Growth in risk-based approaches the ‘main challenge’ to address in 2020

By Vassia Barba contact

- Last updated on GMT

(Image: Getty/Ridofranz)
(Image: Getty/Ridofranz)

Related tags: CluePoints, compliance, risk assessment, Risk management, Risk-based monitoring

This year brought the ‘biggest momentum shift’ in the adoption of risk-based approach to trial management in the clinical research industry, says CluePoints executive.

As we come towards the end of the year, industry experts discuss how the clinical research market has evolved and how they are looking to prepare for the challenges to overcome in 2020.

The past year saw CluePoints, a software developer providing clinical trial monitoring services, build on its agreement with the US Food and Drug Administration (FDA)​ to provide its services supporting the regulator’s oversight of the clinical trial market.

Asked about how market demands have shifted since 2018, the company’s CCO, Patrick Hughes pointed to the ICH E6 (R2) good clinical practice (GCP) guidance, which ‘became a reality’ for sponsors and clinical research organizations (CROs).

As a result, this made 2019, “the year in which we have seen the biggest momentum shift across the industry in the adoption of a risk-based approach to trial management,”​ Hughes said.

Risk-based quality management in clinical trials focuses on identifying the most important compliance risks in a study and setting them as a priority in order to prevent and avoid potential disruptions.

This can be achieved through software services that interrogate clinical and operational data in order to conduct risk assessment and evaluation and support a company on its compliance strategy.

CluePoints have seen its clients become more ‘sophisticated’ in their approach as their experience increases, with this “driving the type of efficiencies expected by the regulators through increased data quality and integrity,” ​Hughes further outlined.

Market demand for risk-based approaches, applied to all areas of clinical trial planning and execution, has increased ‘significantly’ during the last 12 months, and this represents an ‘exciting’ challenge in terms of market growth, the executive noted.

CluePoints’ CCO cited the growing demand as the main challenge that the company looks to address in the year to come, with the company planning to increase its recruitment rates.

This is due to the fact that “getting the balance right between awarded business and the people needed to support the software and provide expert advice will be crucial in 2020,” ​Hughes stated.

When asked about which new technologies are expected to be increasingly adopted by the market in the new year, the executive cited machine-learning techniques as the ‘big game-changer’.

“In the future the entire risk-based quality management will be driven by machine learning and predictive analytics techniques,” ​said Hughes, also noting the increasing prevalence of wearables, which enable collection of real-world evidence data in order to better inform regulatory decisions.

“The industry is struggling with monitoring and oversight of the current crop of data collection techniques, so it will be crucial to use unsupervised and independent techniques driven by technology in order to cope with this ever-increasing volume of data,” ​Hughes concluded.

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