Year: 2025
Type: article
Abstract: As a clinician-scientist, the journey through the PENTACON trial, a multicenter randomized clinical study comparing two surgical techniques for corneal transplantation in keratoconus patients, was both enlightening and challenging. The study, which served as the centerpiece of my PhD research in 2015, ticked all the regulatory boxes and was ethically approved but ultimately fell short due to being gravely underpowered. This reflection aims to dissect the experiences, challenges, and lessons learned from this endeavor. Most importantly, while courses on clinical trial design such as Good Clinical Practice (GCP) certifications can teach important principles, the core value of any study remains somewhat elusive. How can one find the thin golden line between scientific value, innovation, patient recruitment, and overall trial feasibility? The outcomes of a study can never be completely sure; if we knew them ahead of time, it wouldn't be called research. However, in this particular example, there were tell-tale signs of failure early on. Therefore, I believe there are lessons for fellow researchers to be found.
Source: Journal of Trial and Error
DOI: 10.36850/431d-44eb
Author: Robert P. L. Wisse
Institution: University Medical Center Utrecht
Language: English
Topic: Ethics in Clinical Research
Field: Medicine
Domain: Health Sciences
Open Access status: diamond
OpenAlex ID: W4410711775