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New Initiatives for Quality Improvement

rnd systems labOne of the major concerns among the biomedical research community is research reproducibility. It is considered that 50% of published results are irreproducible which leads to a $28 billion loss per year in the U.S. only. Besides the enormous financial loss this tremendously undermines the basis of biomedical research.

It is believed that the following factors contribute to the lack of reproducibility: reagents and reference materials, study designs and laboratory protocols and data analysis and reporting. Since the source of issue has been identified we urgently need to develop a solution and one of the leaders in that field is the Global Biological Standards Institute (GBSI). They have established an action plan, Reproducibility 2020, for the biomedical research community to significantly improve the quality of the preclinical biological research by 2020. More specifically their approach has three major points:

  1. Reagent Validation – cell line authentication, community accepted antibody validation, online registry for sharing biospecimen procurement SOPs.
  2. Shared Protocols and Data – detailed protocols and data should be shared among research communities using newly developed technology tools.
  3. Improved Training – free and online training focusing on experimental design and reagent validation for principal investigators, faculty and other stakeholders. 

Additionally, GBSI recently held a workshop: Antibody Validation: Standards, Policies, and Practices to bring together all stakeholders from the world of research antibodies. Several conclusions were drawn from that meeting: 

  1. Antibodies need to be validated for their particular application.
  2. Transparency – tests used for validations should be available on the company websites. 
  3. Better training for scientists using these antibodies.

More ideas that came up from this workshop were: commercial companies offering training in antibody validation, journal editors requiring proper antibody validation for all papers that they publish and compiling the library of tissues or cell lines that would serve as a standard reference for anyone to use for antibody validation. To see more details regarding the meeting highlights please see this article written by DeeAnn Visk in GEN

Besides antibody validation there is an urgent need for cell line authentication (CLA). Current situation on this topic has been summarized in the recent paper published in GEN (DePalma, 2016). According to the experts interviewed for this article many researchers will acknowledge the absolute need for CLA but often won’t recognize the lack of the same in their own laboratory. 

Up to date there are several CLA technologies such as isoenzyme analysis and karyotyping, short tandem repeats (STR) analysis, DNA sequencing and DNA barcoding. STR analysis has become the most used method for authentication of human cell lines. However characterizing murine cell lines is more difficult because mouse cells often derive from inbred strains and may express genetic drift, as explained by Yvonne Reid, manager and scientist at ATCC. The National Institute for Standards and Technology (NIST), which has developed STR markers to identify different mouse cell-line strains down to the individual cell-line level, in collaboration with ATCC is performing basic research and validation of these STR markers. They are hoping to create a consortium of scientist who will validate NIST’s STR markers with the ultimate goal to have consensus standard. 

leonardfreedman

GBSI founder Dr. Freedman claims that standards and SOPs exist in industry and medicine but there is very little in basic research. GBSI will also examine other factors that contribute to irreproducibility and measure the progress of their Reproducibility 2020 initiative through annual surveys and other metrics. They will spotlight researchers dedicated to change and they will issue annual report addressing progress towards Reproducibility 2020. In addition, there has already been some progress towards improving quality of reagents used by having journals Nature and Science on board and  NIH’s “rigor and reproducibility” initiative launched. Funding bodies and leading journals are now regularly asking for authentication assurances which is all making a difference. 

However, a recent survey GBSI carried out on 500 participants showed that despite everything the compliance rate is less than 30%. Dr. Freedman puts part of the blame onto publish or perish environment now entrenched in academia. 

In Vitro Technologies is working with Bio-Techne and ATCC to make high quality reagents available for your research. If you have any questions please email us at lifescience@invitro.com.au or call us on 1300 552 003.

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30.01.2017