With up to 80% of trial data generated in the lab, locally based central laboratory networks and decentralised services are starting to make an impact - but inter-lab harmonisation is key, say Tomasz Anyszek and Michal Dysko of Synevo Central Labs.
Pharmaceutical companies are 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. To achieve this, companies need much more efficient outsourcing models in place.
Some central laboratory service providers have responded to today's clinical-environment needs by successfully creating locally based central laboratory networks to offer 'decentralised' central laboratory services to clinical trial sponsors. In the decentralised model, the laboratory part of an international clinical study makes use of central laboratories that are locally based within a country or a geo-cultural region. The facilities are selected according to the study-protocol requirements, site location, stability and viability of samples, specimen transport conditions and national regulations.
The model also ensures that all diagnostics and logistical procedures are performed in exactly the same manner across all central labs, and the clinical trial laboratory data is 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.
The model offers significant logistics cost reduction of clinical trial laboratory supplies and samples due to the decreased number of inter-country shipments. Particularly when dry-ice shipments are taken into consideration, the saving can be up to 50%.
The fully harmonised central lab network provides faster access to lab results thanks to shorter specimen turnaround time. The study samples are sent to locally based central laboratories for analysis, instead of going to a global central laboratory, often located several thousand kilometres away from the study sites. The decentralised solution also provides harmonised clinical laboratory data from all lab facilities. The data is provided in a single, standardised database in the format requested by the sponsor. Other key benefits are real local support for the investigator site personnel and the regionally located sponsor's study team, as well as access to emerging markets not yet being used to their full potential.
To offer a decentralised model, a network of laboratory facilities has to be fully harmonised, taking into consideration all clinical trial central laboratory services levels - analytical, IT, quality assurance and operation procedures. The main harmonisation objective is to integrate comparable results from different locally based central labs, avoiding possible bias generated by technical differences.
Establishing the accuracy and consistency of the study samples is of paramount importance if the data is to meet the standards of international regulatory agencies. To ensure results from multiple labs will be considered viable for clinical trial purposes, the central laboratories network has to develop a rigorous programme of harmonisation procedures in conjunction with an ongoing internal quality-control programme. Synevo Central Labs uses a six-step process to harmonise the analytical platform (see figure).
Sponsors want to receive a reliable clean database from a single source. The easiest way is to allow the locally based central lab's laboratory information-management system (LIMS) to transfer the data electronically to the 'global' central laboratory information-management system (CLIMS).
A harmonised quality-assurance system must be implemented to ensure laboratory routine consistency throughout the network and common standard operating procedures (SOPs) must exist in each laboratory's SOP list. All members of the network must have their national and international certification and accreditation. The most frequently requested are EN ISO 17025 and/or EN ISO 15189 accreditation. Additionally, the quality-assurance system has to be compliant with good clinical laboratory practice.
To ensure operational consistency, a networked central laboratory service provider must establish a project-management system focused on the needs of the international clinical trial environment. Key elements include global and regional project management, study documents, laboratory supplies preparation, investigator sites support, and samples logistic management. The decentralised model enables sponsors cost-effective access to geographically remote regions, while benefitting from centralised reporting, analytical rigour and regulatory compliance.
References are available upon request.