Guest Column | March 5, 2020

Inside Janssen's Systematic Approach To Patient Engagement

By Daniel De Schryver, Janssen Pharmaceuticals

Janssen’s Systematic Approach To Patient Engagement

Terms such as “patient-centric” have become a common component of mission statements across the biopharmaceutical industry. In this age of increasing patient empowerment, listening more closely to patients’ needs and priorities is, at minimum, both socially responsible and a means to gather anecdotal perspectives not readily captured by standardized outcome measures.

At Janssen, we have approached patient engagement — partnering and interacting with patients and caregivers – more systematically. Our integrated, cross-functional Global Patient Engagement Leadership Team has been tasked with embedding patient engagement into every facet of our work.

This commitment, supported at the highest levels of our organization, represents a wholesale transformation of our corporate culture, on a global scale. In a manner both methodical and measurable, we aim to move from doing things for patients to doing things with patients. 

Engaging Patients From The Very Start

Our model of patient engagement calls for soliciting patient input as early as possible in product development, to the point of defining unmet needs before we find the molecule to meet them. For every therapeutic area we cover, we want patient input on target product profiles, prioritization of early-stage candidates, and clinical trial protocols, as well as decisions on how to maximize patient benefit from products once approved.

Engaging patients early helps lead to solutions patients actually seek. On top of making clinical research more relevant to patients’ daily lives, this level of engagement makes good business sense. We have found that having patients review a clinical trial’s protocols helps to reduce the number of protocol amendments and increase recruitment.1 This in turn helps speed completion of the trial and reduce costs, allowing us to collect more data for the same investment.

Patients give us insights we cannot obtain in any other way about what it’s like to live with a disease and experience its treatments. Some of these insights seem obvious in retrospect, but they only become actionable when articulated. This was certainly the case when we solicited patient input on the outcome measures used in clinical trials of potential new psoriasis treatments.

The key outcome measure by which new psoriasis treatments are evaluated and compared is the Psoriasis Area and Severity Index, or PASI. This index provides a composite score based on the area of a patient’s skin covered by psoriatic plaques and the degree of lesion severity as judged by plaque redness, thickness, and scaling. Treatment efficacy is documented by the percentage reduction in PASI score. PASI 75 and PASI 90 (75 percent and 90 percent score reductions) are common prespecified efficacy outcomes.

PASI scores predominate as quantitative and readily compared primary endpoints.  Clinical trials include other measures based on clinical assessment, including percentage of affected body surface area (BSA) and investigator global assessment (IGA). Patient-reported outcomes (PROs), while acknowledged as important for gauging the impact of the disease and its treatments, have typically been considered softer data.

One such PRO was based on self-assessment of the percentage of body surface covered with psoriatic plaques. We asked patients how relevant that measurement is to them. They said, not so much. A typical response: “I’d rather have 40 percent of my back covered in psoriasis than 10 percent of my face.” More importantly, even in patients who achieve 100 percent PASI reduction, substantial symptoms and signs can persist. Therefore, in the course of a clinical development program in this disease state, we co-created with patients a new instrument that both conformed to 2009 FDA guidance on PROs and shifted emphasis from lesions to suffering.

Following about five years of development, the resulting PRO instrument, the Psoriasis Symptoms & Signs Diary (PSSD), tracks a set of key symptoms, such as itching and pain, and signs, such as scaling and cracking. Validated in terms of correlation with PASI and other measures, as well as reliability on retesting,2 the PSSD is now accepted by the FDA and the EMEA.

Advocates As Colleagues

Janssen has a long history of collaborating with patient advocacy groups, another significant avenue of patient engagement, to support and amplify patients’ voices in the public sphere. Because patients are the ultimate beneficiaries of their respective healthcare systems, they need their priorities to be heard by policymakers and the public at large.

The need for, and power of, patient advocacy groups truly came of age with the emergence of HIV disease and growth of large international AIDS groups. Starting in the late 1980s, the growing HIV community recognized a dire need for early access to new treatments. Because they saw themselves as ignored, they vociferously advocated for compassionate use, even of agents still under investigation.

HIV groups were not only well organized and vocal but worked hard to advance their scientific literacy around the disease, despite the complexities of virology and immunology. Their informed critiques of conventional trial design helped their efforts to gain early access to new treatments. Subsequently, they began to reach out to industry, asking to review companies’ pipelines of HIV medications to offer advice from the patient perspective. These interactions became formalized as community advisory boards, a model adopted by advocacy groups in other disease areas, such as hematology.

An important example of how HIV groups could help influence clinical trial design in a more patient-relevant fashion concerns inclusion and exclusion criteria. Since HIV patients necessarily must contend with polypharmacy, advocates’ input on factors such as mode of administration are especially valuable. Patient input also helps promote data collection on shifting subpopulations of infected individuals, for example, to take proper account of heterosexual transmission and the increasing prevalence of HIV disease in women.

Global patient advocacy groups are the exception rather than the rule, and engaging with local and regional groups is an important part of Janssen’s advocacy outreach. Geographically separated study cohorts may have the same disease and be subject to rigorously controlled protocols, but cultural and healthcare-system differences can influence the real-world application of the resulting treatments. Regional advocacy groups are best equipped to advise on the practical needs of patients in their locales.

Measuring Progress, Applying Lessons

Deliberate cultural changes take time and commitment, whether societal or within an organization. To ensure that patient engagement continues to deepen systematically throughout Janssen, we have instituted procedures to monitor patient engagement activity across our wide-ranging pipeline.

The centerpiece of this effort is a “Patient Engagement Dashboard,” which measures progress over time and identifies areas where development teams have an opportunity to improve.  We assess this progress for prioritized pipeline product every six months. We ask our Disease Area Leaders to respond whether there was patient input in topics such as disease area strategy, target product profile, trial protocols, patient reported outcomes, formulations, and so on. In addition, we are working to evaluate and quantify the impact of our patient engagement activities as they evolve toward industry best practices.

Our global patient engagement work is part of a broader set of initiatives within Janssen aimed at making clinical development more efficient and patient relevant. These include technological advances to accelerate and prevent errors in data acquisition by clinical trial sites, as well as mobile technologies that simplify patient participation and reduce the need to travel to study centers. These, respectively, can improve patient engagement in the course of a trial by freeing up time for investigators to communicate with participants and by providing patients a direct channel to investigators for questions and data transmission.

Looking to the future, we can expect these kinds of innovations to facilitate collection of more robust and varied PROs that encompass factors most relevant to patients. This should encourage patient participation and adherence to trial regimens, because they know their experiences will help shape solutions that matter to them.

Whether serving as advisors or study participants, engaged patients will have increasingly valuable roles to play in development of therapeutics and regimens. This will give rise to better-defined measures of the outcomes that matter most to patients and help contribute to the broader goal of sustainable healthcare.


  1. Levitan B, Getz K, Eisenstein EL, et al. Assessing the financial value of patient engagement: a quantitative approach from CTTI's patient groups and Clinical Trials Project. Ther Innov Regul Sci. 2018;52(2):220-229.
  2. Feldman SR, Mathias SD. Schenkel B, et al. Development of a patient-reported outcome questionnaire for use in adults with moderate-to-severe plaque psoriasis: The Psoriasis Symptoms and Signs Diary. J Derm Dermatol Surg. 2016;20:19-26.

About The Author:

Daniel De SchryverDaniel De Schryver is patient engagement and advocacy lead for Europe, Middle East and Africa (EMEA) at Janssen. He is part of a global multifunctional leadership team that helps the company to engage with patients in a systematic way and helps build partnerships in developing solutions that better meet the existing needs.  De Schryver also leads a team in the EMEA region that plays a crucial role in working towards a more collaborative approach in innovation. He joined Johnson & Johnson in 2001 and most recently served as. global therapeutic area communications leader for Infectious Diseases and Vaccines, developing worldwide strategic communications and public affairs programs about infectious diseases and global public health.