Abstract
This past year, we received an exciting number of outstanding contributions and, as we enter the new year—the third year of publication for TIRS—we have the opportunity to publish an expanded January 2015 issue of the journal. It has been fascinating, and extremely rewarding, to be the journal of choice for papers addressing important, and now recurrent, themes that are having major impacts on the drug development and evaluation processes.
The role of patients in the drug development process is a topic that will likely continue to be discussed this year in TIRS, and we will see more submissions addressing patient-centered outcomes, with patient involvement early in the drug development process helping to design increasingly meaningful clinical trials. We have had several important papers in this arena submitted in 2014, including the article entitled “Patient Engagement by Pharma—Why and How? A Framework for Compliant Patient Engagement?” by Dewulf 1 in this issue of the journal.
Approaches to benefit-risk is another recurring theme. The article “A Universal Framework for the Benefit-Risk Assessment of Medicines: Is This the Way Forward?” by Walker et al 2 this issue follows on an important paper by Levitan et al 3 published in our September issue entitled “Structured Approaches to Benefit-Risk Assessment: A Case Study and the Patient Perspective.” All of medicine ultimately comes down to benefit-risk assessment—whether in drug development, on a population basis in clinical trials, in drug approval by regulators, or for individual decision making between a doctor and a patient. We are seeing increasingly quantitative approaches to the complex process that should have major impact on the effectiveness and efficiency of the drug evaluation and regulatory processes. Integrated with a growing understanding of individual responses to therapeutics and targeted drug development linked to diagnostic biomarkers, we are now beginning to move toward an era of individualized benefit-risk superimposed on clinical trial– and population-based approaches.
Cross-sector collaboration to address complex areas of defining efficacy and risk has been a recurrent theme in TIRS, and the article “Clinical Development Approaches and Statistical Methodologies to Prospectively Assess the Cardiovascular Risk of New Antidiabetic Therapies for Type 2 Diabetes” by Geiger et al 4 continues to demonstrate the importance of precompetitive partnering. This study examined the cardiotoxicity of drugs used to treat type 2 diabetes. Teasing out disease effects, drug effects, endpoints, and unwanted side effects is critical to the development, approval, and clinical use of medicines. We have seen the complexity of all this, demanding transparent, collaborative, and rigorous biomedical and statistical scientific approaches.
Looking to the future of translational biomedical science, we will have several forward-looking papers later this year that challenge current assumptions and discuss the enormous potential that scientific advances have and will continue to provide.
We anticipate an exciting year for TIRS, publishing papers that facilitate important conversations around the development of safe and effective medical products as well as increasing coordination with the Global Forum and with DIA activities to deliver to you a continuum of knowledge as we work together to foster health and well-being worldwide.