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Pharma is constantly looking for ways to generate more productivity from their R&D investments. The industry is increasingly focused on accelerating the drug development process to reduce the cost and time of getting a drug to market, mainly by allocating more resources to their outsourcing budgets. But to achieve it, companies need to have in place outsourcing models that can deliver much better efficiency than traditional approaches.

In the past, study protocols required simple routine analyses to evaluate drug safety only. Today, drugs entering the development process require laboratory data to prove their efficacy and, in most cases, increasing study logistics costs are higher than the laboratory costs. According to different sources, 60-80 per cent of the data produced during the conduct of clinical trials are generated from labs.

Some central laboratory service providers have responded to these clinical environment needs by successfully creating locally-based central lab networks and offering decentralised lab services to trial sponsors.

Decentralised Approach


The decentralised central lab services model allows laboratories to exchange results instead of exchanging samples, thus overcoming lab logistical obstacles and representing fewer costs and delays for clinical trials sponsors.

In the decentralised model, the laboratory part of an international clinical study is managed and executed by using locally-based central laboratories within a country or a geo-cultural region. The facilities are selected by taking into account the study protocol requirements, site locations, sample stability and viability, specimen transport conditions, and national laws and regulations.

The model ensures that all diagnostics and logistical procedures are performed in exactly the same manner across all central labs. In addition, the clinical trial lab data are automatically transferred from all locally-based facilities to a single study-specific database – designed and validated to provide access to harmonised and consistent data at the end of the trial.

Logistics and Samples

This decentralised model provides many advantages for trial sponsors, and offers budget and time savings that increase the efficiency of a study.

With the growing complexity of clinical trials meaning more speciality tests are required during a study, frozen shipments are becoming more and more common – substantially increasing clinical project budgets. Addressing this, the model offers significant logistics cost reduction of clinical trial lab supplies and samples, due to the decreased number of inter-country shipments. When considering dry ice shipments, up to 50 per cent savings are achievable.

A fully-harmonised central lab network also provides faster access to laboratory results, thanks to a shorter specimen turnaround time. The study samples are sent to locally-based central labs for the analysis, instead of a global central lab often located several thousand kilometres away from the study sites. In some cases, results can be accessed within 24 hours of the sample collection, but it depends on site locations and the type of analysis.

Lab Data and Support

In addition, the decentralised solution provides harmonised clinical lab data from all laboratory facilities within the network. The data are provided in a single and standardised database, in a format requested by the sponsor. The results are automatically sent from each lab during the trial to a study-specific ‘global’ validated database. The final product is the same as it is in the case of a ‘standard’ central lab model, but the study cost savings are undeniable.

Last, but not least, two benefits of the approach are real local support for investigator site personnel and regionally-located sponsor study teams; and access to emerging markets that are still not utilised to their full potential. In the first case, locally-based central lab network personnel communicate in the same language, understand local culture and provide expertise with regards to national laws, regulations and requirements. This saves precious time in trials that may be needed, for example, to interpret lab results correctly, solve daily study-related queries, or re-supply kits and materials. In the second case, locally-based central labs offer access to countries with naďve drug patients, centralised healthcare systems, well-educated and motivated investigators, and overall competitive study logistics costs.

Fully Harmonised

To deliver a decentralised model, a network of laboratory facilities has to be fully-harmonised, taking into consideration all clinical trial central lab services levels: analytical, IT, quality assurance and operational procedures. The main objective of harmonisation is to integrate comparable results from different locally-based central labs, avoiding possible bias generated by technical differences among the facilities.

Establishing the accuracy, precision and consistency of the study samples is of paramount importance if the data are to meet the standards of international regulatory agencies. To ensure results from multiple labs will be considered viable for clinical trial purposes, the network of central labs has to develop a rigorous programme of harmonisation procedures to be used in conjunction with an ongoing internal quality control programme.

Case Study


To illustrate a decentralised model, the following outlines a methodology – used by Synevo Central Labs – to establish and maintain harmonisation of the analytical platform within its network. The process comprises six steps, starting with the selection of one laboratory among the network, which is designated as the lab of reference for the establishment of standard reporting units and common reference intervals.

The next step is to provide consistent samples. The company collaborates with the Canadian External Quality Assessment Laboratory (CEQAL) to establish and maintain testing accuracy. CEQAL prepares and distributes across the network commutable control samples of testing materials in large lots to ensure consistency.

Then the network of laboratories undergoes a baseline assessment of their analytical performance using common sets of human serum samples covering the clinical range of interest for the analytes measured. To check accuracy, many of the analytes within these samples have target values assigned by credentialled reference methods that can be traced to international standards. Post-analytical normalisation equations correct for any calibration bias.

Robust Dataset

Customised, accuracy-based internal quality control samples for the critical analytes are prepared. These samples have target values assigned by credentialled reference methods and serve as an accuracy base to ensure that the calibration of the testing systems for critical analytes does not change over the course of the study.

Finally, harmonised laboratories must take part in an ongoing externally blinded monitoring programme in which a large number of US and international clinical labs participate. The results are aggregated to form a robust dataset that can be used to assess the ongoing performance of the participating labs within the network.

The ongoing analysis of quality control results across a network of laboratories is a significant part of an inter-laboratory harmonisation programme, and the major manufacturers offer software applications for use in managing quality control results across an entire network of clinical labs. Based on a reflexive decision tree that must be established in advance of sample distribution, participating labs can readily resolve analytical bias and establish statistical valid correction factors.

IT Platform

Sponsors want to receive a reliable clean database from a single source. The easiest way is to allow the locally-based central laboratory information management system (CLIMS) to transfer the data to the ‘global’ CLIMS electronically. One of the most important technological advances that has allowed the development of virtual global laboratory networks is the HL7 data transmission standard used within the global healthcare system.

Quality Assurance


A harmonised quality assurance system must be implemented to ensure laboratory routine consistency throughout the network, and common standard operating procedures must exist. All members of the network must have national and international certification and accreditation. The most frequent requested are EN ISO 17025 and/or EN ISO 15189 accreditation. In addition, the quality assurance system has to be compliant with Good Clinical Laboratory Practice.

In order to ensure operational consistency, a networked central lab service provider must establish a project management system focused on the needs of the international clinical trial environment. The key elements of the system include global and regional project management, study documents and lab supplies preparation, investigator sites support, and sample logistics management.

Technical Comparability

The new generation of central laboratory services providers continuously work to accommodate the increasing geographic and analytical complexity of today’s clinical trials by deploying harmonisation strategies across centralised regional labs, drawing together the benefits of both local and central frameworks.

Depending on the level of harmonisation that a group of central labs decides to implement, they may reach a very close technical comparability, and can even be considered as a single entity by the trial sponsor, delivering the same service and results worldwide.

The decentralised central laboratory services model enables sponsors to cost-effectively enjoy access to geographically remote regions, while at the same time taking advantage of centralised reporting, analytical rigour and regulatory compliance.

References

1. Anyszek T, Hayashi E and Morrow F, Logistical considerations on central laboratory selection, Journal for Clinical Studies, July 2010
2. Anyszek T, Hayashi E and Morrow F, Decentralising central laboratories, International Clinical Trials, August 2010

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Tomasz Anyszek is Director of Synevo Central Labs, where he is responsible for clinical trial operations in over 50 laboratories in Central and Eastern Europe. Tomasz started his career with Virtual Central Laboratory in the Netherlands, and his experience also includes coordinating the activities of 16 regional Covance partner labs across Europe. He holds a PhD from Jagiellonian University, Poland. Prior to his business career, Tomasz taught clinical biochemistry and laboratory medicine at the University’s medical faculty.

Michal Dysko is Head of Business Development at Synevo Central Labs. He joined the business in 2008 and is responsible for sales and marketing operations of the whole network. Michal has more than 10 years’ experience in the clinical research industry from the trial services provider perspective, and obtained an MBA degree from the University of Quebec and Warsaw School of Economics in 2003.
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Tomasz Anyszek
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Michal Dysko
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