Better Decision Making through Better Patient Insights
True two-way engagement in clinical trials is now a possibility.
Wouldn’t it be a game changer if feedback from patients on clinical trials could be gathered throughout the trial in real time? One Irish company has developed a simple but effective approach that aims to transform the traditional drug development process by providing a platform for patient engagement that meets the specific needs of pharma, and the patient.
“It is not news to anybody that the economics of the industry are in a bad way, and you could say they are unsustainable,” states Bartley O’Connor, Director of PatientPharma.
"There are too many failures while costs continue to go through the roof. This is something that is badly in need of a remedy".
At the heart of this issue are clinical trials – accounting for the majority of the cost of drug development. Current clinical trials are regarded as “too slow, too expensive, not reliable, and not designed to answer the important questions,” according to FDA’s new Deputy Commissioner for Medical Products & Tobacco, Robert Califf. The pharmaceutical industry is coming to a slow realization that integrating the patient’s perspective may provide the key to improving the success rate of clinical trials.
The right decisions
According to O’Connor, the problem centers ultimately on pharma companies and trial sponsors lacking the high-quality data necessary to make the right decisions at crucial stages in the drug development process.
“At each stage in the clinical trials process, a decision whether or not to proceed to the next stage has to be made based on the data that is available. Ultimately the question is, will it add value to patients’ lives and, if so, do we continue on to the next stage to prove it? Even phase 1 trials can cost tens of millions of dollars, and being able to decide at the end of it whether to go forward to the next phase, or abandon it now because we know it isn’t going to add that value, is a very important thing.”
Companies thus need to be able to discover and, if possible, address unforeseen issues as soon as possible, yet this isn’t possible with the current process, O’Connor asserts.
"It would be ideal for those pharma study teams running the trials to be aware of issues as soon as possible. At the moment that takes months, if not years. It is a long, slow process which ultimately leads to higher failure rates and higher costs".
PatientPharma has developed its unique approach in collaboration with pharma and conducted a pilot project in 2014 involving patients in a live clinical trial. The approach allows patients to record short videos and send them to their medical team via an easy-to-use app on their mobile device.
That is a crucial thing that is missing at the moment, real-time feedback from the patient themselves about what is happening.
Their approach enables pharma companies to know exactly what patients think of the drug they are taking and the impact it is having on them as they are taking it. This kind of feedback, captured directly from patients in their own words, can really help pharma study teams to understand the experiences that patients are going through.
These insights are invaluable in terms of adjusting aspects of the trial, providing support to patients, and identifying issues which require more detailed investigation.
“We find out about the experiences patients are having, how they are living with the condition they have, and most importantly the impact the medication is having on them and their lives while they are on a particular trial. That is a crucial thing that is missing at the moment, real-time feedback from the patient themselves about what is happening,” O’Connor explains.
The goal is to provide this information directly to the pharma study team so that they can better understand the impact of the drug and then make better decisions based on that information.
So what is the PatientPharma approach to patient engagement? O’Connor explains that their video platform allows patients to share video messages with their medical team, and for the medical team to respond to them– all at the touch of a button on their mobile phone.
This simple and secure visual platform provides two-way engagement in a manner that benefits both the patient and the supervising medics, O’Connor explains.
“What we do is provide a very simple way for the patients to share information with their medical team. They can say and show whatever they want, whenever they want - if they are worried about anything, they can say what’s on their mind. In just a one minute video, you can say and show so much. They hit send, and it’s gone – there is no complexity, it is such a simple process.”
O’Connor believes the difference with the user-friendly platform is that it is ultimately geared towards the patient and not simply led by technology.
“Our approach is focused on providing benefits to all stakeholders – it is not about ‘technology for technology’s sake’. You will never solve anything with technology if it is not simple enough for the person using it. This is so simple that people in their 70s can easily use it. The patient records an update about how they are feeling or a question, and the doctor or study nurse gets this video immediately on their mobile phone and can respond to them. This is the first true two-way engagement, achieved in a very human and user-friendly way.”
Security is obviously one of the first questions when it comes to highly confidential patient data. O’Connor explains that the platform has been designed specifically with this in mind. The data is encrypted end-to-end and accessible only to those who are allowed to view it.
If you try to create questionnaires for patient-reported outcomes at the beginning of the trial, you don’t even know what you should ask.
As well as providing the secure video platform for this innovative engagement, PatientPharma also analyze the data collected on behalf of the pharmaceutical company.
“Using our proprietary methodology, we extract key insights that we know are of interest to the pharma study team. We provide that information completely anonymized and with all personalized information stripped out to avoid any regulatory issues.
What the pharma study teams essentially see is a dashboard on a daily, weekly, or monthly basis, of what is happening with the patients, O’Connor continues. This information may ultimately help to reduce the rate of dropouts, as companies can move to address issues in an expedient manner. The company may adjust the protocol slightly, or add a medication, in order to ensure the trial continues smoothly, he explains.
“It may be, for example, that ten of their patients had a pain in their left leg that was so bad they couldn’t get out of bed, and therefore couldn’t go to work, so they dropped out of the trial. These things might seem quite simple but the problem is that you don’t know at the start of a trial what is going to show up. If you try to create questionnaires for patient-reported outcomes at the beginning of the trial, you don’t even know what you should ask. With our approach you are really discovering what is happening with the patient in their own words.”
Other similar efforts using communication strategies such as email and text have proven to be unsuccessful, as patients often find it difficult to properly articulate the problems they are having or correctly use technical or medical terms when explaining their issues.
"We have been working with big pharma on this for over two years, to come up with something that will work and overcome all the hurdles involved. This approach was not developed overnight".
This approach has benefits for all parties involved in clinical trials, maintains O’Connor.
“Working closely with pharma, we have found that there are potential benefits for all parties involved. In reality there has to be – if any one party is not getting value from it then it simply falls apart. If the patient doesn’t see a benefit or think it’s worthwhile then they will stop recording their videos and the show is over. The same goes for the medical team and the pharma team.”
PatientPharma’s overall objective is to provide better insights with a view to improving the clinical trials process. “Ultimately, we want to help pharma companies to make better decisions, and reduce the time it takes to learn from clinical trials,” affirms O’Connor.
In addition, the patient has a greater sense of involvement and also gains satisfaction from helping the overall trial by providing their valuable input. This will undoubtedly aid the reputation of clinical trials, and hopefully lead to a knock-on benefit in terms of increasing enrollment for future trials.
“The key word that came back from the pilot studies we ran last year was ‘reassuring’ – it is reassuring for patients to know that someone is listening to them.”
While still in its early stages, it is clear that innovative technology-based approaches like these have much to offer the pharma sector as it embraces the digital age.
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