India's Central Drugs Standard Control Organization has released its proposed clinical trial reforms, and while most fall in line with industry expectations, ACRO says the suggested rules on patient compensation are vague and problematic.
Parexel CEO Josef von Rickenbach will serve as chairman of industry group ACRO this year, succeeding PharmaNet CEO Jeffrey McMullen.
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.
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.
In a YouTube message from Vice President John Lewis, ACRO refutes what it calls "the entertainment industry's assault on medical research."
With some insight from the Association of Clinical Research Organizations (ACRO) and CROs, such as Icon and Covance, we at FierceCRO set out to identify countries that offer the right mix of features for outsourcing and clinical work. But rather than focus on markets with well-established CRO operations, we looked for promising, upwardly mobile countries.
After 10 years of dwindling interest from medical researhcers, Europe is considering revising its rules on clinical trials. The European Commission is proposing a revision to the Clinical Trials Directive, and CRO groups have praised the idea.
While the study showed data quality from places like India, Eastern Europe and Latin America is on-par with Canada and the U.S., the study isn't perfect, ACRO admits.
ACRO is less than pleased with Toshiba, calling its latest TV ad offensive to clinical research and test subjects.
More than a week after testifying to the FDA on how it can improve its drug development and clinical trial regulations, ACRO wonders whether the FDA took its recommendations to heart.