Clinical research is in a state of evolution, with organizations forced to respond to market pressures while simultaneously adapting to an increasingly digital environment. These pressures include a rise in R&D costs, healthcare consumerism, patient centricity, and a decline in the appearance of blockbuster-status products.
The impact of these pressures has varied among organizations. As a result, organizations are at different stages in their digital transformation journeys. To provide more universal structure, the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) recently released a new draft guideline for Good Clinical Practice (GCP).
The new revision, ICH E6 (R3), intends to modernize, harmonize, and adapt existing GCP guidelines to support the latest innovations in clinical trials.
In what follows, we highlight the changes in ICH recommendations, define what a successful adoption of these changes may look like for your organization, and outline tangible next steps that can be taken to achieve your goals.
Incorporating technology with the aid of ICH E6 (R3) guidelines can provide significant benefits to research organizations and study trials, including increased study safety, patient centricity, participant diversity, data integrity, transparency, and overall efficiency.
While ICH E6 (R3) includes an abundance of recommendations across a wide range of topics, we’re digging into guidelines that we believe can be most impactful for improving clinical trials through the incorporation of digital practices, including:
In response to FDA and ICH directives, the life sciences sector is embracing a risk-based approach to trial design enabled by digital tools and analytics. This approach proactively identifies and mitigates key quality risks, defined as any factor that poses a threat to the safety, integrity, and compliance of the people and processes in a trial.
ICH E6 (R3) provides guidelines on incorporating cutting-edge digital technologies and diverse data sources into clinical trial design and execution—including the use of wearables and the adoption of a Quality Management System. This highlights the need for strict data protection and confidentiality requirements to accompany an innovative, digital transformation.
ICH E6 (R3) provides guidelines for increasing flexibility in clinical trial designs to drive more innovation. This includes a shift from a process-based to a principles-based design that empowers investigators to adapt the guidelines to their specific circumstances and ensure trial outcomes align with patient population needs.
These guidelines introduce the possibility of remote/electronic informed consent. This new approach allows for flexible methods of sharing trial information with patients—including varied digital formats—while still ensuring a comprehensive understanding for participants.
The rapid shifts in the industry’s typical operating models and technological landscape pose challenges in assimilating to new standards, protocols, and regulatory frameworks. For successful clinical trials in this environment, companies should focus on the key changes in ICH E6 (R3) and construct a clear roadmap to apply to their trials.
Adopting a risk-based quality approach involves substantial upfront efforts, including document revision, trial protocol refinement, and personnel training—alongside a transformation of tech infrastructure toward digital solutions. These efforts may result in significant organizational change management while contributing to ongoing trial success.
When shifting toward a risk-based approach, consider having open discussions on quality and risk management during the pre-trial phase to guide protocol development with built-in mitigations and iterations. Additionally, consider utilizing digital tools throughout the trial to ensure consistent oversight, risk monitoring, and analysis. The data captured by powerful digital tools such as machine learning can inform risk evaluation, improve data analysis, enable efficient trial execution, and increase automation.
Digital solutions for risk management such as risk assessment software, electronic data capture systems, and data analytics have capacity to enhance risk evaluation data quality, trial efficiency, and product time-to-market. This approach can also optimize document and data collection by focusing on and recording key risks.
ICH E6 (R3) details methodologies to increase trial flexibility and accessibility that include digital technology adoption, patient-centric considerations, and remote informed consent. These recommendations may allow for a more efficient clinical trial process and a more diverse patient population. Increasing clinical trial efficiency, diversifying patient populations, and instituting more patient-focused trial objectives should result in more accurate trials with better patient outcomes.
Incorporating new technology into clinical trials may result in new costs required to build the infrastructure needed for successful implementation. Organizations should consider how to account for the costs associated with additional investments in new hardware such as tablets and wearables, and new software such as e-consent platforms and cloud storage.
Adopting a patient-centric clinical trial design approach may require the use of digital technology to collect and track data during patient recruitment to ensure all criteria are met. This approach will also require the use of digital technology throughout trials to record data in a safe and efficient manner. When integrating new technology during the study design phase, teams should consider how the data is collected and who has access to it.
Finally, while remote informed consent can increase trial flexibility and accessibility, there may need to be considerations around communication methods and data transfers such as:
While ICH principles provide a comprehensive overview of best practices in clinical trials, the key challenge lies in discerning and prioritizing tactical next steps, especially considering the ongoing implementation of many of these changes. We recommend evaluating your organization's current state to highlight achieved progress, identify prevailing pain points, and outline actionable measures to propel towards enhanced operational efficiency. The ensuing framework can serve as a valuable guide to aid in your evaluation.
What can your life sciences company do to implement digitally focused risk-based clinical trials?
What can your life science company do to increase flexibility in trial design, expand use of digital technologies, and shift toward a more patient-centric environment?
The adoption of digital practices in clinical research, guided by ICH E6 (R3), presents a pivotal opportunity for the life sciences industry. Embracing risk-based trial design and fostering flexibility are essential steps toward enhancing the quality of clinical trials. As your organization navigates this evolving landscape, it is imperative to engage in comprehensive assessments and prioritize patient-centricity to position your organization for success in an increasingly digital era of clinical research.