As we at Hawthorne Effect deeply consider patient-centricity and evaluate models that put patients at the forefront of research, it makes me think about our role in the emergence of “Trials of Tomorrow” and how much has been accomplished in the years since our founding. Like many of you, we’ve been witness to a great deal of change in how clinical research is conducted with the tremendous adoption and traction of decentralized clinical trials (DCT), and we’re also extremely proud to have played an active role in those changes. Some of our notable accomplishments include:
- Bringing several life-saving drugs and medical devices through the FDA and to market that otherwise would have not made it at all, or be delayed due to late or missing data. This was the chief reason for Hawthorne Effect’s founding and is central to our mission.
- Completing a pilot of what will be a landmark trial in both design and proof that patients can participate in trials from Hawaii to Maine with greater representation of diversity and geographical distribution than seen in conventional trial conduct. Our model enabled researchers to define prevalence of a life-threatening disease, and we will continue to be a part of ongoing research. This trial design is seminal in that many more disease prevalence or post-approval surveillance studies can be done with unprecedented efficiencies. This is transformative!
- Building a fully integrated tech stack that intersects clinical trial management with a distributed health network of medical professionals. This is what allows Hawthorne Effect to conduct visits virtually and physically, not to mention serve as investigators that are accessible to patients anywhere, anytime.
- Showing with this proven platform that we enable clinicians in communities to be investigators without the need for research infrastructure through the HE “Hub and Spoke” investigator network model.
- Collaborating with retail health as partners in bringing the clinical trials to patients by enabling the first and last mile in their journey.
- Assembling and maintaining a team of extremely talented people who are down-to-earth, mission-driven, and dedicated to improving the lives of patients by connecting them with cutting-edge therapies and treatments.
- Enabling businesses, clinicians, academic institutions, other healthcare partners to literally transform the way they think about and conduct trials. This includes working with customers and stakeholders as they manage their own budget forecasts that were set in a model of the past and need to undergo transformation.
- Winning credibility with the industry, the FDA, and academics to partner and define a new era in clinical trials.
- Perhaps most importantly, serving and supporting patients and other segments of society underserved not only in clinical trials but in healthcare in general. Hawthorne Effect exists to help the homeless, indigenous populations living on reservations, patients in rural reaches or far corners of the US (Hawaii and Alaska), new moms just leaving the hospital with day-old babies, and so many others.
That’s pretty impressive progress over the last five years, and we’re excited that our trajectory has paralleled the evolution of both the DCT space and new innovations in healthcare delivery. Decentralized trials answered urgent challenges introduced by the COVID-19 pandemic, but we want Hawthorne Effect to move us past the reactive, tactical solutioning of the last three years and into a period of deliberate change. We see two converging trends that point the way forward:
Elevation of Clinical Trials in Overall Consumer Care
You may notice I chose “consumer” over “patient,” and that reflects the general shift in power and choice to patients and their families that we’ve seen happening in healthcare. The industry is wisely, if not slowly, evolving to consider patient-centricity as more than greater patient involvement in a treatment plan. In fact, the shift is toward rebuilding the patient experience as something they choose and control, and clinical research needs to be a part of that new paradigm. Consumers can pick up their phones and have almost anything brought to them where they are – patients should be able to do the same with their healthcare, and clinical trials are a part of that.
Revolution Via New Clinical Research Site Models
We see the true revolution beyond DCT coming through a shift towards treating clinicians as consumers and democratizing research site architecture, if not completely redefining the concept of a site. All clinicians should be empowered to bring novel research to their patients without facing the enormous technology and process hurdles that currently discourage broader participation. This creates the greatest flexibility and power for both patient and clinician, while simultaneously bolstering data quality and access.
The intersection of these two movements led to the creation of Hawthorne Effect, and it’s what led to the accomplishments listed above. As the industry continues to shift toward the model that we have wholeheartedly embraced, we expect to have many more successes to add to that list.
Jodi Akin, Founder + CEO
Jodi is a healthcare executive, leader, innovator, advisor, and serial entrepreneur. She has more than 20 years of experience in clinical development, scientific and regulatory strategy, management, and medtech market development from start-ups to S&P 500 companies. Prior to founding Hawthorne Effect, Jodi was Global VP Clinical Affairs at Edwards Lifesciences, where she led the seminal clinical trials and regulatory approvals for transcatheter heart valve therapy.
She holds an undergraduate degree in Foreign Service from Georgetown University, and a Masters in Physiology and Nursing from Pace University. She also holds eight patents.