The vaccine industry has transformed so completely it has become almost unrecognizable from the disease prevention model originally envisioned over 100 years ago.
Thanks to the tireless efforts of such giants as Jenner, Pasteur, Salk, Sabin and more recently organizations such as GAVI and The Global Fund, disease prevention sits as one of the cornerstones of global public health. Today, vaccine research has expanded beyond vaccines focused solely on disease prevention and now includes therapeutic vaccines, DNA vaccines and recombinant vaccines.
Immuno-therapeutic vaccines are rapidly becoming some of the hottest areas of research in modern medicine and are being investigated by large pharma and small-to-medium biotechs alike. But have clinical trial methods evolved to keep pace? On the surface the answer seems to be yes.
Paper CRFs and diaries, telephone call-back systems and armies of CRAs reviewing paper sources have given way to electronic data capture (EDC) systems, Interactive Voice Response Systems (IVRS), remote site monitoring and CDISC standards. But is this enough?
Historically, new technologies are added to study protocols as afterthoughts, but until the industry commits to standards and insists on interoperability, we won’t be able to fully realize the potential of their use and benefit from the efficiencies. It is critical that as an industry, we carefully consider the appropriate use of these technologies and work together to support and adopt standards to ensure that the systems selected can work together seamlessly. In doing so, study conduct can keep pace with the ever more demanding trial design necessary to support these modern wonder vaccines and possibly the eventual evolution of tailored vaccines.
Written by Guest Writer Darin Seehafer. Seehafer has over 20 years of clinical research experience working in all FDA phases of study design from preclinical benchtop studies through post-licensure. Currently a clinical scientist with PRA, he continues to provide input on trial design and study oversight, liaising with key opinion leaders and serving as a subject matter expert for clients on all things vaccines. He also continues his work as a vaccine advocate and author. Visit www.prahs.com.
This article was reprinted from Volume 23, Issue 05, of The CenterWatch Monthly, an industry leading publication providing hard-hitting, authoritative business and financial coverage of the clinical research space. The Action Items section features short columns focusing on actionable or how-to advice from clinical trial professionals. To submit an Action Item, please contact editorial@centerwatch.com. Subscribe >>
