Clinical Researcher—June 2022 (Volume 36, Issue 3)

OVER THE TRANSOM

Gary W. Cramer, Managing Editor for ACRP (gcramer@acrpnet.org)

“There are two sides, two players. One is light, the other is dark.”—John Locke

First off, an admission that when John Locke, played by Terry O’Quinn, delivers the above line in an early episode of the late, great television series LOST, he is explaining the rules of backgammon to another character, not chess. However, chess, with its opposing armies, fits my mental image of what this column is about more closely than backgammon and I’m charge here, so what I say goes—right? Right.

The stark symbolism of chess, and even older games of a similar nature (see senet, for example), must go back nearly as long as humans have been playing games. The notion of life and competition and our relationships to strangers being boiled down to light versus dark, good versus evil, us versus them—it’s not just buried in our subconscious. It all too often comes out to play in arenas of business—drug and device development, for example—where, yes, one expects healthy competition amongst the inventors and investors, but perhaps greater breakthroughs of real benefit to the masses could come from paying less attention to the scoresheet and more to the end-users.

This column, then, presents excerpts from announcements by various companies and sources of information (no endorsements implied) of new developments in software and service platforms one can imagine arising from strategic sessions that had more than just a “beat the other guy” mentality going on in them. I think it all goes to show that the more the stakeholders in the clinical research enterprise can foster the “we’re all in this together” attitude, the more wins we will all chalk up as we map the way to modern trials for the sake of better health and longer life for all.

Putting Patients in Control of Trial Technology

mdgroup, a provider of healthcare technologies and personalized clinical study services, announced in May that it is “transforming the clinical trial ecosystem with the launch of its enterprise solution,” known as Primarius3. The solution is intended to improve how patients, sponsors, sites, healthcare practitioners, and medical distribution centers connect through an integrated platform serving as a “central information hub and seamless integrated experience for site and home visits, hybrid services, compliant travel, expense/stipend management, and medical supply distribution, significantly reducing the [administrative] burden for all involved.”

According to the company, new technology places the patient in full control of how they receive and interact with all of their trial information, which “facilitates greater access to clinical trials, enhances patient engagement, and significantly reduces dropout rates,” as well as benefits the way sponsors and healthcare providers interact with information. The company adds that eventual updates will include home visit information for decentralized clinical trials, while also allowing management of medical supplies. “A rapid, fully integrated and automated [artificial intelligence (AI)] patient and site payment and reimbursement system is also due for release later this year,” mdgroup notes.

The Next Generation Arrives…

Emmes, a contract research organization, introduced to market its third-generation version of Advantage eClinical at the Society for Clinical Trials meeting in San Diego in May. The product’s cloud platform is now available as a standalone software product after undergoing more than two years of development. “The system has been specifically designed to provide fast study builds, greater flexibility, and insights to clinical trial sponsors of all sizes,” the company says, including apps for study design, electronic data capture, randomization and trial supply management, patient-reported outcomes, safety data and reporting, risk-based monitoring, source data verification, and specimen/shipment tracking. It will be offered as part of combined packages with data consultation services, or simply as a standalone software product. Emmes says the product has supported more than 1,000 trials, for nearly one million patients in more than 70 countries, spanning more than 31,000 clinical trial sites.

Trends in the Global Drug Discovery Software Market

According to a recent overview of the global drug discovery software market, the market is driven by an increasing research and development spend and pipeline, expanding scope and scale, increasing stringency of testing and regulations, growing number and size of biotechs, need for greater cost efficiencies and reduced time to market, and a move toward web/cloud-based software. The market is niche and growing rapidly, driven by the rising pressure on pharmaceutical and biotechnology companies to cut costs in the research and preclinical stage of drug development, reduce timelines, and improve transparency through deep learning software tools.

The overview goes on to note how the life sciences industry is increasingly recognizing the benefits offered by big data and AI/machine learning in drug discovery, and that biologics are expected to experience strong growth in the drug discovery phase; 50% of drugs currently in the preclinical phase are biologics. To leverage growth opportunities, companies are entering/expanding into biologics software space. The drug discovery software industry is slowly moving toward cloud-based solutions, as these can address most of the aforementioned issues with on-premise installations and provide quick deployment, minimum upfront costs, high flexibility, and scalability at affordable rates for even small and medium size pharma/biotechs, academic research/universities, and contract research organizations.

Focus on Cancer Patient Clinical Trial Recruitment

In June, Trialjectory, an AI-powered decision-support platform for patients, healthcare providers, and pharmaceutical companies, presented a poster on cancer patients’ clinical trial participation at the American Society of Clinical Oncology (ASCO) Annual Meeting. The poster highlighted clinical trial registration and participation for patients using the platform, showing significantly higher engagement and enrollment rates compared to reported national averages. The platform was highly effective at offering patients and their doctors access to relevant clinical trials for a patient’s exact diagnosis, which directly converted into higher referral and enrollment rates across different cancer types.

According to the company, the platform “helps patients to understand all of their available treatment options” so that, equipped with this knowledge, they “can then make more informed decisions about their healthcare in partnership with their oncologists.” Trialjectory adds that it uses AI and machine learning to efficiently sift through vast amounts of information that an individual doctor or patient cannot accomplish on his or her own, to successfully match patients to the most relevant clinical trials.

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