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Instant Results

Risk-based monitoring (RBM) is currently a hot topic within the pharmaceutical industry. There has been a lot of talk surrounding the methodology and the ways in which it can cut study costs.

Even though the FDA’s Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring Guidance is focused entirely on data quality and patient protection, concerns of innovation and transparency are not the biggest R&D challenges of today. Low productivity and high costs are – hence pharma’s main focus is on the cost benefits of this new monitoring model.

It is expected that RBM could lower single study costs by 15-20% and save $3-5 billion in total R&D spending each year (1,2). Interestingly enough, these widely cited figures are based on three hypothetical scenarios provided by Vadim Tantsyura et al in Drug Information Journal, 2010 (3). There is no other publicly available, statistical or real-world data confirming RBM cost benefits. But, in the world of evidence-based medicine, we are still great believers.

Theory into Practice

When the FDA guidance was issued in August 2013, the door was closed on past methods of 100% source data verification (SDV). The RBM wheels are turning, but slowly; according to PricewaterhouseCoopers, pharma executives do not have a working solution for translating theory into practice.

Leaving aside the question of who will pay for new software, staff training and a complete reorganisation of the whole monitoring philosophy, it is obvious that RBM is a long-term solution that will take 5-10 years to pay back the implementation investment. It requires the complete ‘perestroika’ – or restructuring – of the whole clinical trial landscape. In the meantime, we need to cut study costs today.

Russia-Based Monitoring

There is another solution which may have a more immediate effect; we call it ‘Russia-based monitoring’. To demonstrate how Russia could cut study costs, we took Tantsyura’s hypothetical example, which demonstrated the highest RBM cost saving of 23.5%, in comparison with 100% SDV. This example involved a Phase 3 oncology study recruiting 460 patients. Only one variable was changed: the US sites were replaced by Russian sites.

As a result of applying Russian average per-patient costs and local CRO monitoring hourly rates, the potential savings reached up to 78%. This means that a single, 460-patient, Phase 3 oncology study could save almost $27 million if conducted in Russia, rather than the US (4). It is worth mentioning that in five years, an extra 23.5% saving on top of that could be added, once RBM is successfully implemented.

Untapped Potential

The cost savings from conducting studies in Russia are one thing, but some may ask the question: how many studies can Russia accommodate?

Even though clinical trials have been conducted in Russia since the early 1990s, the country is still regarded as an emerging market. This refers more to the untapped market potential of the region, rather than its growth rate. There were 358 new international studies approved by the Russian Ministry of Health in 2013. During the same period, 7,928 new clinical trials were approved in the US (5). Assuming the US market is being utilised at 100%, and taking into account the difference in population, 90% of Russia’s potential remains unused. Consider this: if 50% of Russia’s potential is utilised, the industry’s annual savings on clinical trials could reach $10-13 billion, due to the difference in per-patient cost and local CRO hourly rates.

Glasnost and Perestroika

Russia has proved a well-kept secret in clinical trials, and many companies have been unaware of the potential not only for cost savings, but also quality and speed. For some, it seems to be a trust issue. Arguably, Russia, with the help of the ideas of glasnost and perestroika, has seen a lot of positive changes at all levels.

At a Local Level

Today, there are a number of market intelligence reports about the Russian clinical trial market that are available in English. First is the Orange Paper, which was started by Synergy Research Group in 2007. Published on a quarterly basis, the Orange Paper is distributed online at no charge, and contains data covering various aspects of the Russian clinical trial market. The report has done a great deal to establish a transparent trial sector in Russia and to improve the research attractiveness of Russia for foreign sponsors.

Another quarterly report was introduced in 2011 by the Russian Association of Clinical Trials Organizations and – in addition to the Orange Paper data – provides an analysis of clinical trial approval times, as well as a discussion of regulatory initiatives. Both reports are based on a clinical trial database that is publicly available on the official site of the Russian Ministry of Health (MoH). The database allows various online search and filter options, and studies can be selected by date, drug name, sponsor, protocol, dosage form, and so on. The one problem is that it is only available in Russian.

Going Global

The idea of creating a fully-functional, national study registry has been promoted by local Russian CROs and leading study sites since 2008. It was suggested in 2010 that the current MoH database should be converted into a primary registry for the World Health Organization’s (WHO’s) International Clinical Trials Registry Platform (ICTRP). The EU Clinical Trials Register became a WHO ICTRP member in 2011, so the Russian registry idea is very much in line with the global trend.

Currently, the MoH database has 17 of 20 items of the WHO Trial Registration Data Set, so the conversion is largely a matter of straightforward processing. The concept was supported by regulatory officials and included in the official resolution of the Clinical and Preclinical Studies Conference organised by the MoH in Saint Petersburg in 2013. Primary register status will allow Russian data to be accessed directly via the WHO’s clinical trial search portal. Potentially, this could dramatically increase the country’s transparency and rapport with international sponsors.

At a CRO Level

According to the recent annual outsourcing survey published by Contract Pharma in May 2014, 55% of respondents from pharma sponsor companies describe communications and culture as the top challenges of the sponsor-CRO relationship. Sponsors also say that transparency or data sharing plays a key role in project work and success.

Understanding this, local CROs in Russia utilise modern cloud-based solutions, allowing sponsors full access to data, and the ability to track projects and keep study specifications and deadlines organised. Tools such as Gantt charts, daily email alerts with to-do items, dashboards and joint document reviews allow sponsors to better control trials and track results. Features such as agendas, meeting minutes and scheduling create streamlined contact with sponsors that continually drives research programmes forward, and dramatically improves true collaboration between them and CROs.

Reaping the Benefits


Clinical trials in Russia are able to take advantage of the region’s vast system of speciality hospitals that have the ability to enrol large patient populations. The region boasts patients who are compliant and motivated to enter, and finish, clinical trials. Sponsors can utilise the region’s pool of highly qualified and experienced investigators and project management. Furthermore, the cost per patient and for local CRO hourly rates is significantly lower, adding savings onto the benefit of patient access.

RBM is worth the effort, but implementation and cost savings will not be realised until 2019 at the earliest. In the meantime, greater savings can be actualised by looking at regions like Russia, which have the advantages of clinical trial transparency and quality, as well as decreased cost.

In the same way that glasnost and perestroika transformed Russia, new innovations – coupled with the advantages of the region – can deliver today what RBM may bring in the future.

References
1. PricewaterhouseCoopers, Risk-based monitoring: Reduce clinical trial costs while protecting safety and quality, March 2013
2. Getz K, Low-hanging fruit in the fight against inefficiency, Applied Clinical Trials Online, March 2011
3. Tantsyura et al, Risk-based source data verification approaches: Pros and cons, Drug Information Journal, 2010
4. Cutting Edge Information, Oncology clinical trials: Drug development resources and case studies, 2013
5. Visit: www.clinicaltrials.gov
6. Russian Ministry of Health. Visit: http://government.ru/en/department/23


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Igor Stefanov is Chief Executive Officer at Synergy Research Group, and graduated from the Moscow Aviation Institute in 1989. He received an MBA degree in Economics at the Moscow International University in 1993, and went into the business consulting area of developing and implementing localisation strategies for the Fortune 500 companies in Russia – including Pfizer, Johnson & Johnson, GlaxoSmithKline and Roche. Prior to joining Synergy in 2007, Igor served as General Manager for SmartLock, and was recognised as an entrepreneur of the month by the Russian edition of Forbes magazine in 2005.

John Barker is Chief Operating Officer at Synergy Research Group. He was formerly Executive Vice President for global clinical operations in Pharm-Olam and INC Research, Senior Vice President of PPD’s Project Rescue Group, co-founder of InGenium (Ockham), and Vice President of Project Management at Quintiles. John also served in the US Army as a paratrooper with the 82nd Airborne Division and commanded a tank battalion in Germany. He holds a degree in Biology and an MBA, and is Project Management Professional certified.
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