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The use and awareness of risk-based monitoring is now impacting clinical trials of all sizes, indications and types as a core component more than ever before. Sponsors and sites are expected to expand its use to include all phases of clinical research and all therapeutics areas.
Latest survey and research from Quintiles shows gains in RBM awareness and implementation
Recent research indicates that the implementation of risk-based monitoring (RBM) – particularly using centralized monitoring as a core component of clinical trial execution – is impacting clinical trials of all sizes, indications and phases. Based on lessons learned from 150-plus trials involving this approach, and a recent survey of biopharma executives,1 this article will describe current awareness and usage of RBM, key drivers and considerations, an approach to central monitoring as well as implementation challenges.
Awareness and usage of RBM
Awareness of this innovative approach is now close to universal, at 93% for unaided respondents and 96% for aided ones in a recent survey from August 2015 conducted with clinical outsourcing key decisions makers and influences within the pharma industry. Top-of-mind RBM descriptions from survey respondents included:
RBM use is increasing, from around 50% in 2013 to 63% in 2015, with sponsors and sites expressing growing satisfaction of RBM trials and planning to expand their use (Figure 2). Most current users plan to include RBM in future trials, and over half of non-users plan to implement RBM within the next two years over a wide range of therapeutic areas, led by dermatology (32%), oncology (32%), biologics (27%), immunology (23%), allergy/respiratory (18%) and CNS (18%). To date, RBM has been used most often in Phase II through Phase IV studies, but RBM usage is also cited being used in Phase I, including Proof-of-Concept, studies.2
Figure 2: RBM adoption in August 2015 vs. January 2013
Key drivers and considerations
Key drivers for use of RBM are the potential to reduce monitoring costs (cited by 78% of respondents), mitigate risk (55%), enable data-driven decision-making (55%), improve data quality (54%), and use triggered monitoring to prompt an on-site CRA visit (54%; see Figure 3). For non-users, finding an appropriate trial is key, in addition to being made aware of CROs’ RBM experience – including technology and process implementations to help in selecting a suitable partner.
Figure 3: RBM implementation drivers among RBM users (August 2015; n=103)
The most common new operational capability seen in successful implementation of RBM is some form of centralized monitoring. It’s increasingly clear that this capability is a core driver that is improving efficiencies, decision support and unlocking real value by fundamentally changing the way clinical monitoring is performed.
Successful implementation also requires data integration, enabling data from disparate sources to drive actionable insights using integrated IT services (Figure 4). Enhanced decision making based on data insights also clearly depends on sophisticated capabilities in data curation and technology platform management.
As shown in Figure 1, elements of centralized monitoring include:
Figure 1: Centralized monitoring: a core component of RBM
Demonstrating improved data quality and shorter time to make data-driven, key decisions has helped some biopharma companies overcome their initial lack of comfort surrounding reduced verification of all source data – a key component of RBM. Around half of companies surveyed plan to develop their own internal RBM solution: however, these companies will face new challenges with adapting roles, systems, and processes to implement and maximize RBM rather than working with a partner that has those systems, roles and processes in place already. Here, change management is a core consideration, and buy-in needs to be driven from executive levels.
Figure 4: Data integration in RBM
There’s no doubt that awareness and usage of RBM is increasing. Sponsors and sites are broadly satisfied with this approach and expect to expand its use to include all phases of clinical research and all therapeutic areas. Cost savings are key; however, mitigating risk, improving data quality, and enabling data-driven decisions are increasingly important drivers for RBM adoption. As technology continues to drive change, centralized monitoring has the promise to further improve efficiencies to change the way clinical monitoring is performed. New analytics capabilities can help clinical researchers assess the probability of a future event occurring -- for example, a protocol deviation that may require on-site action. The ability to cut through noise and predict potential risks before they occur means teams can optimally allocate current and future site management resources, as well as achieve enhanced patient safety and data quality at greater speed and lesser cost.
Martin Giblin is VP, Data Sciences, Safety & Regulatory, and Head, Risk-based Monitoring, at Quintiles.