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Jenna R. Carl, PhD

VP of Clinical Development & Medical Affairs, Big Health, Inc.

ABCT member since 2008

What is the context in which you work, and what was your path to conducting research in this setting?

My role is VP of Clinical Development & Medical Affairs at Big Health, a developer of digital therapeutics for mental health. In this role, I oversee both product development activities from a clinical standpoint as well as clinical research efforts to evaluate the effects of our therapeutics. I also help communicate the clinical research findings to a broad set of stakeholders, including members of the company, healthcare payers, industry groups, investors, government authorities, etc. I oversee clinical trials to establish the safety and efficacy of our products; large effectiveness and implementation studies across different settings and populations; and mechanistic studies to understand how our products function and support behavior change at a deeper level. We conduct all of our clinical research in collaboration with academic partners at major research institutions around the world.

What tips can you offer to colleagues trying to start a research lab or begin a career in research outside of traditional academic settings?

Working at Big Health has opened my eyes to the world of industry-led research. While much is the same in industry-led research as in traditional academic research, there are some differences that may be of interest to professionals considering their research career options. Industry-led research is subject to more scrutiny from a conflict of interest standpoint, thus clinical trials need to be carefully designed and documented to reduce any potential for bias. For example, industry researchers need to adjust their investigator responsibilities so that they are not personally responsible for conducting outcomes assessments or statistical analyses (these should be done by independent academic researchers). Another major difference is that industry-led research is often funded directly by the company rather than grant-based. This means that the timeline for research can be faster and more predictable than in academic settings. The fast-paced and often collaborative nature of industry-led research can be very rewarding. Understanding these similarities and differences will be key to identifying which type of research setting is the best fit for any clinical researcher.

What strategies have helped you be successful in a challenging funding environment?

Working in industry has been an effective way of conducting a large volume of high-quality research even during a challenging funding environment. Companies that need to conduct clinical research typically have ample and consistent budgets for research year over year. This makes it possible to continue research efforts without interruption due to gaps in grant funding. Of course, some companies do depend on grant-based funding for their research, so this is not always the case.

How did you first become involved in research? What was this first research experience like?

I first became involved in research as a study coordinator at UCSF prior to graduate school. In this experience, I got exposure to the ins and outs of conducting human subjects research, including everything from HIPAA to interviewing participants to cleaning/entering data to writing up results. Then in graduate school, I was a Principal Investigator for the first time and got experience designing, conducting, and publishing clinical trials from end to end. Given how complex the research process is, particularly for psychological studies that involve experiments with human subjects, there is a steep learning curve. My first research projects were very effortful, whereas now the research process feels like second nature. As a result, I am now able to enjoy the big-picture impact of each project to a much greater degree.

Has your approach to research changed over the course of your career? If so, how has it changed?

One way my research approach has changed is that it has become more collaborative. Early in my career I felt it was important to do as much as I could independently. I often waited to have full drafts of protocols or manuscripts prepared before sharing with co-authors. Over time, I started to enjoy being more collaborative across the whole research process from study design to manuscript preparation. This is partly due to practice collaborating over time -- with greater familiarity of the whole process it is easier to navigate shared work on different parts, but it is also because I developed a set of frequent collaborators that I work really well with. It is easy for us to work closely together iterating on the study design and the writing process. This change has increased both my enjoyment of research and my productivity.

What have you found most rewarding about your research?

I find it very rewarding to work across the entire R&D cycle. That is, I am able to develop digital interventions as well as conduct research to validate them clinically, and then monitor the real-world impact of these interventions. This makes the entire process feel closely tied to helping people in the real world, and it makes my work focused at all times on providing the greatest benefit possible to the end user or patient. I have also found it rewarding to conduct large-scale clinical trials with thousands of participants, which is possible because I am evaluating automated digital interventions. Through this work we have contributed significantly to the field's understanding of the potential for digital therapeutics as we have been able to validate the effectiveness of fully automated digital therapeutics for several mental health conditions across many large-scale studies.

How do you balance research with the other demands of your position?

Research takes up approximately 30% of my working hours and is flexibly integrated into my day-to-day schedule. I have a team of clinical researchers that support all of the research we do at Big Health and therefore we are able to divide responsibilities. This means I am able to be efficient with my time while being involved in a large number of studies at any one time. Of course, I also have to manage my calendar and reserve enough time for writing, editing, and the other more time intensive-research tasks.

What does an average day or week look like for you?

My team is based in the UK and the US, so I start my days early in order to connect with my colleagues in the UK. As clinical development and research activities impact many areas of the company, I have frequent-internal meetings with colleagues across different departments in order to coordinate our activities. The marketing department may need time with me or my team in order to understand study results or other aspects of clinical science, or I may be meeting with the product team to review proposed changes to the program. I also have external meetings, such as presenting our data to a potential customer (large healthcare payer), developing an implementation plan with a healthcare provider, or providing webinars or talks at conferences. Outside of this, I spend most of my time developing or reviewing research protocols, clinical content for the programs, and providing thought leadership pieces for media outlets.

What drew you to this particular research question?

I have been interested in creating and disseminating evidence-based treatments for anxiety, depression, and related disorders since beginning my training as a psychologist. Given the difficulty accessing such treatments as traditionally delivered in 1:1 in-person therapy, I was interested in developing interventions that could be more accessible to the broad population. That is why I joined Big Health and committed to research focused on creating evidence-based and scalable digital therapeutics for mental health. My research interest then is about both validating this digital delivery model as well as improving this model of care from both the intervention and implementation standpoint.

What is an example of a set-back you've experienced in your work, and how did you handle it?

Developing digital therapeutic programs that will be provided to millions of people is a complex process. The underlying digital platforms must be extremely robust to withstand vast usage and the products must meet stringent laws and standards for quality, privacy, and security. In some cases there are regulatory requirements as well (i.e., FDA). With these constraints it can be challenging to develop and iterate quickly on a therapeutic program. In the early days at my company, there were times when we had to focus on technological improvements to a greater degree than therapeutic improvements. As we have grown in size and established strong underlying platforms and processes these trade-offs are less necessary. Nevertheless, during times where I was unable to continuously move the therapeutic improvements forward as much as I wished, I had to figure out other ways of continuing to advance our work. That meant thinking about how to plan, prepare, and even test out proposed therapeutic changes in advance of when we could make them in the product. We found creative ways to experiment, advance our thinking, and then be ready to quickly implement changes when the time was right. It also meant I had more time to focus on research and other aspects of my work.

What is one challenge about your research that you didn't anticipate before you started the work, and how have you dealt with this?

One challenge of doing research in an industry setting is that you have to be more aware of the potential and/or the appearance of bias. Although investigator bias is relevant for all research, there is an assumption that industry-sponsored research is more at risk than independent academic research. For this reason, industry-led research should follow specific practices for avoiding or reducing the potential of bias. Many of these are standard academic practices, such as ensuring an IRB has reviewed and approved the study, blinding assessors to treatment condition, publishing study protocols in advance of recruitment, and registering clinical trials. However, there are additional measures that must be taken in industry as well. For example, independent statisticians must be used to conduct all analyses, and industry investigators should ensure they are not involved in any activities that could introduce bias (i.e., study assessments). Coming from an academic research setting, I was used to being involved in all aspects of a study, including running analyses and conducting assessments. So I had to adapt and ensure that independent researchers were responsible for these elements of our studies.

If you weren't pursuing a career in psychology, what would you be doing?

I have always had wide-ranging interests from intellectual to creative to athletic, so I would not have a hard time filling my time if I was not pursuing a career in psychology! Prior to deciding to get my PhD in psychology, I was a finalist for a Fulbright scholarship in which I proposed utilizing girls soccer to support community development for girls growing up in low-income areas of France. My career might have taken a different path had I been awarded that scholarship -- or then again maybe that path would have led me to psychology as well. I have also always been interested in film-making, and still entertain ideas of writing a screenplay when I am between jobs at some point. Writing characters for film seems like a fun application of my psychological skills. Career aside, my favorite way to travel and see the world is on a bike, and if I had more time I would certainly prioritize long (epic!) bike journeys across the US and other countries.

Why did you join ABCT? How does your ABCT membership inform your research?

As a scientist-practitioner focused on the development and evaluation of cognitive and behavioral treatments for mental health, joining ABCT early in my training was a natural step. ABCT involvement has informed my research in a variety of ways over the years. The annual conference serves as a great place to learn about and discuss the latest research in CBT, and it is a convenient venue for connecting with new and existing research collaborators. As the professional organization most focused on cognitive and behavioral therapy for mental health, I consider it important to stay abreast of the work of ABCT members and I also believe it is my duty to share back my own research and learnings for the benefit of the community.

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