Participant Impact Report
In collaboration with
In
the
Participants’
Words
Patient Insights from Psychedelic Clinical Trials
Participant Impact Report
In collaboration with
Patient Insights from Psychedelic Clinical Trials
Reflections
The Patient Council workshops revealed a wealth of valuable insights. To maximise their contribution to the research community, it was agreed that the patient expert reflections should focus on observations that were new, specific to psychedelic research and most critical to the participant community.
1
Conducting a trial vs accessing a treatment
“This trial was sort of a last resort option… You’ve got to be careful that you’re not giving anything away in the recruitment stage and getting hopes up falsely”
Participant quote
“My first trial was open label, which I do think made a massive difference, because you knew you're going to get the help that you desperately hoped for. The second trial was placebo controlled, and there was no open label extension. So that did feel like this is my one shot.”
Participant quote
“For me, the hardest part of the trial is knowing that once a patient knows there’s a remedy for their suffering, knowing that the remedy is not available any more can be soul destroying.”
Participant quote
The FDA defines clinical trials as a means “to determine whether a new drug or device is safe and effective for people to use”1. For the participants, taking part in psychedelic clinical trials represented an opportunity to receive a potentially transformative treatment for their mental health condition. For some, these trials were seen as a last resort. The participants cited media sources and the large amount of “real-world evidence” as drivers of this expectation. Given the context of the perceived quantity of “real-world evidence” specific to psychedelic research, it is important to recognise this nuanced yet important divergence in stakeholder perspectives.
Patients are seeking improvement to their symptoms while pharmaceutical companies aim to develop treatments that are safe and effective, working within the constraints of regulatory guidelines and study design to protect the integrity of the data and scientific and statistical validity. Clinical trials need to be conducted in a way that seeks to minimise bias and prioritise participant safety, whereas the participants acknowledge their focus is on access to a potential treatment. Acknowledging that this is not always possible, PsyPAN advocates for clinical trial design of psychedelics that allow all patients to receive an active dose, and if patients respond, access to further treatment as clinically indicated should be made available.
To reduce this tension, clinical trial teams and sponsors could inform participants of the rationale and reasons for aspects of trial design that participants may perceive as lacking patient focus. Participants acknowledged they would benefit from being thoroughly prepared for a potential allocation to a placebo group (if in the protocol), the potential for non-response or any other unforeseen challenges that may be at odds with the participant's motivations, as well as the time required to complete the assessments and feedback process.
2
The unseen participants
“I think, especially if your support system is psychedelic naive, you come out having had this insane experience, which is life changing and people don't know how to respond to you, your own people, your family.”
Participant quote
“I think I had a session with the study team and my support system to talk about what my support needs might be. So that was a really key element and actually, in my experience, was enormously beneficial.”
Participant quote
Members of the participants' support network played a critical and potentially under-recognised role in participants’ experiences. The workshops identified that the perception of psychedelics from the participant's support network resulted in them either encouraging or discouraging participation. Three participants felt it was their responsibility to educate and inform their support network throughout the process, and the participants acknowledged this as a burden. This was not the case for one participant, as support and information were provided to their support network as part of the clinical trial they took part in.
Providing resources for the participant’s support network may help create a supportive environment around the clinical trial process and contribute to a better overall experience for the participant. For example, a support booklet could include an overview of the clinical trial process and procedures, digestible educational material on the study drug under investigation, and information on the emotional and practical burdens associated with psychedelic clinical trials.
3
The experience with the research site extends beyond the treatment team to every interaction
“The creation of trust begins with the first contact with potential participants. I ended up going to some pretty dark and difficult places. And my belief is that I only did that because I felt safe enough to because of the relationship that started 6-7 months prior to actually having the doses.”
Participant quote
“I think when things start dropping, it does end up falling on the patient…. They (treatment administration team) were phoning me at 9pm with paperwork and follow ups… it was just chaotic.”
Participant quote
The “set and setting” principles of psychedelics research are recognised as an essential consideration within psychedelic clinical trials. Though “setting” can be largely controlled within a clinical trial site, creating or promoting a 'set' conducive to therapeutic changes requires careful consideration. The workshops highlighted that trust was an essential interpersonal feature between the participants and the research team. Participants considered every interaction with the clinical trial team—from administrative recruitment emails to support during treatment—as critical elements of trust building.
Training the research team in compassionate participant communication could facilitate the establishment of trust. Elements include engaging in behaviour and language that promotes trust from the start of recruitment and is continuously built upon throughout the clinical trial process. Incorporating culturally appropriate tools, language, and behaviours could also support participant interactions. Compassionate participant communication also includes the research team who could seek to ensure an organised and smooth clinical trial experience for the participant, enabling the participant to feel confident in the research team to support them throughout the clinical trial process.
4
Due to high public interest following clinical trial completion, some participants have felt compelled to share their experiences publicly, but have had negative experiences doing so
“Psychedelic experiences are ineffable, trying to describe the experience with words, is like trying to describe your favourite piece of music with lego. You end up feeling like you’re either trying to find the most creative language to emphasise the unique and often spiritual experience, that ultimately sounds “crazy” to those who haven’t experienced.”
Participant quote
“I think there is a process of educating the media on these medicines and how to deal with participants coming out of these trials or treatment centres as it becomes mainstream. Stigma still exists, so preparing patients to know reactions might differ. And, you know, making the participant understand it's not about them, it's about that person's reaction to their response.”
Participant quote
Intensified by the stigma that can accompany both psychedelics and mental health, the participants explained the significant emotional toll of reliving the psychedelic experience publicly. In some instances, this sharing was met with dismissive, minimising and negative reactions. The participants believe speaking publicly can/should be empowering, but support is needed before and afterwards to ensure this.
The participants now advise other participants to protect their emotional well-being by only sharing their experiences publicly when they feel they are psychologically strong enough to do so following the clinical trial data publication. PsyPAN currently provides direct peer support before and after media interviews. Furthermore, PsyPAN plans to create media and industry guardrails and guidelines around the appropriate interaction with participants following the psychedelic clinical trial experience to help safeguard participants by educating stakeholders on how best to communicate with participants.
5
Some participants experience end-of-trial termination “grief”
“Having had access to such a transformative, powerful and ineffably cathartic form of 'treatment' or 'medicine', the grief was not only related to the loss of relationships to the therapist/guides/trial team but the ending of an incredibly intense experience. The experience was one of the most important in my entire life.”
Participant quote
“I felt a lot of grief at my trial ending because I trusted my healthcare professionals so much, I felt very connected to them like they had accompanied me in the rawest expression of my emotion, a kind of expression that I don't think anyone in my life has ever seen. They had witnessed aspects of myself that I just don't let other people see. And so the trial coming to an end was quite a painful thing for me.”
Participant quote
Three participants experienced feelings of grief when their clinical trial experience came to an end. The participants felt this was due to the strong relationships they had built with the research team, which were actively nurtured to support the participants through the study. One participant did not feel a sense of grief, they believe this may have been due to their research team clearly articulating the finite nature of the relationship and their encouragement to cultivate participant ownership over their own “healing journey”.
Preparing participants for the temporary nature of the relationship between the research team and the participants could be discussed at the beginning of the clinical trial. This may help mitigate some of the grief experienced at the end of the trial process and empower the participant to continue their own path after the clinical trial. The balance for research teams is to seek to do this in a way that does not minimise the potential depth and importance of that relationship for the participants during the trial experience. Here the participants agreed that signposting to supportive communities at the end of the trial could diminish the feelings of grief. Those responsible for trial design and seeking ethics approval could aim to connect with relevant peer support groups where available and if agreed, submit the group's information or leaflets as part of the trial ethics approval. This would enable researchers to signpost participants to appropriate groups at trial termination.
6
Some participants seek further support and community following the trial
There is a value in spaces for psychedelic clinical trial participants to validate experiences. It is such an extraordinary and extreme experience if you are left alone to manage these experiences… that's poor care.
Participant quote
The participants explained that the fear of stigma (described above) as well as the desire to continue to process and understand the experience led participants to describe feelings of isolation and a desire to seek community following their participation in psychedelic clinical trials. Given the uniqueness of the psychedelic experience within a clinical trial ecosystem, the participants described a desire to connect with other people who had shared in this experience and could mutually support one another. All participants acknowledged that if the treatments were available, they would seek to continue accessing therapeutic support. As this is not currently possible, the participants recognised that supporting each other in formalised support groups (if made available) could be helpful.
Peer support groups may serve as a feasible solution to meet participant support needs after the trial is terminated. A Peer-Support Program may minimise emotional isolation following the psychedelic clinical trial and support participants to integrate their experiences through community and the sharing of personal experiences.
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