Central laboratory

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In a central laboratory , diagnostic laboratory analyzes are carried out centrally in one place. This is in contrast to the implementation of laboratory analyzes in local, i.e. regionally distributed, laboratories.

term

The integration of a central laboratory is intended to ensure that laboratory samples that have been collected in different clinics or medical practices are examined at one laboratory location with the same quality. Diagnostic laboratories usually use measuring devices from different manufacturers, different analytical methods with different norm values ​​or reference ranges or unit scales, and follow different quality standards. If clinics or medical practices, in which patients are treated and laboratory samples are obtained, are located in different countries, cultural and linguistic differences in analysis and diagnostics must also be taken into account. Laboratory samples are biological samples such as blood , serum , plasma , urine , tissue (e.g. as part of a biopsy), sputum or smear .

The term “Central Laboratory” or “Centralized Laboratory” has established itself in English-speaking countries. "Central Laboratory" refers generally to a clinical laboratory in the framework of drug trials on behalf of research-based pharmaceutical and biotech companies, from academic institutions, participating in international cooperation studies and so-called contract research organizations (ger .: Contract Research Organization , CRO ).

Types of central laboratories

Central laboratory as a service provider for pharmacies

One of the best-known central laboratories in Germany is the Central Laboratory of German Pharmacists , which was founded in 1971 with the aim of increasing drug safety. According to the statutes, this central laboratory deals with the testing of pharmaceuticals and common pharmacy goods, in particular carrying out tests on behalf of public pharmacies or on behalf of the pharmaceutical commissions, the health professions, supporting the competent authorities in the field of pharmaceuticals and preparing expert reports. Another purpose of the association is consumer protection.

Central laboratory as a service provider for drug research

A clinical trial is carried out in order to develop new drugs to the point where the responsible regulatory authorities (e.g. BfARM in Germany, EMA for the EU, FDA for the USA) can process the application for marketing authorization. As part of the clinical trial, laboratory tests are carried out on a regular basis in order to monitor the tolerance of the examined substance with regard to kidney and liver function as well as other vital functions in the study participants and to be able to quickly take countermeasures in the event of deviations. Since around 2002, the laboratory values ​​have also been used to record drug efficacy using so-called biomarkers .

In the past, each trial center (e.g. doctor's practice, clinic, hospital department) sent the blood samples to its local laboratory on behalf of the pharmaceutical company that was responsible for the clinical trial (the so-called sponsor). At the end of the test, the laboratory values ​​could seldom be compared with one another, since the methods, standard ranges and units used were different in each laboratory.

Now it becomes obvious what advantages the integration of a central laboratory brings with it. The central laboratory, which specializes in clinical tests, is able to collect the blood or tissue samples from the test centers and ensure proper transport ( dry ice , customs papers, etc.) from the test center to its laboratory within 24–48 hours. There all samples are processed according to the same standards, and all test centers receive the laboratory results immediately. By means of study-specific flagging (identification of values ​​outside the reference range), the investigator can be guided through the various therapy variants. Since all laboratory values ​​were now determined in one and the same central laboratory, valid statistical evaluations can be carried out.

A prerequisite for the scientific evaluability of a clinical trial is that all patients participating in the trial have comparable clinical pictures and confirm their participation in this trial in writing (see AMG Medicinal Products Act). For this purpose, a large number of inclusion and exclusion criteria are specified in the test plan. If now from a statistical point of view z. For example, if a sample size of 500 patients is required, it quickly becomes apparent that several clinics must be involved in the examination. These test centers are often spread across several countries. We then speak of multicenter, multinational or even multicontinental or global studies.

The problem areas of a decentralized laboratory solution can jeopardize the results of the study, especially if examiners from different countries, each with their own laboratory, take part in the study. Language differences and also the different interpretation of values, especially those values ​​that lie outside the reference range, add to the methodological differences. A decentralized solution, in which different equipment, methodology and patient collectives are used, is connected with units and standard areas that vary from laboratory to laboratory. At the end of an investigation, it is therefore unclear whether a significant difference between the treatment groups is due to the drug or the laboratory methods used. The central laboratory ensures clarity in such a situation. The use of the same methods for all centers largely prevents the laboratory from influencing the laboratory results.

In addition to the pure laboratory analysis, as it is also carried out in a diagnostic, clinical laboratory, a central laboratory that is active in the context of clinical tests must fulfill other tasks such as B. cross-border sample transport logistics, dealing with customs formalities and observance of legal requirements and guidelines, such as those of the IATA , training and support of clinic staff for the purpose of standardizing sample collection, long-term storage of frozen samples (e.g. biobank).

The four main advantages of working with a central laboratory are:

  1. comparable laboratory results thanks to standardized analysis;
  2. increased data quality: all data will be made available to the sponsor in the desired format after graduation. This avoids transmission errors and the time-consuming checking of data (monitoring). All laboratory data are anonymized;
  3. Speed: longer waiting times can be avoided even with special parameters;
  4. reliable sample transport, as everything is monitored and coordinated from a single source.

The first central laboratories were founded in the USA in the 1980s (centralized laboratory). The great importance of the pharmaceutical market in North America and the uniform language (English) made this easier. When the movement of goods in Europe in the period after 1990, especially in the EU, was considerably simplified by the elimination of border controls and thus transport costs could be reduced, central laboratories were also created here as new, independent companies or as subsidiaries of the US central laboratories.

In 2012, around a dozen internationally active central laboratories are known worldwide, although the number of regional central laboratories that supervise studies in a limited national or geographical area is greater. The first German global central laboratory was founded in Munich in 1994 and was awarded the Bavarian Export Prize in the service category in 2011. Further international central laboratories are located in Belgium and Great Britain.

There are several types of central labs that can oversee drug trials. 1. Central laboratories that are exclusively active for clinical studies and can usually offer a limited range of methods; 2. Central laboratories that supervise clinical studies and also, often via separate business units, as diagnostic, clinical laboratories also analyze patient samples on behalf of doctors, clinics and health insurance companies; 3. Central laboratories that are integrated as a department in a contract research institute.

Central laboratory as a department in hospitals

Larger hospitals have a central laboratory as an internal service department for the various wards.

Web links

Individual evidence

  1. ↑ Zentrallabor.com , accessed on November 13, 2012
  2. ↑ http://www.interlab.de/index.php?id=11&L=0 (link not available)
  3. ↑ INTERLAB GmbH
  4. ↑ exportpreis-bayern.de ( memento from June 2, 2012 in the Internet Archive ), accessed on November 11, 2012
  5. ↑ merkur-online.de , accessed on November 11, 2012
  6. ^ "Central Labs: Types, Distribution and Capabilities", EPC European Pharmaceutical Contractor Journal, Summer 2007
  7. ↑ uniklinik-freiburg.de
  8. ↑ uniklinikum-leipzig.de