Apple partners with pharmaceutical giant GlaxoSmithKline for first clinical study – The Verge
The Verge reports on GSK’s announcement that it will adopt Apple’s ResearchKit in a study on rheumatoid arthritis. Using the framework to create its own app for the iPhone, GSK plans to use sensors from the smartphone to detect early signs of rheumatoid arthritis.
Rob DiCicco, GSK’s head of clinical innovation and digital platforms, said the company hoped that by using ResearchKit, it could potentially lower the costs of clinical research.
"Certainly you’ve also taken out the site costs, and the costs of having nurses and physicians explaining the studies to them and recording information," he said. "One thing we’ll learn is whether we made [the app] compelling enough to make you want to interact with it every day."
Read more about GSK’s efforts here.
Brainstorm: New ALS Stem Cell Results Support Start of Pivotal Clinical Trial – The Street
Brainstorm Cell Therapeutics (BCLI) has revealed that its experimental stem cell therapy, designed to treat ALS, has had a positive response in patients, reports The Street. BCLI said the results from a stem cell injection given to patients were promising when compared to the findings from participants that were given a placebo.
Although the therapy, known as NurOwn, didn’t indicate any other significant efficacy measures, BCLI said there is enough justification for it to be trialled in a larger phase 3 study for ALS patients.
Finish reading the story here.
Worldwide Clinical Trials Survey Reveals How Sponsors View the Role of CROs in Clinical Development – PR Newswire
According to a study by Worldwide Clinical Trials, 62 percent of respondents are more likely to partner with CROs for clinical research than they were five years ago, reports PR Newswire.
Conducted at the DIA 2016 conference in Philadelphia, Pa., the survey gathered the thoughts of 300 leaders and executives from the pharma and biotech space.
Crucially, 83 percent of respondents from the conference viewed the ability of CROs to deliver high quality data as a central factor in choosing a partner. That was directly followed by their capacity to deliver on time (76 percent) and to stay within budget (68 percent).
The results of the study indicate the “increasingly vital role that CROs are playing in modern drug development, and the importance of partnering with a CRO that offers medical and scientific expertise.”
Click here to learn more about this study.
Proposals to revise guidance on first-in-human clinical trials – European Medicines Agency
The European Medicines Agency (EMA) is to put forward changes on the current guidelines to first-in-human clinical trials in an effort to improve strategies and lower risks to patients, the agency revealed.
In a joint collaborationt with the European Commission and the EU, the changes have been outlined in a concept paper open for public consultation.
To learn more about the EMA’s latest efforts, read here.
Clinical research in India promotes transparency by moving to the cloud – Computerworld
India is rapidly developing as an international hub to conduct clinical trials, according to a report in Computerworld.
In the last few years, the Indian pharma industry has seen a sharp increase from 0.9 percent in 2008 to 5 percent in 2013.
The use of electronic data capture in clinical research, in particular, is on the rise with the Cloud giving researchers a boost in efforts to make clinical trial processes more transparent.
The report said: “This means that costs are manageable, which makes it viable for researchers and sponsors. But costs do vary from study-to-study on the basis of the volume and duration.”