Dr. Ronan Brown, SVP and Head of Integrated Global Compliance, IQVIA03.22.21
During the COVID-19 pandemic, we saw the pharmaceutical sector—including key industry players and regulators around the globe—work collaboratively to rapidly develop and deliver diagnostic tests, treatments and vaccines at breakneck speeds. The incredible success of these efforts has truly shown what the industry is capable of, even under lockdown. This has contributed to the upending of traditional regulatory practices. With vaccine distribution now underway, life sciences companies and regulators alike will need to reflect on what will realistically return to its pre-COVID state and what will benefit from long-term change in regulatory compliance.
The New Normal for Clinical Development Regulatory Practices
With new COVID-19 virus strains still being discovered and COVID-related drugs and treatments continuing to be developed, demands for faster clinical development have become even more pressing—resulting in many traditional clinical trial processes taking on new formats to increase clinical development efficiencies. These new formats include a decentralized approach to collecting patient information and rapid access to regulators in order to assess plans and changes to ongoing studies in near real-time. One example of this is with pre-investigational new drug (IND) meetings with the U.S. Food and Drug Administration (FDA). During the pandemic, some of these meetings have been granted in under 30 days, with select flexibility around the need to include non-clinical information in order to accelerate the review and initiation of studies.
Additionally, regulatory agencies, like the FDA, can complete rolling reviews of the information to accelerate emergency use authorization (EUA) approvals, rather than wait for a full dossier of information for a new drug application (NDA). This process ensures a key balance of safety and efficiency by assessing the risk benefits of a drug or treatment and generally requires a very robust post-EUA safety surveillance plan, or pharmacovigilance strategy, to ensure early detection of potential issues prior to clinical trial studies. On the road ahead, decentralized clinical trials and new formats such as rolling NDA reviews may become more common for industry-regulator collaboration.
Raising the Standard for Compliance to Meet Decentralized Study Design
In tandem with a decentralized approach to gathering patient information, the execution of clinical trials has followed suit, spurring a need for new regulatory guidance in the process. Through more rapid and diverse patient recruitment and increased retention rates, decentralized and hybrid clinical trials will offer faster start-up times, greater efficiencies and higher return on investment. However, scaling up this format, which has historically been based on mobile health apps and restricted to smaller, less complex studies, will require rigorous regulatory compliance practices to ensure meeting the same standard of quality as traditional trials. Pharmaceutical companies will be challenged with implementing the right technology to balance speed with regulatory compliance. Through this process, automation of data capture and reporting will be critical capabilities to ensure accuracy and completeness of submissions that translate to the delivery of safe and compliant products.
The Impact of New Regulatory Practices on Post-Clinical Submissions
Although many processes throughout the drug development lifecycle are changing due to the increased need for accelerated clinical development, required adherence to safety regulations from regulatory agencies will not. In fact, the FDA has issued 74 new COVID-specific guidance documents since March 2020 and is anticipated to issue more in the coming months. Consequently, pharmaceutical companies are eager to discover new methods to maintain collaborative efforts with regulators and keep up with evolving regulations, while maintaining new clinical development speed and efficiencies.
To address this, pharmaceutical companies are looking at new ways to use regulatory intelligence to drive workstreams and automate the more repetitive, tedious regulatory reporting tasks. Such regulatory tasks traditionally take place in siloed teams within pharmaceutical companies, separate from other functional groups (e.g., safety and quality teams). Cloud-based technology is critical to driving efficiency, as it allows teams to work more easily and collaboratively remotely as well as outsource more tasks. Through the power of artificial intelligence (AI) and machine learning (ML), regulatory groups can share data and join forces with safety and quality teams to integrate operations, as well as embrace a more outsourced model and leverage external resources to help increase regulatory information management efficiencies.
Furthermore, real-world data (RWD) and simulation data gathering will play a key role in the discovery and development of new clinical treatments. Initially, pharmaceutical companies did not prioritize the use of real-world data due to a lack of resources and infrastructure to gather and screen it. With broadened COVID-19-related experience illustrating the inherent value, the industry is more accepting of such novel approaches to data. By embracing these new digital processes, clinical study leaders can more rapidly to collect necessary data and help ensure patient safety while ensuring adherence to protocols and regulatory requirements.
A Digitally Integrated Post-Pandemic Era
The COVID-19 pandemic not only exposed gaps within current regulatory practices, but also catalyzed a digital transformation within the pharmaceutical industry, driven by the need for speed and efficiency. In the next year, the industry will continue to collaborate with health authorities and adopt innovative technology to redefine its traditional processes.
Dr. Ronan Brown is SVP and Head of IQVIA Integrated Global Compliance, where he connects IQVIA’s global partners with high-tech solutions to manage their compliance challenges. He has spent his career supporting healthcare companies through technological transformation, starting in the UK as a CRA for BRI International. He later joined Glaxo Wellcome, where he focused on respiratory studies in several capacities, including project management, medical affairs and market support.
The New Normal for Clinical Development Regulatory Practices
With new COVID-19 virus strains still being discovered and COVID-related drugs and treatments continuing to be developed, demands for faster clinical development have become even more pressing—resulting in many traditional clinical trial processes taking on new formats to increase clinical development efficiencies. These new formats include a decentralized approach to collecting patient information and rapid access to regulators in order to assess plans and changes to ongoing studies in near real-time. One example of this is with pre-investigational new drug (IND) meetings with the U.S. Food and Drug Administration (FDA). During the pandemic, some of these meetings have been granted in under 30 days, with select flexibility around the need to include non-clinical information in order to accelerate the review and initiation of studies.
Additionally, regulatory agencies, like the FDA, can complete rolling reviews of the information to accelerate emergency use authorization (EUA) approvals, rather than wait for a full dossier of information for a new drug application (NDA). This process ensures a key balance of safety and efficiency by assessing the risk benefits of a drug or treatment and generally requires a very robust post-EUA safety surveillance plan, or pharmacovigilance strategy, to ensure early detection of potential issues prior to clinical trial studies. On the road ahead, decentralized clinical trials and new formats such as rolling NDA reviews may become more common for industry-regulator collaboration.
Raising the Standard for Compliance to Meet Decentralized Study Design
In tandem with a decentralized approach to gathering patient information, the execution of clinical trials has followed suit, spurring a need for new regulatory guidance in the process. Through more rapid and diverse patient recruitment and increased retention rates, decentralized and hybrid clinical trials will offer faster start-up times, greater efficiencies and higher return on investment. However, scaling up this format, which has historically been based on mobile health apps and restricted to smaller, less complex studies, will require rigorous regulatory compliance practices to ensure meeting the same standard of quality as traditional trials. Pharmaceutical companies will be challenged with implementing the right technology to balance speed with regulatory compliance. Through this process, automation of data capture and reporting will be critical capabilities to ensure accuracy and completeness of submissions that translate to the delivery of safe and compliant products.
The Impact of New Regulatory Practices on Post-Clinical Submissions
Although many processes throughout the drug development lifecycle are changing due to the increased need for accelerated clinical development, required adherence to safety regulations from regulatory agencies will not. In fact, the FDA has issued 74 new COVID-specific guidance documents since March 2020 and is anticipated to issue more in the coming months. Consequently, pharmaceutical companies are eager to discover new methods to maintain collaborative efforts with regulators and keep up with evolving regulations, while maintaining new clinical development speed and efficiencies.
To address this, pharmaceutical companies are looking at new ways to use regulatory intelligence to drive workstreams and automate the more repetitive, tedious regulatory reporting tasks. Such regulatory tasks traditionally take place in siloed teams within pharmaceutical companies, separate from other functional groups (e.g., safety and quality teams). Cloud-based technology is critical to driving efficiency, as it allows teams to work more easily and collaboratively remotely as well as outsource more tasks. Through the power of artificial intelligence (AI) and machine learning (ML), regulatory groups can share data and join forces with safety and quality teams to integrate operations, as well as embrace a more outsourced model and leverage external resources to help increase regulatory information management efficiencies.
Furthermore, real-world data (RWD) and simulation data gathering will play a key role in the discovery and development of new clinical treatments. Initially, pharmaceutical companies did not prioritize the use of real-world data due to a lack of resources and infrastructure to gather and screen it. With broadened COVID-19-related experience illustrating the inherent value, the industry is more accepting of such novel approaches to data. By embracing these new digital processes, clinical study leaders can more rapidly to collect necessary data and help ensure patient safety while ensuring adherence to protocols and regulatory requirements.
A Digitally Integrated Post-Pandemic Era
The COVID-19 pandemic not only exposed gaps within current regulatory practices, but also catalyzed a digital transformation within the pharmaceutical industry, driven by the need for speed and efficiency. In the next year, the industry will continue to collaborate with health authorities and adopt innovative technology to redefine its traditional processes.
Dr. Ronan Brown is SVP and Head of IQVIA Integrated Global Compliance, where he connects IQVIA’s global partners with high-tech solutions to manage their compliance challenges. He has spent his career supporting healthcare companies through technological transformation, starting in the UK as a CRA for BRI International. He later joined Glaxo Wellcome, where he focused on respiratory studies in several capacities, including project management, medical affairs and market support.
