Module 5 DB

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Dec 6, 2023

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Hello everyone, this is my discussion post for Module 5. Answer #1: People working in regulatory affairs are accountable for the strategy and relationship with global Regulatory Agencies. Regulatory affairs professionals act as the “interface between pharmaceutical industries and government authorities across the world” (Praneeth, 2016, Abstract section). For instance, regulatory affairs can include quality control, quality assurance, product development, and manufacturing. This is important, because they can ensure that proper measures are taking place, such as good laboratory practices (GLP) and good manufacturing practices (GMP). Regulatory affairs professionals in the United States are responsible for making sure pharmaceutical companies abide by regulations set by the Food and Drug Administration (FDA), which is an example of a global Regulatory Agency. Overall, regulatory affairs professionals are essential to maintain relationships with global Regulatory Agencies and to oversee many significant processes during drug development. Reference Praneeth, P. (2016, April). Regulatory Affairs and its role in Pharmaceutical Industry. https://www.internationaljournalssrg.org/IJPBE/2016/Volume3-Issue1/IJPBE-V3I1P101. pdf Answer #2: Pre-clinical trials evaluate the safety of a drug, while clinical trials study drug interactions specifically in the human body. According to the U.S. Food & Drug Administration [US FDA] (2018), clinical trials are performed in people. Clinical trials are a lot more extensive, as they consist of four phases (Phases 1-4). For example, in Phase 1, only a small group of people are tested, in which researchers determine safety, dosage, and side effects, while Phase 4 trials take place after the drug is FDA approved, providing “additional information including the treatment or drug’s risks, benefits, and best use” (US FDA, 2018, Phases of Clinical Trials section). Clinical trials go more in depth than pre-clinical trials, as there is more on the stake, considering that pharmaceutical companies are preparing for FDA approval. Pre-clinical and clinical trials provide safety data and information on how a drug or treatment will affect patients, which will educate them on new possible treatments for their diseases. In addition to pre-clinical and clinical trials, Good Clinical Practices (GCP) must be taken into account to ensure the validity of clinical data. For instance, GCP consists of laws and regulations that are “intended to ensure the integrity of clinical data on which product approvals are based and to help protect the rights, safety, and welfare of human subjects” (US FDA, 2019, Introduction section). There are many resources to help researchers abide by GCP, such as Institutional Review Boards (IRBs) and the Investigational New Drug (IND) application. In other words, Good Clinical Practices must be followed to make sure clinical data is presented in the most accurate way, so that patients and human subjects can be educated on the trial findings.

References U.S. Food and Drug Administration. (2018a, January 4). Step 3: Clinical Research . U.S. Food and Drug Administration. https://www.fda.gov/patients/drug-development-process/step-3-clinical-research U.S. Food and Drug Administration. (2018b, January 4). What are the different types of clinical research? . U.S. Food and Drug Administration. https://www.fda.gov/patients/clinical-trials-what-patients-need-know/what-are-different-t ypes-clinical-research U.S. Food and Drug Administration. (2019, December 11). Good Clinical Practice . U.S. Food and Drug Administration. https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/good-clinical-pr actice Answer #3: There are many reasons why clinical trials fail, but some of the leading reasons are failing to demonstrate efficacy or safety and financial issues. The main source of failures in clinical trials is the lack of proving a drug’s efficacy. Even though a drug could potentially be very effective, it can still fail to demonstrate its efficacy abilities, due to “a flawed study design, an inappropriate statistical endpoint, or simply having an underpowered clinical trial” (Fogel, 2018, Failing to demonstrate efficacy or safety section). These may make patients drop out of trials, leading to an insufficient sample size/enrollment. Many clinical trials also fail due to financial issues. The drug development process is extremely arduous and expensive; costs may be up to $2.5 billion (Fogel, 2018). This leads to underfunded clinical trials, and researchers are less motivated to make things work, possibly resulting in failure. Overall, failing to demonstrate efficacy and financial issues are the main reasons why clinical trials may fail. Reference

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