Long-term Planning is Sadly in Short Supply in the World of Clinical Trials

I visited a Royal Horticultural Society garden recently, and one of the things the tour guide pointed out resonated with me. There were several newly-planted copses of trees that looked quite thin on the ground. When I asked how long it would take for these trees to become as big as some of the others in the area, I was told it would be over a hundred years.

And it’s this kind of long-term planning that I believe we are missing out on in the world of clinical trials.

Obviously planning for things that will be happening a hundred years from now isn’t going to be especially useful. But having a vision that stretches at least beyond the constraints of the current trial we’re working on, certainly seems like it could be a valuable approach for the industry to be taking.

Reaching out to Patient Groups for Patient Recruitment

Involving patient groups in the patient recruitment process is a strategy that might seem obvious, but is rarely adopted successfully. One of the issues is that patient groups can be wary of companies whom they may view as being only after their database of contacts in order to make money.

One way to get over this is to involve the patient groups right at the start of the process, during the trial design and protocol development stage. Showing a willingness to include the patient voice from the outset can help build a relationship that can be utilized once the trial launches and is looking for participants.

Providing information is another good way to engage with patient groups. Not necessarily about the condition itself, but maybe unique details about taking part in a trial or the way the treatment being tested was developed.

Reaching out to Community Organizations can be Beneficial for Patient Recruitment

Community outreach is another strategy that can be adopted for recruiting patients for clinical trials. There are different ideas as to what it means – from such things as putting up posters in community halls, to organizing events for people to learn more about a particular condition. (I’ve seen this work particularly well for Alzheimer’s – a topic people are generally interested in learning about).

It can also work for pre-existing events. For instance, through having a stall at a 10k Run. Or through building a relationship with an organization that has members who are likely to be in your target audience – which could include such things as churches or adult learning centers.

Another method is to locate a research site in a community – either a bricks and mortar one, or a mobile one – which can be particularly effective for reaching traditionally underserved populations.

Healthcare Professional (HCP) Outreach is Another Method of Recruiting Patients for Trials

Healthcare professionals (HCPs) would appear to be perfectly positioned for introducing the idea of trial participation to patients. They will generally have a relationship as a trusted advisor, and should be able to identify relevant candidates from their healthcare records.

However, HCPs have never actually been a particularly good source of patients for trials. One reason for this is the limited time available in a doctor’s appointment, plus not having the resources to keep on top of all the available trials.

Also, for those of us in the industry it’s easy to forget that clinical trials are for unproven treatments – so many doctors are wary of putting their patients at risk through taking part.

What I’ve found, though, is if you can successfully engage with HCPs in an informative and encouraging way, they can be a valuable source of patients for your trial.

Digital Direct to Patient Outreach is a Highly Effective Method of Recruiting Trial Participants

Digital direct to patient recruitment is often based on advertising using social media. Facebook is by far the most widely-used platform for this purpose – often generating over half the randomized patients in a trial.

Other social media platforms have also proven to be useful. For example Snapchat for a younger audience, YouTube and even TikTok – where as well as using ads, getting patient or healthcare influencers to promote your message can help encourage people to take part.

My first foray into digital advertising for clinical trials was using Google – which you might expect to be effective, as you can target people searching for phrases relevant to the therapy area for the trial. But I’ve never found as much response from Google ads as I would have liked, and still always recommend Facebook as being a valuable driver of potential trial participants.

Direct to Patient Outreach using Traditional Methods

Direct to Patient outreach is the most common form of solution provided by patient recruitment vendors. It’s based on promoting a message about the trial directly to potential participants – rather than, for instance, going through a research site or healthcare professional.

My own first involvement with this strategy was to augment traditional advertising with a digital approach – more of which in the next video.

While traditional advertising has been somewhat superseded by digital outreach methods, it can still prove valuable – especially for reaching populations who may not be ‘digitally savvy’.

Local radio and press has been the most common form of traditional advertising – targeting the areas around the research site locations.

I’ve also seen organizations make use of such things as bus shelter posters. As well as non-advertising based publicity and PR, putting on events, and promotion through webinars or podcasts.

Research Site Patient Databases Provide a List of Potential Trial Participants

The most common method adopted by sponsors and CROs to plan for patient recruitment is to use the research sites’ existing databases of patients. Sites will have suggested how many patients they think they can recruit and will then search through their patient records to cross check the detail against the Inclusion/Exclusion criteria for the trial.

This kind of chart review process is often laborious and time-consuming – in particular with increasingly-complex protocols being the norm for most trials, so it’s good to see various tools that have been developed in the last few years to help speed up this process. Though there will inevitably be some kind of data standardization processing necessary in order to use them successfully.

Some sites will prove most successful at sourcing trial participants – with a large number of sites providing just one or no patients at all.

The Trial Design Stage is the Best Time to Bring in a Patient Recruitment Vendor

Another scenario where a patient recruitment solutions provider might get involved in a trial is what I recommend as the ideal way to bring them in – right at the start of the trial design process.

A collaborative approach from the outset – indeed one where a process of co-creation might be adopted – is almost certain to be beneficial for achieving the desired results as effectively and efficiently as possible.

The advantages that a good patient recruitment vendor can bring at this early stage include being able to recommend the most effective methods for reaching the target audience for the trial. For instance, some audiences will respond best to a digital outreach campaign, where others may be better suited to finding influential healthcare professionals or community leaders to promote the trial, or perhaps through having a mobile research site positioned in a traditionally underserved area.

Patient Recruitment Solutions Providers often Only Get Involved to Rescue a Situation

Patient recruitment solutions providers quite often only get involved in a clinical trial in order to try and rescue a situation that isn’t going well. When a trial is designed and the protocol developed, the sponsor and CRO will include a prediction for how many patients are going to be randomized into the trial on a monthly basis.

And generally, at least 8 out of 10 of the results fall way short of those predictions. Which leads to the sponsor or CRO bringing in a patient recruitment vendor to get things back on track.

In these kind of rescue situations, it’s usually the case that quick results are required – so it’s most likely to be an advertising solution that’s adopted, as this has proven to be the most effective method for reaching large numbers of people in a short time.

Using the Mental Model Inversion for Patient Recruitment

When starting a new project, I like to use the mental model known as Inversion. This is where you aim for the opposite of what you actually want to achieve, in order to ultimately avoid the mistakes that would entail.

I’ll ask, for example, how can we set things up such that they fail? Rather than how can we set them up for success?

Now, with patient recruitment, it would be quite easy to assume the standard methodology is already based on the Inversion model – as the majority of clinical trials fail to recruit in sufficient numbers.

But what I’m really interested in is defining how things would look if we deliberately designed them so as to not recruit and retain patients. Then take the learnings from this to invert those elements and set ourselves up for success.