The digital transformation of clinical trials

Leveraging technology to speed up drug development (720 words, 3.5 minutes)

Oct 10, 2023

The pharmaceutical industry is embarking on a digital revolution that could forever change the way new drugs are developed, tested and approved. Clinical trials, long a cumbersome process conducted at select locations on small groups of patients, are rapidly being transformed by technologies that promise bigger pools of participants, faster results and lower costs. The shift has galvanized scientists, regulators and drug companies, who see a chance to accelerate the delivery of vital new medicines through clinical trials that are larger, more efficient and easier for patients to join from their homes. While still in its early stages, the digital transformation is already rattling an entrenched system that has seen few advancements in decades.

Traditionally, clinical trials have been known for their intricacies, marked by lots of paperwork, logistical challenges, and prolonged timelines. However, digital transformation is paving the way for simplification, according to a study published in Innovations in Clinical Neuroscience. Developments such ans electronic data capture, digital patient recruitment, and remote monitoring have not only reduced paperwork but also made trials more patient-centric, which is expected to lead to better treatment outcomes.

One of the most significant aspects of this transformation is the use of artificial intelligence (AI) and big data analytics. A study published in the Journal of Health Technology reports that AI can analyze datasets in a fraction of the time it would take a human, identifying trends, outliers, and potential safety issues. By leveraging machine learning algorithms, it is possible to predict patient responses, optimize trial designs, and accelerate decision-making and drug development.

Another aspect of the digital transformation of clinical trials involves remote monitoring. According to an article from McKinsey & Company, the Covid-19 pandemic has accelerated the adoption of remote monitoring and decentralized trials. The article notes that this approach enhances patient convenience but also enables real-time data collection, reducing site visits and associated costs.

The paramount element of the digital transformation of clinical trials is probably the possibility of leveraging technology to expedite drug development. Pharmavoice notes that one of the ways in which technology expedites the drug development process is by facilitating faster patient recruitment. AI-driven patient identification and engagement strategies can swiftly identify eligible candidates, reducing recruitment times. Deloitte notes that it also allows for data-driven decision-making. Real-time data analysis enables quicker identification of safety concerns or efficacy signals, leading to timely adjustments in trial protocols. Additionally, digital tools facilitate adaptive trial designs, allowing for seamless modification of study parameters based on emerging data.

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THIS WEEK 10/10/23

The U.S. FDA approved Novo Nordisk’s nedosiran (Rivfloza) for the treatment of lower urinary oxalate levels in children nine years of age and older and adults with primary hyperoxaluria type 1 and relatively preserved kidney function.
Cyclopharm announced the FDA approved the commercial availability of Technetium Tc 99-m Labeled Carbon (Technegas) in the U.S. market.
Ontario, New Brunswick, and Prince Edward Island joined Quebec to reimburse Biogen’s ranibizumab injection (Byooviz), a biosimilar therapy for serious retinal disorders. Additionally, Byooviz will also be covered by the Non-Insured Health Benefits (NIHB) and Veterans Affairs Canada (VAC) Health Care Benefits programs.
Novavax announced the Novavax Covid-19 Vaccine, Adjuvanted (2023-2024 Formula) (NVX-CoV2601) received Emergency Use Authorization from the U.S. FDA for active immunization to prevent Covid-19 in patients who are 12 years of age and older.

LISTEN UP

In season 10 of the NPC Podcast, Shanil Ebrahim, Partner and National Life Sciences and Healthcare Consulting Leader at Deloitte Canada, discusses improving healthcare literacy, expanding the use and integration of healthcare data, and public-private collaborations promoting equity in healthcare. Hear him in conversation with podcast hosts Mitch Shannon, Jim Shea and Mark McElwain.

HEALTHBIZ REWIND

This feature of NPC Healthbiz Weekly looks back at some of the most insightful moments from previous NPC Podcast episodes. In Healthbiz Rewind, you’ll read bold life sci predictions made during the renowned “Prognostication Korner” segment of the NPC Podcast.

Dr. Angela Genge
Executive Director
The Montreal Neurological Institute
Montreal
Season 05, episode 01
Listen to this episode here

What bold predictions will you make about the life sciences industry during the coming 12 to 24 months?

Lots of things. We established a network called ERADICATE, which is linking institutions from coast to coast to upgrade our clinical trial effectiveness across the country. This upgrade will include a lot of efficiencies and give us the ability to promote Canada for a range of rare diseases. The technologies that are creating the new therapies are mind-blowing. We were approached for a gene therapy FTD trial that they’re doing in the U.S., and they’re looking at two sites in Canada. This is gene therapy for frontotemporal dementia. It’s wild, it’s fantastic! In my lifetime, I expect to see several [fatal] diseases turned into chronic diseases. I expect ALS, or at least certain populations of ALS patients will go from having a fatal disease to a chronic disease. I think the initial steps we’re seeing in Alzheimer’s, or frontotemporal dementia will be realized as much more effective therapies.

Six weeks away: It’s the 17th Annual National Pharmaceutical Congress on Wednesday, Nov. 22, 2023

The 17th Annual National Pharmaceutical Congress will be held on November 22, 2023, at the Mississauga Convention Centre. As Canada’s most significant stage for leaders in the pharmaceutical industry, the Congress presents industry reflections, ideas, and innovations. The Congress is attended by more than 200 delegates annually and is an opportunity to learn, reflect, and network with the industry’s most prominent thought leaders and visionaries. Register now for 50% off the regular price.

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