Reviewing the significant strides made in research and treatments over the past decade, coupled with my role as a research nurse in special pathogens, I found it necessary to understand the programs in place that play a part in the initiation and tracking of proposed new treatments and medications entering healthcare. Investigational New Drug (IND) applications are requests to administer such countermeasures to human subjects. INDs are overseen by the Food and Drug Administration (FDA). Before approving use of an IND in a monitored trial, the FDA has a responsibility to review the pre-clinical pharmacology, toxicology, chemistry, and manufacturing data of the drug in question. If there is sufficient pre-clinical data showing promising efficacy and limited toxicity in animal models, an application for IND status will be considered so that initial limited clinical studies can be carried out.

INDs are separated into two categories (commercial and research) based on the submitting party and the intended purpose of the proposed research. Commercial INDs are primarily submitted by individual companies seeking new drug market approval. Research INDs are for studying an unapproved drug, a new use for an already approved drug, or using an approved drug in a different patient population.

There are three types of INDs: Investigator or research IND, emergency use IND (eIND), and treatment IND are all avenues that use INDs to document and track proposed safety and efficiency. Which IND type of IND is submitted is based on the intended use of the product (e.g., research or treatment), the patient population (e.g., clinical cohort or single patient), and the availability of active clinical trials. Regardless of which type of IND is submitted, clinical safety and efficacy data is collected and submitted to the sponsor and FDA and Institutional Review Boards (IRB) are kept apprised of any changes and oversee ethical considerations for administering investigational products to human subjects.

It is important to remember that INDs are drugs that are still being evaluated for widespread use and may not ever make it to the market. In the case of clinical trials, the efficacy of the drug is being evaluated, usually compared to a standard of care medication or a placebo, and there is no guarantee that the subject will receive the IND or that it will provide any benefit. Before administration of any IND, a patient or study participant must review, discuss, and sign an informed consent to fully understand the potential risks and benefits of receiving the therapeutic and participating in a trial. Often since these drugs are currently undergoing active investigation, there is a degree of unknown including effectiveness and acute and long-term side effects. The clinical care team plays a vital role in evaluating the appropriateness of the clinical trial or use of an IND and assuring the patient and/or their family make the best-informed decision for them.

Administration and study of INDs can serve a diverse range of individuals including patients with rare diseases, advanced illnesses, or those who lack intended beneficial responses to standard medical treatments. They also hold promise for emerging public health concerns such as infectious diseases, or new conditions that lack standard care practices. While they can contribute to medical breakthroughs, they do have risk, and do not promise a cure. Collaboration between healthcare teams, federal, and local agencies must come together to face and overcome healthcare challenges, with hopes of improving patient outcomes for patients in the future.

Malinda Ruelas-Research Nurse SPECTRE

References:

https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/investigational-new-drug-applications-inds-cber-regulated-products

https://www.cc.nih.gov/orcs/ind1.html