Thanks to lax regulations and legal loopholes, Indian regulators have little control over the conduct of CROs in the country, but the government is on the path to reforms that would help rein in "fly-by-night" trial operators, officials said.
The majority of Big Pharma companies use CROs to conduct clinical trials in the developing world, but very few could provide evidence that they'd ever disciplined contractors that ran afoul of ethics codes, possibly putting participants at risk, according to a study by the Access to Medicine Foundation.
Biomarkers play a major role in personalized medicine, supporting diagnosis and identifying those patients who are (or aren't) likely to respond, and supporting drugs through clinical trials.
In an article in Life Science Leader, Pfizer's Craig Lipset talked about how the company's virtual clinical trial rolled out many new tech tools at once to trial the overall bladder drug Detrol, with some setbacks along the way.
The EU is looking to liberalize its clinical trial regulations to spur drug development in the Continent, and the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) wants to hear from CROs and drugmakers on the proposed reforms.
The British Medical Journal is on a crusade. Object: Twist Roche's ($RHHBY) arm enough to win full-and-complete access to Tamiflu data. The Swiss drugmaker did promise to hand over all of the data, after questions about safety and efficacy emerged in 2009, but three years later, the books are still closed.
Just days after nabbing a speedy FDA approval of its cancer drug Stivarga (regorafenib), Bayer says it nailed positive Phase III data on its new drug for rare cases of pulmonary arterial hypertension.
Researchers found that more than half of the lung cancer samples tested--72% of adenocarcinomas and 51% of squamous carcinomas--overexpressed the folate receptor, suggesting that this could be used as a biomarker for these cancers, as well as to target therapeutics.
These apps show just how broad and innovative the life science mobile world has become. Yet each is trying to solve the same critical problem--how can we make drug development more efficient? Here we present 15 mobile apps that tried to answer that question in 2012. Click here to view this slideshow >>
These apps show just how broad and innovative the life science mobile world has become. Yet each is trying to solve the same critical problem- how can we make drug development more efficient? Here we present 15 mobile apps that tried to answer that question in 2012 >>