We shouldn’t think of remote clinical trials as something that will decrease costs in and of themselves, simply because remote clinical trials should cost less. One of the biggest driver of cost savings when conducting remote clinical trials is the reduction in the number of investigator sites. Investment in developing a technology platform will be one of the biggest costs. (Clinical Leader)
Virtual vs. hybrid clinical trials
Virtual clinical trials eliminate the need for study sites. Despite their benefits, fully-virtual trials remain an exception. The hybrid model which allows sponsors to perform some procedures at sites but still reduces the number of sites has come to be popular. Regional variation in laws and regulations is one of the few impediments to hybrid and virtual trials. (outsourcing-pharma.com)
Should digital health startups be required to do randomized controlled trials?
Health care startups are attracting billions of dollars in risk capital, but most do not pursue the validation of a randomized clinical trial. Reflexion, a digital heal care startup, conducted a prospective randomized controlled trial of their product. They concluded that this method is not suited for the typical digital health startup, and propose that we streamline and accelerate the process for collecting proof of value for digital health startups. (statnews.com)
What Apple’s Health Records update means for the clinical trials industry
Apple has updated its Health app to give users access to their medical records – a new feature that could fundamentally change the way research is conducted, says Medidata. (Outsourcing-Pharma.com)
Novartis will expand use of Apple ResearchKit in clinical trials
Novartis says it will be scaling up the use of Apple ResearchKit in its clinical trials as part of its efforts to bring about digital transformation across its business. They will be strengthening their relationships with their tech partners including Apple to revolutionize how they discover and develop drugs. (pharmaphorum)
U.K. will trial online program for treatment of depression
Drawing by Vincent Willem van Gogh
The National Institute for Health and Care Excellence (“NICE”, in the UK), in a first, will be conducting a trial in the National Health Service (“NHS”) of an online program for the treatment of depression. The program uses cognitive behavioral therapy (“CBT”) to treat the condition and will be registered as a medical device. (PharmaTimes online)