A ‘no filter’ Brainstorm can help Develop New and Innovative Ideas and Solutions

After a recent week away from work, it’s been interesting to get back into the swing of things and try to come up with new and different methods of recruiting patients for clinical trials that may help achieve better results.

One thing I’ve done is to go through a ‘no filter’ brainstorming session, simply writing down any ideas as they come up, and I’ll be going through an ongoing process of reviewing what I’ve written to see if there’s any value in exploring anything further.

It’s easy to filter our thoughts and ideas before they’re fully-formed. Bringing our existing knowledge and experience into play and rejecting anything that doesn’t fit with our preconceived notions of what might work.

But it can often prove valuable to simply go with the flow and let the ideas tumble out, as you never know whether there’s something useful that can be developed from them.

Might a Patient Recruitment Agent Service be Useful for Matching Patients to Trials?

We live in an age where the work of all kinds of service-based agents has been eroded by the rise of self-service activities. I often book my own travel rather than using a travel agent. Some people research places to live without contacting a real estate agent.

One area that I’m thinking about, though, is job recruitment agencies. Sure, there are plenty of job boards around, but recruitment agents can still provide a valuable service to those who are looking for specific types of roles within specific industries.

Which makes me wonder if there’s room for such a service-led agency arrangement in the world of patient recruitment – where an agent matches suitable patients to relevant trials.

Certainly there are not millions of people queuing up to take part in trials, but the process of finding one can seem quite daunting, so perhaps that kind of helping hand could prove effective.

Regulations around Clinical Trials Appear to be Designed to Ensure their Failure

I was in Brussels recently, where I visited the European Parliament, which got me thinking about the impact on clinical research that comes about as a result of government organizations around the world setting the regulations for how trials should be run.

It can often seem as though those regulations are designed to ensure a potential treatment fails the trial. And in some ways that makes perfect sense.

What we’re doing when studying the efficacy of potential new treatments, is essentially getting volunteers to expose themselves to something that could be harmful to them.

So, yes, it makes sense to try and ensure from a regulatory perspective that most potential treatments fail at the trial stage. Not because we want to restrict the development of new treatments, but because we want to ensure the only treatments released to the public are the ones that will do the least harm.

Trial Participants Should Receive Better and Easier to Understand Communications

Communication with trial participants is one of the areas you’d expect to work well when it comes to clinical trials. Keeping patients informed about what’s going on would appear to be an essential factor in whether a trial is successful or not.

Unfortunately, however, it’s very often the case that participants are either kept in the dark about the progress of the trial, or they are presented with information that might baffle anyone except the clinicians involved in designing the original protocol.

The EU has mandated that trial information has to include a layperson’s summary – but in my experience, the definition of what a layperson might understand that is used by the people writing the summaries is somewhat different from one that people outside the industry might use.

Better communication with patients – as well as better internal comms between trial operations stakeholders – is a key element for improving results.

Communications Between Trial Operations Stakeholders Need to Improve

One of the issues that frequently comes up when looking at the problems of patient recruitment and retention is that of communication. Or, more accurately I guess, lack of or bad or confusing communication.

Big pharma companies are notorious for having internal ‘silos’ such that one department doesn’t understand what another is doing. Somewhat crazily, this often ends up with completely different people working on procurement for trial solutions than those who will actually be managing those solutions. And I’ve never understood why a company’s medical sales team can’t also provide details of current trials that a doctor’s patients might be interested in.

As well as internal comms, of course, there’s often a very poor level of communication between the trial operations stakeholders. With sponsors, CROs, research sites, and vendors not sharing relevant information with each other – to the detriment of the overall results and outcomes of the trial.

Why Don’t we Collect Feedback from People who Drop out of Trials?

Coming from a background where customer experience methodology is used extensively to determine why people don’t like a particular product or service, it’s always intrigued me as to why there is no standard process in place for asking patients why they drop out of trials.

It’s possible this is based on an interpretation of the Declaration of Helsinki – that enshrines a trial participant’s right to withdraw from a trial at any point in the process.

However, I would suggest that’s a misinterpretation. The right to drop out of a trial at any point does not mean we can’t ask the person why they have done so.

Given that retaining patients on trials is probably the second biggest issue outside of recruiting them in the first place, I’d suggest that finding out why people drop out should provide valuable information for the design of future trials that have a better rate of retention.

Informed Consent is an Ongoing Process – Not a One-off Procedure

The consent process in clinical trials – more formally designated the Informed Consent process – is a key element in getting participants involved. Without a signed Informed Consent Form (ICF) the participant is not able to be enrolled in the trial.

Traditionally, this has been a paper form, which is why eConsent has become a big thing in the industry over the last few years – especially since Covid – with the arrival of many tech solutions providers who want to make the sign-up process easier.

But the key element of the phrase might actually be the word ‘process’, rather than the word ‘consent.’

Comprehensive information about the study and what participating will involve needs to be conveyed to the patient, in language they can understand, in order for them to make an informed decision about taking part.

And this shouldn’t be a one-off procedure, more an ongoing reaffirmation of consent as the trial progresses.

A Look at some of the Decentralized Clinical Trial (DCT) Solutions Available

Many of the DCT solutions that have been developed over the last few years – in particular since the advent of Covid – are based on some kind of technology application. For example, wearable tech to monitor various bio measures – in the manner of an Apple Watch monitoring your pulse – or other digital-based technologies.

Electronic consent forms are also usually classed as DCT – though they will quite often be completed at a research site anyway.

Direct delivery of the investigational product to a trial participant’s home, or a home visit by a trial nurse are also considered to be DCT solutions.

As are such things as video calls – which we’ve obviously all become more familiar with. And the use of local health care facilities for carrying out some of the necessary trial activities – such as at your local primary care provider, or through a mobile research site being located nearby.

An Overview of Decentralized Clinical Trials – DCTs

Anyone involved in clinical research will have come across the phrase ‘decentralized trials’ – or DCTs. Recently, the FDA issued its draft guidance on its approach to regulating DCTs, which it defines as “..a clinical trial where some or all of the trial-related activities occur at locations other than traditional clinical trial sites.”

Which includes what we in the industry might call ‘hybrid trials’ – where some activities occur at a research site, and some occur elsewhere, such as in a patient’s home.

Since the Covid pandemic, there have been a lot of solutions developed for helping to deliver DCTs – the majority of them based on tech or digital applications. And all of them in some way trying to replace the traditional method of doing things with a new way that is supposed to make things easier for the trial participant. I’ll look at some of these methods in the next vid.

Some of the Changes in the Digital Ads Landscape for Patient Recruitment

Over the years I’ve been involved with recruiting patients for clinical trials, the digital advertising landscape has changed and evolved. Back in the day there was no Facebook advertising capability – whereas now it makes-up the majority of digital outreach activity.

Within Facebook itself, there have also been several changes. There’s been a restriction on targeting by health-related interests – formerly a key element in ad campaigns up until a couple of years ago. And in a more encouraging move, Facebook has relaxed its internal restrictions on the messaging you can use. For instance, it used to be that Facebook didn’t like you asking questions in ads – which has changed over the last 12-18 months, such that questions are now more generally acceptable.

On top of this, newer digital platforms such as Snapchat and TikTok have entered the market – providing a wider range of avenues for digital outreach activities.