Aim
Early-phase clinical trials (EPCTs) possess unique recruitment challenges. EPCTs are defined by restrictive eligibility criteria, focus on safety, and testing novel treatments (often for the first time) in patients who may have limited options. Information to support a potential participant's decision to participate commonly relies on the patient information and consent form. However, the nature of EPCTs suggests that additional information is warranted. Research indicates that current resources, where available may not fit the information needs of its audience and were primarily available in English.
Method
Approached as a quality improvement exercise, the VCCC Alliance performed a literature review and contacted Clinical Trials Units (CTUs) regarding the information and process used in EPCTs. Four broad Consumer Focus Groups were undertaken to review the material and methods for their appropriateness. Recommendations were sought to address the shortfalls in resources and clinical usage.
Results
The literature review, scoping exercises and focus groups demonstrated the diverse range of materials available, yet the needs of the potential participants were not met. Distinctions and similarities from the focus groups have been identified, for example, some consumers were keen to see EPCTs with conversations around hope whereas others preferred to highlight if a dose was subtherapeutic. The role of the information Consumers considered. These informed recommendations and will be provided, along with examples outlining the next steps in their distribution, including Culturally and Linguistically Diverse (CALD) populations to make these recommendations widely available.
Conclusion
The participant-informed recommendations in the provision of EPCT information assist in addressing known barriers for potential participants considering these trials. Making such recommendations freely available will encourage participants and organisations to confidently use endorsed procedures and examples of appropriate materials and tailor to their purpose.