Remote monitoring is mitigating the impact of SARS-CoV-2 on clinical trials, marking an acceleration in the adoption of modern clinical trial technologies
King of Prussia, PA – March 18, 2020: CluePoints, the premier provider of Risk-Based Trial Execution (RBx) and Data Quality Oversight Software for clinical trials, has seen a dramatic increase in demand for remote and centralized site monitoring amid the ongoing coronavirus outbreak.
With sites across the globe increasingly proving to be inaccessible patients, staff, and monitors, and with regulators halting inspections, the biopharma industry is facing multiple challenges to ensuring participant safety, and compliance, as well as data quality and integrity.
As the sector strives for business continuity during this global pandemic, it needs to overcome the travel bans and restrictions that are impacting operational work, and potentially putting patient safety at risk.
That is why CluePoints has mobilized to help its clients use remote monitoring and Risk-Based Quality Management (RBQM) to continue to run trials effectively despite the mounting challenges.
COVID’s impact on the clinical research industry
In recent weeks, stay at home orders, designed to control the spread of SARS-CoV-2 have seen remote working transform from a “nice-to-have” into an essential component of business continuity.
This is just as true in the clinical research space, which, arguably, has more to consider than most. Trial participants are often among the most vulnerable to the new disease, which gives infection control measures an added impetus.
In a bid to protect patients, staff, and business continuity alike, sponsors and their CRO partners are increasingly seeking alternative, remote approaches to monitoring study conduct, compliance, safety, and data quality across all participating sites.
The alternative is dire. While the emergence of the novel coronavirus sparked a flurry of research in the COVID space, studies in other disease areas fell foul of social distancing and lockdown measures.
In April 2020, 73% of all clinical trials in the UK had been placed on hold, and, as of early October, more than 40% were still in limbo.
Some commentators expect it to be some time before the industry reaches pre-pandemic levels of non-COVID. They warn of a lost decade of medical advances and progress that would hamper the industry’s mission to get lifesaving medicines to those who need them.
Ultimately, by threatening to add to the already lengthy process of drug development, enforced study postponements could prove extremely costly to the pharma and biotech industries.
Currently, it takes around ten years for a new medicine to travel along the pipeline from initial discovery to market access, with clinical trials taking 60 to 70% of that time. On average, that journey costs $2.6 billion.
COVID-induced stoppages could serve to drive those figures even higher.
Pandemic-induced remote monitoring
By eliminating, or at least reducing on-site monitoring visits, study organizers can keep their teams and subjects safe, and their projects on track. Fortunately, this can be achieved without significantly impacting trial oversight.
At CluePoints, many of our customers have ongoing trials which have been affected by site travel restrictions. Rather than shut down, however, they have worked with us to implement remote and centralized site monitoring.
Sponsors can maintain monitoring efforts and oversight by utilizing our software’s Central Monitoring Platform to interrogate the data, then use remote site follow-up – whether that is online, by phone, or email – wherever risks are detected.
During this COVID-induced shift, study leaders are learning the many benefits of this new way of working, which also lends itself to risk-based monitoring (RBM) and risk-based quality management (RBQM).
Central Statistical Monitoring (CSM) gives sponsors and CROs the ability to uncover unknown problems in the execution of clinical trials. They can use it to identify patients, sites, countries or regions with atypical data patterns that lead to the discovery of operational issues.
By allowing statistical algorithms to interrogate the data in an unsupervised manner, for example, sponsors have been able to identify risks early, protect participant safety, and avoid costly delays to product development.
Commenting on the current situation, Patrick Hughes, Co-Founder and Chief Commercial Officer of CluePoints, said that the industry had been steadily moving towards a new paradigm of central monitoring for some time, but the current crisis was accelerating progress and forcing more rapid change.
“At CluePoints, we have an important opportunity to play our part in supporting all the patients and stakeholders involved in clinical trials to ensure safety and integrity. As pioneers in the field of RBQM, we continually respond to industry demand, to ensure sponsors, CROs and Clinical Technology Partners benefit from constant innovation and transparency.
“We’re passionate about maximizing clinical trial data quality, and remote monitoring is one such area that can have a real impact. We’re all worried about the potential effect of COVID-19, on both a business and personal level. But simple, easy-to-deploy solutions that remove the need for on-site human intervention that can also help to ensure business continuity exist.”
He went on to say that RBM, which has been backed by the EMA, FDA, and ICH, had been steadily gaining traction over the last decade, by offering a more efficient and effective quality-control process.
It has really come into its own during the pandemic – and many believe it is a change that is here to stay.
Sponsors have discovered the power of the approach, which can pinpoint the right information to improve data quality and patient safety with greater speed and accuracy than traditional clinical trial conduct methods.
Said Patrick: “CluePoints is committed to helping companies identify, assess, plan, mitigate, monitor and analyze risk across all elements of clinical trial management to comply with regulatory requirements.
“We believe that RBM should be viewed as the new normal. Regardless of global crises, central monitoring oversight platforms offer extended benefits for participant safety, participant experience, and operational success.”
For further information on CluePoints’ solutions, please visit www.cluepoints.com
Notes to editors
What is risk-based monitoring?
Risk-based monitoring (RBM) is the process of identifying, assessing, monitoring, and mitigating the risks that could affect the quality or safety of a clinical trial. The proactive approach allows the study team to move away from 100% source data verification (SDV) – a time- and resource consuming approach that provides far from perfect results – and instead focus resources on high-value tasks.
First written into US and European guidelines back in 2013, RBM received further validation with the publication of the ICH E6 (R2) in 2016.
Many pharmaceutical companies, sponsors, and CROs now follow the TransCelerate RBM methodology. It is a robust risk identification process that allows trial designers to evaluate study risks, and organize them into the following categories:
- Safety study phase
- Subject population
- Data collection/ CRF source
- End points
- Organizational experience
- Investigational product/ study medication
- IP logistics / supply chain
- Operational complexity
What is centralized statistical monitoring?
Centralized statistical monitoring (CSM) is can be described as a data quality insurance policy. It provides a way to identify and respond to less obvious risks, or those that may not have been identified through risk assessment processes.
Data surveillance, through a central statistical assessment of data quality, can flagging anomalies that warrant further investigation.
It works on the assumption that data should be comparable and statistically consistent across centers, other than random fluctuations and natural variations. Unsupervised CSM performs as many statistical tests on trial data as possible to detect inconsistencies that may point to potential problems, without placing additional burden on study teams.
It can spot atypical patterns that represent potential intentional or non-intentional misconduct, such as fraud, sloppiness, training needs, or malfunctioning or mis-calibrated study equipment.
What is risk-based quality management?
Risk-based quality management (RBQM) brings all of these elements together and applies them to the entirety of a clinical trial.
It uses technology, real-time information, and analytics to monitor risk, giving sponsors the ability to identify and correct issues as and when they arise. This enables sponsors and CROs to take corrective action before problems have a chance to impact on the integrity of a clinical trial.
Its fundamental goal is to improve the operational success rate of clinical research through higher quality data, shorter timelines, and greater operational efficiency.
RBQM boosts both participant safety and the likelihood of trial success. As such, it has been backed by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the International Committee on Harmonization (ICH).
By helping researchers to identify and focus on data that really matter, tech-led RBQM solutions provide the ultimate safety net, both from a patient safety and ultimate success perspective.
The ICH E6 (R2) guideline set out what a gold standard RBQM would cover:
- Critical process and data identification
- Risk identification
- Risk evaluation
- Risk control
- Risk communication
- Risk review
- Risk reporting
CluePoints is the premier provider of Risk-Based Trial Execution (RBx) and Data Quality Oversight Software. Our products utilize comprehensive statistical algorithms to determine the quality, accuracy, and integrity of clinical trial data both during and after trial conduct. Aligned with guidance from the FDA, EMA, and ICH E6 (R2), CluePoints® is deployed to support central and on-site monitoring, medical review, quality risk management and to drive a holistic Risk-Based strategy in all trials. Coupled with thought leadership and consulting expertise to aid pre-trial risk assessment, identification of risk controls and solution implementation you now have everything you need to adhere with global regulatory guidance. The result is increased operational efficiency, lower costs and reduced regulatory submission risk as part of the industry paradigm shift to RBx.
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Patrick Hughes – Chief Commercial Officer, CluePoints
+44 (0) 7703 532 749