Cancer Immunol Immunother. Jan 2011; 60(1): 15–22.
Minimal information about T cell assays: the process of reaching the community of T cell immunologists in cancer and beyond
1III. Medical Department, Johannes Gutenberg-University, Mainz, Germany
2Clinical Development, BioNTech AG, Mainz, Germany
3ZellNet Consulting, Inc., Fort Lee, NJ USA
4Department of Clinical Oncology, Leiden University Medical Center, Leiden, The Netherlands
5Association for Cancer Immunotherapy (CIMT), Mainz, Germany
6Translational and Correlative Studies Laboratory, University of Pennsylvania School of Medicine, Philadelphia, PA USA
7Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD USA
8Human Immune Monitoring Center, The Institute for Immunity, Transplantation and Infection, Stanford University Medical Center, Stanford, CA USA
9Department of Immunhaematology, Leiden University Medical Center, Leiden, The Netherlands
10Cancer Research Institute, New York, NY USA
11Department of Gynecologic Oncology, Roswell Park Cancer Center, Buffalo, NY USA
12Laboratory of Human Cancer Immunology, Ludwig Institute for Cancer Research, MSKCC, New York, NY USA
13Tübingen Ageing and Tumour Immunology Group, Center for Medical Research, University of Tübingen Clinical School Tübingen, Tübingen, Germany
14Division of Clinical Onco-Immunology, Ludwig Institute for Cancer Research, University Hospital (CHUV), Lausanne, Switzerland
15Bristol-Myers Squibb, Wallingford, CT USA
16HHMI, The Department of Microbiology and Immunology, and the Institute for Immunity, Transplantation and Infection, Stanford University School of Medicine, Stanford, CA USA
Received September 27, 2010; Accepted October 23, 2010.
Several major challenges exist for activities that aim to impact current practices and achieve broad consensus among scientists who work in fragmented fields of science (Table ).
To begin, implementation of a new process (e.g., structured framework to report data from analytical assays such as MIATA) in a lab environment is time-consuming. It requires investigators to read, understand and approve the new framework internally, to teach staff members to apply the new process correctly, and to ensure proper execution. Consequently, any new reporting framework proposed to the field has to find a balance between being easy to understand and implement and requesting an amount of information sufficient to fulfill its purpose. Clearly, MI projects should be as “minimal” as possible. However, while minimizing the content of a reporting framework beyond a certain degree might make it easier to implement, it can also decrease its value significantly. Achieving the appropriate balance between not asking for too much or too little information has been and still is one of the most difficult tasks in the evolution of the MIATA project and is the focus of many discussions among the investigators involved. Clearly, the additional workload associated with implementation of MIATA should never outweigh its added value for individual investigators and the scientific community.
Even a user-friendly and technically precise reporting framework will not be of any value unless broadly accepted and adopted by scientists and journals. An investigator’s decision to accept or reject a proposed reporting framework will critically depend on the absence or existence of any concerns related to conforming to the guidelines. Various concerns were also raised after the first draft of MIATA (version 0) was published. It became clear that specific concerns were typically shared by groups of colleagues with a similar focus of their work (e.g., assay validation, research labs, labs performing correlative studies in larger clinical trials, applicants for funding schemes). Part of the MIATA approach has been to carefully consider and address each of these concerns en route to establishing a final set of reporting guidelines.
Finally, the adoption of MIATA will crucially depend on knowledge of the framework and its acceptance as standard practice by peers and stakeholders in the field. Despite the overwhelming redundancy in the nature of the assays used to evaluate immune responses across specialized fields such as cancer immunology, autoimmunity, transplantation, and infectious diseases, scientists in each of those fields have historically tended to operate as more or less isolated groups, developing closely related assays in a parallel, often redundant, fragmented, and non-integrated manner. Geographic fragmentation, facilitated by the establishment of specialty societies in the USA, Europe, parts of Asia, and Australia has further added to the non-integrated nature of T cell assay development. This fragmentation clearly needs to be addressed and overcome by integrating the expertise from as many directly involved peers as possible into the framework, independent of location, affiliation or background.