As the global head of clinical innovation for Eli Lilly and Company, Katherine Vandebelt knows there are many things pharma needs to do better. No drug can make it to market without first navigating the clinical trials process, which creates a burden on the physicians involved. Therefore, it should come as no surprise to anyone involved in the process that many physicians will oversee one trial and then opt to no longer take part in them.
Two issues that always seem to throw a wrench into sponsor/CROs relationships are changes to staffing and pricing. Protocol changes can disrupt trials for CROs and cause price increases for sponsors. Staffing changes can create new learning curves, delay trials, and cause sponsors to feel they were misled. Are penalties an easy way to fix both?
Can the peptide Lunasin help to reverse the debilitating effects of ALS? After one patient (and three experts) noted it could, PatientsLikeMe and the Duke ALS Clinic decided to get involved. Their novel trial will feature an unlimited number of patients, sharing of all patient data, and electronic patient reported outcomes. It also eliminated the use of a placebo.
Fitness trackers were popular holiday gifts this year and sales are on the rise. While counting steps and getting fit may be the primary reason consumers are purchasing Fitbits and other wearables, other sensors these devices include, such as heart rate and sleep monitors, could actually help big pharma collect a wealth of valuable data to revolutionize personalized medicine.
The introduction of electronic data capture (EDC) systems in clinical trial data management and analysis triggered the promise of better-managed clinical trials – with greater efficiency, faster access to higher-quality clinical data and better mapping of data flows to business processes.
With each passing year, clinical trials are becoming increasingly global. The business of product development is moving away from the traditional model in which studies are conducted primarily in the US – in fact, recent estimates indicate that within the next three years, up to 65 per cent of studies under FDA regulation will be conducted outside the US. A review of a US government clinical trials registry and of 300 published reports in major medical journals revealed that one third (157 of 509) of Phase III trials were being conducted entirely outside the US, with over half the study sites (13,521 of 24,206) used in these trials located overseas, many in eastern Europe and Asia.