Clinical trials offer a snapshot of a medication’s efficacy, limited by the race, ethnicity, age, sex, and other factors specific to trial participants. Future R&D efforts should be determined not by a snapshot from the past but based on objective, real-world data.
Clinical trials offer a snapshot of a medication’s efficacy, limited by the race, ethnicity, age, sex, and other factors specific to trial participants. Future R&D efforts should be determined not by a snapshot from the past but based on objective, real-world data.
A longitudinal database provides pharma companies with many years of real-world data that is representative of every cohort in the US census population. Analyzing such information can show adverse effects and overall efficacy in ways that clinical trials of a few months or even a few years cannot replicate.
With this information, drug manufacturers can determine where to focus future R&D efforts, based on efficacy data from drugs with similar mechanisms of action, those that have shown safety and efficacy among certain demographics, and so on.
With the government, payers, and patients constantly demanding lower drug prices, more rigorous clinical trial protocols and more transparency into manufacturer spending and profits, it’s time to start making your most critical decisions based on real-world evidence.
When it comes to hospitals deciding which medications to purchase, as well as determining which ones remain on the formularies, and which have the most value, the method is largely static and antiquated, having changed very little since the 1980s. Generally speaking, Pharmacy and Therapeutics committees, consisting of internal hospital leadership, vote to collectively decide which medications should be added or removed.
The problem with this method is that the decisions are largely subjective – influenced by anecdotal evidence about which drugs are most effective, which ones patients “prefer,” group consensus, relationships with sales reps, brand loyalty, and other unscientific factors.