Europe is embarking on the second, decadelong part of its public-private partnership to improve drug development, with Parliament agreeing this week to contribute to the €3 billion ($4.1 billion) program. And the "yes" vote will mean more cash for IT.
The United Kingdom's long history of public healthcare gives it an enviable trove of patient data. Yet this resource, which is perhaps the one true competitive edge possessed by U.K. biopharma, is at risk of being squandered as the project continues to buried by mismanagement and a blizzard of negative publicity.
During a week in which The Guardian revealed that Britain intercepted and stored webcam images from millions of people, the FDA email snooping revealed in 2012 looks relatively innocent. But Republicans investigating the program think the regulator may have violated whistleblower laws by monitoring employees' emails.
The information comes from Genetic Epidemiology Research on Aging (GERA), a cohort of more than 100,000 adults with an average age of 63 years old.
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.
Over the past few months, even independent advocates of plans to digitize and commercialize U.K. health records have admitted that the government has bungled aspects of the implementation. Now the government is paying the price for its missteps.
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.
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.
Last year 18 universities, companies and government agencies founded the National Consortium for Data Science. The consortium has a broad brief but soon established the challenges and potential of Big Data are writ largest in one field--genomics.
Clinical trials have increased in complexity over the past decade, with sponsors working with an increasing number of sites, countries and service providers. These massive globalized studies place new strains on the organization of essential study documents, collectively known as the trial master file.