OSP: Why is it important to keep the patient’s needs and convenience top of mind when designing decentralized and hybrid trials?
PS: Patient-centricity is at the core of decentralized and hybrid trial design at IQVIA. The idea is to design trials that fit into patients’ lives seamlessly by thoughtfully integrating technology and designing protocols that eliminate unnecessary assessments, biometric screenings or site visits. Doing so supports patient recruitment, engagement and retention, driving efficiencies across the clinical trials lifecycle.
This approach also better serves study participants as a key stakeholder in the clinical development process. In today’s world, patients are increasingly interested in playing a more proactive role in managing their health. They take time to research their conditions or symptoms online and are ready to have a thoughtful discussion with their providers.
For example, a driving demand for information from patients helped spearhead the transparency around COVID-19 vaccine study design and protocols and other details typically not publicly available. And, they quickly engaged in vaccine studies as well.
OSP: Could you please talk about some of the services you offer under the decentralized trial umbrella (such as DTP engagement, telehealth, site management, home health services, wearables, etc.).
PS: One of the greatest benefits of IQVIA’s approach to designing DCT studies is adaptability. It’s not a one-size-fits-all model but rather a carefully designed approach that integrates only the most value-adding DCT elements. Examples of what IQVIA offers in our hybrid and fully virtual offerings include:
- IQVIA Direct-to-Patient Recruitment leverages our unparalleled data combined with machine learning to target patients globally with local market precision. Our multi-channel campaigns are optimized across all media in real-time. Combining IQVIA’s unique data modeling capability with our strategic marketing approach enables us to quickly refine targets to ensure we are delivering the right message to the right patient at the right time.
- IQVIA’s purpose-built DCT platform is available in dozens of languages and enables the orchestration of all decentralized or hybrid study activities, including:
- telemedicine with up to five participants
- patient eDiaries and questionnaires
- intelligent workflow enabling better collaboration
- upload medical records and visit documents
- collaborate across key stakeholders and systems
- 24/7 patient support
- securely track investigational medicinal product (IMP)/lab kits shipped directly to patients
- Home visits and direct-to-patient services: When patients are unable to go to sites – either because of the pandemic or as a result of their condition – trained healthcare professionals, including nurses and phlebotomists, can conduct home health visits to perform lab work, infusions or other home care needs. For example, after the onset of COVID-19, to help ensure study continuity of a highly complex and challenging phase 2b study where many assessments needed to be conducted at a physical site, IQVIA worked with a sponsor to adjust the protocol to include new DCT elements. A thoughtful and quick response plan resulted in the removal of two office-based patient assessments that were not critical and the completion of 47 home health visits for drug delivery and lab testing.
Additionally, to provide patient support throughout the entire trial process, dedicated DCT study team members are part of the solution to help patients manage their study activities and remain engaged. For example, a study concierge can help guide patients through the trial, especially regarding logistics coordination and device training.
OSP: What can you tell us about the more than 60 trials you’ve helped clients with across more than 40 countries? What does that kind of reach say about your services, and the importance of conducting effective decentralized trials?
PS: More than 60 trials spanning over 40 countries utilize IQVIA’s innovative decentralized clinical trial solutions as part of their respective registration trials. Many of these trials launched in 2020 as DCT and patient-centric solutions are providing business continuity measures to sponsors during the global pandemic.
IQVIA is currently managing a mix of fully DCT and hybrid trials for several clients, including five of the top-10 pharma companies globally, enrolling more than 150,000 subjects in a range of therapy areas. Those areas of investigational clinical research include COVID-19 vaccines and treatments, immunology, central nervous system disorders, cardiovascular, oncology, dermatology and various infectious diseases.
As a pivotal example, in the fight against COVID-19, our suite of decentralized solutions played a vital role in advancing timely vaccine research with Janssen Research & Development (of Johnson & Johnson), on the Phase III COVID-19 vaccine clinical trial. Not only does this kind of reach and utilization reflect the growing need for flexibility in clinical research and the proliferation of technology-enabled options that enable decentralized trials, but it also reflects an unprecedented flexibility and openness among regulatory agencies across key markets for innovative, patient-centric clinical trial designs.
Ultimately, we believe, this experience shows our approach to adaptable, scalable DCT delivery works and is proven.
OSP: Do you have anything to add, about your DCT solutions, patient centricity, or anything else?
PS: In looking ahead, we can see that patient-centric solutions and approaches have a growing, permanent role in clinical research. As we continue to enhance our DCT solutions, we stay focused on how to improve user experience and engagement for patients at every stage of the drug development process.
In continuing to explore innovation and develop and integrate new technologies into trial design, it is vital we build solutions that have intentional purpose for sponsors, site teams, and most importantly, patients and ultimately, help improve health outcomes.