The 2018 Revision of the ISBER Best Practices: Summary of Changes and the Editorial Team's Development Process.

An increased need for specimens of reliable and consistent quality for research purposes requires the development of standardized policies and practices for the collection, handling, storage, retrieval, and distribution of specimens and specimen-related data. Providers of specimen resources should strive to incorporate new technologies and state-of-the-science approaches and thus ensure the availability of fit-for-purpose research specimens. Strategies to achieve quality outcomes and performance improvements often include adherence to established standards and implementation of best practices. Although standards represent a rigid set of guidelines that define exactly how a task should be completed, best practices are recommended actions and principles that demonstrate an awareness of standards, solve problems, can be replicated, and work in a given context. Adoption of best practice elements will vary based on the goals and circumstances of a given initiative, and in some instances, may not be possible to implement or may represent an aspirational achievement. In an effort to harmonize the scientific, technical, legal, and ethical issues relevant to repositories of biological and environmental specimens, the International Society for Biological and Environmental Repositories (ISBER) has released the updated ISBER Best Practices: Recommendations for Repositories (ISBER Best Practices). The document provides a comprehensive tool to guide repository professionals in both managerial and technical aspects such as practical details on repository governance, development, and operation; regulatory compliance; and ethical, legal, and social issues relevant to repositories. This summary describes the process for revising the document and summarizes the new topics, updates, and areas of expansion included in the fourth edition of ISBER Best Practices.

Improving clinical trial sampling for future research - an international approach: outcomes and next steps from the DIA future use sampling workshop 2011.

Clinical trial samples collected for pharmacogenomic and future research are vital resources for the development of safe and effective drugs, yet collecting adequate, representative sample sets in global trials is challenging. The Drug Information Association (DIA) sponsored a workshop on future use sampling in September 2011, bringing together experts from regulatory agencies, academia and industry to discuss challenges to future use sample collection and identify actions to improve collection. Several common themes and associated action items emerged, including the need for international guidance on the collection of samples for future research; additional discussion related to coding, scope of research, and return of research results; and additional education about pharmacogenomic/future research and the importance of long-term storage of specimens.

Development of an integrated biospecimen bank and multidisciplinary clinical database for pancreatic cancer.

BACKGROUND: The integration of biospecimens with reliable clinical data is critical to advance molecular findings from the laboratory to the clinic. We describe the development of an integrated pancreatic tissue bank (PTB) and clinical database for patients with pancreatic cancer and other pancreatic disorders. METHODS: A clinical database and PTB were created in 1990 and 2000, respectively, to collect clinical information and biospecimens from patients with suspected or confirmed pancreatic cancer, other pancreatic diseases, and tumors of the duodenum, ampulla of Vater, and distal bile duct. Standard procedures for biospecimen collection and data entry were developed. RESULTS: From 2000 through 2006, the PTB collected 8,061 pancreatic tissue specimens from 620 patients. The most common histologies of pancreatic tumors were pancreatic ductal adenocarcinoma (55.3%) and neuroendocrine carcinoma (16.3%). The biospecimen collection also includes 431 plasma samples, 40 fine-needle aspiration samples, and a tissue microarray containing 85 pancreatic adenocarcinomas and matched normal tissue specimens. The clinical database contains information for 7,647 patients with pancreatic cancer, other pancreatic disorders, and duodenal, ampullary, or bile duct neoplasms. The data are arranged into nine modules: patient, presentation, risk factors, diagnostic imaging, treatment plan, surgery, pathology, postoperative complications, and follow-up. CONCLUSIONS: We have established a pancreatic cancer tissue bank with standardized procedures for collection of biospecimens along with a comprehensive multidisciplinary clinical database. The integrated biospecimen bank and clinical database for pancreatic cancer described here can serve as a model from which other groups may develop similar systems.