Introduction to the EQIPD quality system

  1. Anton Bespalov  Is a corresponding author
  2. René Bernard
  3. Anja Gilis
  4. Björn Gerlach
  5. Javier Guillén
  6. Vincent Castagné
  7. Isabel A Lefevre
  8. Fiona Ducrey
  9. Lee Monk
  10. Sandrine Bongiovanni
  11. Bruce Altevogt
  12. María Arroyo-Araujo
  13. Lior Bikovski
  14. Natasja de Bruin
  15. Esmeralda Castaños-Vélez
  16. Alexander Dityatev
  17. Christoph H Emmerich
  18. Raafat Fares
  19. Chantelle Ferland-Beckham
  20. Christelle Froger-Colléaux
  21. Valerie Gailus-Durner
  22. Sabine M Hölter
  23. Martine CJ Hofmann
  24. Patricia Kabitzke
  25. Martien JH Kas
  26. Claudia Kurreck
  27. Paul Moser
  28. Malgorzata Pietraszek
  29. Piotr Popik
  30. Heidrun Potschka
  31. Ernesto Prado Montes de Oca
  32. Leonardo Restivo
  33. Gernot Riedel
  34. Merel Ritskes-Hoitinga
  35. Janko Samardzic
  36. Michael Schunn
  37. Claudia Stöger
  38. Vootele Voikar
  39. Jan Vollert
  40. Kimberley E Wever
  41. Kathleen Wuyts
  42. Malcolm R MacLeod
  43. Ulrich Dirnagl
  44. Thomas Steckler
  1. PAASP, Germany
  2. Department of Experimental Neurology, Charité Universitätsmedizin, Germany
  3. NeuroCure Cluster of Excellence, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Germany
  4. QUEST Center for Transforming Biomedical Research, Berlin Institute of Health at Charite, Germany
  5. Janssen Pharmaceutica NV, Belgium
  6. AAALAC International, Spain
  7. Porsolt, France
  8. Rare and Neurologic Diseases Research, Sanofi, France
  9. Integrity and Global Research Practices, Sanofi, France
  10. Research and Clinical Development Quality, UCB, United Kingdom
  11. Quality Assurance, Novartis Institutes for BioMedical Research, Novartis Pharma, Switzerland
  12. Pfizer Inc., United States
  13. Groningen Institute for Evolutionary Life Sciences, University of Groningen, Netherlands
  14. School of Behavioral Sciences, Netanya Academic College, Israel
  15. The Myers Neuro-Behavioral Core Facility, Sackler School of Medicine, Tel Aviv University, Israel
  16. Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Germany
  17. Molecular Neuroplasticity, German Center for Neurodegenerative Diseases, Germany
  18. Center for Behavioral Brain Sciences, Germany
  19. Medical Faculty, Otto-von-Guericke University, Germany
  20. Charles River Laboratories, Safety Assessment, France
  21. Cohen Veterans Bioscience, United States
  22. German Mouse Clinic, Institute of Experimental Genetics, Helmholtz Zentrum München, German Research Center for Environmental Health, Germany
  23. Institute of Developmental Genetics, Helmholtz Zentrum München, German Research Center for Environmental Health, and Technical University Munich, Germany
  24. PAASP US, United States
  25. The Stanley Center for Psychiatric Research, Broad Institute of MIT and Harvard, United States
  26. Cerbascience, France
  27. PAASP France, France
  28. Maj Institute of Pharmacology, Polish Academy of Sciences, Poland
  29. Institute of Pharmacology, Toxicology and Pharmacy, Ludwig-Maximilians-University, Germany
  30. Personalized Medicine Laboratory (LAMPER), Research Center inTechnology and Design Assistance of Jalisco State, National Council of Science andTechnology (CIATEJ-CONACYT), Mexico
  31. Scripps Research Translational Institute, United States
  32. Integrative Structural and Computational Biology, Scripps Research, United States
  33. Neuro-BAU, Department of Fundamental Neurosciences, Faculty of Biology and Medicine,University of Lausanne, Switzerland
  34. Institute of Medical Sciences, University of Aberdeen, United Kingdom
  35. SYRCLE, Department for Health Evidence, Radboud University Medical Center, Netherlands
  36. Department for Clinical Medicine, Aarhus University, Denmark
  37. Institute of Pharmacology, Medical Faculty, University of Belgrade, Serbia
  38. Institute of Science and Technology, Austria
  39. Neuroscience Center and Laboratory Animal Center, Helsinki Institute of Life Science, University of Helsinki, Finland
  40. Pain Research, Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, United Kingdom
  41. Avertim, Belgium
  42. Centre for Clinical Brain Sciences, University of Edinburgh, United Kingdom

Decision letter

  1. Mone Zaidi
    Senior and Reviewing Editor; Icahn School of Medicine at Mount Sinai, United States
  2. Michael Curtis
    Reviewer

In the interests of transparency, eLife publishes the most substantive revision requests and the accompanying author responses.

Acceptance summary:

The study reports the development of a novel quality system created under the aegis of the EQIPD Consortium. The focus of this validated toolkit is to support basic biomedical research, both in industry and academia. Major revisions and new data have significantly enhanced the quality of the conclusions and their application.

Decision letter after peer review:

Thank you for submitting your article "Introduction to the EQIPD Quality System" for consideration by eLife. Your article has been reviewed by 3 peer reviewers, and the evaluation has been overseen by Mone Zaidi as the Senior and Reviewing Editor. The following individual involved in review of your submission has agreed to reveal their identity: Michael Curtis (Reviewer #3).

The reviewers have discussed the reviews with one another and the Reviewing Editor has drafted this decision to help you prepare a revised submission.

As the editors have judged that your manuscript is of interest, but as described below that additional experiments are required before it is published, we would like to draw your attention to changes in our revision policy that we have made in response to COVID-19 (https://elifesciences.org/articles/57162). First, because many researchers have temporarily lost access to the labs, we will give authors as much time as they need to submit revised manuscripts. We are also offering, if you choose, to post the manuscript to bioRxiv (if it is not already there) along with this decision letter and a formal designation that the manuscript is "in revision at eLife". Please let us know if you would like to pursue this option. (If your work is more suitable for medRxiv, you will need to post the preprint yourself, as the mechanisms for us to do so are still in development.)

Summary:

You describe the work from the Enhancing Quality in Preclinical Data (EQIPD) consortium, whose main goal was to develop a preclinical research quality system that can be applied in both public and private sectors and is non-proprietary. This constitutes a set of 18 principles, or "core requirements", that define objectives for the planning of research as well as for operations and analysis. Overall, the enthusiasm for this manuscript was modest and while all reviewers agreed that the article should be published, there were major suggestions for improvement.

Essential revisions:

The reviewers noted that the paper was noble for taking on the topic of false or misleading research findings and their goal to improve research rigor and honesty. Moreover, their introduction of a host of processes and box-checking steps to incorporate into research would be appreciated by lab managers. However, the reviewers note that, written in its current form as a process document, there were few concrete examples provided to illustrate the concepts discussed as applicable to a general research lab. This lack of applied concepts also led to confusion regarding the underlying EQUIPD initiative itself: there was confusion regarding its implementation as software vs advisory committee vs regulatory philosophy. In addition to providing examples of how to apply the EQUIPD principles in a practical, concrete example, one reviewer suggested that working with journals to help them understand and check submissions for compliance with such a set of rules may be a worthwhile endeavor; in other words, EQUIPD would seem meaningless if compliance checkers did not exist as part of the overall process. Lastly, a revision of the introduction and context of the work is recommended; reviewers took issue with the notion that reduced drug approvals over recent years is attributable to poor preclinical rigor.

https://doi.org/10.7554/eLife.63294.sa1

Author response

Essential revisions:

The reviewers noted that the paper was noble for taking on the topic of false or misleading research findings and their goal to improve research rigor and honesty. Moreover, their introduction of a host of processes and box-checking steps to incorporate into research would be appreciated by lab managers. However, the reviewers note that, written in its current form as a process document, there were few concrete examples provided to illustrate the concepts discussed as applicable to a general research lab.

We have added a new Table 3 to illustrate “what this is all about” – i.e. five basic principles that explain how the EQIPD QS operates. For each principle, we use an example of randomization for a specific illustration how principles are applied.

This lack of applied concepts also led to confusion regarding the underlying EQUIPD initiative itself: there was confusion regarding its implementation as software vs advisory committee vs regulatory philosophy.

We have removed information about the tools and have revised the text to make it clear that this manuscript presents a novel Quality System rather than software or anything else. We have also provided additional illustrations such as Figure 2 that illustrates optional use of tools developed by EQIPD. Finally, we have added a new Table 5 that provides an overview of how the EQIPD framework cane be used.

In addition to providing examples of how to apply the EQUIPD principles in a practical, concrete example, one reviewer suggested that working with journals to help them understand and check submissions for compliance with such a set of rules may be a worthwhile endeavor; in other words, EQUIPD would seem meaningless if compliance checkers did not exist as part of the overall process.

We have added a new section describing the assessment processes that have been developed by EQIPD.

Lastly, a revision of the introduction and context of the work is recommended; reviewers took issue with the notion that reduced drug approvals over recent years is attributable to poor preclinical rigor.

We have revised the text to make sure that reduced drug approvals are attributable to lacking research rigor. In fact, we emphasize that research rigor is merely “one area requiring immediate attention”.

https://doi.org/10.7554/eLife.63294.sa2

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  1. Anton Bespalov
  2. René Bernard
  3. Anja Gilis
  4. Björn Gerlach
  5. Javier Guillén
  6. Vincent Castagné
  7. Isabel A Lefevre
  8. Fiona Ducrey
  9. Lee Monk
  10. Sandrine Bongiovanni
  11. Bruce Altevogt
  12. María Arroyo-Araujo
  13. Lior Bikovski
  14. Natasja de Bruin
  15. Esmeralda Castaños-Vélez
  16. Alexander Dityatev
  17. Christoph H Emmerich
  18. Raafat Fares
  19. Chantelle Ferland-Beckham
  20. Christelle Froger-Colléaux
  21. Valerie Gailus-Durner
  22. Sabine M Hölter
  23. Martine CJ Hofmann
  24. Patricia Kabitzke
  25. Martien JH Kas
  26. Claudia Kurreck
  27. Paul Moser
  28. Malgorzata Pietraszek
  29. Piotr Popik
  30. Heidrun Potschka
  31. Ernesto Prado Montes de Oca
  32. Leonardo Restivo
  33. Gernot Riedel
  34. Merel Ritskes-Hoitinga
  35. Janko Samardzic
  36. Michael Schunn
  37. Claudia Stöger
  38. Vootele Voikar
  39. Jan Vollert
  40. Kimberley E Wever
  41. Kathleen Wuyts
  42. Malcolm R MacLeod
  43. Ulrich Dirnagl
  44. Thomas Steckler
(2021)
Introduction to the EQIPD quality system
eLife 10:e63294.
https://doi.org/10.7554/eLife.63294

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https://doi.org/10.7554/eLife.63294