Essential Datasets for Tracking Drug Development from Discovery to Market

The FDA breaks down the drug development process into 5 main steps:

1. Discovery and development
2. Preclinical Research
3. Clinical Research
4. FDA Review
5. FDA Post-Market Safety Monitoring

Here, I’ll break down some of the most useful datasets for learning more about what companies and researchers are doing at different stages of the drug development and delivery pipeline. I consider many of these datasets as primary sources, and use them when conducting research or building new data products to keep tabs on the industry.

Discovery and Development and Preclinical Research ¶

This can be the most opaque area, because we have the fewest regulatory requirements for data disclosure and companies can be quite secretive about early programs. To keep tabs on researchers and early indications, we can use academic literature, citation databases, and intellectual property records.

Clinical Research ¶

Clinical trials are vital to the drug and biologic approval process to demonstrate safety and effectiveness. Since the stakes are higher for clinical research, there are more regulations around how research is conducted and transparency. Clinical trials are the most important data source to track to keep tabs on regulated products moving through the pipeline. There are different trial phases, typically numbered Phase 1 through 4, with Phase 1 being a general safety and dosage study with a small group of 20-100 healthy people, and phase 4 being safety and efficacy study on thousands of volunteers with and without the disease/condition¹.

FDA Review ¶

During FDA review, most data is confidential and embargoed. However, once drugs, devices, or biologics are approved, FDA provides a lot of useful information in many different databases and API’s. Below are some of the data sources we use most frequently to track companies and learn more about commercial activities and opportunities.

FDA Post-Market Safety Monitoring ¶

After drugs are marketed and in use, we use safety monitoring data from FDA and pricing/use data from Medicare and Medicaid. Due to extensive public private partnerships, complicated deals/rebates, and generally insufficient transparency, payments and drug prices get a lot trickier to track. We will provide more information about how we track, estimate, and monitor pricing in the future.