What are the keys to building a comprehensive pharmacovigilance (PV) program? Be forward thinking, invest wisely, and question everything.
It is so easy as a sponsor of a first-in-human clinical trial to forget that the decisions you make now will have downstream effects during the lifecycle of the product. With each new clinical trial, you might employ a different CRO for the clinical and PV needs, in order to get the lowest possible price. Perhaps you have a different medic reviewing the cases at each CRO as well. Surely your narrative template has varied elements at each institution. Then you find that to draft each Analysis of Similar Events, you're requesting, reminding, and combining data from multiple databases in order to simply have visibility to the number of similarly coded events. At some point, you realize that the different CRO teams are all coding the events slightly differently than each other and no overarching convention has been set. You start to question the accuracy of the data you've been so diligently capturing for the last several years and now you are faced with harmonizing the coding according to a new convention that you still need to create.
What if instead, those initial decisions were made mapping out the whole program over the next ten years? The first step would be to pick a single location for all of the safety data and establish some coding conventions. Being forward thinking at this early stage will reduce the rework of cleaning up inconsistencies later.
What's the Difference Between a Clinical Database and a Safety Database?
The most striking difference between a clinical database and a safety database is that sponsors need to build a completely new clinical database with every trial, while the safety database is only built once. To avoid regrets later, and since you are only building this safety database one time, invest in the best that your wallet will allow. Look for features that will make your life easier when you have a blinded study or want to implement an electronic reporting gateway. You may not need those bells and whistles now, but it's sure nice to have options when you do need them.
Investing wisely in a safety database can afford you capabilities that seem like luxuries in the early stages and are absolutely essential in the later stages of clinical trials. Investigate the database's capabilities for slicing and dicing your data to ensure that you will be able to review data at a trial level, a product level, a moiety level, or across all data globally. It may seem far enough now, but should you acquire another compound, does the safety database accept data transfers easily and align with other databases to make this task more cost effective and accurate for the ongoing program? Since this cost is only incurred once, be sure to invest wisely in critical items like the safety database.
The Importance of Consistency with Your Safety Database
There are two phases when the volume of work in a PV program overwhelms the need to manage consistency—approximately two months into a pivotal phase III trial, and nine months after marketing authorization. At these points, due to the growth of the PV program, consistency becomes less important than productivity as the client and vendor teams scramble to adjust to the rapidly increasing workflow. No one is asking those key alignment questions such as:
- Is everyone understanding acronyms in the same way?
- Are the formulas for measuring quality being used the same across all teams and vendors?
- Is the same regulatory intelligence being used for all submissions globally?
The trick to surviving the chaos of a blooming program is to have asked all of these questions early on and establish written conventions. At the threshold of each next step, question everything! Before moving forward, double check that everyone is on the same page to eliminate confusion down the road. Understanding the current tasks and activities will be key when making decisions for the next steps, too. Is there any difference in the data capture requirements when moving from a DSUR to a PSUR? Does it make more sense for the PV team to be aligned regionally or by market phase (pre vs post-market)? Does the PV provider offer different costing options including unit-based, time and materials, or functional service provider budgets? Making sure that the processes and expectations are aligned between the client and the PV vendor will ensure that future questions for the program can be resolved smoothly.
How to Select a PV Provider for Your Safety Data
Here's one last suggestion for building a comprehensive PV program: select a PV provider with a built-in escalation path. There will always be the need for major pivots to occur during the life cycle of a product, and valuable time can be lost trying to find the individual who can provide solutions for you and then execute them! Whether the requirement is for staffing changes or fresh ideas, you deserve a higher-level resource eager to hear your feedback, ready to help smooth out the rough spots and course-correct the program.
Pharmacovigilance is complicated enough without the provider adding to your burden. Make an informed selection by being forward thinking, investing wisely, and questioning everything.
At ProPharma, our team of pharmacovigilance experts is dedicated to ensuring the safety and efficacy of pharmaceutical products. We offer a range of services to support companies in their pharmacovigilance efforts. Contact us today and tell us how we can help.
