Histopathology is a necessity for a successful clinical trial. Histotechnologists are equipped with an understanding of tumor biology and mechanisms of disease. Histotechnologists also have the unique knowledge of optimal types of tissue needed, how to handle the tissue and requirements for proper study delivery, such as the evaluation for biomarkers, tissue acquisition and turnaround times. Because of this, histotechnologist's input is vital during every stage of research and clinical trials, which often goes unrecognized. Shared resources help with the continuous need to learn and discover more in quality biospecimens for researchers and academic research institutions.
The understanding of cancer can be directly linked to the advancement in the interpretation of the biology of the tumors and immunology. This has led to treatments that are now being developed to fight the cancers based on specific molecular markers of immune phenotypes that are specific to tumor histology. The approvals of pembrolizumab for the treatment of patients whose tumors have a high microsatellite instability and Larotrectinib and entrectinib for those harboring NTRK fusions, a regulatory submission pathway has been created to facilitate the approval of histology-agnostic indications. Providing support to Histotechnologists requires funding for resources and to be recognized for the contributions made by these professionals.
Histotechnologists are often under increased pressure with the advancement of medical technology and in targeted treatment in clinical trials, that has led to an increase in workload pressure that has been confounded with the worldwide shortage of histotechnologist. Many Baby Boomers are retiring, and labs are losing the strong work-ethic and the willingness to stay until the job is done. As Generation Y & Z are the ones filling the positions, more flexibility with work and life balances is going to be needed to keep them around so that histotechnologists can continue being a key component in cancer research.
References:
Woodcock, J. & LaVange, L. M. Master protocols to study multiple therapies, multiple diseases, or both. N. Engl. J. Med. 377, 62–70 (2017).
Hobbs, B. P. et al. Seamless designs: current practice and considerations for early-phase drug development in oncology. J. Natl Cancer Inst. 111, 118–128 (2018).
Beckman, R. A., Antonijevic, Z., Kalamegham, R. & Chen, C. Adaptive design for a confirmatory basket trial in multiple tumor types based on a putative predictive biomarker. Clin. Pharmacol. Ther. 100, 617–625 (2016).
Written by: Twila Westbrooks, HT (ASCP)
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