Clinical Trial Outsourcing to Emerging Markets and Risk Based Monitoring

Yashesh Mehta

Global Outsourcing Trend:

Global Pharma companies need to continually innovate to find better, cost efficient and regulatory compliant solutions to control research costs and remain competitive. These companies thus leverage global resources by outsourcing services to service providers, both full-service CROs as well as providers of niche clinical trial services and technologies.

The recent June 2015 article published on PharmaVoice highlights that the global clinical trial service market is expected to exceed $64 billion by 2020, up from $38.4 billion at present, i.e., a CAGR of 9% between 2015 and 2020. Also, by 2020 the average outsourcing would reach around 72%. Almost 63% outsourcing would be to global CROs in emerging markets, a remarkable 68% jump from the 2014 survey, when only 43% reported outsourcing to these markets.

Almost 88% of Global Pharma companies are predicted to outsource a large chunk of their clinical trials businesses to CROs that conduct businesses in Emerging Markets geographies.

Outsourcing Trends in Emerging Markets:

Over the past decade Global Pharma companies have successfully established different sourcing models and service lines in Emerging Markets either through their local affiliates or service providers. Sourcing from the Emerging Markets started with clinical trials to take advantage of the large patient population but today these geographies offer their inherent skilled services independent of clinical trial placement. Pharma companies and CROs started sourcing from these geographies beginning with data entry services and soon expanded to add data management, safety programming, scientific writing, biostatistics and more recently Pharmacovigilance and regulatory operations. India, due to its several advantages was the first destination of choice for outsourcing in emerging markets and was followed by units set up in China largely due to its commercial relevance. Other emerging countries like Brazil, Russia, Phillipines are being tapped for services that they specialize in, like bioequivalence studies, pharmacovigilance, medical call centres etc. Clinical trial placement in Eastern Europe, Latin America and China continues to increase.

Risk Based Monitoring and Emerging Markets:

In the last decade, the complexity and costs of clinical trials increased dramatically. The industry 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 to identify risk trends.

The global clinical trials industry is thus already evaluating RBM to replace the resource heavy, reactive and costly on-site monitoring.

Site Solutions:

Investigator sites in emerging markets are different from those in developed regions. KOLs here cater to a much larger patient population and often work across more than one congested site. These sites are often not well organized for clinical trial conduct. Non-study patient management takes majority of KOLs’ time compared to the time spent on clinical research. These sites have been 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 innovate the site services model rapidly and equip sites to be FTR in the study conduct. Professional sites and Site Solutions Organizations need to move from the Investigator dependent FTE based business models to

  1. Process and Metrics driven; and
  2. Delivery and incentive based models of services to match up to the metrics driven RBM approach to study conduct.

Technological Solutions:

Global pharma companies leverage the inherent technological strengths and scalability of IT BPOs and KPOs for solutions in areas such as statistics, programming, data management and other technology-enabled areas. All of these skills are essential for developing and studying risk trends as a part of RBM implementation across global studies.

The KPO industry in the cost effective emerging markets is ideally placed to provide front-end analytics as well as back-end platform to support RBM implementation for the global biopharmaceutical companies. The CRO industry has also developed or acquired such RBM tools and capabilities. All service providers need to adapt their erstwhile processes in order to customize their services for RBM.

Summary:

Globalization of clinical trials has several advantages but traditional 100% SDV based monitoring approaches are cost and resource intensive and thus considered nonviable. Establishing Risk Based Monitoring for sites in the Emerging Market countries becomes important as it is predicted that 88% of Global Pharma will be sourcing services from these countries by 2020. Investigator sites in these regions have a low patient:doctor ratio. The sites need to become highly process and metrics driven to be First Time Right. Hence, bringing in technology-based solutions to predict risk trends is imperative. The KPO and CRO industries have the talent pool but need to rapidly adapt processes to collaborate for providing front and back end Risk Based Monitoring services to Global Pharma.