Can We Learn to Do Less, but Still Do it Right?
As our magazine embarks on the next 25 years of hopeful service covering the clinical trial enterprise, a quest for industry will be lessoning the complexity of drug development while remaining vigilant in protecting the patient.
Early in the year, during an Editorial Advisory Board meeting, one member noted that for the 25th Anniversary issue, we might want to explore why hasn’t the promise of clinical trial efficiencies been realized? Specifically, and statistically speaking, trials should be smaller, less complex and less expensive based on collective experience, trial design and statistical analysis. But, in the past 25 years, the exact
opposite has occurred. Trials are more complex, have increased protocol requirements, have more regulations to follow, an increase in outsourcing relationships, an increase reliance on technology, and a continuing need to adhere to basic principles.
Individually, they aren’t responsible for complexity, and all of them have a benefit. But under the layers, contribute to complexity and cost.
You wouldn’t want to do away with years of regulatory guidance in place to guard patient safety and evaluate benefit and risk, but maybe you’d want to look at some of the outdated or less relevant practices and re-evaluate their effectiveness in the current culture.
Technology is a tough one because it evolves so quickly that it’s hard to stay on top of, but it’s necessary to get to the clinical trial of tomorrow, which we described in our
Outsourcing trials is upwards to 70%, and as we noted in the
Ken Getz calls this industry the Clinical Research Enterprise, which is so fitting because it’s a very large and cumbersome thing to maneuver and change course, whether it’s the Starship Enterprise or the USS Enterprise aircraft carrier. It does not turn on a dime.
So in this issue, we mark the 25th Anniversary of Applied Clinical Trials and celebrate its contributions to the enterprise. And in the
There are two articles that I’d like to single out. First, from Ken Getz, the Closing Thought, where he provides four axioms of clinical development. His views coalesce his many years of experience, so a definite must read. Another, in the themed section, a former EAB member, Marijke Korteweg, provides a seasoned vantage on the ongoing need for Good Clinical Practice. Unfortunately, she points to a recent incident of investigator violations of GCP. Even after all this time, something as basic as protecting people who participate in research is still needed. It should be OK to do less, more efficiently, but vigilance for patient safety will never be up for debate.
Lisa Henderson is Editor-in-Chief of Applied Clinical Trials. She can be reached at
Articles in this issue
Newsletter
Stay current in clinical research with Applied Clinical Trials, providing expert insights, regulatory updates, and practical strategies for successful clinical trial design and execution.
Related Articles
- NIMBLE Trial Reveals New Insights on Complement Inhibition in gMG
September 15th 2025
- Q&A: Strategies for Successful Global Clinical Trial Delivery
September 12th 2025