The company assembled a suite of solutions designed to help clinical trial teams address concerns about risk assessment and mitigation during the global pandemic. Offered at no cost to users, the package is designed to help stakeholders meet requirements and follow guidelines issued by the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and other bodies, and to address other risks.
Determining risks
Patrick Hughes, CEO and co-founder of CluePoints, told Outsourcing-Pharma that the risk management package will prove useful to sponsors and CROs in quickly pinpointing areas of risk in their ongoing studies.
“Once these risks have been identified it is possible to effectively control them through the regular interrogation of the clinical trial data using a suite of statistical tools and data visualizations. The CluePoints COVID-19 Support Package allows companies to get a head start on the processes of both assessing and mitigating these risks to ensure patient safety and improve data quality and integrity at a time when traditional oversight methods are simply not possible,” he said.
Traditional issues
Hughes explained sponsors are being mandated to execute a new risk assessment for each study to identify and mitigate risks pertinent to the COVID-19 crisis. However, there are a number of issues with this approach, he told us:
- Increase in missed patient visits
- Increase in missed assessments even for patient visits that occur
- Increase in missed study treatments, for various reasons including missed patient visits and IP supply chain disruptions.
- Increase in patient early terminations (“study drop-outs”)
- Difficulty recruiting new patients
- Slower site responsiveness, including delays in EDC data entry and query response.
- Gaps in reporting of adverse events, especially to the extent that sites will have less frequent interactions with their patients.
- Less frequent on-site monitoring visits
However, Hughes said, the scope and impact of common risks vary by study, as likely will proposed mitigations. Study-specific risks may remain, such as higher risks for specific patient populations or treatments.
Performing assessments
To help address some of these specific challenges, the CluePoints platform includes an online Risk Assessment solution that, Hughes says, can be leveraged for performing risk assessment and mitigation planning during this crisis.
“Our team of experts has developed a special coronavirus-specific Risk Assessment template for use by our clients, that includes a set of relevant risk categories and associated considerations gleaned from the regulatory guidance documents issued by FDA, EMA, MHRA, and PMDA,” he said.
The complimentary risk assessment package includes:
- Free access to the CluePoints Risk Assessment Categorization Tool (RACT) for the duration of the crisis
- Complimentary guidance supporting users to focus on the new COVID-19 specific risks that are likely evident in most studies and how to control them
- Access to simple online eLearning (30 mins) to allow rapid setup
- Support via CluePoints Subject Matter Experts (SMEs) to facilitate onboarding
Lasting impact
While clinical trial teams and other life-sciences professionals are striving to adapt to the effects of the pandemic, Hughes told us the impact likely will be felt long after the crisis has passed.
“It is certain that clinical trials will never be the same again following the COVID-19 pandemic. The industry has been content to use the same methodologies for decades to manage clinical trial sites and oversee data quality and integrity,” he said. “COVID-19 has proved that this is simply not appropriate, acceptable or good enough any longer and it is likely to be the catalyst the industry has long needed to spark a paradigm shift to better, more efficient ways of working that will also drive better cost and resource efficiencies.”
Organizations interested in registering or learning more about the package can do so by visiting the CluePoints website, www.cluepoints.com.