I am deeply honored and privileged to accept the position of Editor-in-Chief of the Journal of Biopharmaceutical Statistics. The long history of this journal unfolding through the helm of many brilliant Editors before me make me feel as if I am standing on the shoulders of giants. I want to thank them for and celebrate their accomplishment of letting this journal grow as one of the main peer-reviewed journals in the area of pharmaceutical statistics. The weight of that accomplishment is now a weight of responsibility I must carry to continually pursue excellence in scientific publishing while maintaining scientific integrity for many more years. I also would like to acknowledge the growing role of women in statistics and applaud the journal’s mission to foster diversity and inclusion in statistical research. Statistics as a discipline emerged as a response to many of society’s diverse scientific inquiries which are shared by women as well.
For almost three decades, the Journal of Biopharmaceutical Statistics has been a platform for education and dissemination of statistical research and innovation, repository for statistical solutions and choices, and a forum for scientific opinion on issues impacting methodology and applications in the pharmaceutical industry. Throughout the history of the Journal, the stream of scientific research published reflect both the scientific and evolving landscape of drug development. The first two decades exhibited statistical issues ranging from proper use of one-sided vs two-sided tests in hypothesis testing, appropriate analysis for stability and expiry, bioequivalence, non-inferiority and superiority, subgroups and multi-center trials, interim analysis and adaptive designs, multiplicity, linear models analysis of endpoints, meta-analysis, among others for which the journal has provided the stage for consensus and application. While some of these may seem routine and mere textbook topics today, these topics were state of the art and highly relevant in their time. The Journal’s mission has been and will continue to be a commitment to the principle that better education of statisticians enables informed debate and decision-making about the appropriate application of new methodologies and aids in addressing misuse of scientific discoveries.
The Journal has seen a transformation in scientific topics becoming more diverse and responding to the complex problems encountered within the pharmaceutical industry. This is influenced by shifts in research & development and the growing number of stakeholders. For example, a big trend has been the move to a more patient-centric health-care model, closely followed by the impact that technology is having on all areas of the life sciences and the changing business models. Many of the published manuscripts revolve on topics such as efficient trial designs including the use of external data, estimation and uncertainty for go-no-go decisions, finding optimal individualized treatment rules or biomarker-guided treatments, treatment heterogeneity and considerations for regional and payer evaluation of multi-regional clinical trials, among others. Some proposed solutions apply an agile, iterative test-and-learn approach, rather than running long and expensive development processes to concoct the perfect solution. Other solutions often require modern technological innovation such as Artificial Intelligence (AI) and Machine learning (ML) which provide significant opportunities to enhance drug discovery, clinical development, and commercialization. The Journal will continue to strive to achieve excellence by publishing articles that present important new advances in an ever-changing field of statistics within the pharmaceutical industry.
Through the changes, the journal stands by and reaffirms its responsibility to keep readers informed in emerging technologies and trends relating to statistical sciences to open new horizons for the future. Every time research is carried out, the solution found brings out new possibilities and many more hypotheses to be verified and studied compared to the possibilities before the seminal research itself. The journal will explore new avenues to accelerate statistics and scientific progress by proactively highlighting key research via social media platforms, conference symposia, and partner with organizations for webinars and podcasts relating to published articles to create interest and encourage discussion. Our goal is to continue to expand our readership so that state-of-the-art research reaches out to a broad audience promoting continuous scientific progress and benefiting society. The journal believes in the collective influence of its readers in shaping the future of the pharmaceutical industry through changes in healthcare policy, technological trends and public engagement.
Consistent with the mission of publishing prime statistics articles after rigorous peer-review, the Journal will strive to promote multidisciplinary research as a logical response to the expanse and pace of scientific revolution and transformation of the field. Not one discipline will be able to integrate all aspects of any problem or issue of interest alone with proper applicability and sufficient viability or competitiveness across a multi-stakeholder industry. Increase focus on statistical research that has good cross-functional appeal apart from just pure statistical interest is important. The Journal believes that effective science is achieved not just by one discipline but by the collaborative and multi-disciplinary effort within the entire biopharmaceutical field.