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International Clinical Trials

Decentralising Centralised Labs

Tomasz Anyszek of LabConnect Europe and Synevo Central Laboratory, and Eric Hayashi and Frank D Morrow of LabConnect, LLC assess the importance of centralised regional laboratory services for clinical trials

Drug developers and their supporting cast of clinical outsourcing providers have driven a remarkable change in the central laboratory industry over the past two decades. Seeking reduced drug development cycle time and costs, sponsors today search for eligible study participants in increasingly remote and underutilised geographies. At the same time, sponsors demand more complex laboratory testing than the industry has ever witnessed. In this shifting landscape, the ‘traditional’ model of building ‘bricks and mortar’ laboratories dedicated to clinical trials has become increasingly expensive and burdensome to both the central laboratory services providers and sponsors alike. In response, the industry is evolving to provide more costeffective operating and logistical models to accommodate the complexity of today’s clinical trials.

A BRIEF HISTORY OF CENTRAL LABORATORIES

In the early 1980s nearly all laboratory work was conducted utilising ‘local’ laboratories. Laboratory testing was primarily focused on safety rather than treatment efficacy. Benefits of this approach included low logistical expenditure, rapid result turnaround time, and little loss of sample integrity due to time and temperature exposure.

The 1990s witnessed a shift from ‘local’ laboratories to large ‘central’ laboratory facilities able to quickly and efficiently process high volumes of samples. After a substantial upfront investment in facilities, information systems and laboratory personnel, central laboratory services providers enjoyed significant profit margins attributable to the low variable costs of processing safety samples. Furthermore, these large facilities were not only able to standardise the collection kits, but also consolidate the laboratory results into a single database which improved consistency while reducing administrative costs. These advantages came at the expense of steadily increasing logistical costs and deteriorating sample integrity. Consequently, test cancellations increased as a result of time and temperature variables.

By the turn of the century, globalisation, mounting analytical complexity, and the inclusion of new treatment efficacy parameters apart from safety posed heightened challenges for central laboratory services providers. Low sample volumes in non-traditional geographies coupled with high fixed costs forced service providers to choose among three undesirable realities: suffer reduced profitability, significantly increase test prices, or pass along high logistical costs of transporting samples long distances to the nearest ‘centralised’ testing hub.

In today’s clinical trial space, conducting studies in the more remote areas of the world is now a permanent fixture of pharmaceutical development. Large multinational trials often involve more than 20 countries and four or more regulatory bodies depending upon the registration strategy established by the sponsor. For reasons related to cost and geographic coverage, sponsors typically secure central laboratory services from virtual networks comprised of reference and clinical laboratories spanning multiple continents and regulatory agencies.

The current generation of central laboratory service providers seek to combine the benefits of the ‘local’ and ‘central’ laboratory operating models. These providers use local laboratories for testing proximal to investigator sites. Working with resident scientists offers both capital and knowledge advantages. Capital benefits include access to existing facilities, information systems and test menus. Knowledge benefits are in the form of experienced laboratory personnel attuned to cultural, linguistic and regulatory nuances. Simultaneously, these providers offer ‘traditional’ central laboratory benefits including consistency, costefficacy and reliability through standardisation. Enabling standardisation are information systems, reporting platforms and harmonised operational processes.

INDUSTRY OUTLOOK

In response to a decline in the number of new products successfully registered with the agency in recent years, the FDA launched the Critical Path Initiative (CPI). The CPI is a broad and sweeping initiative which calls on pharmaceutical and medical device sponsors to identify new and innovative strategies aimed at increasing overall productivity and reducing the time required from discovery to product registration. This is a particularly challenging time for Big Pharma as major blockbuster drugs approach patent expiration and the industry enters the era of personalised medicine and companion diagnostics. Controlling costs in this phase of product development has now become a fundamental driver behind the change in the delivery of outsourced contract research services including the central laboratory industry.

DRUG SAFETY DRIVES THE GROWTH IN CENTRAL LABORATORY SERVICES

Central laboratory data have represented more than 60 per cent of all data submitted in an NDA for more than 15 years. This percentage is expected to approach 80 per cent within the next several years. The key driver behind a growing reliance on central laboratory data has been FDA guidance related to subject safety and the subsequent reliance by industry on drug safety monitoring committees and post-marketing pharmacovigilance programmes. In order to maximise the ability of these efforts to detect drug-related effects, it is imperative that central laboratory service providers develop and use globally harmonised analytical and data management platforms when delivering safety and screening parameters for subjects enrolled in clinical trials.

Market demand for central laboratory services has grown dramatically during the past decade, especially in the more remote and underdeveloped areas of the world where large populations of drug-naïve patients are available for recruitment into new studies. Barclays Capital estimates the global market for central laboratory services to be approximately $2.3 billion (£1.6 billion).

In addition to the use of harmonised analytical platforms and global reference ranges, another factor positively influencing the growth of the central laboratory industry is value-added services. These include sophisticated data management capabilities, project services, study-specific clinical trial materials, logistics services and specimen management.

CENTRAL LABORATORY SERVICES FOR CLINICAL TRIALS

Central laboratory services for clinical trials are especially complex due to the logistics associated with multinational studies. The central laboratories play an independent role in ensuring sample drawing kits and ancillaries (tubes and packing materials) are delivered in a timely fashion before the initiation of a study. To a central laboratory, ‘logistics’ means ‘all activities to enable the timely arrival of a subject specimen and reporting the results back to the investigators.’ Figure 1 shows the spectrum of functions of a full service central laboratory provider.

A NEW APPROACH: CENTRALISED REGIONAL LABORATORY SERVICES PROVIDERS

Evolving as a reaction to today’s clinical trial environment, some central laboratory service providers have successfully created global networks and offer centralised regional laboratory services to clinical trial sponsors. This new approach is applied in most cases globally (one facility in each continent); however, it may also serve as an effective solution on a regional scale (one facility within a distinct geo-cultural region, for example eastern Europe).

For clinical trial sponsors, this method provides significant advantages over the ‘traditional’ central laboratory approach, including access to high volume laboratories with larger inhouse test menus, reduced specimen transport costs, and enhanced knowledge of the local culture and applicable regulations. Unfortunately, this model does not offer identical analytical platforms across all network laboratories typically. Central laboratories deploying this model must harmonise operations to ensure analytical rigour and regulatory compliance among these centralised regional laboratories.

Table 1: Global central laboratories versus centralised regional laboratories 
Key aspects
Global central labs
Centralised regional labs
 Uniform analytical platform
 Yes Harmonised and validated
 Global logistics and sample management
 Yes  Coordinated globally but performed regionally
 Turnaround time (TAT)
 Longer (intercontinental shipping)
 Short (no intercontinental shipping)
 Kits management
 Yes  Yes
 Frozen sample storage and logistics
 Yes  Yes (available regionally)
 Cost of shipping
 Very high (intercontinental shipping)
 Much lower (no intercontinental shipping)
 Investigators support locally
 Limited  Yes (frequently in local language)
 Uniform IT platform (DM, reporting and EDT)
 Yes  Harmonised and validated
 Global quality assurance
 Yes  Harmonised and validated
 Single study database
 Yes  Yes
 Esoteric tests
Yes
 Yes (often in different locations)

ANALYTICAL HARMONISATION

During the past 15 years, manufacturers of clinical laboratory instruments have significantly improved the technologies used to provide the safety and screening tests most commonly performed in clinical trials. Stricter adherence to calibrator assignments, traceable to the WHO and other international consensus groups, allows clinical laboratories operating disparate platforms to produce highly concordant laboratory data. Taken as a whole, these advances allow today’s sponsors to secure services from networked laboratories that are cost-effective and of similar quality to those produced by the largest players in this market.

Even with these advances in instrument and reagent technologies, central laboratory service providers must nevertheless establish a rigorous harmonisation programme, with a goal to manage analytical bias among participating laboratories. If managed properly, an interlab harmonisation programme ensures the consistency and combinability of laboratory data provided by network partners to their clinical trial clients. Improvements in the formulation and distribution of stabilised quality control materials have made this process both practical and manageable. The largest globally situated manufacturers are able to sequester single lot numbers of materials and drop-ship specified quantities to networked laboratories on a pre-determined schedule. Moreover, unlike the situation 15 years ago, today’s materials are derived from pooled human specimens and thus are free of the matrix-effects that confounded efforts to assess interlab bias across platforms and reagent methodologies. When undertaken in a rigorous and statistically valid manner, a well-designed interlab harmonisation programme can readily document analytical bias and utilise internode correction factors derived from a common reference point.

CONCLUSION

Central laboratory services providers continue to evolve in response to the changing landscape of clinical trials. In the 1980s and 1990s, the industry evolved from strictly ‘local’ laboratories to ‘central’ laboratories. The new generation of central laboratory providers seeks to accommodate the increasing geographic and analytical complexity of today’s clinical trials by deploying harmonisation strategies across centralised regional laboratories offering the benefits of both ‘local’ and ‘central’ frameworks. This new model enables sponsors to cost-effectively enjoy access to geographically remote regions while at the same time reaping the benefits of centralised reporting, analytical rigour and regulatory compliance.

Reference

1. Stephen DeSantis, Rising Stars in the Central Lab Market, CenterWatch Monthly 13(5), May 2006


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Tomasz Anyszek is Director of LabConnect Europe and Synevo Central Laboratory and is responsible for clinical trials operations in more than 40 laboratories in central and eastern Europe. Tomasz started his career with Virtual Central Laboratory, Netherlands, and his experience also includes the coordination of activities of 16 regional laboratories in Europe. Tomasz has a PhD from Jagiellonian University, Poland. Prior to his business career, he taught clinical biochemistry and laboratory medicine at the Jagiellonian University medical faculty.

Eric Hayashi is President and CEO of LabConnect, LLC, and is an 18-year veteran of the clinical trials industry. He holds a BA from Whitman College and an MBA from the Wharton School of the University of Pennsylvania, and is an affiliate professor at the University of Washington’s masters’ degree programme in clinical trials. Prior to LabConnect he was Vice President, Corporate Development for Radiant Research, where he continuously served on the company’s threeperson executive team and was responsible for sales, marketing and acquisition activities.

Frank D Morrow is Chief Operating Officer of LabConnect, LLC. He is a veteran of the central lab business, having served as Founder, President and Chief Scientific Officer at Quintiles Laboratories Worldwide. Subsequent to Quintiles, he served as VP, Worldwide Operations and VP, Systems Integration & Strategic Planning at Quest Diagnostics Clinical Trials. He has a clinical laboratory directorship license in more than 10 states, an MSc in Human Physiology from Pennsylvania State University and a PhD in Clinical Biochemistry from the University of Georgia.

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Tomasz Anyszek
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Eric Hayashi
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Frank D Morrow
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