Wednesday, November 18, 2015

Partnerships, patients and what to do with data


It's the end of day one of the PCT meeting here in Hamburg. The sessions are over, company execs (well, some of them) have danced to the Beatles tribute band, and now it's time for a quick overview of the tastiest topics of the day.

The big theme of this year's event is "patient centricity" – getting patients more closely involved in clinical trials – which means finding out what they want from trials, taking their views into account in trial design, and how to work out where the patients are that will make your trial worthwhile running.

For me one of the most interesting presentations on this theme came from Vincenzo Garzya of Astrazeneca, who summed up "patient centricity" as "open and sustained engagement of the patient" to get the best outcome for them and their family.  

Patient centricity is now the focus across the healthcare landscape, Garzya said, noting the various initiatives under way such as the US Patient Focused Drug Development (PFDD), PCORNet – a large, national network for conducting clinical effectiveness research with a $250m investment, the European Medicines Agency's move to incorporate patients into its benefit-risk decision-making, and the UK NHS "No decision about me, without me" campaign.

That's all very well, but what is pharma doing about it? Companies apparently are becoming more interested in working with patients – and some would say that's none too soon – but as Garzya noted, it is a cultural change that "needs to come from the top." AZ, for example, had taken the initiative through forging a collaboration with PatientsLikeMe, which has access to data from around 300,000 patients and more than 2,500 conditions across a range of diseases.

David Wright of Amgen said there were pockets of patient engagement activity, but this was still really fragmented, and "not stitched together well." Companies don’t share information well internally among the different parts of the organization, he observed. "What does patient centricity actually mean?" 

The point was made that in practice it is quite challenging to get the right people round table to talk about what patients really want. In any case, there are two types of patient – those who are experts, for example because they are working actively in the charitable sector, and they have real value in terms of disseminating information to patient groups; and those who have to trek into hospitals to give blood samples or have biopsies taken, who feel tired or sick on chemo, and so on. These are the people you really need to talk to in order to get an idea of what is really on patients' minds, and the factors that will determine whether they are willing to enter a trial or not.

One session examined the concept of "social listening". Now, while this might sound suspiciously like something the intelligence services are doing behind your back, it is apparently a good way of finding out what your potential trial subjects might need before they do. It could involve scanning the social media communications of patients in a network, such as that for lupus, for example, to find out what their worries and priorities are and then addressing these issues when designing recruitment programs.

Also on the menu today was the future of clinical trial partnerships, in a session chaired in typically witty and provocative style by Dr Phil Hammond, UK GP and media personality rolled into one.
It seemed that partnerships weren't all they should be. Some speakers suggested there were no truly strategic partnerships that had stood the test of time, and that a new partnership model was needed. Sponsors needed to consider what they wanted the future landscape to look like, it was suggested. 

One issue that cropped up several times during the session was the fact that while new tools and technology are allowing us to gather more and more patient data, we don't know exactly what to do with it when we've got it. "The challenge is to transform that data so that we can read and interpret it," said Christian Tucat of CRO INC Research. "This will be the biggest challenge over the next five years." Others pointed out that the data is likely to be in many different places, and that ways would need to be found to bring it all together in one place.

The interesting question was asked: how far are the regulators enablers or limiters when it comes to clinical trials? Opinion differed, but the general agreement seemed to be that they should be involved in some way, as should all other stakeholders – indeed the Transcelerate initiative is trying to do just that in an effort to forge more meaningful partnerships. But what scope is there for greater collaboration among pharma firms? Could we see the day when several major companies come together to work on big trials for, say, combinations of their own drugs? One day perhaps, but not quite yet, it seemed.

At the end of the day, the impression I came away with was that there is a great deal of potential for collaboration among sponsors, CROs, patients, regulators and other stakeholders when it comes to efficient and practical clinical trial design, but that there is still some way to go before this becomes a reality. Where the roadblocks are depends on where you stand, but there seemed to be a strong feeling that sponsors need to be less cautious, more open to collaboration and more prepared to bring the patient much more nearer to the core of the clinical trial process. 




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