Although the prevalence of cardiovascular disease (CVD) is similar for men and women, men comprise 70% to 80% of enrollees in CV device trials. A new position statement published in Journal of the American College of Cardiology (JACC): Cardiovascular Interventions issued a call to action to multi stakeholders to halt the perpetuating cycle of female underrepresentation in CV studies. (Healio)
“Synthethic control” trial design can save time and money
An innovative approach to collecting control group data in clinical trials called “synthetic control arms” means that, instead of collecting data from a newly-recruited control arm, synthetic control arms model those comparators using real-world data that has been previously collected. This approach reduces the number of participants needed for trials and eliminates participants’ fears that they will end up in a placebo group. (STAT)
New research ‘supergroup’ looks to reduce the number of required clinical trials
The MI-based CRO MMS Holdings is among the team at the Health Analytics Collective, a research group hoping to reduce the need for new clinical trials by using readily available data – and an MIT-incubated programming language. (outsourcing-pharma.com)
Real-world survival rates with medical device much worse than in trials
Survival rates in the post-approval study for the Abiomed Impella RP right ventricular assist device were dramatically worse relative to the device’s clinical trial data. While 73% of the device’s users survived at least 30 days in the premarket study, just 17% have met this primary survival endpoint since the device went on the market in 2017. (MEDPAGETODAY)
Global contract research organization (CRO) market may reach $55 billion by 2025
According to a new report, the global contract research organization (CRO) market was valued at approximately USD 34.12 billion in 2018, and is expected to generate around USD 55.16 billion by 2025, at a CAGR of around 7.10% between 2019 and 2025. The main factors expected to drive the CRO market in the coming years include an increasing number of clinical trials and growing R&D expenditure. (Zion Market Research)
CRA burnout in clinical research
By Eleanor Houston, Senior CRA, Industry Gain insight into the factors of CRA burnout in clinical research from the 2018 PharmaTimes Clinical Researcher of the Year New CRA. It is no secret that CRA turnover is a huge issue in the clinical research industry. It is not uncommon for sponsors Read more
“Hey Alexa, find a Clinical Trial for me….”
Article by Guest Blogger Kathy Perez In this age of smart phones, cloud-based voice helpers and all things “Google” the public and medical profession have many ways to find a clinical trial. The most comprehensive listing of clinical trials in the world can be found at www.clinicaltrials.gov but when you Read more
Eligibility criteria exclude most ALS patients from clinical trials
According to a recent study, if the eligibility criteria of ALS targeted clinical trials were applied to a population of ALS patients in the Netherlands, nearly 60% of these patients would have been excluded from clinical studies. The authors recommend that we use a prediction model to select patients for clinical trials, rather than standard eligibility approaches. (ALS NEWS TODAY)
Trials exclude patients with mental or psychiatric disorders
According to the FDA, nearly 50% of investigational new drug applications excluded patients with mental or psychiatric disorders. Should cancer clinical trial eligibility regarding mental illness be relaxed? One viewpoint is that we should relax enrollment criteria and avoid unnecessary exclusion of patients with serious mental illness. (Healio)
National Cancer Institute expands eligibility criteria for trials
The National Cancer Institute (NCI) has revised its clinical trial protocols to expand access for previously excluded patients. The revisions expand access for potential participants with preexisting conditions in 4 categories, and patients under the age of 18 years. (OncLive)
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