Perspectives covers a wide range of topics within therapeutics development from advice on regulatory submission to adaptive clinical trial design to aligning your trial with investment priorities, and much more. Here are some of the top topics covered this year:
First-in-human clinical trials
Ulrika Andersson on First-in-Human Clinical Trial Development
First-in-Human Drug Substance and Formulation: The Challenge of Achieving Flexibility and Quality
Guidelines Are Not Instruction Manuals: Customize Your Way to First-in-Human Clinical Trials
Don’t Forget the Development of Your Placebo: Overcoming Common Obstacles
Regulatory considerations
How to Ensure Your Adaptive Trial Is Appropriate for Regulatory Submission
How to Ask the Right Questions at an Authority Meeting
Aligning your trial with investment priorities
Aligning Clinical Trial Design with Investment Priorities
Bayesian strategies
Bayesian Strategies in Rare Diseases
Why Are There Not More Bayesian Clinical Trials?
Bayesian Approach in Oncology Trials
Early phase clinical trials
Design Considerations for Early Phase Trials of Immuno-oncology Drugs
Creating a clinical development plan
How to Create and Optimize a Clinical Development Plan
Drug manufacturer auditing
Drug Manufacturer Auditing: Ensuring Quality, Control, and Safety
A big thank you to all of the authors represented in these posts: Ulrika Andersson, Ari Brettman (Blackstone Life Sciences), Bodil Fornstedt Wallin, Michael Fossler, Martin Frenzel, Bengt Hedin, Åsa Holmgren, James Matcham, Natalia Muehlemann, and Ann-Kristin Spiik!
If you’re interested in therapeutics development, don’t forget to subscribe to our newsletter below to stay up to date on upcoming insights!
Read more from Perspectives on Enquiry and Evidence:
Sorry no results please clear the filters and try again
Maria Lundberg on a Holistic Approach to Therapeutics Development
Writing a Successful Study Protocol for Real-World Evidence Studies
Epidemiological Methods to Tackle Real-World Evidence Challenges
