"I sometimes joke that I turn feelings into numbers," says clinical psychologist William Lenderking, PhD. "That may sound cold, but we have to communicate subjective phenomena in a way that’s more objective in order to demonstrate reliability and validity."
As vice president of patient-centered research at Evidera, a health-economics and outcomes-research consultancy, Lenderking works with teams that conduct research for pharmaceutical companies that evaluates patients’ experiences with new medicines. He spoke to the Monitor about how his early roles in HIV/AIDS research sparked a career in patient-centered research.
What do you do at Evidera?
I’m vice president within Evidera’s patient-centered research group in Waltham, Massachusetts, where we provide consultancy services to pharmaceutical industry clients. Our job is to try to bring the voice of the patient into the drug development process. We do this by developing and applying standardized measurements of the patients’ experience with given health conditions to evaluate whether new medicines have value to them. I’ve worked across a wide range of conditions during my 10 years at Evidera, including depression, rare diseases, oncology and Alzheimer’s.
Clients can work with us for the whole drug development cycle, or pieces of it. Sometimes we may do a literature review to help the client assess the benefits of a drug. Or we may develop symptom measures and functioning measures for patients to report their experiences with a treatment. We can also run large trials to look for less common side effects or provide global evidence of a drug’s efficacy.
As principal investigator, I steer the conceptualization of the projects and oversee the team’s research, then I’m responsible for the final quality steps before the project is delivered to the client.
How important is patient-centered outcomes research in the drug development process?
There’s been a push in the last five to 10 years to make outcomes research more patient centered. Patients have become more empowered, and patient advocacy groups have increased their visibility.
Regulatory agencies and pharma companies are increasingly aware of the importance of incorporating the patient’s perspective. The Food and Drug Administration has even published guidance on how to develop and validate patient-reported outcome measures.
How did you first get started in patient-centered research?
I’d had a long-standing interest in health, but my first role came almost by accident. In 1990, I was working on my PhD in clinical psychology at the University of Connecticut when I heard through a friend about a position at the Harvard School of Public Health for a master’s-level statistician in the Quality of Life Section of the Statistical and Data Analysis Center, which provided analysis for the AIDS Clinical Trials Group. I was intrigued.
My application caught the eye of Dr. Marcia Testa, the head of the section, as she wanted someone both experienced in SAS, the statistics software program, and with a psychology background. Serendipitously, I’d taught myself to program SAS for my master’s and doctoral work and, thankfully, I’d put it on my resume on the very last page. Marcia was a statistician who had majored in psychology as an undergraduate, so she saw the value in my training. That programming/psychology combination won me the role, which evolved into a postdoctoral fellowship.
Not long after, I took on an additional post-doc at Massachusetts General Hospital in Boston, working with HIV/AIDS patients with psychiatric issues. I crunched quality-of-life data for the AIDS Clinical Trials Group a few days each week and then spent another two days in the HIV clinic, gaining an understanding of the patients’ quality of life from their perspective. There was a powerful synergy between the two roles.
You’ve had a rich and varied career since then, often with concurrent roles. Can you tell us about some of those?
My late uncle used to joke with me, "How many jobs do you have now?" At one point I had five, and I think that’s typical of many psychologists. We consult, we have a job somewhere where we work 20 hours a week, and then we have a private practice. It keeps things interesting.
After completing my PhD, I continued to hold part-time roles at Mass General over the next decade. This included about five years conducting research with outpatients in the Andrews Unit HIV Clinic, before switching to general psychiatry, and included an assistant professorship at Harvard Medical School. As I developed my private practice, I also worked with Dr. Testa’s consulting company, Phase V Technologies, including work on measuring depression.
Later, I was a consultant to the pharmaceutical industry with Abt Associates Clinical Trials, where I designed research studies and developed tools to assess the quality-of-life impact of various conditions. At Abt, I was also able to serve as psychometrician for the HIV Vaccine Trials Network and contributed to one of the largest HIV behavioral prevention trials, the EXPLORE trial. I then joined Pfizer as director of worldwide outcomes research, where my work covered infectious diseases, traumatic brain injury, stroke, neuropathic pain and depression. The latter included adapting a daily version of the Quick Inventory of Depressive Symptomatology—the well-known scale for assessing the severity of depression symptoms. After seven years at Pfizer, I moved to Evidera.
How did you come to work at Evidera?
I’ve found every job I’ve had through word of mouth, which shows the value of building relationships and pursuing interests and side projects. I’d known one of the early partners of Evidera (originally known as Medtap), Dennis Revicki, for over 20 years, and I had prior consulting experience. So, when I was approached to join the company in 2007, it was easy to make that jump. I was initially hired as a senior research scientist, and was later promoted.
You’ve also been a big fan of side projects. What are your current ones?
Side projects have always fueled and supported my career. I co-developed a course for health professionals through the International Society for Quality of Life Research. It’s an introduction to the field of patient-reported outcomes and patient-centered research. We’ve been teaching that internationally for a couple of years now, and we’re in the process of developing a similar course tailored to the pharmaceutical industry.
I also teach yoga for healing and inspiration. I’m a Level 2 certified Kundalini yoga instructor, and I’m currently teaching in a study funded by the National Institutes of Health that’s testing cognitive-behavioral therapy versus Kundalini yoga as a treatment for generalized anxiety disorder.
What would you say to psychologists and graduate students who may not have considered outcomes research as a career path?
It’s a great opportunity to bring the insights of psychology into medicine. It’s somewhat like health psychology, but with the added specialization of operating within the regulatory space.
The FDA has become very involved with trying to develop standards for psychometric evaluation and validation, so there’s a great opportunity for psychologists to contribute. Psychologists have been thinking about the patient’s perspective for 100 years. It’s not a new concept for us.
