In the process of adapting to pandemic conditions, sponsors and CROs have discovered that Risk-Based Quality Management (RBQM) and remote monitoring are key to more efficient clinical trials with a higher chance of operational success.
 
Patrick Hughes, Chief Commercial Officer and Co-Founder at CluePoints, discusses why it took a global health crisis to modernize drug development.

Contract Pharma: What challenges did sponsors and CROs face at the start of the pandemic?
 
Patrick Hughes: It is hard to overestimate the impact of SARS-CoV-2 on clinical trials. When the virus first emerged, safety concerns among the public saw trial participants miss visits, assessments, and treatments, and many sites reported increased dropout rates. 
 
At the same time, global supply chains were heavily disrupted, and staff absences slowed site responsiveness, leading to gaps in adverse event reporting and less frequent interactions with participants.
 
Crucially, infection control measures, such as stay at home orders and social distancing, made on-site visits if not impossible, then at least undesirable.
 
In short, sponsors and CROs faced multiple layers of challenges to keeping their studies on track and their plans on schedule.
 
CP: How has the industry responded to COVID-19?
 
PH: The clinical research community has moved heaven and earth to rise to the challenges of the pandemic.
 
Global regulatory agencies, including the FDA and the EMA, recommended sponsors and CROs perform a fresh risk assessment for each ongoing study. The idea was to identify and mitigate risks pertinent to the COVID-19 crisis.
 
Tailored risk assessments and remote monitoring have become essential tools in this endeavor. They have helped companies navigate the minefield of regulations and inherent risks in order to ensure their clinical trials could continue safely and effectively.
 
For example, CluePoints launched a COVID-19 package that incorporated a coronavirus-specific risk assessment template. It featured a set of risk categories and considerations informed by the regulatory guidance documents from FDA, EMA, PMDA and MHRA.
 
The initiative offered recommendations regarding risk controls in the form of detailed Key Risk Indicators (KRIs) and included an online Risk Assessment and Control solution to drive and navigate optimal risk planning and mitigation.
 
Of course, one of the most pertinent risks to clinical research in the time of this pandemic is the infection among participants and site staff themselves. The practice of working remotely, then, has transformed from a “nice-to-have” to an imperative for business continuity, and the industry has embraced remote monitoring like never before.
 
Fortunately, remote approaches to monitoring study conduct, compliance, patient safety, and data quality across all participating sites are available and can be straightforward to implement with the right mindset.
 
CP: How has the industry used this new approach?
 
PH: RBQM and centralized monitoring are nothing new, but COVID-19 has thrust them into the spotlight – and demonstrated their value.
 
RBQM solutions provide biopharmaceutical and medical device companies a better way to identify, visualize, manage, and document the risks that may impact the outcome of a study. They use statistical models to determine the quality, accuracy and integrity of clinical trial data, and help sponsors to remotely monitor clinical and operational data in real-time. This increases efficiency, improves patient safety, and reduces costs.
 
During the pandemic, the approach has been fundamental. It played an instrumental role, for example, in the race to find a vaccine – large pharmaceutical companies used the methodology and software to interrogate data on a frequent basis, ensuring data quality and integrity, and accelerating study timelines.
 
In fact, one of the world’s top pharmaceutical companies utilized RBQM solutions to support the rapid development of an mRNA vaccine, giving surety in the process in record time.
Meanwhile, Central Statistical Monitoring has become an obvious alternative to on-site monitoring. By leaving no stone unturned in interrogating all clinical and operational data, it allowed stakeholders to focus their attention on the atypical sites, patients, regions, or countries that could be ‘at risk’.
 
CP: What has the industry learned from COVID-19?
 
PH: I think sponsors and CROs now recognize the benefits of early risk identification – and that RBQM allows them to focus their attention on what really matters most to study success. It pinpoints areas of risk quickly and guides stakeholders to actions required to mitigate and eradicate issues quickly as they occur.
 
The concept of dealing with risks evident in the most critical data, i.e., the safety and endpoint data, has proved to be invaluable in effectively managing studies and getting to database lock with all the necessary assurances and whilst complying with regulatory guidance to embrace these risk-based approaches.
 
Organizations have also implemented RBQM solutions, including centralized monitoring, to circumvent the challenges associated with the overnight disappearance of onsite monitoring.
In this respect, COVID-19 has accelerated the movement set in motion by the publication of ICH E6 (R2) in 2016 and has helped to drive change away from inefficient, legacy practices.
 
Sponsors now know they can maintain monitoring efforts and oversight remotely by utilizing a central monitoring platform to interrogate data, with site follow-up by web-based applications, phone, and email wherever risks are detected.
 
Last year gave everyone the chance to reflect on what matters most and demonstrated what can be achieved when we all work together towards a common goal. We must not lose sight of that.
 
Effectively, the scientific community achieved 10 years of discovery in 10 months. But there is scope to go even further. To do so, the industry must seize the moment and use what it has learned to aspire to even greater achievements.
 
CP: How will the last 12 months affect the future of clinical development?
 
PH: I believe the industry’s pandemic experiences will ensure the long-promised paradigm shift in clinical trial conduct will finally become reality. Indeed, many organizations have already committed to adopting these data-driven approaches as their permanent operating practices.

Drug development timelines have been extending and profit margins dwindling for some time. If we are to have any chance of seeing an increase in pipeline activity, drug developers must do more with less. That means virtual trials, remote monitoring, wearables, and RBQM will all become standard in the coming years.
 
The industry has been steadily moving towards a new paradigm of RBQM and centralized monitoring for the last few years, yet the current crisis has now forced more rapid change for the better.
 
COVID-19 was the catalyst the industry needed to embrace a new way of working. The changes made in the last year have demonstrated that modern trial conduct is safer, faster, and more efficient. And there is no going back now.