Very soon, blogs and independent writing will be the only source of unadulterated truths. One such article is shared here written by Adam Kroetsch , formerly in the FDA
A review and comments
The above article compellingly recounts how clinical trials evolved from ad-hoc, investigator-led efforts in the mid-20th century to the bureaucratic behemoths of today. It highlights the “golden age” of the 1980s-1990s, when academic “trialists” pioneered large simple trials like ISIS and GISSI. These mega-trials enrolled tens of thousands with minimal protocols ,one-page forms, no routine monitoring or source data verification (SDV), proper randomization, and focus on clinical hard endpoints and mortality delivering transformative, low-cost evidence on treatments like streptokinase and Aspirin.
The decline followed the rise of Contract Research Organizations (CROs) in the 1990s, global Good clinical practice -GCP guidelines (1996), and FDA missteps. Trials are now industrialized and bureaucratized: extensive on-site monitoring, exhaustive adverse event reporting, data audits, and risk-averse compliance layers inflated the costs (rising 10% annually). Academic and NIH-funded large trials plummeted .Pharma shifted to smaller, often useless biomarker-driven studies instead of clinical outcome. (Eg Drug X reduce NT-pro BNP by this,and it is crowned in glory ). The irony is ,the trialists are crying “foul” at GCP, and call it unscientific as they interupt the industry.
Who is responsible for this chaos?
Primarily commerce and greed in a profit-driven ecosystem .Alos pharma’s risk aversion and demand for speed and volume. Other factors were, heavily empowered CROs, Perverse incentives and Industry balance sheets, dictated the how science should behave. No surprise , true academics and genuine funders retreated amid prohibitive costs.
Final message
GCP is not a taboo subject, as some non- academic forces would like to envisage. Let us bring back the golden age of simple trials—even observational ones will bring the truth when done appropriately .Let us stop this big commercialised RCT nonsense with ultier motives.
Dr.S.Venkatesan MD 