In our last blog, we spoke about 7 things patients from our focus group felt should be done to better support patients during clinical trials. This week, we share more details of what patients told us about their clinical trial journeys to arrive at a summary wish list for clinical trial patients.
The majority of patients found out about the trial they took part in directly from their nurse or doctor, with a minority mentioning a patient organization as the source of trial information. Motivating factors to take part in a clinical trial were various, including access to better clinical care, potential health benefit from new medicines, advice from their doctor, helping to expand society’s knowledge on the disease, and engaging in the research process. All of the patients involved said that contributing to the discovery of better treatments for patients was a main motivator to take part.
In terms of how the study was explained before the patient signed up to take part, conversations with doctors and nurses featured most prominently, followed by a step-by-step walk through of the consent document with the doctor. Some patients mentioned leaflets, flyers, and presentations being shown to support the consent process.
Interestingly, only two patients in the focus group said they felt very well informed throughout the process of taking part in their trial, with others saying they had good information at the start of their participation but that little information was generally provided or made available thereafter. Information about the trial was overwhelmingly provided through in-person conversation with a doctor or nurse during clinical visits. All of the patients involved said they had no access to information outside the clinical visit setting via website or mobile-based application, although all agreed that an online source of trial-specific information would have been a great benefit and of interest for them.
Some of the patients mentioned that during the initial discussions about the trial, they had received information about the number of countries and patients taking part, as well as other general information. All who received this type of information found it useful, valuable, of interest, and motivating.
A small number of the patients involved had received upcoming visit reminders via letter or email and all who received them said this was helpful for them to stay on track with the visit schedule. Some of those who had received the upcoming visit reminders noted they included some useful instructions to help them to prepare for the next visit, whilst others only received the next visit date in the reminder. All agreed that both upcoming visit reminders and instructions for the patient about what to expect at the next visit would have been useful to help them to prepare.
In terms of the main challenges experienced, travelling to and from the clinic was cited as being the most burdensome aspect of trial participation. This was closely followed by the length of clinic visits and the length of the studies. One patient mentioned a burdensome medication adherence requirement for their trial that required them to take the medication at 7AM daily. They also needed to use an electronic diary and the experience had been very negative for them due to the device beeping constantly as a reminder, a limited amount of time allowed for diary completion, and connectivity issues with the diary device itself. This patient mentioned that a vibrating wristband or something quieter would have been a much nicer way of reminding them to take the medication.
Of all of the patients participating, only two had received the end of study results. Of the two that had received results, one person felt the results were well communicated and clear whilst the other felt that more information should have been provided, such as whether or not they had received the placebo and more details on the overall trial findings and outcomes. Everyone else stated that not receiving the results was a major issue for them and they would have liked to have gotten full and transparent information that clearly explained the trial outcome.
One patient mentioned that they did eventually obtain the end of study results for their trial but had to push hard and follow-up to get them because they weren’t being provided as standard. Despite the majority of patients not receiving the end results, all of the patients stated that the clinic staff thanked them for their time and participation, which made them feel appreciated.
To summarize, key patient wish list items include:
- Better, comprehensive, and practical support for patients
- A source of online information that the patient can access with ongoing information about the clinical trial, how many people are taking part, in how many countries, etc.
- A reminder of upcoming visits, including some information about the visit, so that they come prepared and know what to expect
- A minimized vist burden for patients in so far as is practical within the confines of the trial
- Clear communication of the end of study results and a summary of the trial outcomes