If you need pharma data of any kind, it is likely out there for the taking. There are millions of records on clinical trials, drugs, organizations, publications, and much more available for to the public for free. The trouble lies in knowing where to get the data you need, and how to leverage it.
We’d like to share with you a list of the top free online sources for retrieving pharma data. Due to the number of valuable data sources, and the detail about them we’d like to share, this will be a 2-part post. Welcome to Part 1 where I will disclose the top US sources. Become an email subscriber of our blog to be alerted when Part 2 comes out, which will be about international pharma data sources. But to be clear, both US and international sources contain global data. The data sources we’ll cover in this post are:
- Sunshine Act Database
- FDA 1572 Database
- Drugs @FDA
These databases contain a staggering amount of information related to clinical trials, pharmaceutical products, and biomedical research organizations. Take our first item on the list for example, PubMed, which has 27 million records. Obtaining the exact information you need from such a volume of data is still no easy task, and for that we recommend using a clinical trial intelligence tool. However, understanding where this data lives is the first step to improving your research, sales, commercial planning, and other processes. Allow this list to be your guide.
About the Data: 27 million citations for biomedical literature from MEDLINE, life sciences journals, and online books.
Maintained By: National Center for Biotechnology Information (NCBI) at the U.S. National Library of Medecine (NLM) located at the national institute of health (NIH).
Backstory: MEDLINE is a database maintained by the NLM of references and abstracts on life sciences and biomedical topics. According to Wikipedia online access to the database was available from 1971 to 1997. PubMed was created in 1996 to search the MEDLINE database for free from home or office, and was offered to the public for free in 1997. It has evolved to its current form since then.
More Information: Publishers submit citations to the NCBI then provide access to the full-text of articles.
Users can search for keywords, names, and organizations across the database, or for specific fields such as:
- Publication Year
About the Data: 240,893 trial records on clinical studies conducted in 197 Countries (at the time of this writing).
Maintained by: The NLM at the NIH.
Backstory: ClinicalTrials.gov (CT.g) was created to “provide patients, their family members, health care professionals, researchers, and the public with easy access to information on publicly and privately supported clinical studies on a wide range of diseases and conditions.”
The registry was created because of the Food and Drug Administration Modernization Act of 1997 (FDAMA). It was made available to the public in 2000 after being developed by the NIH and FDA. Legislation in 2007 required pharma and pharma services teams to really start using it with the passing of the FDA Amendments Act of 2007 (FDAMA). Look at the image here to see how dramatically the volume of trials registered on CT.g increases after 2007.
More Information: In our post Why Isn’t There a Global Source for Clinical Trial Data? we estimate this registry has records on over 80% of the clinical trials conducted across the globe. This is because organizations need an NCT number to ever
- Publish information about a trial in ICMJ (International Committee of Medical Journal Editors) approved literature
- Use the information or the product from a study for commercial purposes.
The only way to acquire an NCT number is to register a trial on ClinicalTrials.gov. Therefore to prevent any work from being shutout from publication in international medical journals, or commercial opportunity in the US (which is 55% of the global pharma market by sales), trial coordinators across the world use CT.g.
This online registry is the most comprehensive public source for finding information specific to a clinical trial.
Users can do advanced searching to build queries based on fields like:
- Study status
- Eligibility criteria
- Funding type
- Key dates
Sunshine Act Database
About the Data: 28.2 million records covering $16.57B in clinical trial related payments to physicians and institutions.
Maintained By: The U.S. Centers for Medicare & Medicaid Services (CMS)
Backstory: The Sunshine Act Database, also known as the Open Payments Program, is a repository that publicizes all payments made to physicians and institutions related to clinical trials conducted in the US. The payment data extends to things like travel, research, gifts, free meals, and speaking fees. Information about the ownership interests that physicians and their family members have to clinical trial organizations is also available.
The disclosure of this information was originally required by the Physician Payments Sunshine Act in 2010, and is now additionally required by the Affordable Care Act.
More Information: The payments data on the 28.2 million records on file in the Sunshine Act Database represents 1868 companies, 812,000 physicians, and 1,180 teaching hospitals. According to the website, the program:
- Encourages transparency about these financial ties
- Provides information on the nature and extent of the relationships
- Helps to identify relationships that can both lead to the development of beneficial new technologies and wasteful healthcare spending
- Helps to prevent inappropriate influence on research, education and clinical decision making
CMS maintains an impartial role on Open Payments, and does not identify which relationships are beneficial or which cause a conflict of interest, but they do define “conflict of interest” on the website.
The information is updated annually.
FDA 1572 Database
About the Data: 1,048,576 records of “clinical investigators, contract research organizations, and institutional review boards involved in the conduct of Investigational New Drug (IND) studies with human investigational drugs and therapeutic biologics
Maintained by: The FDA’s Center for Drug Evaluation and Research (CDER)
Backstory: This database, also known as FDA’s Bioresearch Monitoring Information System (BMIS), was created to provide transparency into the organizations involved with biomedical research within the US. It was made available to the public in 2012, but has records on file dating back to 2008.
More Information: This database gets its unofficial name, FDA 1572 Database, because any investigator engaged in research of CDER-related drugs and biologics needs to submit a form called FDA 1572. This form allows an organization to generate an ID number the FDA uses to file the organization name, primary contact, and address of the investigator. This is the data that populates the BMIS.
The information on file is updated quarterly. The data is difficult to work with in its public state, and requires some cleanup due to duplicated records, incomplete records, and obviously fake records. As an example, Mickey Mouse is on record 12 times as a CDER investigator.
About the Data: Over 35,000 FDA approved drug products dating back to 1939.
Backstory: The FDA has been collecting information on drugs and drug applications since 1939. The Drugs@FDA database is their way of disclosing all approved information with the public. There is little available information about when the database was developed into its current form, but we estimate it was around 2008.
More Information: According to the website, “the main uses of Drugs@FDA are:
- finding approved labels for approved drug products
- finding generic drug products for an innovator drug product
- finding therapeutically equivalent drug products for an innovator or generic drug product
- finding patient information for drugs approved from 1998 on
- finding all drugs with a specific active ingredient
- viewing the approval history, including approval letter(s) and review packages of a drug”
Users can search for drug name, active ingredient, or application number, or browse by drug name.
Details on what kind of products are and are not in the database can be found on the website.
The information provided includes information about drugs, drug applications, patient information, labels, approval letters, and reviews.
Listed with each drug record is its application number, product number, form (route of administration), strength, drug name, and active ingredient.
Information is updated daily.