While cancer is a global health challenge, the United States is the largest oncology drug market in the world.
For sponsors with little to no U.S. presence, designing and managing clinical trials for oncology drugs in the U.S can be an arduous task. It’s difficult to effectively manage your first U.S. phase I studies from China, Japan or Korea, so most Asian-based sponsors establish a small office in the U.S. when launching.
But it’s often not enough to successfully launch their first study.
Even for experienced oncology teams, entering the clinic in the U.S. for the first time presents a learning curve. It takes experience to acquire the first-hand knowledge to
For sponsors launching their first oncology studies in the U.S., most fail to meet their enrollment targets. This causes cost overruns and delays – additional stress for the team managing the clinical development.
The most common cause of low patient enrollment boils down to site selection. Everybody wants to have the top research sites on their study – M.D. Anderson, Johns Hopkins, Sloan Kettering, Dana Farber – but only experience in working with them allows you to understand the real timelines to get the first patient enrolled. Having a prestigious academic center in your study can bring valuable recognition. However, it can also dramatically affect your enrollment rates if you’re not experienced in working through the administrative hurdles that most larger academic sites present, while also understanding how to keep your study visible among the many other studies running at the site.
Other common causes of delays include:
On overview, to overcome these, sponsors should give extra attention to:
For immuno-oncology studies, there are an entirely different set of complexities that cause additional delays. Medelis has been pioneering immunotherapy studies since 2008, running many CAR T-cell therapy studies, checkpoint inhibitor studies and bispecific antibody treatment studies.
Common delays for immuno-oncology studies include the following:
As a specialty oncology CRO, Medelis can design the plan for bringing a non-U.S.-based company’s drug into the clinic. This short-term consulting engagement can have a dramatic impact on your pathway to the U.S. market – giving you the assurance of a team of oncology experts, who have a comprehensive understanding of the nuances of the U.S. market, to guide your drug development plan.
Having our team of oncology drug development experts guiding your U.S. development plan gives you
For a more in-depth discussion, contact us.