Transparency in clinical trials is continually changing, and to stay on top of the news, TrialAssure brings a weekly round-up of some of the key stories surrounding disclosures in clinical trials. This week’s stories are as follows:
Should people share their DNA for drug development purposes? – USA Today
Many people don’t realize that sharing a DNA sample with Ancestry.com, 23andMe and others can result in their data being shared. However, this week, the companies pledged that they would disclose when data is shared with corporations or the government. With a $300 million investment by GSK in 23andMe, they state that approximately 80 percent of customers have agreed to share their DNA data. This data is being de-identified before it is shared.
Read the full article here.
Transparency in drug pricing – CNBC
Representatives Jan Schakowsky (D-IL) and Francis Rooney (R-FL) discussed a bipartisan bill with CNBC that would require pharmaceutical companies to explain large increases in the price of their drugs. It is called the Fair Accountability and Innovative Research (FAIR) Drug Pricing Act. Currently the industry does not have an obligation that requires such disclosure for elevated prices.
Read more here.
Policy 0070 redaction packages suspended by EMA until 2019 – MMS Expert Insights Blog
Last week, a forum thread in DIA Communities spoke to redaction packages being suspended until 2019 in Europe. This week, one of our clinical research organization (CRO) partners responded to the suspension in a question and answer session with redaction expert Rashmi Dodia, Senior Regulatory Operations Specialist, MMS. Rashmi states, “It is important for all sponsors to stay the course in the area of redactions, continuing to develop robust processes in advance of the regulation taking effect. This will allow them to be ready and proactive to get going when the suspension is lifted.”
Read the full Q&A here.
