Adapting Monitoring Models During COVID-19

The outbreak of COVID-19 has affected the world in many ways. In clinical trials, site visits by patients, CRAs, and site personnel have been severely restricted or cancelled. This fast-changing situation has led IQVIA to re-evaluate how they adapt their monitoring models to continue to help their customers bring potential healthcare treatments to patients. Applied Clinical Trials had the chance to speak with two leaders at IQVIA to take us through the process of how the company is adapting to a COVID-19 world; Rajneesh Patil, Senior Director, Clinical Operations at IQVIA and Head of Process Design, Technology and Advanced Analytics and Chris Varner, a project manager for IQVIA virtual trials.

ACT: What does remote monitoring involve, and how can it be done safely and with accuracy given limited access to sites and documentation? 

Patil: In traditional trial models, clinical research associates, or CRAs, physically visit trial sites to monitor for compliance of three vital components: patient safety, appropriate clinical practices, and trial integrity and data quality.

With widespread travel restrictions and stay-at-home orders in effect today, we are seeing just how remote monitoring can help maintain trial continuity while keeping patients safe - a top concern during this pandemic. Adopting a remote monitoring model, CRAs can work through a central technology for data aggregation and automated workflows to identify signals and monitor safety trends across sites, subjects, or regions. Being able to consistently monitor key risk indicators and identify signals early on can help enable risk management, patient safety, and protocol deviations which are likely to show an uptick during this period.

Using rapid analytics and existing technologies historically implemented for risk-based monitoring (RBM) trials, it is possible to pivot all non-RBM trials to utilize these solutions by amending the clinical operation plans and training the CRAs and Clinical Leads on these tools. For IQVIA, the quick shift from non-RBM to RBM trials was made possible because of the data infrastructure support in our foundational technologies.

ACT: Before making any changes in trial design and processes, what do sponsors need to consider? 

Patil: It’s important to help sponsors methodically evaluate all the risks and variables within their trial protocols and patient populations so that we can best assess the suitability of remote solutions for their unique trial.

There are several key components to this study risk impact assessment. First and foremost, can patients complete trial requirements in the current environment? And, if so, what components will need to be implemented into the trial to help facilitate participation such as televisits or home health delivery? In terms of logistics and supply management, including lab tests or patient medications, we would also need to think about how to seamlessly manage these processes remotely.

Rajneesh Patil

If staff at sites is reduced and CRAs are not able to visit sites, remote site monitoring and data review are critical to consider. This includes weaving in a document exchange platform, CRA televisits, and incorporating a remote monitoring and risk management strategy.

The other key factor is to ensure site staff are properly trained and comfortable using the technologies and data platforms as well as adapting patient engagement strategies that support the telemedicine practice.

As regulatory updates are provided, how to support alternate trial execution models with protocol adjustments are variables to plan for as well.

ACT: How do trials proceed with virtual patient visits and communication? What is necessary for successful implementation? 

Varner: Decentralized trial models are giving sponsors a much-needed lifeline to continue their research during the pandemic. In recent years, sponsors have noticed that when trials are brought to the patient, they can speed recruitment, improve engagement, and produce higher quality data, all of which help shorten study timelines and decrease related cost.

Strategically selecting the right technology platform is the first step, putting it to work for patients is the next. To ensure patient safety standards and data quality remain high, site staff must be trained to effectively facilitate patient discussions and study visits in a virtual setting. Maintaining eye contact during televisits and recognizing body language that signals a patient’s need for additional support may seem like small things but are critical to successful patient engagement in a virtual environment.

Our technology, the IQVIA™ Study Hub, provides a “one stop shop” approach to ensure patients are able to openly communicate with study teams and vice versa. This includes televisits, but also opportunities for patients to ask questions anytime or to share e-diaries and capture data remotely from wearable devices. And, as trial adjustments are made, study teams can secure electronic consent forms from patients as well.

When a higher level of direct engagement remains critical to the success of a trial, home health visits with trained healthcare professionals can be incorporated into the virtual trial model to ensure necessary testing and direct-to-patient deliveries of study drugs and supplies continue in the remote format.

ACT: What is the regulatory perspective on remote monitoring and virtual capabilities to manage trial continuity? 

Varner: The support from regulators globally was rapid and specific for virtual tools and models as COVID-19 spread across the globe -an indication that agencies see decentralized models and patient-centric technologies as a viable solution to this crisis, and potentially beyond.

Chris Varner

Typically, virtual trials tools are selected early in the protocol development stage of the clinical research process and incorporated into the trial plan long before recruiting begins. However, due to the COVID-19 crisis, regulatory bodies across the globe are encouraging sponsors to consider integrating remote, patient-centric solutions into clinical trials already in progress. Also, agencies are more openly recognizing that remote elements minimize disruption for study participants, sites, and data collection, perhaps paving the way for broader use in the future.

In late March, the FDA and the EMA separately updated guidance to recommend sponsors incorporate virtual assessment tools and clinical monitoring to main trial continuity. The FDA is also allowing for changes to be made to any investigational plan or protocol without prior approval so long as the change intends to eliminate hazard and protects life the life and well-being of study participants.

In guiding sponsors through trial site modifications, we work to not only consider regulatory updates, but also geographic and individual country guidelines as well as subject rights and safety, maintaining data integrity and proper documentation, and managing protocol deviations. There are a lot of critical pieces to the puzzle that need to be considered along with the regulatory perspective.

ACT: To transition to hybrid or virtual trial models, what budgetary impact will sponsors have to think about? 

Patil: In working with customers and industry stakeholders, we know the collective priority and focus remains heavily on how to manage trial continuity safely and with quality for the sake of patients. For individual sponsors and trial study teams, it is vital to consider and identify what skills and resources are necessary to shift to a hybrid or virtual model.

Because solutions are customized to fit individual trial needs, budgetary impacts may vary. For example, some trials may need to incorporate home health components to transition to virtual models successfully, and this can impact trial cost. On the other hand, as virtual components are incorporated to manage trial continuity, we know there will be fewer on-site resources needed, which can also impact cost. 

As a service provider, we can help to identify those variables and implement changes efficiently. In adopting digitization to pivot from on-site to remote monitoring elements, including risk based monitoring, we never lose sight of the fact that cost is always a factor for sponsors, now and pre- and post-pandemic and we’ve been able to help sponsors reduce trial monitoring costs by up to 25%.

ACT: Post-COVID-19, how do you envision the future of trial design?

Patil: As we look ahead over the coming months and years, the demand for innovative therapies that improve patient lives is on the rise. Key stakeholders in the industry are recognizing more and more that patient-centric technologies and approaches are viable solutions well beyond the pandemic.

As market needs evolve and change, trial models will need to better account for anticipating roadblocks and making real-time adjustments quickly, so, research can continue. Time will tell what our “new normal” will be.

Customized remote monitoring solutions let us monitor safety trends across sites, participants, or regions to make needed changes quickly.  AI models have been adapted to help assess pandemic impact on individual trial sites in order to better understand when study activities can resume safely. And, at the heart of it all, we are able to bring trials to patients. Through technology-enabled solutions, patients can communicate with site teams for televisits, upload patient updates through e-diaries, manage patient documentation, and share data outcomes through connected devices. To supplement those efforts, some trials can also incorporate at-home support such as lab tests or infusions through trained nurses and healthcare professionals.

What once seemed impossible is now a growing reality and changing the landscape for clinical development around the world.