Black Friday, the day after Thanksgiving, is the biggest shopping day of the year in America. According to US News and World Reports, this year 99.1 million Americans shopped at malls and stores. However, an even larger number – 108 million – shopped online. Remarkably enough, this gap appears to be widening rapidly — in 2015, 103 million shopped online and 102 million shopped in stores.
This growing disintermediation enabled by technology is not limited to retail. For example, the traditional taxi service is quickly getting supplemented and supplanted by ride-sharing services like Uber and Lyft. Interestingly, these new offerings ultimately grow the market instead of just replacing the existing medium as evidenced by Uber’s estimated sales of $500 million in San Francisco adding to the $140 million sales for taxis.
While this disintermediation is highly disruptive to existing players, the benefits to the consumer are significant in terms of cost saving, convenience, and potentially new offerings. However, the existing players often adjust to the new models (for example, Walmart is one of the largest online retailers) and prosper alongside new entrants so long as they are willing to adopt.
The technology takeover has recently extended to healthcare. Hospitals such as Brigham and Women’s Hospital (BWH) in Boston are embracing virtual care or telehealth. Patients recognize the convenience and time saved by using virtual visits, and the speedier responses of e-visits. By embracing virtual care, Brigham and Women’s Hospital expects to reduce no-shows and increase the number of patients engaging with their doctors.
Clinical trials are conducted in the typical brick-and-mortar retail model since pharmaceutical companies use clinical trial sites (hospitals or ambulatory clinics) for conducting them. During the conduct of the trial, sites are responsible for recruiting, treating, and following up on the patients. Additionally, clinical trial sites act as intermediaries, receiving shipments of Investigational Products (drugs that are being tested in the trial), and then dispensing them to the patients.
In clinical trials, access to patients is one of the biggest factors driving costs higher and delaying completion of clinical trials. A study sponsored by the U.S. Department of Health and Human Services (HHS) estimates the patient recruitment and retention costs to be three percent of trial budgets (or approximately $2.28 billion per year). However, pharmaceutical companies are unable to directly recruit patients and run trials as healthcare providers are the intermediaries running clinical trials on behalf of pharmaceutical companies.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
In 2011, Pfizer with backing from the FDA, pioneered the concept of a virtual clinical trial in its US Research on Electronic Monitoring of OAB Treatment Experience (REMOTE). The objective of the trial was to study the safety and efficacy of Detrol LA (tolterodine tartrate) on patients suffering from overactive bladder. It used mobile and web-based technology for collecting study data from patients, thereby eliminating the need for a clinic visit. The goal of the study was to enroll 600 patients across 10 states in the US. Pfizer expected that if successful, this new approach could both speed up trials and improve their quality. Pfizer also promoted this study as an entirely new way for patients to participate in trials and contribute to biomedical research.
Although the Pfizer trial was not successful, it created a starting point for virtual clinical trials, and there are many resulting lessons that the industry learned. Strengths of the trial included the extensive online process to ensure that applicants were qualified, and the process Pfizer used to guarantee that patient consent was properly acquired. However, the main problem of the study was that Pfizer failed to recruit enough of the 600 qualified patients that they needed. Although Pfizer advertised their trial through a cartoon video and thousands created accounts to participate, not enough of these people were qualified candidates for the trial.
Craig Lipset, Pfizer’s head of clinical innovation, believes that the process of recruiting people online for the virtual clinical trials could potentially be successful, but that conventional offline channels are more effective for certain diseases and severity levels. Thus, the industry has not given up on the concept of the virtual trial.
In 2015, Sanofi announced that it would hold its own virtual clinical trial in Europe. However, instead of testing a drug, the trial used Mendor’s 3-G-capable, wireless glucose meter to automatically send patient blood glucose levels to physicians. Therefore, measures could be taken in real-time to stabilize sugar levels. Additionally, the trial process was handled differently from the Pfizer trial. Although there was no physical trial area, the VERKKO remote online Phase IV clinical trial for diabetes used multiple partners. Although both Pfizer and Sanofi’s studies used social media recruitment, Sanofi’s trial was successful in recruiting patients, proving that the problem may have been with the specific disease studied in the Pfizer trial, rather than with virtual clinical trials themselves.
Just as virtual clinical trials are currently being explored to improve the patient experience, direct-to-patient trials are also being tested. Similarly, in direct-to-patient trials, clinical trial centers are eliminated as intermediaries. Instead, doctors make home visits to patients, and patients receive their medications directly in the mail. This system could potentially greatly increase patient convenience and engagement. Geographical barriers would no longer limit participation since patients would not be required to live close to clinical trial sites, or make long, time-consuming journeys.
Companies such as Science 37 are exploring this idea to pioneer better clinical trial programs. Science 37 offers “metasites”, or direct-to-patient trials in which patients can use their existing doctors, or receive home visits. To create the optimal direct-to-patient experience, Science 37 uses a cloud-based mobile platform, NORA (Network Oriented Research Assistant), to connect patients, researchers, and health professionals. The use of smartphones, which almost two-thirds of Americans use, could also make clinical trials much more accessible and easy for people to participate in.
Similarly, Elligo Health Sciences is a company dedicated to running direct-to-patient trials. The company believes that the convenience of receiving care from home, and receiving investigational products directly at home will help to create trials in which more patients participate, thus accelerating the trial results.
Although virtual clinical trials and direct-to-patient trials could revolutionize the healthcare industry, they are not sufficient for every type of trial. For example, cancer treatment trials would be best run from clinical trial sites since patients need biopsies. In other cases, finding participants for specific trials is easier in offline situations. However, the reform of the health care industry through technology is undeniable, as the concepts of virtual clinical trials and direct-to-patient trials are currently being explored. While these models are still currently being reformed, they could ultimately help expand the patient population—improving trial results, and potentially leaving clinical trial sites as a notion of the past.
Jasmine Syed contributed to this article.
Photo: Jirsak, Getty Images
