“The Normalisation Era” – or Back to Basics

Sub title - a trial is a trial is a trial.

As identified in the last blog, The DCT sector is recovering post the COVID-19 pandemic bubble and we are entering what I have termed the ‘Normalisation Era’.?

Lessons learned

Underlying the recovery is the fact that we have learnt a lot of lessons after the innovation peaks.? These fall into three categories. Although there are a myriad of details, the core conclusions in my view are :

1.???? Patient Centricity is the underlying value of DCT that drives uptake.

2.???? Regulators still regulate

3.???? Clarity of purpose.? Solutions need to provide speed, cost effectiveness and data accuracy, all harnessed through the reins of regulatory compliance.

Conclusions 2 and 3 are (frankly), a relief.?

That regulators still regulate may seem self-evident, but to me it is reassuring. Just because we are providing more services digitally, we are not simply changing / ignoring the rules of research to accommodate innovation.

Tech revolutions in other sectors do tend to start with the premise that all the rules can be rewritten and simply ignored if inconvenient.?

With time, we have learnt this is often not appropriate.? We may be slow, but we are speeding up. It took us decades to learn that the internet was not actually free, years to learn that if we hired a taxi on a mobile phone app we still expect it to be regulated to keep the passengers safe, or if we rented out a property on a platform we still had to pay tax on the income, and probably months to learn that AI is in fact not intelligent.

In our case, during the pandemic the industry regulators during the pandemic were generally supportive of the DCT innovations that were sweeping world.? However, they made their requirements clear:

if you use services designed to keep patients out of hospitals , (and specified just two – digital platforms and mobile HCPs visiting the patients in their home), they will still apply all their rules when reviewing submissions

The regulators felt their present rules were general enough to be applied to these situations. They also issued a clear warning to keep good documentation to justify all actions. It is, as yet, too early to say yet just how much this position is going to play out as future NDA submissions are made.? At the very least, whatever issues are yet to be uncovered, the regulators received a master class in the mechanisms of these tools, learning quickly what they like and don’t like about how they are implemented, leading to a flow of new guidance in recent months.

?As for clarity of purpose – ?these statements have always been seen as self-evident within the industry.?

In all the conversations I have had over the years, essentially everyone agrees our targets are speed, cost effectiveness and data quality whilst complying with regulation.?

What a relief this list has not been extended to include words such as automated, or digitised, as the industry recognises these simpy refer to tools that are a means to an end.

This leaves us with the third lesson, that Patient Centricity – underlies the value of community based trials, and shows us we need to look at this as one of the key goals for a nurse home visits or DCT technology.?

In essence, if we can get the implementation of a tool right so it is providing a positive patient impact, then we can be assured the trial will be faster and have a better ROI.

Applying the test “How patient centric is this tool?” to the two major solution types designed to bring trials into the community - DCT and Home Healthcare - we can see that each face different challenges.

Digital providers of DCT solutions are learning that the tools themselves are not guaranteed to be patient centric.? Although they do allow patients to remain at home for some trial visits, they also tend to give the patient work to do in device management, data entry and data cleaning.? We are also learning that how they are supported contributes hugely to their being more or less patient centric as well as site friendly.? The software must be much more that an interface, which alone is challenging, but also provide

1.???? proper integration into the users working patterns and provide

2.???? International, personal, local language support for sites and patients

Both of which are critical and expensive.

Clinical providers of DCT - home healthcare solutions - know that although the service is inherently patient centric, its value is diminished if they cannot meet the challenges of scale up.? If a patient still has to travel to another location to see the nurse (because the nurse is still based at a physical location), even if closer than the site, the value of the service is reduced.? Conversely, if the nurse has to travel a long distance to get to the patient, then the cost goes up.? So you need local nurses to go to patients own homes if possible. Furthermore, this has to be in enough countries to cover the majority of the trial for the speed up to be truly effective.?

Of course, accessing enough healthcare practitioners in every country within (ideally) 1 hour travel of a patient (who could be anywhere) is just the start.?

Once found, the HCP interactions with the patient and site are crucial, requiring detailed training and careful relationship management.

Conclusion

So why is this the period of Normalisation?? All of the above leads to the conclusion that what the sector is looking for has not fundamentally changed, hence the sub title – a trial is a trial is a trial.? Same old, same old!? This is “Normalisation”. We are mapping the new solutions against the old drivers, which remain constant.

Innovation meets Normality.?

And in the Era of Normalisation, what we have discovered is that

1. Tools used to run a trial are not always helpful
2. A trial is defined by its needs, not by the tools it utilises
3. A key metric to determine a tool’s value is the level of Patient Centricity achieved, calculated by?balancing out the positive and negative impacts of the trial on a patient’s life.

For more info on how to manage community based trials, go to the MRN web site

https://themrn.io/

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#decentralizedclinicaltrials

#hybridclinicaltrials

Medical Research Network