Proactive Risk Mitigation in Early Phase Oncology

High screen failure rates:

The potential for a high screen failure rate was immediately identified as a concern for this Phase 1 FIH oncology trial, especially given the complexity of the inclusion and exclusion criteria.

High screen failure rates are a common challenge across oncology trials, resulting in considerable time and money spent collecting data from participants who are ultimately never enrolled. Outside of the logistical and financial impacts, a high screen failure rate can also be emotionally challenging for patients who are often eager to participate in new research due to limited treatment options, only to be later disqualified.

There does not appear to be a widely-agreed upon average screen failure rate for cancer trials conducted in the United States (potentially due, in part, to a lack of standardized definition for “screened”). ^{1, 2, 3} In one publication from The Josephine Ford Cancer Center in Michigan, the “assumed screen failure rate” nationally was stated to be 80%, adding in that their own overall rate at the time of publication was 78% for Phase 1 cancer trials.³

Additionally, details such as trial timing might further impact screen failure rate within oncology trials, with studies offered at the time of primary treatment reporting higher screen failure than trials offered at the time of disease recurrence.⁴

Concern over site burden:

The success of a study depends heavily on the success of individual site performance. Site staff, including principal investigators and clinical research coordinators (CRCs), are often stretched thin, and both PharPoint and our client agreed that there was a shared responsibility to reduce that burden whenever possible.

Broader research supports this concern: In 2015, an ASCO and AACI stakeholder survey was sent out to ask about administrative and regulatory burdens associated with conducting and managing cancer clinical trials. Over half of respondents (n=1,200) reported that they lacked adequate staffing to manage regulatory demands.⁵

More recent studies go on to highlight burnout and turnover among CRCs as ongoing challenges⁶, both of which may affect trial conduct as the CRC plays a demanding role critical to the success of a trial with a wide range of responsibilities.⁷

Risk of protocol deviations surrounding visit windows:

Finally, it was quickly determined that protocol deviations due to out of window visits would be a challenge in this study given the complexity and timing sensitivity of the protocol.

Research shows that oncology clinical trials, in particular, have the highest relative mean number of protocol deviations – affecting more than 40% of patients enrolled in each trial.⁸