Volunteer support – the power of decentralised trials8 December 2016
Technology’s reach extends beyond the boundaries of geography and captures a virtual globe. The rise of social media as a recruitment tool has proved a boon and a burden to the clinical trials industry, and connected sensors have made data capture and analysis more efficient. Bradford Keen speaks with Jeremy Sohn, global head of digital business development and licensing at Novartis, about the power of decentralised trials and the fundamental importance of gratitude.
Leafing through The Quintessence of Ibsenism, the reader will discover a passage about the “folly, which sees in the child nothing more than the vivisector sees in a guinea pig: something to experiment on with a view to rearranging the world to suit his own little ideas”. So wrote George Bernard Shaw in 1913. Through those words, it has been suggested that the Irish playwright was responsible for coining the notion of human guinea pigs, although, more prudently, others say his writing used the rodent as a general symbol of what was wrong with experimental science at the time.
Whatever Shaw’s true meaning, the idea of clinical trials being carried out in the dark chambers of subterranean laboratories is fostered these days only by scriptwriters of dystopian sci-fi films and government conspiracy theorists.
Companies conducting clinical trials tend rather to advocate the ethos of Harold T Shapiro. “Research using human subjects will continue to play an important role as part of a great humanitarian effort to understand ourselves better and to relieve distress and disease,” said the former chair of President Bill Clinton’s National Bioethics Advisory Commission. “To use human beings as subjects in medical experiments – or any type of research – is a special privilege, which carries with it special responsibilities.”
Indeed, this is partly what drew technophile Jeremy Sohn to healthcare and life sciences. “There is so much opportunity to make meaningful change,” he says, “by bringing better drugs to patients faster and more cost-effectively. You feel how it impacts everyone’s life.”
Grand benevolence, however, is not the only factor motivating the global head of digital business development and licensing at Novartis. Sohn also enjoys the challenge of being able to develop technology in a tirelessly competitive market place.
While the focus at Novartis remains on traditional biopharmaceuticals, Sohn says the company has seen the power technology brings to its development model: “Novartis wants to take full advantage of all the tools at its disposal to achieve the best outcomes for its patients.”
Consider how the firm is using a computer keyboard to help diagnose dementia. A program is being developed that is able to monitor remotely patients at high risk, or those presenting with early symptoms, by tracking the movements of their fingers across a keyboard. A record of how quickly common words are typed can be compiled; those with dementia will usually see a marked deterioration of their typing skills over time.
It’s the utility of remoteness that becomes so valuable in clinical trials. “Novartis is looking at multiple ways to bring trials to patients,” Sohn says, “so, where and when possible, actually going to a clinical trials site is avoidable.”
Sohn likes to talk about “virtualised trials” – although he suggests “decentralised” is a clearer concept – and the many benefits this boundless reach brings. Consider that 70% of eligible participants are often located more than two hours away from traditional clinical trial sites, precluding their participation, or placing a heavy burden on patients. Setting up sites is also hard work: it’s expensive, time-consuming and labour-intensive.
“If we can create a virtual meta-site that supports patients wherever they are located,” Sohn says, “we can significantly improve the speed and cost-effectiveness of a trial. By managing the study at the patient’s home, the gap between clinical trials and clinical practice can be narrowed.”
Clinical trials are designed to control external factors so the impact of drugs can be isolated and more accurately measured, whereas clinical practice reflects a wider variability of real-world factors. This subtle geographical change yields a tectonic shift in being able to understand a patient’s progress, or decline, in response to the intervention in his or her real-life environment.
Deciphering the data
Novartis’s relationship with Microsoft is an example of what can be done when digitally enthusiastic pharma seeks the help of influential technology companies. Tests for multiple sclerosis usually happen in a doctor’s office and require a patient’s movement to be measured and analysed, by holding their arms out to their sides and touching their nose, for example.
Using Microsoft’s gamification platform with cameras and sophisticated algorithms, this program will be able to measure the movement more consistently than doctors. “As good as doctors are,” Sohn says, “it’s often difficult for them to see variation in a person between visits. It’s even difficult to know the variation between two different patients. This is not to say physicians and their current practices are bad, it’s just that you can always make it better.”
The technology will create repeatable and consistent measurements by removing the potential for bias and making it easier for doctors to interpret.
The drive for clean and consistent information is critical. “If we remove some of the noise introduced into the data,” Sohn says, “we can run better trials and see the impact of that particular intervention more discretely. We can run smaller studies as well, because the more punctuated the outcome, the better the data.”
Novartis’s partnership with mobile tech firm Qualcomm, which Sohn describes as “synergistic”, enables the collection of clean data in passive ways in decentralised settings.
“We are driven by science and understanding healthcare and therapeutic area conditions,” Sohn says, “and Qualcomm is one of the best technology companies in the world.” Together, they have launched a ‘Trials of The Future’ programme aimed at providing a better experience for trial participants and product patients through connectivity. Examples of this type of connected technology include an intelligent inhaler for patients with chronic obstructive pulmonary disease (COPD), which uses connective sensors, apps and smartphones to improve patient adherence to optimal drug use and collect data at the same time. The companies have also licensed Google’s smart lens technology to develop new types of contact lenses and to measure glucose levels via tears, with the results then digitally stored.
“We know that the drugs are good,” Sohn says, “and they have the potential to meaningfully improve the conditions of our patients, but if we can augment those drugs, if we can augment the experience by better engaging patients, by empowering and enabling those patients with additional, helpful and supportive tools to encourage them to be adherent to their drug regimen, we feel that is an important responsibility as well.”
Combining pharmaceutical expertise with integrated technology and hardware can also help redefine markers in the prognoses of diseases by being able to take almost constant measurements. “Connected sensors allow us to think beyond existing clinical end-points,” Sohn says, “and maybe capture novel ones.”
This is especially important, he says, when it comes to disease progression, particularly neurological afflictions, such as multiple sclerosis, Alzheimer’s or dementia, and depression. “Passively, we can begin to use these techniques to understand disease progression without having to bring that person into the office, without having the person go through rote tests.”
Amid the discussion of wearable tech and connected sensors, mentioning social media seems a little antiquated. However, as a recruitment channel, a means to inform patients and way to build a community, its value remains undimmed.
Pfizer tried recruiting for a clinical trial in 2012 using only social media, but had to shut it down due to insufficient numbers. The company noted the hurdle over which it had tripped – trying to execute multiple technological tests at once – and vowed to jump higher next time. It honed its methods and continued renewed, along with Lilly and Novartis – among others – to run successful recruitment drives on social media.
The point, Sohn says, is that these platforms are ubiquitous components of modern life: they have to be used. He is quick, however, to note that certain discussions must be had at the beginning of a trial to safeguard against misuse. For instance, the major problem social media can present is unblinding participants.
People in clinical studies often go online to talk about the kind of drugs they are receiving in a trial, and to see what side-effects the other participants are experiencing. They become sleuths in the mystery of their own illnesses and meddle with the trial’s ultimate investigation. There are multiple websites – with a collective user base of more than 250,000 people, according to a 2015 report by contract research organisation Chiltern – designed for this very purpose, the most notable being PatientsLikeMe.com.
“We need to help participants understand why it is important to remain blinded to a study,” Sohn says. “This is critical research and, to the extent that it is possible, we don’t want that to affect the outcome of the study.”
The real way to benefit from social media, Sohn says, is to build a community and foster a culture of engagement.
“On a trial, there are hundreds, if not thousands, of similar people in their situation so, in this respect, social media can be used so they don’t feel lonely or isolated.”
According to the study titled ‘Like or Dislike? Impact of Facebook on Ewing Sarcoma Treatment’ published in JMIR Cancer, 89% of participants agreed that being in contact with other affected people through the group makes it easier to handle the diagnosis; 20% said the group affected their choice of treatment; and 15% reported being influenced in the selection of their specialist.
Say the magic words
Helping to build a community by informing and supporting patients is a vital aspect of clinical trials. It is important to provide information in suitably sized chunks at appropriate times, not like the deluge of the past.
“In the old modality of running a clinical trial,” Sohn says, “you would be told about all the things that were going to happen over the next year, two years, or even five years. It was like drinking from a fire hose.”
If a patient is having an MRI or a blood test, he or she should know exactly what is going to happen, and when.
“There are a lot of pharmas talking about the importance of giving back,” Sohn says. “Novartis can do it by helping inform the patient. The firm wants to be saying thank you, because it realises that, at every point in the clinical trial, volunteers are giving their time and energy. Novartis needs to say, ‘Hey, we understand and are really appreciative’.”
Taking trials to patients, and using technology to engage participants and capture data can help make clinical trials more effective, bidirectional and a more beneficial experience for all involved. “That convergence is extraordinarily powerful,” Sohn says.
While the relationship between researchers and participants will never be equal, the bidirectionality Sohn espouses goes far to foster respect for the willing patients driving medical progress.
In this current culture of engagement and empowerment, perhaps Shaw would have been gentler with his pen and celebrated instead the pursuit of grand and global ideas.