Research

Clinical trials

Are you planning a clinical trial and want to work with a biobank? What exactly do biobanks offer, though? What are the requirements for the storage of samples and what costs can you expect? Find answers to frequently asked questions here.

 

In the following film, Prof. Dr. Esther Herpel (Heidelberg) illustrates the advantages professional biobanks offer for clinical trials.

Frequently asked questions

How can biobanks of the German Biobank Alliance (GBA) offer support during clinical trials?

From the initial consultation to sample storage and data management, GBA biobanks offer comprehensive services. Standardised work processes and a high degree of automation create the conditions for reproducible research results.

Among others, GBA biobanks offer:

  • advice on all aspects of biobanking (e.g. tailored study design) and project management
  • high sample quality due to prompt and professional processing
  • depending on the biobank, additional services during processing (e.g. DNA extraction)
  • clear documentation in special biobank software (external access possible at some biobanks) and linking of biobank data with clinical information
  • ‘on-demand’ storage and retrieval of samples
  • safe storage in partly robot-controlled cooling systems at -20, -30 or -80 degrees Celsius or approximately -165 degrees Celsius in the gas phase of liquid nitrogen
  • 24-hour monitoring; issue of proof of temperature maintenance in conformance with good clinical practices (GCP)

How do GBA biobanks ensure high quality?

The GBA biobanks have established uniform quality standards. Compliance is ensured through internal audits and so-called round robin tests during which samples from an identical source material are processed in all biobanks, then analysed by a reference laboratory and the results compared. Most GBA biobanks also afford certification or accreditation.

What requirements must samples meet?

Whether liquid or tissue samples, pre-processed or not, there are hardly any restrictions for the samples stored. It is very important for biobanks for information to be transmitted with the samples.

Study management should make at least the following data available in a digital format:

  • donor and study ID
  • sample type
  • sample volume
  • donor’s birth year and gender
  • ICD-10/ICD-O code (for tumour entities, potentially also the histology, staging, location of primary tumour/metastasis)

The following additional information is also desirable:

  • status of patient consent
  • details of preanalytical processes, e.g.:
    • time/date of sample collection
    • for frozen samples, date and time of freezing

How much does it cost to use a GBA biobank?

The prices depend on the amount of work involved – on the quantity of samples, whether and how they are processed in the biobank and if further analyses must be conducted, for example. GBA biobanks prepare transparent quotes; reduced prices generally apply for on-site studies. To give an example: GBA biobanks charge €300–500 per year (net) for the long-term storage of 600 plasma aliquots.

Who “owns” the stored samples and associated data?

The rights to samples and associated data from clinical trials remain with the respective study management. Samples and data can only be used for other projects with the consent of the study management. Information on the collections of GBA biobanks can be found in part in a highly aggregated form in the BBMRI-ERIC directory or also sample-specific via the GBN sample locator (e.g. sample type, ICD-10/ICD-O code, quantity).

Do biobanks make templates available for patient consent?

Biobank staff can assist in determination of the form of consent (e.g. study-specific and/or broad consent) and adjust the text accordingly. The Permanent Working Party of Research Ethics Committees in Germany (AKEK) offers a broad consent template for the use of samples and associated data in biobanks. Broad consent enables the collection of samples for medical-related research with a long-term storage period without being bound to a specific research purpose.

Questions?

germanbiobanknode@charite.de

Tel. +49. 30. 450 536 347


Fax +49. 30. 450 753 69 38

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