Ensuring Success in Early Phase Oncology Clinical Trials
Ensuring Success in Early Phase
Oncology Clinical Trials
The numbers of oncology drugs in clinical development is more than twice the
number in any other therapeutic area (PharmaLive.com). Yet despite being the
most commonly tested therapies, oncology drugs have the worst approval rates.
Only 5% of agents with anticancer activity in preclinical development are
licensed (Hutchison and Kirk, 2011).
The main reason for failure is that preclinical strategies to evaluate novel
oncology agents are suboptimal. In addition, conducting clinical trials in cancer
patients is challenging because of the number and type of prior treatments
patients have undergone and because novel agents are tested in patients with
late-stage malignancies, which are inherently more difficult to treat than earlier
malignancies.
The current landscape of cancer therapeutics is evolving as the genetic and
molecular mechanisms involved in cancer are increasingly understood. More
targeted and individualized therapy has presented exciting possibilities to
combat disease, but the new approaches have also added complexity to clinical
development.
In any disease state, conducting successful Phase 1 trials is a key component of
ushering a novel therapy through clinical development. Although Phase 1
studies in most therapeutic areas consist of healthy patients, Phase 1 studies in
oncology consist of patients with active disease. This creates unique challenges
and potential opportunities. Understanding these challenges and opportunities
is paramount for designing Phase 1 oncology studies and keeping them on track.
Unique Aspects of Phase 1 Oncology Studies
Oncology trials are bound to enrolling patients with later-stage disease who
have already been treated with standard of care. The reason for this
distinctiveness is an ethical one; any new investigational agent bears the
potential of failure or suboptimal therapeutic efficacy, and the inclusion of early
stage patients who do have proven treatments would be regarded as unethical
unless the new agent has shown activity.