MHRA Guidance: Building Resilience into Clinical Trials

01/19/2021

In March 2020, the Medicines and Healthcare Products Regulatory Agency (MHRA) of the United Kingdom released a guidance describing best practices for managing clinical trials during the COVID-19 pandemic. In November 2020, another guidance was issued describing how to minimize disruptions in the conduction and integrity of clinical trials amid the ongoing pandemic. The MHRA published this guidance to help the industry avoid interruptions caused by a persisting health crisis but also to support the applicable use of available flexibilities into routine procedures that better serve trial participants. The MHRA is asking us to build resilience into how we conduct clinical trials. One positive outcome from continuing clinical trials during the pandemic is that it has generated more evidence that remote monitoring using a risk-based approach is feasible and will likely remain a part of clinical trials moving forward.

Described in the most recent guidance titled “Guidance minimizing disruptions to the conduct and integrity of clinical trials of medicines during COVID-19” are actions that sponsors can take to build resilience into clinical trial design and a move towards a decentralized model of trial conduct. Conducting visits via telemedicine, implementing a risk-based approach to monitoring, and having concise trial endpoints support social distancing, and therefore create a safer environment for both the trial participants and those working on the trial. The flexibilities mentioned should only be used if deemed appropriate after a rigorous risk assessment evaluating each trial. In order to maintain the priority of trial participant safety, it should be determined if the benefits outweigh the risks involved in continuing a clinical trial during the climate of COVID-19. Ways to build resilience into clinical trials mentioned in the guidance are:

  • Updating Standard Operating Procedures (SOPs) to reflect decentralized methods for trial conduct

  • Updating training documents for staff on these SOPs

  • Flexible protocol design with concise endpoints and the use of decentralized and digital/virtual aspects

  • Implementing telemedicine

  • If possible, self-administration of investigational product (IP) or home visits, if not

  • For data integrity: consider how to obtain auditable data from non-traditional sources into the electronic data capture system (EDC)

  • Changes to analytical methods

  • Flexible monitoring strategy with full support for a risk-based approach

A robust risk assessment is foundational to the outcome and successful continuance of trials during the ongoing pandemic. There are many tools available currently such as a risk-based approach, encouraged by the MHRA, that could assist in clinical trial execution during these times, although, it is seldom adopted.

The COVID-19 pandemic has necessitated a requirement for using innovative and novel endeavors to continue our work in the clinical trial industry. Perhaps, this is the push needed in order to embrace new operating methods which will provide a secure and flexible foundation, not only during this environment of a global pandemic but beyond.

 

-The Clinical Pathways Team

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