Why Do Clinical Trials for Cancer Drugs Take So Long?
Click to view quick news summary (Spoiler)
A response to a guest essay argues that while clinical trials are costly and slow, rigorous Phase 1 safety reviews remain essential given the high attrition rate of oncology drugs.
Readers respond to a guest essay about the costs and delays in getting experimental treatments to patients.
To the Editor: Re “Doctors Who Discover Miracle Cures Worry About Medicine’s Future,” by Ruxandra Teslo (Opinion guest essay, Sept. 6):
Dr. Teslo is right that America’s clinical trial system has become too costly and cumbersome, particularly for emerging biotech companies. But faster Phase 1 oncology trials should not be the sole measure of reform.
Phase 1 is where an experimental therapy first enters humans, and where safety, tolerability and dosing must take precedence over speed. Oncology has extraordinarily high attrition: One analysis found that only about 6 percent of oncology drugs entering Phase 1 ultimately received Food and Drug Administration approval. That underscores why rigorous review remains essential.
The missing piece is how smaller biotech companies access the expertise needed to navigate that rigor efficiently. Rather than weaken safeguards, we should expand partnerships with specialized contract research organizations. These smaller organizations can be leaner and more agile, using advanced technology to model trial scenarios, improve study design and identify the most effective path before execution. They can then bring together clinical operations, data management and statistical and regulatory expertise with greater flexibility and attention.
If we want more patients to benefit from innovation, the goal should be smarter, more efficient trials — not simply faster ones.
Armen Margaryan, Los Angeles. The writer is the chief executive of NoyMed, a medical contract research organization.
