How Planning For Failure Can Bring Patient Recruitment Success

By Ross Jackson, consultant

Most clinical trials do not recruit sufficient patients in the timescale they originally set out to. Indeed, many never recruit sufficient patients to be able to complete successfully at all.

Given this, if I were to set up a clinical trial specifically so it wouldn’t recruit the required number of patients, a natural route might be to simply do things the way they are currently being done.

The obvious follow-up, of course, would be to ask why would we want to set up a trial to fail?

Which is where the mental model of inversion comes in.

Inversion is a way of looking at things that sees us take the opposite point of view from that which we would really like to achieve.

Thus, in the case of patient recruitment, using inversion we would design our project with the goal of not recruiting patients. (Ultimately, of course, what we’re really doing is highlighting the bad practices we could adopt, in order to do the opposite and actually recruit patients successfully.)

The ‘No Patient’ Recruitment Method — Awareness

One of the biggest issues affecting patient recruitment is the lack of awareness of a suitable trial that an eligible patient could participate in. This is great news for our “no recruitment” strategy as it means we simply have to keep people unaware of the existence of the trial.

What this would mean in practice is that we only go along with any regulatory requirement — e.g., posting the details only on ClinicalTrials.gov — and make no additional efforts to publicize it or try to reach out to patients where they might be. Elements we should incorporate in our strategy include:

• No site feasibility selection process re: existing patients. One of the first things CROs usually think about for patient recruitment is to look for research sites that have a preexisting pool of potential patients that fit the criteria for the trial. Ignoring this, and simply going with a minimal number of sites that have no demonstrable list of relevant contacts will work well for keeping our enrollment levels down.
• No trial-specific website. If we had one, it would have a chance of being found by an interested patient, so we should keep away from this.
• No digital advertising. If we had digital advertising — aimed at the relevant demographics of people for the trial, especially if it went to a website where they could apply to take part — we run the risk that there may actually be people who register their interest. Steering clear of digital advertising is obviously our best policy, then.
• No traditional advertising. While the internet is clearly a good way to reach people, traditional advertising methods can still be effective — especially for reaching a local or interest-based targeted audience. Ignoring the range of options here (radio, local newspapers, magazines, etc.) will help us stay out of the spotlight.
• No liaison with patient groups. Pretty much every disease and condition has at least one related patient support and/or advocacy group. The people who are members of these groups would be a good potential audience for hearing about our trial if we could engage with these groups the right way (for example, by providing educational materials that help explain the latest developments in potential treatments and such things as patient interviews regarding what it’s like to participate in a trial). Steering clear of these groups will be our best bet for not attracting patients to find out more about the trial.
• No community outreach. Within the local areas around our selected research sites, there will be a range of community organizations and promotional opportunities such as events or large gatherings of people. These can provide a source of patients who may otherwise never have been aware of the possibility of taking part in a trial, which means we obviously won’t be engaging with any of these.
• No HCP outreach. Primary care physicians and other healthcare professionals, including pharmacists — while not usually a large source of patient referrals for trials — are an obvious potential means for people to find out about relevant clinical research. Being able to engage with these trusted healthcare advisors — especially where they are noted for being KOLs or influencers in a particular therapy area — can be beneficial for recruiting patients. We’d best avoid them for our purpose, then.
• No engagement with patient influencers. Similar to the HCP opinion leaders, there are patients who have a following among people living with the same conditions. Engaging with them in a manner that is not simply about trying to promote something to their audience (i.e., through sharing information of real value or providing support in other ways) could be useful for encouraging eligible patients to investigate a trial. We should ensure we don’t have anything to do with these people, so they don’t share any information.

The ‘No Patient’ Recruitment Method — Access

One of the other main issues for a traditional recruitment campaign is the lack of access to take part in a trial. Again, this is great news for us in our quest to not recruit any patients, as we can simply ensure that situation remains in place. To that end, we’ll set things up in the following way:

• A small number of research sites in low population areas. Locating research sites in areas where there are likely to be large populations of potential patients is obviously something that can help when appealing for participants. Keeping the number of sites low, and locating them in areas of low population density, will keep patients from being interested.
• No element of decentralized trial functionality. DCTs have become something of a buzzword over the last few years — given something of a boost by the COVID-19 pandemic, obviously. The idea behind the concept is to offer choices to trial participants such that they don’t have to attend research sites in order to take part. (This represents the decentralized element — i.e., no central location where the trial operations are performed.) Examples of the sort of things that might provide DCT functionality would be making use of tech solutions for ongoing patient monitoring, utilizing mobile research sites to reach traditionally underserved populations, and offering home visits so patients don’t have to travel to a site for blood draws and physical checkups. Obviously for our purposes, DCT functionality might represent an opportunity for additional patients to be recruited, so we should leave them out of our plans entirely.
• Patients to make their own travel arrangements. With our research sites being located in areas that may require long journeys for potential patients to reach them, we should ensure there are no additional services involved to help with travel and possible accommodation requirements. Such services do exist, so we should steer clear of them.
• Excessive time commitment. Ensuring your research sites are only available to attend on weekdays during working hours will significantly reduce the number of people who might be able to take part. This is especially true if you ensure there are multiple site visits required on an ongoing basis — making it unappealing for anyone who works or who has other things they’d rather be doing.
• No compensation for trial participation. Only paying minimal expenses (e.g., for travel) will put people off attending. Not providing compensation for lost earnings also will help keep people away.
• Strict eligibility criteria. The most effective means we have at our disposal for ensuring we have no patients in our trial is to make the I/E criteria so strict and inflexible that we’re effectively looking for superhumans with no comorbidities or other issues outside the condition for which we’ve developed a potential treatment. One highly effective method of achieving this is to simply copy and paste eligibility criteria from previous trials — especially those that haven’t recruited patients very successfully (i.e., most of them) — without paying any attention to whether it is actually relevant for the current trial.

Inversion As A Means To Conversion

Following the principles above — as many trials commonly do already — will ensure you don’t recruit sufficient numbers of patients into your trial. And a high proportion of any that are recruited are unlikely to remain in the trial through to completion.

On the other hand, if you actually do want to recruit and retain patients in an effective manner, you could try doing the opposite of the recommendations outlined here. After all, the results are unlikely to be any worse than what most trials currently achieve.

About The Author:

Ross Jackson is a patient recruitment specialist and author of the books “The Patient Recruitment Conundrum” and “Patient Recruitment for Clinical Trials using Facebook Ads.”

Having started out with digital marketing in 1998, Ross quickly developed a specialty in the healthcare niche, evolving into a focus on clinical trials and the problems of patient recruitment and retention.

Over the years Ross branched out from the purely digital and now operates in an advisory capacity helping sponsors, CROs, sites, solutions providers, and others in the industry to improve their patient recruitment and retention capabilities — having advised and consulted on over 100 successful projects.