Ensuring Success in Early Phase Oncology Clinical Trials | Page 6

Investigators and site personnel who are familiar with these things are more
likely to deliver quality data. To maintain patient safety, investigators need to be
able to discern whether adverse events were likely caused by the investigational
drug, the disease itself, or other therapies. Less experienced investigators can
be misled by events or overlook them.
If possible, clinical research associates (CRAs) should have experience in early
stage oncology trials. As the liaison between the clinical research organization
and study sites, CRAs are key in communicating trial conduct to both parties. An
understanding of clinical oncology is important for interacting with study sites
and recognizing the significance of certain toxicities.
Oncology is one of the more global and internationally harmonized therapeutic
areas, but there are regional standards and differences in how to handle
medicine, treat patients, and do clinical investigations. Service providers should
have regional knowledge of these areas so they can specifically address them in
training investigators. This helps set up the framework for a trial and helps avoid
mistakes and misunderstandings.
In the US and Europe, many oncology studies are done in large universities or
independent commercial Phase 1 units. Both have access to patients and have
staffing to handle the types of collections that need to be done for Phase 1
studies, such as 12-hour pharmacokinetic samples. An advantage of university
sites is that they have key opinion leaders, but start-up can take a long time and
overhead costs are often high.
Emerging locales, such as Latin America, have large cancer centers with
investigators who may be good candidates for taking part in Phase 1 trials.
Investigators should have extensive experience in oncology and clinical
investigation before participating in Phase 1 studies.

Staying on Pace Throughout Phase I Studies
Phase 1 studies require daily monitoring. This population of patients can have
rapid changes in the course of their disease or response to therapy. Frequent
communication between investigators and patients as well as investigators and
the sponsor is critical for maintaining patient safety in case toxicities arise.
CRAs must monitor screening and enrollment at each site. They also need to
have frequent contact with sites to make sure data are logged in a timely
manner.