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Meeting the Information Needs of Patients
Pfizer's Craig Lipset on new efforts to drive clinical trial recruitment in the digital age.
“Clinical trials are about trying to generate patient level data, and in order to do that you need patients coming in and you have to have ways to get data coming out. It’s no surprise that those are two of our biggest drivers and cost challenges in the context of clinical trials, getting the right patients in and generating high-quality data.”
These are the words of Craig Lipset, who is Head of Clinical Innovation within Worldwide Research & Development at Pfizer. He spoke to eyeforpharma about current efforts to transform clinical trial recruitment within the new era of patient centricity.
According to Lipset, a key difference in how Pfizer approaches clinical trial recruitment is their overarching aim to meet the information needs of the patient.
“We are very focused on listening to patients before, during and after clinical trial participation; we are really trying to make sure we understand what the information needs are of the patient who is considering a trial in order to help them find information about a trial and support them making an informed decision to participate.”
This has to be a concept delivered right through all stages of clinical development; Lipset says he believes that information provided downstream of patient recruitment still serves to influence recruitment.
“The focus is not so much, ‘how do I get patients into my study’, but how can I meet their needs so that they can make that informed decision to participate.
“If the patient knows that they will get certain types of information while they are in the study and if there is a visibility and transparency to the process, I think that will only help improve participation.
“The focus is not so much, ‘how do I get patients into my study’, but how can I meet their needs so that they can make that informed decision to participate.”
In many cases, this is done in conjunction with the patient’s own doctor; this important aspect of patient engagement cannot be forgotten, Lipset advises.
“We have to respect the fact that most of the patients we are looking to enroll in our trials are already diagnosed with a condition and under the care of a treating physician; we cannot reach the patient without providing resources to reach the treating physician so they can support that decision to participate.”
Practical issues at play
This refreshing viewpoint is not always mirrored within the pharmaceutical industry, and much of this relates to inherent practical and organizational issues. Lipset explains that many of his industry colleagues are working in a particular area, and thus are focused on individual study protocols.
“It’s how we tend to organize most of our resources, and it is difficult for those focused on a particular protocol to think about the broader information needs of the patient; where we can generate more data and evidence to show that those goals are intimately aligned, that will be important for those individuals.”
We have to respect the fact that most of the patients we are looking to enroll in our trials are already diagnosed with a condition and under the care of a treating physician; we cannot reach the patient without providing resources to reach the treating physician so they can support that decision to participate.
Roles such as Lipset’s allow a wider perspective on patient recruitment; “I am fortunate to be in a positon to work across the portfolio and to be able to have that focus to look at the patients’ needs and if we are meeting them, but for many of my colleagues, it is a little more challenging to be able to look beyond their individual protocols in order to do that.”
It is evident that these organizational issues, which contribute to a lack of emphasis on patient engagement with a view to trial recruitment, cannot be overcome overnight. A cultural change is necessary, one that will also reverse the current thinking on patient centricity.
“We need to understand what it is that the patients are actually looking for, rather than focusing exclusively on what information do I want to push. We need to speak to patients about what they believe they need to know.”
Currently, the available sources of information for patients seeking to partake in clinical trials are something of a mixed bag. Despite being the epicenter of clinical trial information, the obvious limitations of the much-maligned clinicaltrials.gov contribute to a lack of patient understanding. Downstream, the picture is even bleaker, according to Lipset.
“You have a cacophony of sites you could go to, but then it gets spread very thin, and it doesn’t have the gravitas and objectivity of clinicaltrials.gov.”
Lipset makes a salient point when he comments that “nobody wants to be in a clinical trial” and reiterates that many patients are already in the care of a doctor and often receiving some form of treatment. A more seamless transition to clinical trial participation is the goal.
“Our limited ability to enable research to run more routinely in healthcare settings is our biggest barrier to opening those floodgates but also our biggest opportunity.”
A direct route
One way in which this could be achieved is through the use of social media. This represents a direct route to patients that has not yet been exploited fully by an industry slow to change and adapt.
Pfizer is increasingly “listening” to patient conversations on social media, however, and Lipset says it is important to understand where patients are seeking their information.
“After their physician, the next stop for a patient to find out more about a trial is often Google, and it’s important that we have information for them wherever they are looking, whether it’s social media, the web in general, or anywhere else.”
Pfizer has engaged in a number of digital initiatives in recent months, and Lipset says that one with great potential was Pfizer TrialFinder, an additional resource on Pfizer.com that aimed to provide more information about the various clinical trials actively enrolling.
“It’s not that we necessarily expect patients to come to our website looking for clinical trials, although we have had thousands of hits per month. I think that the real other reason we put it there is that Pfizer.com is heavily indexed and searched by major search engines, and as a result when a patient does search for any actively-enrolling Pfizer trial, it gives that additional resource for information for that patient, beyond what’s just on ct.gov.”
Lipset says that currently, most organizations using social media as a platform for clinical trial recruitment, or other endeavors, are “using it in an anti-social way”; simply advertising on Facebook or other networking sites does not quality as true engagement. The medium can be leveraged as an effective communication tool when used in a more specific way, however.
“Tweeting about a clinical trial opportunity, for example, that’s an important way of getting content out there and in certain diseases areas patients really tend to rely upon this as they want to know what others in their community are talking about.”
Failing to engage and share content makes companies essentially “invisible”, but Lipset cautions against “engaging without first listening”.
“I have been very pleased to see the pace at which our study teams are now able to understand which conversations are already happening, and be able to build from there, rather than just getting content out on social media. If you think of social media as a very large conversation, it needs to start just by listening.”
In terms of other online efforts, Pfizer has also collaborated with Lilly and Novartis on the highly-praised Patients 2 Trial Consortium, which worked to develop a standard language for patients interested in clinical trial opportunities.
“This was really about creating another API [application program interface], a data resource with content for those that are looking to help patients match for trials. One of the best features of ct.gov is the fact that it’s an open data resource, all of the listings on ct.gov can be accessed by entrepreneurs and developers looking to populate other search engines.”
Yet the data on ct.gov remains limited, and thus the companies sought to deliver an adjacent dataset that would augment the information on that site, and Lipset says this has helped create rich content that’s more meaningful for prospective patients in a very open way.
Baby steps – what next?
The industry are clearly on its way to dealing with the difficulties posed by clinical trial recruitment, but are nowhere near the finish line. Baby steps have been taken – what’s the next move for an industry that historically moves at glacial speed?
Lipset says these types of shared resources will continue to expand, and adds that there will be future collaborations for Pfizer, all with the aim of providing “richer and better” content for patients.
Another untapped resource for the industry is “screen failed” patients; for every patient that enters into a clinical trial, there is another five, or eight, or 10 that screen fail. Data from Center for Information and Study on Clinical Research Participation has shown that 65% of patients who are ineligible for a study do not attempt to enter another study, despite clinical trials having spent considerable effort to collect their data.
“It’s defeating, it’s exhausting… They have to go back to zero and start all over. Patients who are already activated and looked for and found a trial and were screened but ultimately didn’t match the restrictive eligibility criteria for that study hold great potential. Helping them connect with other trials for which they may be eligible, whether from Pfizer or elsewhere, is a vital resource for the entire research ecosystem to be able to leverage.”
Lipset considers this cooperation with other companies “paying it forward”, and hopes other companies will share this attitude and refer patients to them in turn.
While companies have begun listening to patients, true engagement still has a long way to go, but Lipset feels that there are “signs of hope”.
“The trends in patient engagement and participation in healthcare have to have downstream benefits to the research community but there are no holy grails out there, no silver bullets or quick fixes. It’s going to continue to be a long persistent journey to drive better patient participation.”
Craig Lipset will be speaking at Clinical Excellence Europe 2016, 14-15 June.
Read more about Pfizer's unique approach to engaging and listening to patients digitally in their case study in our latest clinical whitepaper "Advancing Patient Recruitment & Engagement in Clinical Trials".
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