As Easy as ABC?

Editor’s Note: This article was published in Pharmaceutical Technology Europe’s June 2019 print issue.

Recently, it was announced that several pharma companies, namely Novartis, Sanofi, Otsuka, and Pfizer, were to be strategically aligned with Verily, an Alphabet company, in an initiative aimed at engaging more patients and clinicians in clinical research (1). As clinical trials can sometimes prove to be a sticking point for drug developers, in terms of dwindling or even lacking participation numbers, could this initiative offer a paradigm shift by making trials more accessible?

The basis of Project Baseline

Project Baseline was originally launched in 2017 by Verily with the goal of closing the gap between clinical research and patient care. Partners of the original project included Duke University School of Medicine, Stanford Medicine, the American Heart Association, and Verily’s sister company, Google. Technology and tools, including DNA tests and wearable devices, were developed and built for the project, and were used to map out human health.

Now, Verily is looking to enrol more patients within its registry and the aforementioned industry partners will leverage the Baseline Platform-an end‑to-end evidence generation platform-to support their clinical studies across a variety of therapeutic areas. The ultimate aim is to create patient-centric trial programmes that will deliver ‘real-world evidence’ for the companies, which is certainly seems to be a buzz term currently experiencing enthusiasm within the bio/pharma sector.

“Evidence generation through research is the backbone of improving health outcomes. We need to be inclusive and encourage diversity in research to truly understand health and disease, and to provide meaningful insights about new medicines, medical devices, and digital health solutions,” said Jessica Mega, chief medical and scientific officer, Verily, in a press release (1). “Novartis, Otsuka, Pfizer, and Sanofi have been early adopters of advanced technology and digital tools to improve clinical research operations, and together we’re taking another step towards making research accessible and generating evidence to inform better treatments and care.”

Reinventing the clinical trial wheel

However, reinventing the clinical trial wheel is not necessarily a brand-new concept. There has been a plethora of news items in recent years on how various companies or research bodies are implementing technological solutions to help accelerate the costly and time‑consuming clinical trial process. 

The difference that perhaps makes Project Baseline stand out from the crowd is the ability of Verily to lean on its sister company, Google, to engage with patients using tools such as personalized advertising functionality for engagement. For example, if a patient performs a Google search for treatments within a specific therapeutic area, an ad that offers enrolment within a clinical trial from Verily could be placed on the web page being viewed by said patient.

“Our scientific knowledge has exploded over the past generation, but efficiently bringing these new breakthroughs from lab bench to patient requires us to greatly improve the way we conduct these complex clinical trials,” said Lionel Bascles, global head of clinical sciences and operations, Sanofi, in a press release (1). “Project Baseline will allow us to better recruit appropriate patients and more efficiently integrate data for a greater understanding of diseases, reconnecting trials to our patients’ healthcare journeys.”

Not in Europe, yet …

So far, the project is solely focused on the United States, but the company is hopeful to expand it out on an international scale. However, there may be some bumps in the road ahead for these plans, as European data protection could prove a challenging obstacle to overcome.

Google is already facing investigation by the Irish Data Protection Commission (DPC) surrounding the way it uses personal data for targeted advertising (2) and whether or not this adheres to the 2018 General Data Protection Regulation, which may mean Europe is not as attractive as other regions for rollout of Project Baseline. 

It will be a case of waiting and watching as to whether data protection becomes an issue for the initiative on the whole and whether the global uptake of stricter data regulations, a possibility given the political draw such issues can have, hampers the potential this project may have on accelerating the lab bench-to-bedside timeline of drugs in development.

References

1. Verily, “Verily Forms Strategic Alliances with Novartis, Otsuka, Pfizer, and Sanofi to Transform Clinical Research,” Press Release, 21 May 2019.
2. DPC, “Data Protection Commission Opens Statutory Inquiry into Google Ireland Limited,” Press Release, 22 May 2019.

Article Details

Pharmaceutical Technology Europe
Vol. 31, No. 6
June 2019
Page: 5

Citation 

When referring to this article, please cite it as F. Thomas, “As Easy as ABC?,” Pharmaceutical Technology Europe 31 (6) 2019.