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Abby Abraham, Vice President, Data Analytics, and RBM for OmniComm Systems, writes about a new survey that highlights gaps in the conversation surrounding the industry’s adoption and implementation of risk-based approaches to monitoring.
From digital conversations to live panel discussions, the topic of risk-based monitoring (RBM) often dominates discourse in the clinical trials industry. The popularity of the topic, however, obscures the inconsistencies surrounding the industry’s adoption and implementation of risk-based approaches to monitoring. A new survey from eClinical Forum, in partnership with OmniComm Systems Inc., highlights the gaps in the conversation, including the sharp divergence in RBM adoption between larger organizations and other institutions.
Background about RBM and ICH-E6(R2)
Regulatory endorsement in the form of guidance and reflection papers generated the impetus to adopt risk-based approaches to monitoring1,2. A position paper from TransCelerate Biopharma Inc., (a not-for-profit consortium of organizations in the Life Sciences space) provided the much-needed guidance to operationalize risk-based approaches to monitoring3,4,5. Other industry forums, including eClinical Forum, have promoted best practices to enable risk based approaches to monitoring6.
In the last couple of years, formal amendment of E6 section of ICH (International Conference for Harmonization) - pertaining to Good Clinical Practices (GCP) and now commonly termed as ICH-E6(R2) - has taken center stage for clinical operations. The formalization of ICH-E6(R2) in 2016 and subsequent adoption of the same by regulatory agencies such as EMA and Health Canada7,8 established a regulatory expectation on organizations to comply, thus setting an inflection point for organizations to transition to a new and holistic mechanism of functioning.
Over the last two years, the industry has seen increased awareness of risk-based approaches to monitoring. It is encouraging that large sponsors and contract research organizations (CROs) have streamlined processes and offered risk-based approaches to monitoring as the primary model of delivery for outsourced studies. This approach or model is still developing, and organizations have utilized a variety of interpretations and approaches to achieve the same outcome. The industry has yet to adopt a standard delivery model for RBM.
How extensively has the industry implemented RBM? eClinical Forum, a non-commercial, global discussion and action forum, and OmniComm Systems, a leading global provider of clinical data management technology, sought insights that organizations could utilize to shape operational and business strategy in the changing paradigm.
Survey results indicate that larger organizations have either developed mature processes or are well onto the path of carving out a delivery model that accommodates ICH-E6(R2) requirements. In contrast, small and medium-sized organizations are only beginning to recognize the requirements of ICH-E6(R2) compliance.
The survey was launched in June 2018 through eClinical Forum member channels and through an email survey campaign to professional contacts in the industry. The survey was conducted in a neutral manner irrespective of size, type or geographical basis. Respondents were anonymous. More than 3,000 emails across 3,397 organizations were sent, and 211 respondents participated in the survey.
Summary and conclusion:
It can be inferred from the survey that the adoption of those principles has been mixed in the industry. Large organizations are well on the path to implementation. Many of those organizations seem to have mature processes to implement risk planning and monitoring. Small and mid-size organizations (grouped as non-large organizations) are primarily in the early stages of implementation. Those organizations are beginning to accept the requirement to transform their operational processes and methodology.
Key findings from the survey responses are as follows:
In conclusion, small and mid-sized organizations must recognize that pursuing global markets for new drug approvals is increasingly at risk, especially in Europe and Canada in short term, given the requirements to adhere to ICH-GCP(R2) requirements.
The gap in value differentiation between small/mid-size CROs and large CROs have significantly widened in recent years – from a scalable regulatory and quality compliance perspective, given the ICH-E6(R2) requirements. It would serve the small and mid-size CROs well to expedite remedial interventions at a process, people and technology level to continue being relevant in the global clinical research landscape.
Abby Abraham is the vice president of Data Analytics and Risk-Based Monitoring at OmniComm Systems, Inc.
The author acknowledges Ken Light, executive vice president, Corporate Strategy, and Meredith Bell, clinical solutions consultant, both of OmniComm Systems, Inc., for their contributions to the design and execution of the survey featured in this article. The author also acknowledges the editorial assistance of Sharon Harvey Rosenberg, scientific journalist at OmniComm.