Biotech Values

[AlpineBV_Miller]

The 25-30% number is at least twice as high as any data I've seen presented for randomized P2 oncology trials. Walking through posters at ASCO or ASH I certainly don't see every third P2 poster as a randomized trial.

Of the 703 phase II trials examined,
only 143 (20%) abstracts mentioned any control subjects,
which are subjects not exposed to the experimental intervention
in either a prospective or historical design. Although the
traditional phase II trials may implicitly invoke historical
response rates, we opted against including such trials in the
controlled classification. Among oncology trials, only 13% (77/
586) of published abstracts mentioned control subjects,
compared with 56% (66/117) of published abstracts from
other specialties (P < 0.001).

The authors then move to speaking about blinded, randomized trials.

Otherwise stated, 50/117 (43%) of non-oncology phase II trials were done with a randomly selected control population that was blinded to the intervention, but only 7 (1%) trials conducted by oncology specialists met those same criteria.

Phase II Trials Published in 2002: A Cross-Specialty Comparison
Showing Significant Design Differences between Oncology
Trials and OtherMedical Specialties
Laura C. Michaelis and MarkJ. Ratain
Clin Cancer Res 2007;2401 13(8) April 15, 2007

Perhaps 2002 was an outlier year, but I've talked with Dr. Ratain at length on this subject and he has other data suggesting it was not. In subsequent presentations, he draws a pretty bright line between the high failure rate of oncology drugs (92% of oncology entering human clinical trials fail to reach approval) and the lack of randomized Phase II trials.