Recognizing that some trials must ask patients to share the cost of expensive investigational drugs, supplies or tests, the Secretary’s Advisory Committee on Human Research Protections (SACHRP) has developed recommendations to help sponsors stay on the right side of that ethical line.
The recent growth of the “pay to play” concept has led to a number of fraudulent trials — especially in the area of stem cell therapies — that draw patients into paying high costs for medically unsound treatments.
Whenever Amir Kalali asks himself if clinical trials are becoming too exclusive or competitive, he considers one point: How would the patient react?
“Would they applaud a competitive attitude that inevitably makes drug prices higher, or would they applaud a more collaborative effort, where we are in it for a particular disease,” asks Kalali, who is founder, chief curator and chairman of CNS Summit and former global head of Quintiles’ neuroscience center.
Defending against research misconduct is the responsibility of everyone involved in a trial, from the principal investigator down to the lowest lab technician.
Red flags can appear in any aspect of a trial, ranging from missing or altered data, significant omissions in published reports, investigators’ failure to disclose intellectual property interests or industry relationships, and generally results that seem too good to be true or apparently “perfect” protocol compliance, Donna Kessler, Duke University research misconduct review officer, reminded attendees at the Society of Clinical Research Associates annual conference last week.
The number of new trials rose in 2018, but sponsor investment in research and development remained steady, a new survey shows.
Phase 1 through phase 3 trial starts rose 12 percent in 2018 to 7,606, up from 6,794 in 2017, according to an Informa survey. Phase 1 starts totaled 2,900, up 3 percent, while phase 2 fell 4 percent to 2,469. Phase 3 trials held their ground with 1,373, less than a 1 percent increase.
To help increase the number of effective trials of regenerative medicine therapies, the FDA will work with researchers and sponsors to focus on the populations, endpoints and designs best suited to prove success.
Approximately 5,000 regenerative medicine trials are being conducted under the watch of the Center for Biologics Evaluation and Research (CBER) and Center for Device and Radiologic Health, but the agency is working to encourage more legitimate research in the area to combat the rise of untested treatments that put the public
at risk.
Half of all cancer drugs approved by the European Medicines Agency (EMA) from 2014 to 2016 were the result of trials that exhibited a high risk of bias and even exaggerated treatment effects, a new research study says.
Researchers at seven institutions in the U.S. and UK examined data from 39 studies resulting in EMA approvals following concern that new drug submissions in Europe lack enough scientific evidence to support approval. According to the study, risk of bias was seen in 19 of the oncology drug trials — in 10 trials owing to missing outcome data and seven due to the way outcomes were measured.
Drug manufacturers are making progress toward the FDA’s goal of increasing access to investigational drugs outside clinical trials, the GAO says in a report released last week.
Of 29 manufacturers GAO surveyed, 23 companies reported having an expanded access policy and only four stated they would not consider expanded access requests.
Bridging the gap between clinical care and clinical research may not be that far away.
The future of clinical trials will mean carving a new approach to how patients and doctors view clinical research, which will be a much more central part of everyone’s lives, even healthy people, says Ken Getz, director of the Tufts Center for the Study of Drug Development.
The best approach to mitigating placebo response is to develop a strategy that has all participants measuring the same things in the same way, two experts say.
Avoiding using a placebo arm in an efficacy trial is not always realistic, WCG Analgesic Solutions chief science officer Nathaniel Katz and WCG MedAdvante-ProPhase chief research officer Mark Opler told attendees at a recent WCG webinar.
The FDA’s draft guidance on broadening eligibility criteria and increasing diversity in clinical trials needs more definition and depth, according to drugmakers, clinical trial organizations and patients responding to the agency’s call for comments on the document.