![diagram][1] > *"It's my responsibility if things go wrong, and I would be very uncomfortable devolving that responsibility to anybody else"* A community of senior and early career oncologists were asked to pause and reflect on what experiences, values, behaviours, motivations, skills, mode and style of thinking, shape a successful cancer Phase 1 trialist. Participants were asked about the skills and experience needed to be a trialist. The aim was to define the philosophy of people working in trials, their strengths and the value that they bring. **Lifelong learning / curiosity** - #### Cancer is a constantly evolving field, with new drugs, new treatments, new ways of working… #### Trialists are curious people who keep up to date with changes and learn from others. *"We're all going to need to have a lot more knowledge. As we go forward, you know, the science is becoming more and more specialized, and some of the side effects are really different for different types of drugs. So I think there'll be a much bigger piece going forward about education, (...) People will need to be highly motivated and clever to be able to keep track of all of that."* *"I think it's important to have the ability to first of all challenge the status quo. (...) It's about being able to identify where the tangible unmet needs are."* **Dealing with Uncertainty** - #### Due to the experimental nature of Phase 1 trials, trialists need to proactively look for signals in patients and have good pattern recognition to spot unexpected side effects. They also need the clinical and problem solving skills to then deal with these side effects appropriately. #### Trialists keep an open mind and stay “prepared for anything”. *"I remember a little while ago, sitting with a patient, who had no toxicity from the previous cycle of treatment, but just was blinking and just looking slightly strange. And I'd asked her if her eyes were sore. And she said, No. So it's just, it's just these flashing lights that I've started seeing. And so picking up these side effects, we have an idea what the side effects may be, but we're also more and more looking for unexpected side effects, and being open to those and having the clinical awareness to hopefully identify them, I think is important."* *"You need to have a pretty broad knowledge of medicine, to deal with unexpected side effects and good problem solving skills. There's also telling apart toxicity from disease and from comorbidity as it’s important to understand what's drug related, and what's not."* **Communication** - #### Communication is a key skill for working in early phase cancer trials, to collaborate with colleagues who have very diverse skills, coordinate with other centres, as well as talking closely with sponsors. #### Cancer trialists are also willing to have difficult discussions with patients. *"It's in the nature of those trials, that you're being very open with the patient about their situation, the limited likelihood of benefits, the stage of their disease. It's these conversations, which we welcome, which many colleagues may actually feel that they would prefer to avoid. (...) We tend to see the early phase trial patients more frequently. So we tend to be a smaller team looking after the early phase trial patients (...) I find myself getting to know these patients better."* *"One of the challenges I feel in the clinic is when patients come to see me as they will tomorrow morning. And they know they've got no treatment options left. They might agree with anything I suggest. However, unreasonable, uncertain, time consuming it is. The role of the research nurses in talking to patients and making sure they understand properly about the trials and aren't just saying yes to anything"* *"Clinical trials are probably the absolute epitome of teamwork and communication, because there’s so many different highly skilled individuals involved. And so to tie up the whole thing, everyone needs to talk to each other in a language that the other person understands. So I suppose this practice and awareness of what the colleagues’ scope of skills and language are to then tailor your (communication) accordingly. And you want to communicate effectively so that everyone feels part of the team and (it) is easy and efficient."* **Empathy** - #### Trialists are driven by wanting to improve care, and they see patients as partners. Openness and empathy are important skills to use at all times so that trials are designed and conducted in the most humane way possible, and their implications are made clear to patients. They take responsibility of their actions. *“Because at the end of the day, if it's not important to actual patients and the public, then it's probably not something you should be focusing on.”* *“It's about a drive to want to make things better, and to understand what would make a patient want to participate in a trial. But it's also about being able to give patients sufficient information that they can make an informed choice of what's right for them. (...) You've got to want to seek to do better. You've also got to want to really understand what the patients want, which is often very different from what the investigator wants to do. And sometimes that can be really challenging bringing those things together."* *"(Amending) dosing protocols can really help (patients) with their treatment, and that brings satisfaction. You might be monitoring a patient who's getting excessive toxicity, because they're being dosed too high. Being able to (monitor drugs) is pretty great, because you've had some impact and can have impact for future patients as well, so that they don't have to go through kind of excessive toxicity, or have the potential of being under-dosed."* **Evidence based** - #### The complexity and uncertain nature of Phase one trials requires trialists to be thorough throughout the research process and document with care and insight, ensuring evidence is recorded appropriately. Trialists bring their experience, insight and interpretation to complex data. *“Everything needs to be very well documented in everything that you’re doing, whether it’s taking samples, sending samples, noting adverse reactions or toxicity or response. If you want to make sense of what’s coming out at the end, it needs to all be well recorded. Sometimes just small things, like even the units of a dose might be wrong, that someone’s written down, and then kind of the interpretation of that later, can really impact your findings.”* *"It's about being very thorough, good documentation, following things through, but also being prepared to go into the unknown. With these new agents, I think you've got to know a bit about a lot of things. You need to know about if you've got a patient with a specific tumour type coming through, you need to quickly get your head around how their treatment pathway may have been, regardless of where they've come from. You need to be prepared to do a bit of background digging. You need to very much know the evidence that's coming through about different types of drugs and approaches, so that you're not just thinking of your one particular trial, but might see patterns that have developed elsewhere."* You can view the full enhanced report here: https://osf.io/azg8e/ You can download the full enhanced report here: https://osf.io/azg8e/download [1]: https://mfr.de-1.osf.io/export?url=https://osf.io/sfu3p/?direct%26mode=render%26action=download%26public_file=False&initialWidth=560&childId=mfrIframe&parentTitle=OSF+%7C+whomakes.jpg&parentUrl=https://osf.io/sfu3p/&format=2400x2400.jpeg