Table 3.

Concerns about RTT and the federal RTT law^a

Themes	Example quotes
Lack of adequate oversight and patient safety	I think that [RTT] could lead potentially to some risk beyond what the patient might be willing to take if they had been informed or what might be in the best interest of the patient…Certainly, we don't know the risks when we put a patient on a phase I study, but there, at least we have some safety checks in place more so than you might have when you are going without IRB or FDA oversight and there’s been no vetting. (Participant 13)
	I would say, as much as the regulatory work is for the Expanded Access Program, there is enough rigor in there. You have to fill out the IRB application. You had to put out your—the monitoring, for example, what's your monitoring plan. You had to have some solid rationale to do this, and then there were checks and balances. You had to then—once my patient was off study, I had to give follow-up…How did the patient do and what were the toxicities? I think that that is a robustly regulated way to do it. I am a little concerned about, ‘Hey, there's a drug. It's out there. I can get access to it.’ [With RTT], I'm a little afraid that if you weren't being careful by someone who wasn't detail-oriented and rigorous, certain things could fall through the cracks. What's the monitoring plan? How often should they be seen? How often should you do lab tests? (Participant 15)
	As much of a hassle as it is, oversight remains important. These are drugs where not all the side effects are known. Managing risk, managing reporting and things like that, I take a somewhat more conservative stance on that. Yes, it’s a hassle, but there are reasons for it and until the drug has been through the development process and you know what it is, I don’t like the idea of just, ‘Sure, go ahead. Try it. See if it works.’ (Participant 21)
Lack of process structure and data collection about investigational drugs	I think that the lack of the lesser amount of FDA involvement is sort of a double-edged sword, right? I suppose it makes it easier for patients to get, and less burdensome for their physicians to get it, especially in the community where they may not have as much regulatory help as we do on the academic side. The flipside is that without that FDA monitoring and outcomes collection, you’re potentially missing out on a whole trove of data that we can learn from, right? (Participant 8)
	When I think about the headlines that come out when this black box wording and these things that we learn sometimes even after FDA approval…If the signals are there early when there is a major safety concern if right-to-try if we are not collecting this data and this information, we are not going to learn these important things if they’re all happening in isolation and nobody’s talking, nobody’s reporting, and that’s the whole darn purpose. (Participant 10)
	I don’t see it for me in the near future, just because it’s a complete black box. If somebody comes back and explained to us and there is way to do this, there is little less regulation involved, but like I said, I’m still going to be responsible, but maybe if we could get the same drug sooner with less people involved, then maybe we would try that. I just don’t know yet. (Participant 16)
Increased patient expectations and confusion	Yeah, I think it sets up an expectation that we have a right, so I think that that's potentially damaging and actually gets in the way of the doctor-patient relationship and confuses good care. I'll also tell you the flipside of that is it's been a zero issue in my clinic. (Participant 6)
	It could be very disappointing for patients once they see that. It could also create some extra work for the oncologist because now a patient is coming in saying, ‘I want this drug. I have the right to take this drug.’ The oncologist has to argue why you should not take that drug, why it doesn’t make sense to take that drug. I think maybe it should be rebranded to an oncologist right to consider, rather than a right-to-try. (Participant 12)
	I don’t think [patients] do [understand], because they come in and go, ‘I read about that. I want it. Why can’t I? Don’t I have a right-to-try?’ Then you have to walk through that process. (Participant 18)

^aFDA = Food and Drug Administration; IRB = institutional review board; RTT = federal Right-to-Try Act.