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Blog
Enabling clinical trial continuity in today’s environment
In this blog post, Rajneesh Patil, senior director, Clinical Operations, shares how critical remote monitoring is to keep clinical trials on track during the COVID-19 crisis.
Rajneesh Patil, Head of Process Design, Technology & Advanced Analytics for Risk Based Monitoring IQVIA
Jun 12, 2020

The COVID-19 pandemic has affected us in many ways – collectively and individually. As communities across the globe are ordered to shelter-in-place, clinical trials contend with the reality that site visits by patients, CRAs and site personnel have been severely restricted. We’re being challenged to adapt quickly as COVID-19 changes the scenario for developing medicines and executing trials, today and into the near future

COVID-19 has created several critical challenges for clinical trials as sites/investigators, patients and monitors become compromised in their ability to conduct trial processes:

  • Lack of clarity in which components of a trial are at risk
  • Risk for protocols, as patients cannot get to trial visit for endpoint collection
  • Limited capacity for site and CRO monitoring
  • Lack of access, as site staff are restricted in their ability to be at sites

At IQVIA, we are addressing this challenge with a responsive solution to monitor sites & patient data and to keep studies on track. Core to this solution is enabling innovative technology with advanced analytics to broaden the implementation of risk-based monitoring and central monitoring principles to the broader clinical portfolio.

The critical questions we need to ask:

  • With limited or greatly restricted access to clinical sites, what changes need to be made?
  • How can we help ensure the safety of patients, monitors (CRAs) and site personnel?
  • How can we keep current trials on track and deliver study milestones?
  • What operational modifications need to occur to conduct monitoring effectively?
    • During the pandemic
    • Post-pandemic environment

With expertise from cross-functional groups, we’ve built out approaches that, depending on protocols and desired endpoints, rapidly implement remote and risk-based monitoring principles.

Study Risk Impact Assessment

It is critical to quickly understand, prioritize, and triage which trials components are impacted by COVID-19 outbreak and determine what strategies and tactics need to be taken.

A trial-level impact assessment is performed to determine how COVID-19 disrupts country/site operations, and reviews the Regulatory Authority and Ethics Committee guidance, along with local government and health authority guidance. The review includes clinical operations plans along with study management risks to understand the overall continuity needs. It includes a multitude of patient considerations, such as safety, enrollment, dosing, assessments with retention and adherence in the study protocol. Additional items covered in the tailored trial-level COVID-19 risk plan cover data integrity, investigational product handling, site activation considerations, lab testing, change control documentation and vendor management.

Our monitoring continuity plan includes 4 key components:

  1. Patient visit enablement services, to ensure patients can complete trial requirements – remote, or via support to get the site. This may include televisits or home health support.
  2. Logistics and supply management where lab, supply chain and logistics are in place to ensure lab tests and patient drug are seamlessly managed both on-site and remotely.
  3. Site support services to provide sites with training and support services enabling the site’s ability to deliver upon trials in the current environment.
  4. Remote site monitoring and data Review where we enable key analytics solutions for risk identification and mitigation. This includes secure document exchange, CRA televisits and remote site support to progress trial activities.

This monitoring aspect is where we will focus the remainder of this piece, but with the understanding the this supports the overall alternative trial execution models with protocol modifications and regulatory considerations.

Focus on Patient Safety, Data Quality and Risk Mitigation

With extensive experience in Risk-based Monitoring (RBM) and Centralized Monitoring, we can enable remote visits and review the potential of remote source data verification (SDV) with a focus on patient safety and develop the best approach to mitigate the risk to data integrity. This is an analytics-driven approach to risk management, identifying site outliers swiftly. We enable data integrity checks and have a continuous review of safety data reporting with protocol non-compliance to mitigate risks by using our remote monitoring and engagement tools.

Adjusting Processes to Optimize Remote Monitoring

Using data, analytics, technology and by leveraging site monitoring expertise the study teams adjust monitoring levels quickly and seamlessly to ensure appropriate level of trial management support.

In working closely with our customers, we are making steady progress to navigate the challenging period of this pandemic to ensure the safety of those engaged in clinical development process. Our efforts are focused on keeping patients safe and clinical trials on track, and on continuing to provide the research environment for development of therapies needed today and in the future.

About the author

Rajneesh Patil is Senior Director, Clinical Operations at IQVIA and Head of Process Design, Technology & Advanced Analytics for Risk Based Monitoring. He is a gold medalist in Dental Surgery from India with Foundations in Public health from Australia alongside certified six sigma greenbelt with an MBA in organizational behavior.

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