Clinical trials can be fake – and dangerous – too

Worse than Fake News

From 2013 to 2016, more than two dozen people who thought they were participating in a clinical trial to obtain a vaccine for herpes. The participants, from the Caribbean island of St. Kitts and in the state of Illinois, had no idea that the Southern Illinois University (SIU) professor had never gotten approval for the so-called clinical trials from the U.S. Food and Drug Administration (FDA), a safety panel or the government of St. Kitts and Nevis. Participants had side effects such as dizziness, aches and ringing in the ears, although nobody had life-threatening issues.

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Lilly invests in Sigilon diabetes cell therapies

“Living Therapeutics”

Eli Lilly - a global healthcare leader founded more than a century ago – is paying $63 million up front to license islet cell encapsulation technology from Sigilon Therapeutics, a Cambridge, Massachusetts-based, privately-held biopharmaceutical company focused on discovering and developing "living therapeutics" with its Afibromer™ technology product platform. Sigilon, which is using the technology for Type 1 diabetes, could garner an additional $410 million in milestones and royalties, according to an article by Amirah Al Idrus in Fierce Biotech.

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Facebook wanted hospitals to share data about vulnerable patients

Patient Benefits vs. Privacy Concerns

It might have been a mission with merit, but its value is obscured when contemplating the potential for problems. Those problems have actually become a reality.

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New funding helps company to bring clinical studies to more doctors

Inclusiveness with Elligo

A new round of funding will go a long way to enable Elligo Health Research to fulfill its stated mission of providing “physicians and their patients the opportunity to participate in clinical trials using advanced health care informatics.” According to the company’s website, “Improved access to physicians and patients means sponsors reach trial enrollment goals faster, and new products are accelerated to market, benefiting patients everywhere…We accomplish this by being the preeminent provider of clinical research infrastructure (CRI) services and technologies. As a CRI provider, we bring together and empower sponsors, clinicians, patients and CROs to improve clinical trial access and efficiency.”

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GSK buys Novartis out of joint venture

$13 Billion Deal

GlaxoSmithKline (GSK) is buying Novartis out of the consumer healthcare joint venture the two companies had. The $13 billion buyout will give GSK full control of products such as Sensodyne toothpaste, Panadol headache tablets, muscle gel Voltaren, and Nicotinell anti-smoking patches. Under the terms of the 2014 deal to pool their consumer assets, Novartis had the right so sell its 36.5 percent stake to Glaxo. The transaction should be complete in the second quarter of 2018, subject to necessary approvals.

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Clinical Trial Registries Show Many Mistakes

Tracking Trials

A review of 10,492 clinical trials that are registered on both the United States government’s ClinicalTrials.gov registry and the European Union’s Clinical Trials Register (EUCTR) found that 16.2 percent had differing statuses on the two sites, and 33.9 percent of trials shown as “completed” on ClinicalTrials.gov were only “ongoing” on EUCTR, reported Melissa Fassbender in OutsourcingPharma.com.

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Researchers suggest ways to renew commitment to biomedical research funding

Competitive Edge

“Yesterday’s triumphs may pale beside the promise of tomorrow’s breakthroughs — if pressures on research funding don’t threaten the future of biomedical research,” said researchers Jeffrey A. Bluestone, David Beier and Laurie H. Glimcher in an article called “The NIH is in danger of losing its edge in creating biomedical innovations” in STAT.

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Delayed reporting leads to shaming by tracking

Scrutiny for Sponsors

There are consequences when clinical trial sponsors fail to report study results on time to clinicaltrials.gov. A new online tracker developed by the clinical trial transparency advocacy project AllTrials publicly shames these sponsors by putting them under public scrutiny,

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MIT research shows that 14% of drugs coming out of clinical trials get approved

Better Than Expected

A study published in the journal Biostatistics recently offers good news for pharma. Not only is the approval rate for drugs that go through clinical trials higher than anticipated (14 percent), but it is trending upward since 2013, according to researchers at the Massachusetts Institute of Technology (MIT). The study, which covered the period from 2000 to 2015, indicated that approval rates were lower between 2005 and 2013, but “have been trending upward since then,” according to an article by Ben Adams in Fierce Biotech.

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Blockchain Use Will Improve Clinical Trials

The huge amounts of data created in clinical trials make it increasingly hard to share the information safely, keep it from being compromised, protect subject privacy and increase subject recruitment.

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Major companies partner to control drug costs

Three very large companies, Berkshire Hathaway, Amazon and JPMorgan Chase bank, have agreed to jointly address the costs of prescription drugs for their combined 1.1 million employees, reported Ben Popken and Lucy Bayly on NBC News. The partners will create a new company to provide drugs “…at a reasonable cost.” An event of this size could have an impact on all of medical economics.

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Getting Genomics Data: DNAnexus completes $58 million financing round from strategic investors

Major companies have invested in a $58 million financing round for DNAnexus, a California-based genomics platform firm that offers a worldwide network for sharing and management of genomic data and tools to expedite genomics research. Directed by the healthcare-focused investment firm Foresite Capital, the funding included strategic investment from Microsoft, Alphabet’s investment arm GV (formerly Google Ventures) and Wuxi, reports Angus Liu in Fierce Biotech.

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Personnel Problems in Clinical Trials

Worker shortages, uneven performance top list

Despite the many advances in instrumentation and procedures, the clinical research sector still faces a major hurdle, reports Jim Kremidas, executive director of the Association of Clinical Research Professionals (ACRP), on the website www.outsourcing-pharma.com: both a shortage of workers in several categories including investigators, coordinators and site monitors, and the uneven performance and variability among research personnel. In the article, “A turning point: Examining the clinical research workforce in 2018,” he makes a case for bringing more people into the workforce and imbuing them with the appropriate skills to succeed.

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Should clinical researchers meet competency standards?

Clinical researchers have to balance increasing demands on their time with maintaining a patient-centered approach. Sometimes, professional standards are not meeting the reality of the positions.

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What are the emerging issues in pharmaceuticals in 2018?

New Year, New Trends

The new year is likely to bring notable development in several areas of the pharma industry, according to Ned Pagliarulo, Lisa LaMotta and Jacob Bell, writing on the website www.biopharmadive.com.

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