Table 2

Summary of practical PTA challenges and potential strategies to overcome them

Uncertainty in the pre-trial period
Uncertainty regarding PTA to an approved product within healthcare systemRevisit initial PTA plan as trial proceeds or commit to develop strategy to ensure access during course of trial (with admitted uncertainty to participants).
Uncertainty regarding commitments of manufacturers and trial sites for PTA to products not yet approved for any useRevisit PTA plan as more data become available and/or stakeholders may reconsider commitments.
Transitioning participants to healthcare system for PTA of approved products
Finding welcoming healthcare professionalsDevelop network of healthcare professionals familiar with the study population and willing to welcome as patients.
Helping participants navigate the health systemBegin preparing participants for transition during study visits; assess needs and enrol in available assistance programmes if needed; build PTA preparation into study visits; potentially fund a dedicated staff position to assist participants.
Adjusting to changes in the experience of careIdentify changes participants are likely to experience and discuss ahead of time; where possible, conduct study at regular site of care to eliminate change at time of study conclusion.
Managing participant preferences about site of PTAConsider range of partner clinics in different locations to offer participants a choice of convenience or anonymity.
  • PTA,┬ápost-trial access.