The DPHARM Conference was Founded on the Principles of Disruption and Innovation

Many people in clinical research have been attending the DPHARM conference in Boston over the last few days.

Looking on the website, it explains the origins of the conference – the first one being held twelve years ago in 2011 – and how it was designed to bring together people who wanted to disrupt the clinical trials industry in order to transform it for the better.

I’ve often wondered whether disruption and innovation for their own sake are necessarily always good things. In many fields, the natural evolution of practices and methodologies will generally bring about improvements without wide scale operational changes.

Within the world of clinical trials, however, I agree with the principles behind DPHARM, that revolution, not evolution, is probably the best way to achieve the goals of improved practices and better outcomes.

Disrupting the status quo might not always be a good idea, but for our industry I’d suggest it’s definitely a path worth pursuing.

World Alzheimer’s Day – 21 September – Also my Dad’s Birthday

Today is World Alzheimer’s Day, and also my dad’s 81st birthday. Unfortunately, these two events are linked by more than just sharing a date, as my dad has been living with Alzheimer’s for several years.

I’ll be visiting him tomorrow to share some birthday cake, and we’ve also organized a singer to entertain the care home residents.

My dad was previously a very talented amateur songwriter and singer himself, but sadly doesn’t seem to get the same enjoyment from music as he used to.

In the early stages of his diagnosis, he was prescribed Galantamine – one of the few approved treatments for the symptoms of Alzheimer’s. And I don’t know whether it had much effect or not. But if it enabled us to spend even just a few short months with dad more like he had been than he is now, it underlines the value of the industry I’m proud to work in.

Embedded Interviews are a Great way to get Qualitative Data about Trial Participation

Another good takeaway from the recent C3 Summit was about the practice of embedded interviews for gathering qualitative data regarding a patient’s experience of participating in a clinical trial.

Alongside the data collected against the desired endpoints and outcomes for the trial, this kind of information is useful for understanding people’s experience of their condition, and elements of trial participation that may affect a trial’s effectiveness.

The interviews can be performed at various stages – such as prior to trial participation, at regular intervals while in the trial, and an exit interview regarding the overall experience the patient had.

The FDA is moving toward guidance that incorporates ongoing interviews as a standard part of the trial process, and the industry as a whole is paying more attention to the patient experience while taking part.

Which can only be a good thing for helping improve recruitment and retention rates for current and future trials.

More Learnings from the recent Transperfect C3 Summit in London

Patient engagement was another session at the C3 Summit – with feedback being highlighted as an essential part of the process. Building trust with patients can come from engaging with different groups, plus ensuring diversity of backgrounds in staff members at clinics and sites can help encourage diversity among patients. (Diversity not being limited to ethnicity, of course).

A patient perspective underlined the problems of trying to discuss all the different issues in a 15 minute doctor’s appointment, as well as suggesting that patient-centricity is a bad term, as patients don’t want to be in the center of things, they want to be seen as collaborators and partners.

eCOA issues were discussed, including how costs to implement these solutions are falling as trials are being designed from a digital perspective in the first place.

And there was a look at the EUCTR regulations and the impact they are having on trial design in the EU.

Some Learnings from the recent Transperfect C3 Summit in London

A few days ago I attended the C3 Summit in London, which was very valuable, featuring good sessions and networking, and is an event I recommend people attend if you get chance.

The event started with a session on digital health, where it was highlighted that AI functionality is set to be a gamechanger in the industry, including for natural language processing in order to interpret patient records and other data.

Wearable tech and ongoing journalling should be able to help eliminate ‘parking lot syndrome’ (where a patient fills in their reporting immediately prior to site visit).

A key point was to ensure there isn’t simply data collection for the sake of it, by asking ‘why am I doing this?’ and ‘what do I need to know?’ before simply collecting everything possible.

Sharing of data was viewed as being a potentially good thing – with patients ultimately owning it. More thoughts in the next vid.

Keeping an Open Mind while Reading and Listening can Help Deepen Understanding

Newsletter and email subscription overwhelm is a fairly common feature of modern professional life. Despite my every so often culling the ones I’m less likely to read, I still find there are too many coming into my inbox each day to be able to get round to them all.

But when I do read them, there’s almost always something of value to be learned – even if it’s just a different perspective on something I already understand.

Similarly with attending conference sessions. It’s always good to keep in touch with what people in the industry are doing, and perhaps equally importantly what they’re saying. And again, I generally always find something of value from any session I attend.

I think the key to it is to read and listen with an open mind, allowing myself to absorb the information being imparted without necessarily putting my own slant on it until I review things afterward.

Private Patients can also be Recruited Using Patient Recruitment Methods

For most of my time in patient recruitment, I’ve focused on recruiting participants for clinical trials – for investigative drugs and sometimes medical devices.

I’ve also recruited patients for private medical practices. That’s actually where I started off, in 1998, when one of the first clients for my digital marketing consultancy was a local doctor who wanted to recruit patients for his specialist service in the gastro realm.

I subsequently recruited patients for aesthetic surgery – face lifts, nose jobs, botox etc. And also spent a lot of time attracting patients to a cognitive impairment clinic – which also ran trials for such things as Alzheimer’s.

The main difference between the two disciplines is in the regulations. Obviously trial recruitment requires ethics approval, while attracting private patients doesn’t have the same focus on non-coercion.

And it’s something I always suggested to research sites – recruiting patients for any non-trial work can help provide additional funds.

Recruit Patients through Promotions at Relevant Events – e.g. Charity Runs

I mentioned in the last vid that doctors surgeries could potentially have a dedicated clinical trials desk for disseminating information to potential participants.

Expanding on this idea, it can also prove effective to have a presence at relevant events that are likely to attract people who may qualify for trials, or who should know people who would qualify.

Examples of these would be things like charity gatherings and condition-specific events (such as an Alzheimer’s or Heart Disease Walk), or even attending a convention that will attract health care professionals who work in the area that fits your trial.

For a more digital approach to this, you could investigate geotargeting those areas with ads. As I previously noticed, people are often on their phone in doctor’s waiting rooms, and obviously the same will be the case at events and conferences, so backing up any physical presence with location-targeted digital ads could prove worthwhile.

It Should be Possible to Promote Clinical Trials in Waiting Areas of Healthcare Clinics

I’ve been in a couple of medical waiting rooms recently, and each time it’s occurred to me that these should be good places for recruiting patients for clinical trials.

In particular, where there is a clinic based on a specific therapy area – which by its very nature is likely to attract people who should qualify to participate in relevant trials.

I also observed that the majority of people were using their phone, so not necessarily paying much attention to the posters or TV sets around them.

But that isn’t to say that having posters, flyers, business cards, or targeted TV promotions would be completely ignored by everyone there.

And I can even see the potential benefit of having a dedicated clinical trials promotions desk situated within certain waiting areas – ideally staffed by someone with knowledge of relevant trials, or featuring an interactive screen to encourage people to learn more.

The term ‘Bid Defense’ Appears far more Adversarial than Collaborative

It seems that many people within the industry are keen to move forward with a collaborative relationship between all the main stakeholders when it comes to patient recruitment – ie patients, research sites, CROs, sponsors, solutions providers, patient groups etc.

But I’m not sure I actually see a lot of evidence of this ‘in the field’.

Indeed, it’s always struck me as being odd that the term used to describe a CRO explaining its proposal items to a sponsor is ‘bid defense’. Which seems to automatically put the relationship into an adversarial one – with one of the parties having to defend itself against attack from the other.

In order to foster an environment where truly collaborative relationships can develop, I would suggest changing from ‘bid defense meeting’ to something like ‘strategy development meeting’ might be beneficial.

As would be setting up effective feedback loops between all the stakeholders for better communication and ongoing improvements.