Rob Scott, chief medical officer and vice president of development at AbbVie, recently gave OutsourcingPharma an inside look at how the company is disrupting industry standards in clinical development, detailing the ways in which companies are meeting the changing needs of the industry.
“Clinical development is really hard and getting harder every year,” Scott said. “It consumes the biggest chunk of dollars, it’s the most labor-intensive, and it takes a community of around 10,000 people.”
According to Scott, there are many variables that complicate clinical development. One of these challenges is collecting patient data through experienced clinical investigators. However, Scott said that finding patients can prove difficult as well and increasing regulations on how to collect that data adds an additional layer of complexity.
“We live in a time where there is an abundance of information and the pace of innovation is rapid. That certainly contributes to the challenge of clinical development, but ultimately it brings many opportunities,” Scott explained.
Using tech to tap into data
In an aim to improve the clinical development process, AbbVie is currently exploring the use of new technologies, including digital health tools, such as wearables.
While wearables collect huge volumes of data, access to that data can vary by device, Scott told us Often, user-friendly consumer devices process data through an algorithm. However, medical-grade devices, which are often not user-friendly, provide the raw data researchers need. No matter what, these types of technologies are now considered an important part of clinical trial design.
“In five years, I expect every clinical trial will incorporate some type of digital health element. In 10 years, we will see a lot of the manual work in clinical trials being automated, allowing us to do more with less,” Scott said.
Technology won’t just be a part of the clinical development process, but also is, and will be, a component in providing researchers better access to patients, noted Scott. AbbVie, and other clinical research companies, use systems that enable researchers to use ‘big data’ to identify sites with potential study participants, while still protecting the privacy of patients.
In particular, AbbVie has access to data from 32 million patients through a clinical trial database. As part of its development design center, the company has the technology package, IQVIA Design, which provides the company with much of its data.
Additionally, site identification tools enable companies like AbbVie to work with health care providers at a site to make patients aware of trials on a broader scale, said Scott.
“With digital health technologies, we can more frequently access real-time health metrics that help us understand how patients are doing in the trial,” Scott added.
AbbVie also uses patient-engagement apps to facilitate patient involvement in clinical trials. Patients also can be monitored through patient reported outcomes (PROs) via mobile applications. Informed consent can be done electronically, as well, informing companies that a site is meeting protocol without the need to send a monitor to the site.
With this data access and ability to standardize clinical trial design, Scott predicts there will be a paradigm shift in the industry, “a tsunami of change is coming to clinical development and we will ride that wave all the way into the future.”
Imagining a pocket-sized research site
Despite the possibilities of digital technologies, Scott told us their use in clinical trials “does not necessarily preclude the inclusion of standard protocols. Rather, digital technologies allow us to enhance those protocols and make the clinical trial even better.”
Randomized clinical trials will always be the gold standard for research, he said.
“When it comes to clinical trial design, we are just scratching the surface of how much data can be collected with very minimal effort,” Scott stated.
“I liken it to the banking industry in the 1980s, when everyone had a few ATMs where people drew cash, but most of the work was still being done using paper and pen in a branch office. People could not imagine that they would be carrying what amount to their own branch office, on a phone, in their pocket.”
However, according to Scott, in 2019 the clinical research industry has the advantage of being able to imagine carrying an entire clinical trial site and laboratory in their pocket in the same way.