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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guidance in place to guard patient safety and evaluate benefit and risk, but maybe you’d want to look at some of the outdated or less relevant practices and re-evaluate their effectiveness in the current culture.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 February/March issue.
Outsourcing trials is upwards to 70%, and as we noted in the April/May issue, these relationships are complex. They surely help the pharmaceutical company’s bottom line in fixed costs, but managing the overall process and quality of the vendor is not an easy task. In fact, it impacts the role of the project manager in ways that just didn’t exist 10 years ago.
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 section titled after this milestone event, we touch on each of the aforementioned complexity issues. How technology is envisioned for the future, how roles are changing in the clinical trials profession, how collaboration among stakeholders can make for a more patient-centric research environment, what inefficiencies can be tackled to make processes more streamlined, and what does the future of the site landscape look like?
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.