Putting patients first and incorporating patient-centricity in the design of trials has become the mantra of the industry. But what do these things mean in terms of how you go about designing and managing a trial? Here’s an overview of some of the things you should consider in order to recruit and retain more participants through having your trials be properly patient-centric. (And, indeed, viewing patients as people can be a fundamental part of this process, turning the phrase ‘patient-centric’ into ‘person-centric’. I’ll stick with the conventional term for this article, though, as it is in common use).
CISCRP Perceptions and Insights Study
Every couple of years, the Center for Information and Study on Clinical Research Participation (CISCRP) carries out its Perceptions and Insights Study, surveying public and patient views on clinical research around the world – https://www.ciscrp.org/services/research-services/perceptions-and-insights-study/. I’ve incorporated a few of the findings from the most recent one, in 2021, in the recommendations below.
Patient Engagement
One of the main industry buzzwords of recent times, patient engagement is about so much more than conducting surveys or focus groups. Having the patient voice incorporated in the design and management of clinical trials throughout the process is an oft-overlooked method of ensuring they are patient-centric. Obviously, there is going to be a balance between what patients would ideally want and what might be possible to include in the protocol. But having patients involved from the outset will help to build a process that is as close to the ideal as possible.
Pre-Recruitment Activity
Even before a study is live, there are certain things you can do to build up a database of potentially interested people via such means as digital advertising regarding a particular condition. From a patient-centricity angle, pre-recruitment activity should focus more on education and rapport building with relevant communities. Nothing smacks of ‘big pharma’ more than only being interested in a patient population when recruiting for a trial, and paying no attention to them before or after.
This is another area where true patient engagement will help generate interest in the trial, plus build more trust and credibility for the world of pharma as a whole. (Which, as well as being a good thing in general, should be useful for the next time a patient recruitment campaign is being conducted). Having people ‘on the ground’ to support any digital or printed resources that have been developed can help to raise awareness of the value in trial participation and generate an audience that is more receptive once the recruitment phase begins.
Reducing the Burden of Participation
One of the main aims of patient-centric design is to reduce the burden on the participant, such that taking part is an easy process that doesn’t impact on their life more than is necessary. To achieve this, we should start at the trial design stage, to ensure the protocol is an attractive one for people to adhere to.
It’s a common issue raised by research site owners that some protocols place such an onerous burden on participants re: multiple site visits, that they sometimes wonder why anyone would sign up to participate at all. Clearly there are many factors involved here – with the necessity for specific testing that can only be carried out at a site being one that is difficult to get around.
One area that can be looked at for helping reduce patient burden is the number and type of endpoints that are being measured in the trial. It would be nice to generate as much data as possible from each interaction with a trial participant. But if that leads to an unwillingness to continue on the trial due to the excessive burden, the data is ultimately of no use anyway. Far better, more likely, to focus on the key endpoints to help retain more people on the trial for longer.
Making Site Visits Easier
The advent of the Covid pandemic saw a huge amount of interest in Decentralized Trials (DCTs) – where all or some of the treatment and measurement that is normally provided in a research site setting is carried out elsewhere, such as in the patient’s home, a local pharmacy or surgery. The focus has primarily been on providing DCT tech solutions to deliver the desired results. However, since we started getting ‘back to normal’, the industry has realised that the tech has to actually be useful, rather than simply innovative, and has to be able to be combined with the human approach that the sites have been offering all along. Which has led to a situation where trials are still conducted primarily through site visits, but with additional options available as well.
Interestingly, the CISCRP study highlights that there is little difference between people’s willingness to participate in a trial that is purely conducted through site visits, through nurse visits to the patient’s home, through some site visits and some home visits, or through having all the data recorded through the use of tech in the home. What this indicates, of course, is not that it doesn’t matter which option you pursue – more that it helps to provide a range of options that people can choose from for themselves.
Whether you are managing a trial that consists solely of site visits, or one where there is a mix of site and home visits, to be patient-centric you should invest in a means of getting patients to the site that makes it easy for them to do so. Transportation and accommodation being provided to trial participants – and arranged by you without the participant having to expend much mental energy or any of their own funds – will help in this regard.
Providing the Treatment to all Participants
One successful method of increasing recruitment into a randomized trial is to inform all participants that they will eventually be able to take the treatment – if appropriate in terms of its efficacy – even if they are in the placebo arm of the study. This is also a great means of retaining people on the trial once they’ve consented to participate.
The CISCRP study had ‘Feeling/seeing benefit from the study drug’ as the top-ranked statement expressed by their respondents for ‘items that would be most likely to keep you enrolled in a clinical research study’ – supporting the idea that people are keen to take the active treatment, so should be allowed to do so at an appropriate time.
Another factor to consider here for recruitment purposes is the possibility of having a higher ratio of active treatments to placebo in the randomization split. If a participant believes they have more chance of receiving the active treatment (eg through a 2:1 split of active:placebo, rather than 1:1), it will likely be more attractive for them to take part in the trial.
Incentives for Participation
Clearly this is dependent on the regulations in the area you operate in, but fundamentally we should always keep in mind that patients are giving their time and access to their physiologies to take part in trials. At the very least, expenses should be covered – and, as I say above, travel and accommodation should be dealt with on their behalf and not as an out-of-pocket expense they get reimbursed for – with, ideally, a separate payment being made for the time input involved.
Outside of monetary compensation, providing the ongoing health monitoring that goes with trial participation is another incentive that can attract people both to take part in the first place, and to remain on the trial once it’s underway. Having regular check-ups of various health indicators is something that most people will not experience in their everyday life, and is almost certainly going to be viewed as a benefit of being on a trial.
Keeping Participants informed
The CISCRP study indicated that the second most important factor that would help retain patients on a trial was ‘Being informed of the clinical research progress on a regular basis’. This is not surprising, when you consider what participants are being asked to do during the trial, so it’s simply common sense that they would wish to be updated. However, it is still not universally the norm for there to be a good level of communication between the study organisers and participants – an easy fix that can be implemented to help with retention.
The CISCRP study went on to indicate that the primary means of communication people were interested in for study updates is having a summary emailed to them. Other options – such as a printed summary being mailed, results being available through an online portal, a teleconference or webinar detailing results – were also methods of communication people expressed a preference for. Again indicating that offering choices is the most patient-centric approach.
The Personal Touch
Having personable people as the main point of contact for trial participants is a simple approach that can help build rapport and keep people motivated in participation. On top of this, additional touches such as sending birthday cards and remembering important details about individuals (favourite sport, where they went on holiday etc) can help reinforce the sense that they are a valued member of the team.
Conclusion
Ultimately, being patient-centric is about being person-centric – treating the people on the trial as we would wish to be treated ourselves. If we look into this a little more, we can see that a key factor is the availability of choice. Offering participants a choice of how they participate – in clinic, fully remote, a hybrid of the two – plus assisting with whatever means are necessary to facilitate these choices, as well as offering different methods of communication etc, will help make the process of patient recruitment and retention more effective and efficient for all concerned.