NEWS

A first from Clinical Research Association

4^th National Clinical Research Congress will be held between 6-7 February 2020 virtually.

Switzerland, Sweden, and USA are on the top 3. Turkey ranks 49th.

The FDA said Tuesday that Novartis submitted manipulated data as part of its application for a new gene therapy, and didn’t tell the agency until after the treatment was approved. The drug is called Zolgensma. It is used for children less than 2-years-old with spinal muscular atrophy and costs $2.1 million.

ICH E8 General Considerations for Clinical Trials was first released in 1997. Due to changes during years clinical study design and conduct have become more complex, impacting the time and cost required to develop drugs. The draft reflects these changes.

Placed inside the Boğaziçi University Center for Life Sciences and Technologies ‘’Experimental Animal Care and Breeding Unit’’ (Vivarium) has received full accreditation from the only accreditation institution on using animals for science experiments AALAC International, making it the only accredited experimental animal laboratory.

A study is performed to determine the level and prevalence of spin in published reports of cardiovascular randomized clinical trial reports. Spin is defined as the manipulation of language to potentially mislead readers from the likely truth of the results, can distract the reader and lead to misinterpretation and misapplication of the findings.

According to an analysis in Annals of Internal Medicine clinical trial results involving 90,000 people were never reported.

According to an analysis in Nature Drug Discovery the best selling drug is AbbVie’s Humira (adalimumab) and the best selling company is Pfizer..

President Donald Trump, Vice President Mike Pence, Senate Majority Leader Mitch McConnell, Senate Minority Leader Chuck Schumer, and Speaker of the House Nancy Pelosi joined a conference today addressing the national patient enrollment crisis in clinical research studies.

The purpose of the study is to research the effects of microgravity on the human body. The study simulates the effects of long-duration spaceflight by having test subjects lie in beds for the 70 day period.