This guidance document replaces the Center for Devices and Radiological Health (CDRH)’s 2002 Least Burdensome Guidance. It defines “least burdensome” to be the minimum amount of information necessary to adequately address a relevant regulatory question or issue through the most efficient manner at the right time. (fda.gov)
An overview of microbiome research
The microbiome is the population of microscopic organisms that live in the digestive tracts of animals, including humans. Recent studies have identified new gut microbiome interventions to promote human health and combat disease. This article gives a brief history of microbiome research and outlines four main areas of ongoing research. (Medical x Press)
TrialAssure discounts trial disclosure software for universities
www.clinicalinformaticsnews.com
Only 11% of universities post clinical trial results to the European Clinical Trial Register (EUCTR) within required timeframes. TrialAssure is offering a program called TrialAssure Academic Pricing (TAP) to assist universities globally through managing and disclosing their clinical trial results in a cost-efficient manner, thus avoiding penalties for non-compliance. (CLINICAL RESEARCH NEWS)
How to increase the number of women in CV device trials?
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)
New FDA Guidance. February 2019
The purpose of this guidance is to assist sponsors of drug and biological products for the treatment or prevention of rare diseases in conducting more efficient and successful drug development programs. Although the statutory requirements for marketing approval for drugs to treat rare and common diseases are the same and issues discussed here are encountered in other drug development programs, these issues are frequently more difficult to address in the context of a rare disease. (fda.gov)
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
- « Previous Page
- 1
- …
- 6
- 7
- 8
- 9
- 10
- …
- 46
- Next Page »