Summary of practical PTA challenges and potential strategies to overcome them
| Challenges | Strategies |
| Uncertainty in the pre-trial period | |
| Uncertainty regarding PTA to an approved product within healthcare system | Revisit 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 use | Revisit 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 professionals | Develop network of healthcare professionals familiar with the study population and willing to welcome as patients. |
| Helping participants navigate the health system | Begin 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 care | Identify 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 PTA | Consider range of partner clinics in different locations to offer participants a choice of convenience or anonymity. |
PTA, post-trial access.