A Sponsor approached O4 Research to provide a full service delivery for their pilot, Phase II clinical trial to assess an investigational product for palliative care patients with advanced cancer. The Sponsor was working on a therapeutic area outside of their scope of expertise and O4 was able to assist by taking responsibility for navigating the complex disease area on their behalf.
The Sponsor relied on O4 to design and execute a comprehensive and feasible clinical development programme ranging from protocol design to study report. This particular investigational product had not been previously studied in this patient population and O4 provided advice in relation to conducting a pilot study to assess safety prior to progressing to a Phase III efficacy study. O4 was able to provide specialised expertise for this study in order to ensure the trial design and protocol were appropriate for this vulnerable population. A key consideration was ensuring the burden of study participation was minimised by designing the protocol to facilitate the conduct of study site activities in parallel with standard of care visits, where possible.
We at O4 pride ourselves on our ability to provide an optimal patient centric study design. We value our engagement with patient advocacy groups which allows us to gain a thorough understanding and appreciation of the relevant patient population.