Verily, the life sciences company owned by Google parent Alphabet, has partnered with Novartis, Sanofi, Otsuka, and Pfizer on a project that aims to speed up clinical trials. The pharma companies will use Verily’s clinical research tools- known as Project Baseline – to try to improve the recruitment of patients into clinical trials and make studies faster and more efficient. (pharmaforum)
North America leads the clinical trials market
The global clinical trials market size is expected to reach USD 6.89 billion by 2026, and one of the key drivers is the globalization of clinical trials. North America leads the market in terms of revenue share; Phase III trials are expected to dominate the market; and the oncology segment will grow the fastest. (Yahoo Finance)
Postapproval clinical trials are poor quality
Between 2009 and 2012, most newly approved therapeutics had at least 1 postapproval trial evaluating safety or efficacy. However, only 12% of the trials studied first FDA-approved indications, and more than 60% focused on unapproved or supplemental indications. Most were nonrandomized and uncontrolled, and more than one-third focused on a surrogate marker of efficacy rather than a clinical end point. (Cancer Therapy Advisor)
Cardiovascular trial reports “spin” negative results
A disturbing trend in cardiac randomized controlled trial (RCT) reporting in recent years is when negative study results are “spun” to sound positive. One spin strategy is focusing on statistically significant secondary results when the primary outcome is non-significant. According to a recent review, 57% of abstracts and 67% of cardiovascular articles put a positive spin on statistically non-significant primary outcomes. (Medpage Today)
Radiation therapy consent forms too complex
Before radiation, cancer patients usually get written consent forms to sign, which are intended to clearly spell out the treatment risks. A new study found that these forms are too complex for most patients to easily understand, suggesting that informed consent is not taking place. Although the National Cancer Institute recommends these documents be written at an eighth grade level, 92% were written above this level. (Reuters)
BMS taps Concerto HealthAI to bolster protocol design
Bristol-Myers Squibb enters a multi-year strategic agreement with Concerto HealthAI to use machine learning to aid in protocol design for precision treatment and improved patient outcomes. (outsourcing-pharma.com)
New drugs approved with only one clinical trial
In 1997 the U.S. Food and Drug Administration Modernization Act stipulated that the FDA may consider data from just one clinical investigation to approve a new drug. Of 59 novel drugs approved in 2018, 42% (25) were approved on the basis of only one trial. A large proportion of the drugs relying on only one trial were new orphan and cancer drugs. (Regulatory Focus)
Scaling down: Clinical research shifts its focus
Smaller companies last year led in new drug approvals, nearly half of which were for the treatment of rare diseases, as the industry shifts away from the need to scale infrastructure, says Tufts director. (Outsourcing-pharma.com)
Cost of clinical trials doubles in a decade
Clinical trials have recently become very complex, especially for small and medium biotech companies, due to increased costs and regulatory requirements. Between 2008 and 2019, the cost of clinical trials increased by around 100 percent. In a 2018 study, a central cluster of trials had estimated costs of $12.2 million to $33.1 million. The trials cost a median of $41,117 per patient and $3,562 per patient visit. (Clinical Leader)
Industry-sponsored clinical trials a boon to US state economies
Biopharmaceutical manufacturers in 2017 invested approximately $15.2bn at clinical trial sites around the country – resulting in a total economic impact of more than $42bn, says PhRMA director of public affairs. (outsourcing-pharma.com)
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