There are mounting challenges around the sustainability of clinical trials as the pharmaceutical industry is faced with increasingly complex and expensive trials. But new models and collaberations are emerging, creating new opportunity around ways data is being captured and around the efficacy and safety of new medicines through novel collaberations which will help ensure the sustainability and delivery of new medicines for the patients of the future. Craig Lipset, Head of Clinical Innovation at Pfizer speaks to Pharma IQ.
Pharma IQ: I'd like to start, Craig, by asking you to give an overview of the clinical trial scene today and what the future holds?
C Lipset: I think that we're certainly at an interesting time when it comes to clinical trials. The data is known to most of the folks in this field around the mounting challenges of sustainability of the current clinical trial model and we're faced with increasingly complex and expensive clinical trials to conduct. We're juxtaposing that against an environment where reimbursement for medicines, as they become available, is increasingly in doubt. And so the models we've had to date are often looked as unsustainable.
However, we’re seeing new models and collaborations emerge, and so the future is not as dim as we might have thought. There are opportunities for us to reinvent how we’re capturing data, on the efficacy and safety of our new medicines, and to do that in novel collaborations which, ideally, will help ensure the sustainability of the work that we're doing and ensure the sustainability of the delivery of new medicines for patients in need.
Pharma IQ: What’s Pfizer's vision for the future of clinical trials?
C Lipset: There is an important role for collaboration with a range of stakeholders as never before; we see that embodied in the range of collaborations that Pfizer is executing today. We have created collaborations with academic medical centres through Pfizer, at our centre for therapeutic innovation, where we have shared space, intellectual property and transformational new collaboration models.
We are also partnering with other peers in the pharmaceutical industry; companies with whom we would have once exclusively viewed as competitors, we're now looking at as collaborators to make this sustainable.
We have formed alliances with non-profit organisations and patient groups and have found new ways of partnering with CROs, where once they were viewed as vendors, they are now considered partners in the process.
So the future vision state that we’re trying to achieve is really one of convergence between clinical research and healthcare. But, healthcare is almost disrupted by the notion of clinical research; such research stops healthcare in order to get aid and participation, which is a challenge. The future that Pfizer would like to try to work towards is one where research can be integrated as a natural part of healthcare.
We need to look at ways to enable a future where each interaction of a patient with their healthcare provider, is also an opportunity to inform the next generation of new medicines and development. It's an opening to capture data that may be of importance to research, or an opportunity for that patient end-provider to directly participate in a research study.
Pharma IQ: Thank you, Craig. What challenges do you think are affecting innovation in clinical trials, and how can these be overcome?
C Lipset: Historically, one of the biggest challenges is ‘ourselves.’ We were comfortable with the existing processes, and because we work in an industry that is so highly regulated, so process-driven, there is a perception that we can’t innovate; we could only achieve a gold standard of operational excellence. We could try to execute against our processes, but we could really go no further than those boundaries.
Today there is a much greater sense of urgency than ever before, we’ve moved on. We really need to work together to push boundaries to ensure that we're able to fulfil our moral, ethical and legal obligations to patients. But at the same time we need to find creative new ways to work with patients, investigators and other stakeholders to understand efficacy and safety.
That sense of urgency is going to help become an important driver for innovation in our space.
Pharma IQ: Craig, you've spoken a lot in the past about the e-patient. Can you perhaps explain how an e-patient and clinical trials can be brought to work together effectively today?
C Lipset: The notion of an e-patient can mean a lot of different things to different people. For some, when they hear the term, they think just about a patient who is online and accessing information on the Internet, that’s a part of it. But, the ‘e’ is really about engagement.
The notion of an e-patient goes a step further into the realm of participatory medicine, where the patient isn't looking to displace their healthcare provider; instead, the patient is at the table with a voice, able to say that they do have information. They have experiences to share, to complement the decisions that are being made about their health. When the patient has a voice in that plan, they’re better engaged and they're more likely to persist and to follow that regime. And ultimately, they see better outcomes.
Now, when we look at that notion of an e-patient and look at the traditional subject in a clinical trial, there's an interesting misalignment. A subject in a clinical trial is inherently not well informed. We take their name, we give them a number, and we assign them a blinded drug. We extract information from them to aggregate in our study database. But traditionally there's not very much that they're getting back in terms of being an engaged participant in that study. And so I think that for us to be able to keep the patient of tomorrow engaged in research, we are going to have to be creative in finding new ways to ensure that they have that same sense of engagement. Otherwise, I think, we're going to marginalise and lose those patients, moving forward.
So if the trends are all pointing in the direction of greater use of the Internet, greater numbers of patients taking on this highly engaged and participatory role in their health, I think it's important for us to keep pace in terms of how we are looking at ways to engage those folks in research. And that means engaging them in terms of making them aware, through patient recruitment straight through to the life of the study and beyond, ways in which we're engaging, keeping them informed whilst still maintaining the scientific integrity of the study.
Pharma IQ: We've come a long way since the first clinical trial was started by James Lendemer. What’s your vision of clinical trial say for 2020?
C Lipset: Clinical trials have and will continue to move forward in three domains, which all carry some level of convergence.
We see the changes in healthcare around patients and patient engagement.
There are opportunities for changes that relate to our interaction with investigators in the studies as we execute clinical trials at a system's level, rather than conducting each individual clinical protocol as an instance.
And we have unprecedented levels of electronic data, increasingly growing in healthcare, as a result of electronic health records maturing in their implementation, seeing greater uptake on a global basis.
And so when we see these movements happening around patients, the investigator and access to data, I think that they are all important enablers of that future state of convergence between research and healthcare, of opportunities for every healthcare interaction to be an opportunity for research participation.
Pharma IQ: We look forward to seeing what the future holds. Thank you so much, Craig Lipset, Head of Clinical Innovation at Pfizer, for your time today.
Written by Niamh Madigan
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