From The Editor | November 11, 2016

Clinical News Roundup: Artificial Intelligence Ready To Run Clinical Trials

Ed Miseta

By Ed Miseta, Chief Editor, Clinical Leader
Follow Me On Twitter @EdClinical

ClinicalNews

There are those who believe that artificial intelligence (AI) can make clinical trials cheaper and faster. We are about to find out if that hypothesis is true. A British start-up is about to begin testing its AI technology to optimize drug development.

BenevolentAI specializes in AI, and its BenevolentBio division, formerly Stratified Medical, is now applying it to human health and biotech. The technology is expected to speed up late-stage development of drugs and provide richer clinical data. The company has announced it will test the technology using clinical stage drug candidates licensed from Janssen.

Although there are no details on the agreement, BenevolentAI is confident that it can accelerate clinical development and begin Phase 2b trials in mid-2017. If everything works out, the company will have exclusive rights to develop, manufacture, and commercialize these candidates.

BenevolentBio focuses on inflammation, neurodegenerative disease, and rare cancers, although its machine learning technology is flexible enough to be applied to any biomedical area. Before the agreement with Janssen, the company had already identified two novel targets for Alzheimer’s and licensed the discovery.

UPS Expands Clinical Reach With Marken Acquisition

UPS has entered into a definitive purchase agreement to acquire Marken, a global, privately-held provider of supply chain solutions to the life sciences industry. The transaction, which provides UPS with growth opportunities across the life sciences customer base, is expected to close by December 31, 2016, subject to customary conditions and regulatory approvals. Terms of the acquisition were not disclosed.

Clinical trial logistics is an area of growth for many companies involved in the life sciences, with PAREXEL, Catalent Clinical Supply, and others building up their capabilities to deliver to this sector. This is, in part, due to clinical trials requiring strict regulatory compliance, streamlined logistics services, and global reach. Marken currently operates a global network of clinical supply chain services to meet these increasingly complex demands. The acquisition of Marken follows multiple UPS acquisitions that have expanded the company’s healthcare logistics services portfolio.

“Healthcare logistics is a strategic market for UPS,” says Teresa Finley, chief marketing and business services officer for UPS. “Our acquisition of Marken strengthens our portfolio and demonstrates our commitment to customers. We plan to offer new solutions to our customers and generate further growth opportunities for UPS.”     

Marken CEO Wes Wheeler notes his company is excited to join the UPS organization, citing UPS’s capabilities in mature markets as a key reason the merger will provide many opportunities for Marken to enhance its service offerings in clinical trial logistics. “With UPS, we will improve our efficiency, while continuing to provide our clients with the high-touch, personalized services that they have come to expect from us,” he says. Wheeler will continue to lead the Marken business, which will operate as a wholly-owned subsidiary of UPS.

New Tool Helps Track Unpublished Trial Data

Results of nearly half of all clinical trials conducted in the last decade by Big Pharma  have not been published, according to an analysis of data from TrialsTracker, an online tool that identifies studies on ClinicalTrials.gov that haven’t published results two years after the trial has ended.

TrialsTracker was developed by the AllTrials consortium, a group calling for the results of all clinical trials to be published. The tool includes sponsors with more than 30 interventional trials and excludes Phase 1 trials. According to the analysis, since January 2006, trial sponsors completed 25,927 eligible trials and have not published results for 11,714 trials, or 45.2 percent. These 11,714 trials with missing results enrolled an estimated 8.7 million patients. Síle Lane, director of campaigns at Sense About Science, which runs the AllTrials campaign, stated in a news release that we should all be outraged.

"Everyone has been talking about this problem for far too long,” adds Ben Goldacre, MBBS, MRCPsych, one of the founders of the AllTrials campaign for clinical trial transparency and one of the researchers behind the TrialsTracker. “We hope that increasing accountability will help to drive change forward. The TrialsTracker helps to identify the individual universities and companies with the most overdue trials."

Of course not all pharma companies agree with the analysis and findings of TrialsTracker. Ameet Nathwani, MD, chief of medical affairs for Sanofi, told Medscape Medical News the company disagrees with the analysis, noting it does not capture many publicly available clinical trial results. Of the 285 Sanofi study results deemed missing by TrialsTracker (the most of any sponsor company), he notes results for 255 of those trials (90 percent) are available on either the EU Clinical Trials Register or the Sanofi website.

"We respect and follow all relevant governmental regulations concerning the disclosure of clinical trial results," adds Nathwani.

Zika Vaccine Declared 100 Percent Successful On Rats

Trials of a new Zika vaccine have been 100 percent successful in blocking the virus and its devastating side effects, according to a new report. The global spread of the disease shows no sign of letting up, and efforts to control it have so far proved futile. The first clinical trial to test Zika-susceptible animals has found that a synthetic DNA vaccine successfully protected the immune system and brain of lab rats in every case.

It is the most promising result of a Zika vaccine to date and it is the same one being tested in the first human clinical trials. None of the lab rats in the study in Philadelphia's Wistar Institute contracted Zika after getting the vaccine. Those that were infected before being vaccinated were protected from any kind of damage to the brain's hippocampus and cerebral cortex, the targets of the virus.

“Our results support the critical importance of immune responses for both preventing infection as well as ameliorating disease caused by the Zika virus,” says lead researcher David Weiner, M.D. and director of The Wistar Institute's vaccine center.

Takeda Announces Clinical Trial Digital Health Collaborations

Takeda is looking to up its digital strategy game, pairing with a few companies to advance clinical trials, analyze data, and develop biosensor and wearable technology. Takeda has adopted the platform of Koneska Health, an early stage technology company that works with data gathered through mobile, wearable and other digital technologies to measure health indicators, to power some of the pharmaceutical company’s clinical trials using biosensors and wearables.

The goal for Takeda is to develop what it calls “digital biomarkers” – data gleaned from devices that continuously monitor patients’ vital signs, activity levels, and sleep metrics. Ultimately, Takeda hopes such metrics will aid in decision-making and help establish endpoints to assess a patient’s functional status in an everyday setting.

“Working with Koneska enables us to take advantage of technologies and expertise that provide access to novel data streams and make our clinical trials more patient-centric,” Takeda’s Senior Director of Novel Data Streams and Devices Elena Izmailova said in a statement. “Koneska’s end-to-end solution allows us to collect this data in our studies using Koneska’s sensors and devices. Takeda’s commitment to digital health involves working with an ecosystem of external partners that, like Koneska, have a focus on both rigor and innovation."

This comes just a few months after Takeda launched a pilot project using wearable technology to manage symptoms and triggers for inflammatory bowel disease. Takeda is also collaborating with German image analysis and data company Definiens for another aspect of clinical trials – tissue analysis. Using Definien’s cloud-based digital pathology platform VeriTrova, which allows for biomarker analysis, Takeda will leverage the technology reduce the normal analysis time from months to weeks.

Tips On Setting Up A Successful Community-Based Clinical Trial Program

Clinical research in private practice is thriving and the future is bright, according to urology physicians Daniel R. Saltzstein and Lawrence Karsh. “Clinical research allows practitioners to positively impact their community and patient care while advancing their careers and generating revenue,” says Karsh, director of clinical research at The Urology Center of Colorado in Denver. The pair gave pointers for setting up a clinical trial program during a breakout session at the 2016 Large Urology Group Practice Association (LUGPA) Annual Meeting.

According to Karsh, physicians have many possible reasons to participate in clinical research. He cited benefits such as ensuring that patients have access to cutting-edge therapies at no additional cost and contributing to society’s greater good. But there are also practice-related reasons for doing so. Researchers receive an ancillary revenue stream, build their professional stature, and increase the odds of being published in scientific journals. “Research ‘feeds the beast’ by attracting new patients to your site and ensuring utilization of your in-house labs and imaging facilities,” he said.

Karsh speaks from experience. He has 20 trials that are currently enrolling participants plus 15 more trials that are ongoing. “I think it’s a huge bonus to learn how to use therapies before they even enter the market because it gives you the edge against other practices,” he said. “Be clear that this won’t be a windfall and you can even lose money if it is not managed properly. But we’re getting market rates for all we do, not Medicare or negotiated rates.”

According to Saltzstein, director of clinical research at Urology San Antonio, community physicians make attractive partners to pharmaceutical companies. “When they deal with academic medical centers, they often encounter slow review of proposals, delays in enrollment and start dates, competing priorities, and a lack of urgency,” he said. “Community physicians are able to review proposals and contracts faster, recruit patients more rapidly, and offer an overall lower trial cost and greater diversity of patient base.”