And, assuming the results were again “negative” (regarding objective responses), these definitive data would have been available for viewing by the academic community and prospective patients (following confirmation of the protocol-defined endpoint of futility) within a very short period of time, possibly even 6 months from trial activation.
If this study had been undertaken through the hypothetical process described above, the actual 5-year timeline to report an important negative result could have been reduced to 6 months, or less. Of course, the reporting of positive study results could be similarly expedited.
Finally, the number of such innovative clinical trials that could be ongoing on a national level at the same time theoretically could increase substantially, rather dramatically accelerating research productivity for the benefit of patients everywhere.Maurie Markman, MD, editor-in-chief, is president of Medicine & Science at Cancer Treatment Centers of America, and clinical professor of Medicine at Drexel University College of Medicine. email@example.com.
Pusztai L, Moulder S, Altan M, et al. Gene signature-guided dasatinib therapy in metastatic breast cancer [published online August 29, 2014]. Clin Cancer Res. 2014;20(20):5265-5271.