Clinical care and clinical research, till date, are viewed as discrete areas, that actually have the same ultimate aim - patient benefit. With advancements in various technologies and new found awareness for the need of research, especially after the pandemic, the profound importance of research is explicit. Therefore, integration of clinical care and research appears to be the next inevitable step for healthcare delivery.
For above reasons, the Clinical Trial Unit (CTU) at Spine Service is a central facility that takes a spine-surgery-related studies through its life span from inception to publication. Conceived in 2021 (Covid wave 2), CTU is a team of experienced spine clinicians, senior researchers, statisticians, PhD students who have extensive experience in evaluating the safety and efficacy of innovative pharmaceuticals, devices and diagnostics. The 3 phase work-flow comprises of Study design (feasibility testing), study plan (ethics approval) and study execution. Study execution entails vital processes such as recruitment, follow-up, sample logistics (from clinic to laboratory) and data analysis to fulfill the study objectives per ICH-GCP standards. CTU focuses on spinal surgical recruitment, that is usually a challenge along with maintaining longitudinal cohort which requires an approach which is care-management centric. Hence CTU is uniquely positioned for surgeon’s participation.
At present, CTU is coordinating sponsored device-related (AuDi), imaging related (TAO & PSR) trials along with spine registries (DegenPro) with on-going recruitments. Apart from sponsored trials, CTU also coordinates investigator-initiated research studies encompassing diverse fields such as human microbiome-pain axis, novel decay variance & DTI imaging techniques, obesity-pain axis, outcomes of XLIF, TLIF, ACDF’s and many more. CTU is also expanding to other areas such as shoulder.
Though time and again COVID interruptions impact the recruitment process for patients, CTU has come up with innovative digital ways to acquire patient e-consent and also maintain all data record electronically. We aim to make CTU an integral part of regular surgical clinical practice, where both present and future patients would immensely benefit with new knowledge generated with each study.