Clinical Trial Outsourcing
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The practice of using contract research organizations to conduct clinical trials is continuing to grow in popularity. This trend reflects pharmaceutical companies’ efforts to cut costs and improve efficiency in an increasingly demanding regulatory environment. By seeking help from external resources pharma companies are able to work towards creating a fast, accurate and consistent framework for managing all types of data generated during a trial and for ensuring the streamlined flow of information about a trial.
To discuss the key trends and future of this rapidly evolving market we spoke to Yashesh Mehta, Director Delivery Partner at Sciformix Pvt Ltd.
Which factors are currently influencing clinical trial outsourcing the most?
Pharmaceutical companies have leveraged global resources by outsourcing clinical trial activities to service providers, both full-service CROs as well as providers of niche clinical trial services and technologies. This trend is expected to continue in the second half of the decade from 2015 – 2020, however the volumes are expected to increase. A recent report 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% of the total clinical trial market. (3) Almost 88% of Global Pharma companies are predicted to outsource a large piece of their clinical trials to CROs which conduct business in emerging market geographies.
Have global pharmaceutical companies been successful with emerging market strategies?
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.
India, due to its several advantages was the first destination of choice for outsourcing and was followed by units set up in China, given the commercial relevance of the market. Other emerging countries like Brazil, Russia and Philippines are being tapped for services that they specialise in, like bioequivalence studies, pharmacovigilance, medical call centres, etc. Clinical trial placement in Eastern Europe, Latin America and China continues to increase.
Why is Risk Based Monitoring expected to be the key trend setter for the future of clinical trial outsourcing?
Over the last decade, the complexity and cost of clinical trials has 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 so as to help ensure subject safety and generate quality data in a more efficient manner. In 2013 the US FDA formalised their Risk Based Monitoring (RBM) guidelines which define how monitoring can be proportionate to the identified risk. Introduction of RBM guidelines and the sponsor’s need to innovate and institutionalise cost-effective monitoring techniques has drawn sponsors and service providers to adopt RBM and also to consider technology solutions that identify risk trends. Thus, the global clinical trials industry is evaluating RBM to replace the resource heavy, reactive and costly on-site monitoring.
Is the implementation of RBM different for different geographies?
Absolutely. 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 organised corporate site monitoring teams to provide continual training through their oversight visits.
With the introduction of RBM, the focus for these 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 Organisations 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.
Is there a technology-based play in the outsourcing market in the context of RBM?
Over the past decade, global pharmaceutical companies have leveraged the inherent technological strengths of IT BPOs and domain experience and analytical expertise of KPOs and niche providers for solutions in areas such as data management, programming and other technology-friendly areas. All of these skills are essential for developing and studying risk trends as a part of RBM implementation across global studies. The CRO industry has also developed and/or acquired such RBM tools and capabilities.
Providers in the cost-effective emerging markets are ideally placed to provide front-end analytics as well as back-end platform to support RBM implementation for global companies. Clinical research and clinical study conduct experience and expertise is invaluable in ensuring effective implementation of RBM. Thus providers who can deploy a combination of technology, data analytics and clinical research skills in a cost-effective manner will play an important role. It is a given that all service providers need to adapt their processes in order to customise their services for RBM.
How has technology influenced study conduct by shrinking conduct timelines?
In the early days when paper-based CRFs were used for capturing patient data, a Site Coordinator would wait for clarification from a site monitor for certain data that was transcribed onto the paper CRF to avoid erroneous entries and legibility issues. With the introduction of the EDC platform this dependency almost disappeared but the responsibility to accelerate accurate data reporting shifted to the site, independent of the monitor’s contribution. The monitor’s role moved closer to verification and advising about corrective actions. In emerging market geographies like India, the sites are typically able to recruit patients at much higher rates than in the West. Thus, the pressures of real-time EDC capture and updates in these geographies are different from those in the emerged geographies. Same is true for other technological solutions such as CTMS and IVRS.
References:
1. Cynthia Verst & Eric Gemmen, Maximizing Value and Quality in Phase IV Trials. (Internet) http://www.quintiles.com/~/media/library/presentations/maximizing-value-and-quality-in-phase-iv-trials.pdf [Accessed 21/09/2015]
2. The 2013 Avoca Report: Sponsor and Provider Perceptions on Managing Clinical Development Risk
3. PharmaVOICE, 2015. Clinical Solutions: Clinical Services Market Poised For Growth (Internet) http://www.pharmavoice.com/article/clinical-services-0615/ [Accessed 01/09/2015]
To discuss the key trends and future of this rapidly evolving market we spoke to Yashesh Mehta, Director Delivery Partner at Sciformix Pvt Ltd.
Which factors are currently influencing clinical trial outsourcing the most?
Global pharmaceutical companies need to continually innovate to find better, cost-efficient and regulatory compliant solutions to control research costs and remain competitive in the market. While impacted by multiple macro and micro trends, several key influencers of the clinical trial outsourcing market are worth noting. First, is the commercial relevance of emerging markets such as Asia and Latin America. Not only do these regions provide new market and revenue opportunities, but they also afford access to large populations for running clinical trials. The number of phase 2 to 4 clinical trials being placed in emerging markets countries is rapidly growing.
Furthermore, the regulatory environment in many of these countries is constantly evolving, resulting in a very complex ecosystem. These factors, along with the advantage in terms of speed and cost, has increased clinical trial placement in these countries. Secondly, the clinical research spend on post-approval studies has increased by ~29% between 2010 to 2015(1) since these studies have become more critical for drug effectiveness data and have increased in number and in complexity.
Finally, there have been many global regulatory changes, perhaps one of the most important among them being the approval of Risk Based Monitoring guidelines by the US FDA in 2013. This development is a trend setter for the future of the outsourcing market. Resource optimisation is at the heart of RBM and is being driven by process changes and technology-based solutions. The pharmaceutical industry is expected to use RBM in almost 50% of their upcoming studies. (2)
Is the global clinical trials outsourcing trend between 2015–2020 expected to be different from that seen in the first half of the decade?
Furthermore, the regulatory environment in many of these countries is constantly evolving, resulting in a very complex ecosystem. These factors, along with the advantage in terms of speed and cost, has increased clinical trial placement in these countries. Secondly, the clinical research spend on post-approval studies has increased by ~29% between 2010 to 2015(1) since these studies have become more critical for drug effectiveness data and have increased in number and in complexity.
Finally, there have been many global regulatory changes, perhaps one of the most important among them being the approval of Risk Based Monitoring guidelines by the US FDA in 2013. This development is a trend setter for the future of the outsourcing market. Resource optimisation is at the heart of RBM and is being driven by process changes and technology-based solutions. The pharmaceutical industry is expected to use RBM in almost 50% of their upcoming studies. (2)
Is the global clinical trials outsourcing trend between 2015–2020 expected to be different from that seen in the first half of the decade?
Pharmaceutical companies have leveraged global resources by outsourcing clinical trial activities to service providers, both full-service CROs as well as providers of niche clinical trial services and technologies. This trend is expected to continue in the second half of the decade from 2015 – 2020, however the volumes are expected to increase. A recent report 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% of the total clinical trial market. (3) Almost 88% of Global Pharma companies are predicted to outsource a large piece of their clinical trials to CROs which conduct business in emerging market geographies.
Have global pharmaceutical companies been successful with emerging market strategies?
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.
India, due to its several advantages was the first destination of choice for outsourcing and was followed by units set up in China, given the commercial relevance of the market. Other emerging countries like Brazil, Russia and Philippines are being tapped for services that they specialise in, like bioequivalence studies, pharmacovigilance, medical call centres, etc. Clinical trial placement in Eastern Europe, Latin America and China continues to increase.
Why is Risk Based Monitoring expected to be the key trend setter for the future of clinical trial outsourcing?
Over the last decade, the complexity and cost of clinical trials has 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 so as to help ensure subject safety and generate quality data in a more efficient manner. In 2013 the US FDA formalised their Risk Based Monitoring (RBM) guidelines which define how monitoring can be proportionate to the identified risk. Introduction of RBM guidelines and the sponsor’s need to innovate and institutionalise cost-effective monitoring techniques has drawn sponsors and service providers to adopt RBM and also to consider technology solutions that identify risk trends. Thus, the global clinical trials industry is evaluating RBM to replace the resource heavy, reactive and costly on-site monitoring.
Is the implementation of RBM different for different geographies?
Absolutely. 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 organised corporate site monitoring teams to provide continual training through their oversight visits.
With the introduction of RBM, the focus for these 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 Organisations 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.
Is there a technology-based play in the outsourcing market in the context of RBM?
Over the past decade, global pharmaceutical companies have leveraged the inherent technological strengths of IT BPOs and domain experience and analytical expertise of KPOs and niche providers for solutions in areas such as data management, programming and other technology-friendly areas. All of these skills are essential for developing and studying risk trends as a part of RBM implementation across global studies. The CRO industry has also developed and/or acquired such RBM tools and capabilities.
Providers in the cost-effective emerging markets are ideally placed to provide front-end analytics as well as back-end platform to support RBM implementation for global companies. Clinical research and clinical study conduct experience and expertise is invaluable in ensuring effective implementation of RBM. Thus providers who can deploy a combination of technology, data analytics and clinical research skills in a cost-effective manner will play an important role. It is a given that all service providers need to adapt their processes in order to customise their services for RBM.
How has technology influenced study conduct by shrinking conduct timelines?
In the early days when paper-based CRFs were used for capturing patient data, a Site Coordinator would wait for clarification from a site monitor for certain data that was transcribed onto the paper CRF to avoid erroneous entries and legibility issues. With the introduction of the EDC platform this dependency almost disappeared but the responsibility to accelerate accurate data reporting shifted to the site, independent of the monitor’s contribution. The monitor’s role moved closer to verification and advising about corrective actions. In emerging market geographies like India, the sites are typically able to recruit patients at much higher rates than in the West. Thus, the pressures of real-time EDC capture and updates in these geographies are different from those in the emerged geographies. Same is true for other technological solutions such as CTMS and IVRS.
References:
1. Cynthia Verst & Eric Gemmen, Maximizing Value and Quality in Phase IV Trials. (Internet) http://www.quintiles.com/~/media/library/presentations/maximizing-value-and-quality-in-phase-iv-trials.pdf [Accessed 21/09/2015]
2. The 2013 Avoca Report: Sponsor and Provider Perceptions on Managing Clinical Development Risk
3. PharmaVOICE, 2015. Clinical Solutions: Clinical Services Market Poised For Growth (Internet) http://www.pharmavoice.com/article/clinical-services-0615/ [Accessed 01/09/2015]
To learn more about Sciformix visit www.sciformix.com.
