If one of the global pharma giants develops a new blockbuster drug, they can’t just ship it. They need to perform extensive testing. Even if, from test #1, it seems evident that the drug does exactly what they hoped it would do, it still needs to be tested to cover all manner of public health concerns and ‘what if’ scenarios.
What the above means is that, regardless of the spellbinding technology that has been used in the research, development and manufacture of the latest blockbuster drug, to get to market everyone involved in the production cycle is reliant on one thing – patients.
Well Informed Patients means a Need for Patient-Centricity
Fundamentally then, if companies want their drugs to come to market faster then what they need is more patients.
However, despite social media making the world a significantly smaller place, this can ironically make patients more difficult to recruit. That’s because they’re better-informed than ever and more likely to be selective of the trials they participate in as a result of their own research.
Whereas previously the recommendation of a doctor/physician may have been enough for a patient to participate, today it’s far more likely that a patient could offer resistance based on their own research, or even be aware of more clinical trials and testing processes for drugs than the doctors themselves.
Therefore, connecting CRO and pharma companies with engaged networks and advocacy groups of suitable patients is huge business and technology is helping some companies tap into these networks.
I spoke with the CEO of one company doing just that, Ian Rentsch from Clinerion, to try and find out about the challenges that a patient-centric market posed for CROs and pharma companies.
Clinerion offer a solution for companies looking to recruit patients, leveraging technology to create a platform which handles everything from protocol feasibility to site selection to patient search and identification.
When I spoke with Ian, he felt that data was the key to effective patient selection. Namely, the collection, collation, storage and processing of that data.
In the same way that technology has filled a knowledge gap for the patient in terms of what is involved in a clinical trial and which trials are out there, technology and big data analytics can be used by companies to review and have access to more patients than ever before. To give an idea of the scale of data this facilitates access to, Clinerion now have access to more than 70M patients across 95 sites in 15 countries.
However, whilst companies like Clinerion can act as virtual Site Management Organisations (SMOs), it’s the bricks-and-mortar SMOs that, for the time being at least, have the best access to patients. This access has some CRO companies making attempts to tap into their networks in more innovative ways than ever before.
Short Term – Powerful SMO’s
Whereas companies like Clinerion and their competitors build their highly sophisticated global networks of patients, the traditional reality has been that individual sites have networks which may be only accessible to them.
Therefore, for companies who need access to patients now – from big pharma to CRO – it’s important to try and gain access to these networks through establishing new partnerships, or even through M&A.
One example is from one of the industry leading CROs who have been investing in site & patient networks and prime/partner sites to spread their net ever wider. Another example trend was from top 5 CRO PPD, who acquired patient enrolment specialists Acurian in 2013 as well as Site Network Organisation, Synexus.
Albeit moves like this may have a positive impact on recruitment, the fact that new approaches are still being attempted alongside the emergence of new technologies like Clinerion’s means that there is clearly still no ‘silver bullet’ for patient recruitment, which leave us in an interesting position today as we ask what the future of patient recruitment holds.
Long Term – Who Will Win the Battle for Patients?
Ian from Clinerion said that whilst challenges remain in patient recruitment it’s important not to lose perspective. He said that, although pharma needs patients it’s important to remember that it goes both ways and that patients also need pharma.
So perhaps whilst the industry seems to have taken a massive swerve towards patient-centricity in recent years, the company, technology or organisation that really cracks this issue will be the organisation that manages to strike a balance between serving the needs of both.
As technology evolves, this could mean more of a reliance on technology like Clinerion’s, or it may mean we see a proliferation of new methods like virtual trials coming to the fore. Or, it could be something completely different.
What’s certain is that whoever can secure access to the widest network of patients most easily will be able to get their drugs from the lab bench to the pharmacy fastest and gain a huge competitive advantage along the way.
Decentralised, virtual, home, remote… whatever the name of this type of trial, it's widely agreed they will be crucial to advancing healthcare.