Engaging Patients as Co-Creators

Dr. Kalahn Taylor-Clark on translating principles of patient-centricity into specific actions.



Smart devices and associated technology are a fairly new development in the clinical trial process. Kalahan Taylor-Clark discusses the impact smart devices have on data accumulation in real-world evidence: “Smart devices, and wearable devices can provide a lot of information about people, such as heart rate and blood glucose; there are literally volumes of evidence we can gain – real world evidence – on how products and solutions are having an impact in real-time. These data can be fed back not only to commercial teams, but across the life cycle management process, from pre-discovery to post-market surveillance and evidence communication.”

“Collecting and systematically analyzing this information,” she continues, “is vital to designing innovative strategies for understanding both the impact of our solutions in real-time, and how to develop patient-centered clinical trials that reflect improved protocol designs, reduced attenuation and better patient health outcomes.”

Technology changing the way surveys are conducted

While Taylor-Clark concedes that smartphone devices, as well as computer-based technology allows for the development of patient experience surveys, she did sound a note of caution,  “While most populations have unfettered access to computer technology, that is, we are seeing less of a ‘digital divide’ globally, the concept of ‘digital inequality’ can still present challenges for some populations.” She explains her position by saying that differences in peoples’ abilities to navigate and use technology-based applications may lead to biased survey samples and reduced effectiveness of technology-based solutions. In order to rectify this, Taylor-Clark believes, “As you push for internet-based surveys you have to push for greater digital literacy among all populations so that you can appropriately target and learn from the segment of the population that you want.”

Social online listening facilitates better clinical trial design

Taylor-Clark says in relation to the recruitment process for clinical trials, “Being able to conduct social online listening for a pharmaceutical company is extraordinarily helpful – we can observe what people are saying in the real world without prompting them,” she adds that it can also be helpful, “in defining patients we are interested in recruiting for clinical trials and (helping us in) designing protocols that fit into those patients lives,” she adds.

In-home monitoring a plus factor in recruitment and retention

With regard to Sanofi’s commitment to improved trial cycle management through data and technology advances, Taylor-Clark highlights that innovations in the marketplace offer promising opportunities.  For example, “in-home monitors of clinical trial participants, achieved through wearable devices, can allow clinical trial participants greater ability to adhere to protocols…and could possibly lead to an improvement in recruitment and retention rates as well as better patient experience.”   Taylor-Clark shares the experience of her mother who lost her battle with breast cancer: “My mother was in a Phase 2 clinical trial for breast cancer. She was treated like a subject. She had to go to on-site for daily monitoring and this created huge inefficiencies in her life.” By improving the ability to collect data from participants, where they are, we might also improve the efficiencies for the patients taking part in clinical trials.”

Improving patient profiles

For pharma companies wishing to recruit and retain participants in clinical trials, a recognition of the fact that they are first and foremost human and secondly “subjects” for a trial will go a long way in improving outcomes. “Once we have the technology at a state that the breadth and depth of the potential trial can be conveyed to the patient, it will be helpful to ensure that we are communicating with patients based on their personal needs,” says Taylor-Clark.  “The wants and needs of different patient populations are incredibly varied,” she points out. “You have to break down populations by gender, age, socio-economic and health literacy statuses (among others). To retain patients and ensure a successful outcome means taking varied wants and needs into account. There are work (some people may have three jobs) and trust barriers, as well as demographic challenges.” There is also the necessity to take into account whether a participant is a caretaker for the family or the stage of disease progression. New technology and social media have a role to play in understanding patient populations by, “allowing us to better identify patient profiles – to recruit and retain populations that have not historically participated in clinical trials, but also to improve the reach of our solutions and products,” says Taylor-Clark.

Public-private partnerships important in driving innovation

“If we are able to take real world evidence and feed it back to the lifecycle management process huge efficiencies will be created – whether we want to acquire an asset or design clinical trials or post-market supports for a similar solution or product that has already been out there.”  Taylor-Clark believes that “public-private partnerships can help facilitate innovations that will be supported by multiple stakeholders.”

Bringing patients in, not as passive onlookers, but as true co-creators in the design and development of solutions, will be key to improving efficiencies.

“We are supporting a proposed project at the moment, that would develop a public-private partnership in Europe through the Innovative Medicines Initiative (IMI), which brings together patient groups, pharmaceutical companies, and regulators, that will aim to create a data repository of patient insights that can be used across the industry, across different patient groups for their own purposes and advocacy, and across regulatory bodies such as the European Medicines Agency in Europe.”

FDA and public to benefit from Cures Legislation

The 21st Century Cures Legislation passed the House in May 2015 and a bill by the Senate is expected to be passed by the end of the year. “One asset is to develop patient-reported outcomes that would be useful in the regulatory process in terms of defining the risks and benefits of different drugs,” says Taylor-Clark, who goes on to explain, “Having these at the fingertips of regulatory bodies will help them design risk/benefits assessment in a very different way,” as the focus will not just be on clinical quality, but will emphasize patient experience.

Moving from passive patient engagement to co-creation

“As an industry we have to start partnering with patients in ways that can fuel improvements in outcomes. Patient advocacy groups and associations are becoming more involved not just in the clinical trial process but also in co-designing and co-creating products and solutions. Bringing patients in, not as passive onlookers, but as true co-creators in the design and development of solutions, will be key to improving efficiencies.” The message is loud and clear: Innovations that bring patients to the decision-making table as partners will have the most impact in improving outcomes for pharma and the end-users they serve.

As an African- American researcher herself, she adds, “On the African-American side, you have an issue of trust in the system. The idea remains that ‘you are experimenting on us’ and this, understandably, doesn’t sit well with a lot of the African-American population. We need to improve the process for people so that we can improve trust.” Indeed, retaining patients in trials is the difficulty. A better understanding of the hard to reach populations in terms of what their needs and risk benefit analysis would be, and then being able to design a trial that really addresses those needs may be key to recruiting and retaining a broader population for a broader clinical trial population and success.


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