Our sponsor was keen to outsource the development programme design and delivery relative to a new indication for an existing Product License with potential for ‘first in market’ for the specific indication.
Current treatment and supportive care was based on no, little or poor evidence resulting in inconsistency of care.
No licensed comparator and many unknowns and considerations, including clinical opinion, study population, dosage regimen, treatment duration and radiotherapy scattering.
Recognising the lack of a consensus on ‘best practice’ by the radiology, oncology, and dermatology fraternity, O4 Research conducted a national survey to elicit standard of care throughout UK/Ireland and attitudes to treatment and management.
The O4 team’s next step included direct consultations with Key Opinion Leaders (KOLs) in order to establish drivers of prescribing/endorsing treatment and explore opinions towards the potential development approach.
O4 Research subsequently worked collaboratively with the Sponsor to implement innovative trial designs which addressed all key objectives but which proved feasible for the cohorts required across the programme including patients receiving adjuvant radiotherapy and critically the palliative care patient cohort.
O4’s patient centricity imperative which is firmly embedded within O4 EngageTM, made it easy for us to focus on palliative care patients to better understand the burden of disease and how we could better serve their needs in the trial.
We established a Patient Focus Group and engaged with a Cancer Patient Advocacy Group throughout the study lifecycle, ensuring that our unique study identity that extended across all key communications significantly increased study visibility and resonated with site staff and patients alike.
Knowing what patients wanted and expected before, during and after the trial ensured that we were able to address patient-specific concerns that influenced the study criteria recruitment, retention and compliance.
All participants noted to the investigative site teams that they enjoyed participation in the study as exemplified by a patient retention rate of 90%.