The benefits associated with medical cannabis therapy may be overestimated because of inadequate blinding in clinical trials. Many trials are flawed by inadequate blinding because subjects can distinguish between active cannabis and placebo. It is difficult to design a well-blinded study for cannabis therapy; in the meantime we should use caution when interpreting the findings of cannabis trials. (Psychiatry Advisor)
New book. “The Danger Within Us: America’s Untested, Unregulated Medical Device Industry and One Man’s Battle to Survive It”
Drugs must undergo two clinical trials before being allowed on the market, but the overwhelming majority of medical devices that are on the market that are implanted in patients undergo no clinical trials. The 21st Century Cures Act passed in 2016 allows the level of evidence that’s used to approve medical devices to degrade even further. (wbur.org)
Investigation raises concerns about animal studies used to support clinical trials
An investigative report published in the British Medical Journal raises new concerns about the quality of animal research and the misrepresentation of findings from animal studies. Flaws in the design and reporting of animal studies that are used to justify the launch of clinical trials are not universally recognized. We need better ways to establish when a drug is ready for clinical trials in humans, and when it is not. (MEDPAGE TODAY)
Predictions for 2018: A radical rethinking of the clinical trials process
From the Editor in Chief, Fortune. His predictions of three developing trends for the new year include, among others, a radical rethinking of the clinical trials process. This year, we will have a new tool to explore in the clinical research setting: artificial intelligence, which will allow us to use computer learning to better anticipate which drugs will work well in any one person. (Fortune)
AI and machine learning may double the odds of success of clinical trials
On November 21, Clinical Research Currents had the opportunity to interview Travis May, Co-Founder and CEO, Datavant As a technologist looking at the biopharma industry, it’s surprising and disconcerting how little data is shared. Biopharmaceutical data is siloed across big pharma companies, universities, healthcare consortia, CROs, research groups, hospital systems, regulatory Read more
Cambridge Healthtech Institute will launch inaugural conference on AI in clinical trials
Artificial Intelligence and Machine Learning in Clinical Research:
AI, ML, ROBOTICS, ADVANCED ANALYTICS, BIG DATA
FEBRUARY 14-15, 2018 | HYATT REGENCY ORLANDO | ORLANDO, FL
Artificial intelligence (AI) and machine learning (ML) have propelled many industries and are now starting to make their way into clinical research. Many pharmaceutical companies and CROs are starting projects involving some elements of AI, ML and robotic process automation in clinical trials. Cambridge Healthtech Institute (CHI) will launch this inaugural conference, part of the 9th Annual SCOPE Summit, to accelerate the adoption of these approaches in clinical trials. (scopesummit.com)
Pharma companies are recruiting top talent from tech giants like Google and LinkedIn
GlaxoSmithKline, Johnson & Johnson, and other pharma companies are actively recruiting technologists from companies like Google and Microsoft’s LinkedIn, to help modernize the processes that big pharma uses to discover and develop new drugs. According to a GSK spokesperson, there are plenty of opportunities for tech workers to build machine learning tools that analyze health information. An ongoing project may use previously-collected clinical trial data as an alternative to a control arm in a study, which could potentially reduce the cost of clinical trials and provide a better patient experience. (CNBC)
IBM Watson, CDC hunting for new blockchain applications for healthcare
The Centers for Disease Control and Prevention (CDCP) has signed on with IBM Watson Health to explore new applications for blockchain in healthcare. IBM says this is an expansion of its existing work with the U.S. FDA, which is exploring potential blockchain applications for EHRs, clinical trials, internet-of-things, genomics and more. Blockchain technology offers a high level of security, and when combined with AI holds big promise for managing patient data. (HealthcareITNews)
Will New Jersey’s crackdown on doctor kickbacks hurt clinical trials?
New Jersey is considering passing a new rule that would limit a physician’s compensation received from pharma companies at $10,000 a calendar year. However, according to ACRO (Association of Clinical Research Organizations), if not modified, this ceiling would also include clinical trial payments and would make it impossible to enroll a single patient in many trials, as the cost per patient of a cancer trial is around $10,000 to $20,000. A recent bill passed in California restricts such payments but leaves clinical trials out. (FierceBiotech)
Growing cancer drugs in chicken eggs could lower the cost of drugs by 90%
Japanese researchers may have found a way to produce cheaper drugs from chicken eggs. They have successfully genetically modified hens using CRISPR to produce eggs containing large amounts of interferon beta protein, a very expensive protein used to treat various illnesses including multiple sclerosis and cancer. The protein costs between $300-$1000 for just one microgram procured with current methods; for treating MS, the interferon dosage can start at 30 micrograms. This technology could reduce the price of cancer drugs by 90% if proven successful in further trials. (CNN)
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