The process by which new drugs are developed and approved are quite intricate and time consuming, but that’s because the US Food and Drug Administration (FDA) must ensure that all newly marketed medicines meet the necessary standards for safety and effectiveness. However, as medical writers, we just chop it down to document by document and section by section. Below, we’ve put together a brief overview of the process (from our perspective as a vendor) with a few links for further reading.

Investigational New Drugs ^[1,2]

When a sponsor prepares to begin human clinical trials, they must submit an Investigational New Drug (IND) application to the FDA. This is usually where we, as medical writers, come in to help capture or edit its components—typically the initial synopsis and protocol, Informed Consent Form (ICF), and Investigator’s Brochure (IB), which we may write from scratch for smaller biotechnology companies.

Technically, the IND approval allows the sponsor to transport unapproved drugs across state lines to clinical sites for testing; but beyond the legal aspects, it also communicates the sponsor’s intentions to its investors, other pharmaceutical companies, and the clinical medicine community at large. In addition, like many medico-clinico-regulatory documents, the IND serves to inform internal stakeholders.

The IND includes preclinical testing information (animal pharmacology and toxicology studies), manufacturing information, investigator brochures, and the aforementioned clinical trial protocols. In addition, the IND requires other commitments that the sponsor must adhere to, such as obtaining informed consent from research subjects, as well as obtaining review of the study by an institutional review board (IRB).

As the trials begin to enroll study participants, and the clinical scientists and operations team see the procedures “in action,” medical writers like us will help develop protocol amendments as changes are needed. When the data start to emerge, we help compile, write, and edit sections of the Clinical Study Report (CSR).

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References

1. Food and Drug Administration (FDA). Investigational New Drug (IND) Application. https://www.fda.gov/drugs/types-applications/investigational-new-drug-ind-application Updated May 12, 2020. Accessed September 18, 2020.

2. Food and Drug Administration (FDA). New Drug Development and Review Process. https://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/new-drug-development-and-review-process Updated June 1, 2020. Accessed September 18, 2020. 

Further Reading…

Explore the FDA website’s drug development process for a more in-depth look at how drugs are approved, and take a look at some drugs that have already been approved for 2019 and approved for 2020. In addition, visit clinicaltrials.gov to search their database of clinical studies from around the world.

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