Call for Papers: Regulatory Statistics in Drug Development
Engaging with regulatory bodies is crucial to the development of new therapies and technologies. Historically, regulatory statisticians have collaborated closely with industry statisticians and academia. We envision Pharmaceutical Statistics as a platform for exchanging ideas and sharing insights among these diverse stakeholders, fostering a dynamic dialogue that benefits the entire community—without obligations or breaches of confidentiality.
Therefore, Pharmaceutical Statistics now invites submissions focused on regulatory statistics. We welcome papers that explore the following areas:
- Guideline Commentaries: Analyses of new guidelines, concept papers, or reflection papers from ICH, regulatory agencies, and HTAs, such as ICHE20.
- Collaborative Projects: Papers on projects where regulators, pharmaceutical statisticians, and academia collaborated under initiatives like IHI and/or via learnt societies, e.g. PSI, ASA, DIA or Dah Shu, among others.
- Regulatory Insights: Articles by regulators discussing the implementation of specific methods or recurring themes from Scientific Advice or Marketing Authorisation Applications.
- Industry Reflections: Perspectives from pharmaceutical companies on feedback received from regulators about implementing particular methods, while maintaining confidentiality.
- Calls to Action: Viewpoints advocating specific regulatory actions, like initiating a reflection paper on a particular issue.
We recognize that published viewpoints may evolve as the landscape changes and further experience accumulates.
To encourage an exchange of perspectives, we particularly welcome articles jointly authored by regulators, pharmaceutical statisticians, or academia.
This call for papers encompasses a broad scope of therapeutic innovations such as medicines, vaccines, medical devices, and companion diagnostics, and has no specific deadline.
Primary contact: Olivier Collignon, Editor in Chief