IRBs / ECs play an Important Role in the Patient Recruitment Process

When trying to recruit patients for trials, it can seem as though the Institutional Review Board, or Ethics Committee, acts as a barrier to success.

Looking from a marketing perspective, the restrictions on not including language or imagery that might be unduly persuasive can appear to be unnecessarily strict and effectively anti-recruitment. What the IRB or EC is looking for is to ensure there is nothing coercive about the promotional material for a trial – with messaging such as ‘Take part in trials, earn lots of money’ being deemed to fall into that coercive category.

This has often led to some very ‘on the nose’ messaging being incorporated in recruitment materials – for example ‘we’re looking for people with xyz condition to take part in a clinical trial.’ But it can also lead to more interesting approaches being taken – sticking within the IRB/EC guidelines, while allowing creativity to flourish.

Collaborate with your Vendors for Continuous Improvement in Results

Having looked at some of the main metrics that sponsors will want to keep track of from the patient recruitment vendor, the next stage in the process is to discuss the results and attempt to institute a process of continuous improvement.

In the marketing world, the concept of ‘beat the control’ is one where you have a control advert that performs best, then you put other ads against it in a series of split tests – the ultimate goal being to ‘beat the control’ and thus have an ongoing cycle of improved results.

Sponsors, CROs, and Research Sites can help with this process by providing feedback based on any learnings they have regarding what works best for attracting patients – in particular focusing on why patients might fail a pre-screener or drop out of a trial. This kind of collaboration is a key driver of a successful recruitment campaign.

A Look at Some Key Metrics for Patient Recruitment Campaigns

As a sponsor, when dealing with a patient recruitment solutions provider, you’ll want to have sight of particular metrics that give you a snapshot of how well things are going.

If you have an agency-style payment model in place – where you are covering the ad spend – you’ll obviously want to see how much is being spent.

In the pay-per-patient model, it’s unlikely you’ll see how much is being spent on advertising, but you should still be provided with stats that show you how many Impressions the ads have received (which represents the number of people who’ve seen an ad), the number of click throughs to your trial pre-screening website, and the number of conversions. (ie the number of applications to participate in the trial). All of these metrics should be readily available to you on an ongoing basis, either in a dashboard format or via reports.

Sponsors Should have Visibility & Transparency of Relevant Stats from a Patient Recruitment Campaign

Something that comes up quite a lot in projects that I advise on is the lack of visibility and transparency afforded to the CRO or sponsor by the patient recruitment vendor.

There are often lots of excuses given for this related to data privacy concerns. But really there is no issue at all for a CRO or sponsor being able to see the relevant statistics regarding how the recruitment campaign they are paying for is going.

Obviously, there can’t be any personally identifiable information available to the sponsor. But having a snapshot overview of the key metrics regarding how the campaign is going is a fairly easy thing to set up. And can help with improving results – as interaction and collaboration between the key stakeholders is a major factor in a project’s success. I’ll provide an outline of the key metrics to focus on in the next vid.

Reducing the Burden of Participation Helps Retain Patients on Clinical Trials

One of the key things we can do to retain patients on clinical trials – and also because it just seems to be the right thing to do – is reduce the burden of participation. People taking part in trials are volunteers in the process, so making it as easy as possible for them would certainly appear to be a good idea.

Sadly, this is not always the case when you look at what’s involved – the multiple site visits, the recording of Patient Reported Outcomes, the sometimes debilitating procedures that have to be undertaken, the general disruption to a person’s daily routine etc.

Which is why I always recommend having patient involvement from the outset when designing a trial – so you can incorporate their feedback into the protocol, and help to reduce the number of people who drop out of trials due to the burden of participation.

Not all Potential Trial Participants Belong to a Patient Group

Patient advocacy groups can be a key stakeholder in the clinical trials process. I’ve been involved with many trials that never involve a patient group, and many that do. And the ones that do involve the patient groups are generally more likely to be successful at recruiting and retaining patients – especially if the patient voice is heard at the initial stages of trial and protocol design.

But what about those people who are not in a patient group? Much as I respect and admire the patient advocates who put themselves out there – attending conferences, posting on LinkedIn etc. – there are a lot more people who do not get involved in that kind of activity.

So, while it’s a great idea to involve patient groups in your recruitment and retention process, you should also seek out the voice of those patients who perhaps don’t speak quite so loudly.

Some Thoughts on the Value of Clinical Trials Industry Conferences

Each industry has a range of conferences that can be attended each year. Some of them more valuable than others, and obviously some of them more relevant to your own circumstances.

A couple of examples of clinical trials industry conferences coming up in the next few months that people involved in patient recruitment are likely to attend include SCOPE Summit Europe and the CNS Summit.

It’s always great to be at these conferences and network with people in the industry, and I certainly get a lot out of the sessions that the good conferences are known for.

However, every time I come away from one, it occurs to me that perhaps the people who attend conferences are already those most likely to be striving for improvements within the industry. As the kind of best practices and excellent results often discussed on stage are rarely replicated in the world outside.

Instant Interaction with a Trial Applicant can Help with the Recruitment Process

A major factor that can affect the success of a patient recruitment project is the number of people who express an interest in participating, but are then unable to be contacted to arrange an initial site visit.

In many of the trials I’ve worked on, this can represent well over half the people who submit an application. Which obviously leads to a reduced number of potential participants – even though these are people who are aware of the trial and want to take part.

In order to reduce this number of ‘non-contactable’ people, a swift follow-up to their initial application is key. For immediate engagement, this follow-up method can be done by automated text or online chat (whether live or via a chatbot). Each of which methods enables instant interaction with the person volunteering for the trial, which can significantly increase the likelihood of them becoming a participant.

A Simple 4-step Strategy for Recruiting Patients for Clinical Trials

One highly-effective strategy for patient recruitment is a 4 step process. Firstly, attracting potential patients via an advert – such as on Facebook or YouTube. This could also be based on promoting the trial through, for example, HCP outreach or a community awareness program.

In the second step, the patient visits a trial-specific website for more information and to fill in a pre-screening questionnaire. This helps to filter potential participants based on the trial’s Inclusion/Exclusion criteria.

Thirdly is a follow-up process – often via a phone call – that happens very soon after the screening questionnaire has been submitted. This helps further qualify the person for the trial, and is often best performed by a medically-trained person.

And the fourth step is to book the patient in for the initial visit to the research site – a step which generally sees best results if it can be performed during the follow-up call.

There are 3 Main Payment Models used by Patient Recruitment Vendors

There’s a few common payment models used by patient recruitment firms. The agency model where the client will pay a fee for the service. Any associated costs – such as advertising spend – are also paid by the client. The main risk here is that there may be no patients recruited.

The ‘pay per patient’ model is based on a fee per consenting trial participant. The risk here is taken by the patient recruitment firm for any ad spend.

And the ‘pay per lead’ model – where the firm is compensated per patient lead referred into the system. This model tends to be more widely open to abuse, with low quality leads still attracting a fee, whether they become trial participants or not. So my main recommendation is to use the ‘pay per patient’ model, or the agency model if it better fits your circumstances.