Johnson & Johnson was cautiously lauded for its clinical trial data-sharing initiative, but Roche's project was pilloried. Now Novartis has joined its Swiss peer in rolling out an underwhelming transparency program.
The BMJ and others spent years trying to get Roche to release Tamiflu data, and the criticism continued even after the Swiss pharma put in a new results-sharing policy. Now, Roche is facing a situation where sharing trial data may be the best way to clear up the effect of Avastin on brain cancer.
Merge Healthcare shareholders got a nasty shock at the start of the year after the discovery of falsified contracts prompted the company to wipe $15 million off its eClinical backlog. A string of press releases discussing potential legal action followed, but Merge has dismissed the criticisms as meritless
Clinical trial data collection has evolved slowly over the past two decades from site visits and paper questionnaires to telemedicine and electronic patient reported outcomes. The transition is far from complete though, with the likes of CamNtech and Medidata now looking to bring wearable computers to clinical trials.
Oracle is bringing voice recognition technology to clinical trials through a partnership with a company that helps power the iPhone's virtual assistant, Siri.
When the FDA began drafting plans to meet Congress' drug safety legislation, the agency predicted that postmarket surveillance would ultimately become as big a task as premarket review. Since then, the system those plans spawned--named Mini-Sentinel--has given credence to the prediction by growing to cover more than 160 million patients.
Trialbee informs people about upcoming trials by talking directly to patient groups on social media and through mobile apps.
The slow seep of software into the running of clinical trials has accelerated in recent years as its reliability has been proven by pioneers and everyone has become increasingly desperate to boost productivity. After this period of growth, the eClinical market is on the cusp of becoming a $5 billion sector.
The merger expands the range of medical imaging services BioClinica can offer while also moving it into new areas, notably clinical trial services and patient recruitment.
With pressure mounting on drugmakers to make clinical trial data more transparent, Pfizer has started to take steps to open up its results, unveiling more concrete details and a timeline for adoption this week.