The Clinical Trials Transformative Initiative (CTTI) is a public-private partnership to develop and drive adoption of practices that will increase the quality and efficiency of clinical trials. This author has found some useful. When updating investigator safety reporting features for a software application they provided useful general requirement considerations. There are a number of other practical clinical operational guidance examples. They now comprise more than 80 organizations from across the clinical trial enterprise—including government agencies, industry, CROs, patient advocacy groups and academic institutions not to mention investigator groups.
Formed in 2007 by the US Food and Drug Administration and Duke University, it is active in a number of activities from policy recommendation to pragmatic regulatory requirement considerations. We include a link to a video where Dr. Rob Califf, MD, MACC, discusses CTTI strategy. Most recently, they released their recommendations for patient and site engagement centering on mobile clinical trials. As with many recommendations involving the maximizing of benefits and minimizing of challenges a number of factors influence industry sponsors including regulatory and legal compliance concerns, ethical and professional boundaries and business driven considerations. Frankly this author thinks patient and site “engagement’ is an over used word at this point. True engagement may require a profound shift in business process which in a risk averse industry such as life sciences is not always easy. The reality is that a confluence of forces is converging to transform clinical research in material and potentially profound ways. From new GxP validated smart phone apps to collect patient data to telehealth platforms a myriad of new engagement opportunities now exists. Study the CTTI recommendations. TrialSite News welcomes your comments for publish here.