For a disease like endometriosis, which has global incidence but lacks definitive clinical classification for diagnosis, staging and therapy, multicenter collaboration is important for progress in research.
However, multicenter collaborative projects require standardized operating procedures to harmonize all steps of the project, from clinical information gathering to sample collection and storage. This is vital for ensuring consistency and eventual accuracy in data reporting. In addition, it helps with comparisons between centers and planning for future collaboration.
Through two workshops held during 2013, the World Endometriosis Research Foundation (WERF) established standard operating procedures (SOPs) for the Endometriosis Phenome and Biobanking Harmonisation Project (EPHect).1, 2, 3, 4 These SOPs include recommended and minimum requirements for tissue collection, processing and storage, as well as surgical/clinical data collection
During the workshop discussions, WERF found that there was no uniformity for data collection and tissue sampling. With the aim of reaching consensus, the foundation sought to establish consistency in all areas of a collaborative research project. A standardized approach to characterizing the disease should aid elucidation of pathogenesis and improve treatment in individual cases.
Working with 54 experts from 34 centers around the world, WERF amalgamated SOPs from a variety of relevant sources, distilling them into an effective working protocol for review and revision prior to modification during the second workshop. The SOPs, covering minimum acceptable practices in addition to the advised standards of care, are available as open access publications with updates incorporating feedback from users in addition to the regular reviews established by the workshop committees.
Furthermore, the WERF EPHect Working Groups each published primary papers detailing the SOPs as they relate to surgical phenotype data collection;1 clinical and covariate data collection;2 fluid biospecimen collection, processing and storage;3 and tissue collection, processing and storage.4
With particular relevance for biobankers, the sample collection SOPs prescribe all steps in the process, from tissue or specimen identification, to collection or biopsy, to appropriate storage regimes. This includes, for example, listing all types of samples routinely collected with explanation of protocols that maintain integrity and biomarker stability. The SOPs cover minimal time lapses between collection and processing with further recommendations on optimal standards for long-term storage.
As an aid to compliance for clinical investigators, the WERF EPHect SOPs are available as individual patient questionnaires and forms as well as systematic sample collection instructions. Although the forms state minimum conditions for sampling, WERF EPHect recommends adhering to the standard protocols to ensure consistency and optimal results.
With development of these SOPs and their widespread use by the clinical research community, WERF is confident that they will generate major advances in elucidating the pathogenesis of endometriosis.
1. Becker, C.M., et al. (2014) “World Endometriosis Research Foundation Endometriosis Phenome and Biobanking Harmonisation Project: I. Surgical phenotype data collection in endometriosis research,” Fertility and Sterility, 102 (pp. 1213–22), doi: 10.1016/j.fertnstert.2014.07.709.
2. Vitonis, A.F., et al. (2014) “World Endometriosis Research Foundation Endometriosis Phenome and Biobanking Harmonization Project: II. Clinical and covariate phenotype data collection in endometriosis research,” Fertility and Sterility 102 (pp.1223–32), doi: 10.1016/j.fertnstert.2014.07.1244.
3. Rahmioglu, N., et al. (2014) “World Endometriosis Research Foundation Endometriosis Phenome and Biobanking Harmonization Project: III. Fluid biospecimen collection, processing, and storage in endometriosis research,” Fertility and Sterility 102 (pp.1233–43), doi: 10.1016/j.fertnstert.2014.07.1208.
4. Fassbender, A., et al. (2014) “World Endometriosis Research Foundation Endometriosis Phenome and Biobanking Harmonisation Project: IV. Tissue collection, processing, and storage in endometriosis research,” Fertility and Sterility 102 (pp.1244–53), doi: 10.1016/j.fertnstert.2014.07.1209.