Yashesh Mehta

	Over the past decade global pharmaceutical companies have successfully established different sourcing models and service lines in emerging markets either through their local affiliates or service providers. While clinical trials were initially outsourced to these geographies to take advantage of their large patient population, today emerging markets offer a broad range of advanced skilled services that can support the entire clinical trial process. Outsourcing of data entry services soon expanded to data management, programming, scientific writing, and subsequently biostatistics, pharmacovigilance and regulatory operations.

	The past decade has also seen a dramatic increase in the complexity and costs of clinical trials. The industry has tried to move away from the traditional on-site monitoring approaches and 100% Source Data Verification (SDV) to risk based approaches to help ensure subject safety and generate quality data. In 2013, the US FDA formalized Risk Based Monitoring (RBM) guidelines that define how monitoring can be proportionate to identified risk trends. Introduction of RBM guidelines and the sponsors’ need to innovate cost-effective monitoring techniques has drawn sponsors and service providers to consider technological solutions that identify risk trends. The global clinical trials industry is evaluating RBM to replace the resource heavy, reactive and costly on-site monitoring.

	Investigator sites in emerging markets have a different set of challenges from those in developed regions. They cater to significantly larger patient populations, and are often not as well organized for clinical trial conduct. Moreover, the Key Opinion Leaders (KOLs) work across several such busy sites. Non-study patient management takes a majority of their time compared to the time spent on clinical research. These sites are highly dependent on the more organized corporate site monitoring teams to provide continual training through their oversight visits. With the introduction of RBM, the focus for sites needs to shift to be First Time Right (FTR) rather than being dependent on the quality checks performed as part of the monitoring oversight. Thus for RBM to be successfully implemented at busy emerging market investigator sites the industry needs to be innovative to equip sites to be FTR in study conduct. Site Management Organizations and in general Clinical Trial Sites need to move from the person-dependent model to one that’s process and metrics driven. This model should include real time delivery measurement related to Key Result Areas (KRAs) such as eligibility, consent, efficacy endpoint measurement etc. and have Key Performance Indicator (KPI) linked incentives to drive sites to be FTR. This in turn would help these sites match up to the metrics driven RBM approach to study conduct.

	Globalization of clinical trials has several clear advantages however traditional 100% SDV based monitoring approaches are cost and resource intensive. RBM for sites in emerging market countries is important due to the increase in clinical trial placements. Investigator sites in these regions have a high patient: doctor ratio and therefore need to become highly process and metrics driven to be FTR. KPO (Knowledge Process Outsourcing) organizations and CROs have the right talent pool yet they need to rapidly adapt their processes and implement technology solutions that facilitate collaboration, predict risk trends and provide front and back end RBM services to global pharmaceutical organizations.

	Yashesh Mehta is Director Delivery Partner, 

Articles

Investigator sites in emerging markets have a different set of challenges from those in developed regions. They cater to significantly larger patient populations, and are often not as well organized for clinical trial conduct.

Yashesh Mehta

Articles

Equip Sites in Emerging Markets for RBM