Comprehensive assessment of the regulatory landscape of PD-1 and PD-L1 inhibitors
Miguel Bronchud, Co-Founder and Advisory Board at Regenerative Medicine Solutions, shared a post on LinkedIn:
“Impossible to know for sure the answer?- unless by direct comparisons in prospective randomized controlled large clinical trials (that will never be done)?
Interchangeability of immune checkpoint inhibitors: an urgent need for action
Authors: Michiel Zietse, Roelof W F van Leeuwen, PhD, Sahar Barjesteh van Waalwijk van Doorn-Khosrovani, Jolanda E de Boer, Rudy Dupree, Prof Ron H J Mathijssen,
“Prevailing uncertainties regarding the therapeutic interchangeability of PD-1 and PD-L1 inhibitors affect both clinical decision making and health-care budgeting. This Personal View from the Low Countries (Rotterdam) presents a comprehensive assessment of the fragmented regulatory landscape of PD-1 and PD-L1 inhibitors, highlighting the complex dynamics of market competition, pricing, and the effect on health-care budgets.
‘Our paper – explain the authors- explores the current state of clinical trials, uninformative trial designs, and the challenges they pose in evaluating the therapeutic interchangeability of these drugs. To address these challenges, research that will inform us of the extent of interchangeability of PD-1 and PD-L1 inhibitors is needed. We recommend head-to-head randomised controlled trials, standardised study designs for indirect comparisons, trials with monotherapy groups, post-approval trials funded from private or public sources, and adoption of a near-equivalence framework in both conducting and evaluating trials’.
‘To know nothing is the happiest life. …’
Once said (some 500 years ago) Erasmus of Rotterdam.
Erasmus (born October 27, 1469 [1466?], Rotterdam, Holland [now in the Netherlands]—died July 12, 1536, Basel, Switzerland) was a Dutch humanist who was the greatest scholar of the northern Renaissance, the first editor of the New Testament, and to some extent a defender on the scientific method and human tolerance.”
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