May 6, 2019
Trial professionals with questions about research ethics and oversight can turn to a new forum from WCG Clinical.
“Ask the IRB Experts” is a conduit to WCG’s industry authorities Lindsay McNair, chief medical officer; David Forster, chief compliance officer; Jeffrey Cooper, vice president of process and strategic improvement; Daniel Kavanaugh, senior scientific advisor, gene therapy; David Borasky, vice president of IRB compliance; Stuart Horowitz, institutions and institutional services head; and Yvonne Higgins, vice president of quality management for Copernicus Group IRB.
Questions may be submitted anonymously to the forum, and answers are posted on the WCG Clinical website.
To ask a question of the experts, go to: https://bit.ly/2XAzDTt.
Sharpless Points to Planned Guidance on Non-Opioid Trials
Speaking at the 2019 Food and Drug Law Institute conference last week, acting FDA Commissioner Ned Sharpless outlined the agency’s priorities this year, including new guidance for the development of non-opioid drugs.
“We are planning updated guidance,” Sharpless said, “outlining the appropriate clinical endpoints and clinical trial approaches for the development of non-opioid drugs for use in the treatment of acute and chronic pain.” He did not indicate a date for releasing the guidance.
Sharpless, a cancer researcher and oncologist for nearly 20 years and former head of the National Cancer Institute, also pledged to stay the course set by his predecessors, saying “I feel up to the task because of the great and stable leadership at the FDA who provide advice, and because of my relevant background.”
FDA Offers Clinical Guidance for Developing ADHD Meds
The FDA has released a draft guidance to guide sponsors developing stimulant drugs for attention deficit hyperactivity disorder (ADHD), outlining general considerations for trial design, clinical pharmacology and research involving pregnant women.
The guidance suggests several considerations for trial design. For example, it’s a good idea for sponsors to include data from adequate studies in pediatric patients in their NDAs, as the disorder begins in childhood.
A single trial in adult patients can support adult indications, the agency says, because there is a sufficient similarity between the pathophysiology, disease characteristics and treatment outcomes for children and adults.
NDAs also should include data adequate to assess the drug’s safety and effectiveness for patients four years of age and up. Sponsors should conduct one study in adolescent patients 13 to 17 years of age and one study in patients aged four to 12 to generate evidence of effectiveness.
Safety and effectiveness should be assessed using randomized, double-blind, placebo-controlled, parallel-group design trials, and sponsors should conduct at least one randomized, fixed-dose trial that examines more than one dose.
Many Oncology Approvals Based on Sub-Standard of Care, Study Says
Not all cancer therapies the FDA has approved in the past six years were evaluated against the appropriate standard of care, an independent study says.
Researchers from the Mayo Clinic and Oregon Health & Science University examined data on 96 cancer drugs approved by the FDA between January 1, 2013, and July 31, 2018, evaluating the strength of the control arms used in the randomized clinical trials (RCT).
They determined that 16 RCTs, 17 percent, relied on suboptimal control arms. Four of the 16 trials omitted active treatments in the control arm by limiting the investigator’s choice of agent, 10 used a control agent known to be inferior to other available agents and two relied on a previously used treatment with a known lack of benefit.
Fifteen of the trials were conducted outside the U.S., according to the study, published last week by the Journal of the American Medical Association Oncology. Two of the drugs were approved under an accelerated FDA pathway.
“Although anticancer drug approvals are increasing,” the researchers concluded, “a proportion of these drugs are reaching the market without proven superiority to what is considered the standard of care at the time of patient enrollment in pivotal trials.”
Most European Academic Centers Fail to Report Trials, Study Finds
More than four-fifths of European clinical trials are not complying with EU transparency laws, an analysis by a group of nonprofits has found.
Researchers at TranspariMED, Buko Pharma-Kampagne, Test Aankoop and Health Action International analyzed trials run by 30 different universities in Europe and the UK and found that 778 trials were “verifiably missing data” that was supposed to be reported to European regulators. Under European Union rules introduced in July 2014, every clinical trial registered in the EU must post summary results within 12 months of a trial’s completion — or within six months in the case of pediatric trials.
Fourteen universities — located in France, Italy, Norway and Sweden — have failed to post a single clinical trial result, the report shows, and 13 others “perform weakly,” with reporting rates ranging from 2 percent to 33 percent,” the researchers found.
The UK proved to be the bright spot in the study: Oxford University, University College London and King’s College London all have posted more than 80 percent of their trial results.
Universities in the U.S. are performing better than their EU counterparts, but still lagging in reporting compliance, according to a similar study TranspariMED and Universities Allied for Essential Medicines released last month (CenterWatch Weekly, April 1, 2019). One-third of U.S. academic research institutions have failed to comply with FDA reporting rules similar to the EU’s, the report says.
Read the report here: https://bit.ly/2IVS7uy.
Caris Life Sciences Buys Up Pharmatech
Biotech firm Caris Life Sciences has acquired Pharmatech, an oncology-focused site management organization (SMO) that has developed a way to speed up trial enrollment.
Pharmatech, an originator of the Just-In-Time rapid enrollment system, also brings to the table the largest research-ready oncology network, which Caris will use to connect hundreds of cancer research centers across the nation.
Caris’ acquisition is intended to shift the company from a traditional physician outreach model to a real-time approach that takes care of patient identification at the lab. The strategy removes the need for patients to travel to a central trial site by enabling the patient to be enrolled days earlier and stay in the local physician’s care.
Hacker Pilfers Client Data from Charles River Labs
A “highly sophisticated, well-resourced” hacker recently made off with some of Charles River Laboratories’ client data, the CRO reported last week.
On April 30, the company informed clients that parts of its information systems were accessed by an unauthorized intruder. Upon noticing “unusual activity” in mid-March, Charles River launched an investigation with the help of federal law enforcement and cybersecurity experts that is still ongoing.
Some client data was taken during the March breach, the CRO said, but it noted that there’s no evidence at this time that the data was deleted, altered or corrupted.
“The number of clients whose data is known to have been copied represents approximately one percent of Charles River’s total number of clients,” the company said.
Medicines Discovery Catapult Launches R&D Platform
In an effort to improve UK competitiveness in life sciences research, biotech nonprofit Medicines Discovery Catapult (MDC) has kicked off its Virtual R&D Discovery Services Platform, which features partnerships with 22 CROs.
The platform offers a matching service that helps small- and medium-sized enterprises (SMEs) in the UK link up with participating specialist, private-sector CROs to propel drug discovery. It also provides members with tools like comprehensive project reviews, data package assessments and development plan advice.
MDC said that 42 percent of the country’s biotech SMEs consist of fewer than five employees and require connections with outsourced scientific expertise and technology.