Case Study: Regulatory Documentation |
Using GBD data to simplify regulatory documentation.
Pharmaceutical companies routinely prepare and maintain Risk Management Plans (RMPs) when applying to market their products. These plans contain information on the underlying epidemiology of indicated conditions, risks associated with new products, and other information that may be utilized to inform regulatory decisions and prescribing practices.
The challenge
Pharmaceutical companies devote substantial resources to ensure that their RMPs are based on the most up-to-date information. One pharmaceutical company asked IHME Client Services for help simplifying an RMP that had become unwieldy. The epidemiological section alone was over 30 pages long. Two factors contributed to the document’s complexity:
An initial draft document cited dozens of different studies from a range of institutions and countries. More than 200 references were cited in the epidemiological section alone – each source needed to be vetted, contextualized, and synthesized to provide a clear picture of disease burden globally and in markets of interest. The number of references also made layout and publishing more complicated, leading to delays in releasing the final draft.
The challenge
Pharmaceutical companies devote substantial resources to ensure that their RMPs are based on the most up-to-date information. One pharmaceutical company asked IHME Client Services for help simplifying an RMP that had become unwieldy. The epidemiological section alone was over 30 pages long. Two factors contributed to the document’s complexity:
- The drug in question was already indicated for numerous conditions, and under consideration for still more new indications. Expanding the descriptive epidemiology section for each additional indication promised to complicate an already hard-to-read document.
- The drug could be prescribed for a range of age groups, yet few sources included information about the epidemiology of each indicated condition across the lifespan. The RMP required a synthesis of epidemiological data for both pediatric and adult populations, which was time-consuming to produce.
An initial draft document cited dozens of different studies from a range of institutions and countries. More than 200 references were cited in the epidemiological section alone – each source needed to be vetted, contextualized, and synthesized to provide a clear picture of disease burden globally and in markets of interest. The number of references also made layout and publishing more complicated, leading to delays in releasing the final draft.
IHME Client Services role
With the help of IHME Client Services, condensing the epidemiological section was straightforward. The Client used data from IHME’s Global Burden of Disease (GBD) Study on each of the indicated conditions for pediatric and adult populations. The revised document included up-to-date incidence and prevalence rates broken down by age groups, sex, and country. This solution saved the pharmaceutical company an estimated hundreds of hours of staff time—and will continue to reap benefits in the future, as the document can be easily re-populated with each new iteration of the GBD Study. Reducing the number of references shortened the document considerably without diluting its content, and eliminating scores of references from the text makes it easier to read, too. The end result is that regulators, healthcare professionals, and other end users are far more likely to read and digest the full document—a critical component of pharmaceutical risk management.
With the help of IHME Client Services, condensing the epidemiological section was straightforward. The Client used data from IHME’s Global Burden of Disease (GBD) Study on each of the indicated conditions for pediatric and adult populations. The revised document included up-to-date incidence and prevalence rates broken down by age groups, sex, and country. This solution saved the pharmaceutical company an estimated hundreds of hours of staff time—and will continue to reap benefits in the future, as the document can be easily re-populated with each new iteration of the GBD Study. Reducing the number of references shortened the document considerably without diluting its content, and eliminating scores of references from the text makes it easier to read, too. The end result is that regulators, healthcare professionals, and other end users are far more likely to read and digest the full document—a critical component of pharmaceutical risk management.