Moving Your Trials To The USA? Here’s What You Need To Know.

Gavin L.

By Gavin Li

Director, Business Development, Asia-Pac

As the biggest market under one regulation, the US is always at the top of our clients’ lists. However, not all trials are designed for US regulations. We’re here to help you decide whether the US is the best fit for your trial, and where else you might consider running your trial for the best chance of success. 

Before diving into a US-based trial, you should know these five things about getting an IND in the USA: 

  1. Start with the end in mind. Where do you want to end? Be certain of the product labeling claims, efficacy, and safety data needed for approval. With this information, you can determine the most efficient route to plan your overall development pathway and achieve your end goal. Even if you aren’t planning to take the product across the finish line yourself, it is still worth outlining the development program as if you are to help predict challenges along the way. 
  2. Hold a pre-IND meeting. You are typically granted a finite number of Type B meetings (e.g., one pre-Investigational New Drug (IND) application meeting, one pre-New Drug Application (NDA)/Biologics License Application (BLA) meeting). Be sure to avoid open-ended questions.  You should have a fleshed-out plan to present and ask the appropriate approval agency if they agree with that plan. 
  3. Go Phase 3-2-1: Outline the ideal phase 3 study or studies in the target patient population. After designing the phase 3 study (or studies), outline the early-phase studies necessary to establish the initial safety and proof-of-concept data needed before embarking on a phase 3 program. 
  4. Be strategic—utilize plans. Use strategic development plans such as a target product profile (TPP) or an integrated product development plan (IPDP) to organize your strategy. Remember, the TPP is a roadmap of a development program and the basis for annotated product labels (for marketing applications) and intended labeling claims. The IPDP includes detailed plans for clinical, nonclinical, and Chemistry, Manufacturing, and Controls (CMC) programs. 
  5. Be brave. Don’t follow the usual path. It’s easy to fall into the same strategy and game every other trial runs through. Be sure to step outside the box. Are you working with a site because it’s the best site to work with, or is it because the site is well known? Are you working with vendors that can deliver effectively and on time, or are you sticking with the same vendors that everyone else is using? Seek advice, research, and don’t be afraid to try something new. 

Looking for help planning your trial in the US? I’m here to help. Please visit my page to schedule a meeting.  

About the Author: With more than 12 years of industry experience, Gavin Li is Director, Business Development, Asia-Pac, at PSI CRO.