In response to the spectrum of interaction that I have experienced with this blog’s readers, I am excited to announce that guest writers from the Health Decisions staff will begin contributing to Trials without Tribulations. I will have one guest blogger each month. Health Decisions staff members with deep experience in clinical research will share their expertise and opinion about issues in clinical development.
I am pleased to feature Samuel Bell, MPH, as our first guest writer. Sam has worked in clinical drug and device research for two decades in a wide range of therapeutic areas, including four years as a project manager. He is currently the lead medical writer at Health Decisions. Sam has served as primary author of five Clinical Study Reports, has overseen preparation of two initial IND submissions and has served as lead or co-author on numerous protocols, Investigator’s Brochures and IND Annual Reports. Sam holds degrees from Vassar College and the University of North Carolina at Chapel Hill.
You’ve finished the preclinical program for your new drug and it’s time to assemble your IND submission and clinical investigation plan. You’re starting a long, grueling journey through three phases of clinical trials, thousands of hours of labor, tens or hundreds of millions of dollars in costs, and submission of the NDA in hopes of reaching the market.
What can serve as your map through this maze – a guide to get you started and keep you moving on the most beneficial path to your goal? It’s something you may not be thinking about very much when you’re preparing your IND. It’s a single long sheet of thin paper, covered front and back with small type, and folded up tightly. That’s right. It’s the drug labeling. The prescribing information. The package insert. The cryptic document that patients usually throw away when they find it draped over a bottle of prescription medicine after picking it up at the pharmacy. The fine print, of course, is really written for prescribers and healthcare professionals; but the details that go into that information can serve as the roadmap for a clinical development program.
In my experience, most teams working on developing a new drug are not focused on the final labeling when they’re at the very beginning of the clinical program. I think that’s a mistake. The labeling is what defines the market for a new drug. The labeling that gets approved in your NDA names the drug’s indication and the target patient population. The label defines the size of the drug’s market and the claims that can be made in promotional materials. The maximum benefits for patients, healthcare professionals, and sponsors depend upon producing the best labeling, and that depends on the planning you’ve done for – and during – your clinical trials.
You can understand and articulate your investigational plan with much greater clarity if you keep in mind that the whole complex effort is intended to fill in information that’s required on the final drug labeling. Your goal is to create an evidence base for the claims that you make on the label and that you can use when marketing the drug. This thinking should influence the design of clinical trials and the selection of endpoints and assessments. You can improve trial designs, avoid expensive and unneeded procedures and assessments, add beneficial assessments and better describe the final indications and usage for the drug.
What does that mean in practical terms? Three things. First, essential reading at the beginning of your development program should include:
- 21 CFR 201 Subpart B, “Labeling Requirements for Prescription Drugs“
- The draft FDA guidance on “Labeling for Human Prescription Drug and Biological Products.”
Second, you can avoid blind alleys and streamline your program if you ask some simple questions at each decision point during clinical development, such as:
- How does this issue relate to what I want to include or can include in the final labeling for my product?
- What data can I collect now that will provide useful information to include in the labeling?
- What data would strengthen the position of my product?
Third, you should draft the first preliminary version of your labeling at the same time that you draft your initial IND submission. Of course much will be missing or speculative, but it will be a working document that will help create a roadmap for your clinical program, and will give you a tool to assess where you are now, what you still need, where you should be headed, and what you should stop to look at along the road. You can avoid mistakes and see if there are new avenues that you should explore. In short, you can keep your development program on target by keeping your eye on the information you’ll be printing on the package insert at the very end.
Begin, in other words, with your end product in mind; and remember that the end product of your clinical program is not only a bottle of medicine on the shelf, but also what you can tell prescribers and patients about that medicine.
To contact Sam, or to suggest topics that you would like featured in future posts, please email email@example.com.
Questions and comments are always welcomed on his posts as well!