I have loved this conversation. It seems that everyone is in agreement that the needles needed to be provided because it is the ethical thing to do. What about the poewr of the trial? Hedi raised a great point that providing clean needles would have led to an increased number of participants needed to maintain the same statistical power in the trial. The trial could have gone on longer and used more resources that could have been used for additional trials.
Would it make a difference to anyone if the trial staff and leadership had consulted the stakeholders and explained to them that there was no way to include clean needles because of the statistical power and the budgetary contraints of the trial?
