The clinical development discussion paper

The development of a drug is also referred to as clinical development. This process includes the testing of drugs on microorganisms and animals in the stage of pre-clinical research and then testing the effects of the drug on the clinical trials that are done on human volunteers. At the end, regulatory approval and bringing the drug to the market are done. A drug is a chemical or biological compound that has biochemical and physiological effects on the human body. It can be either of a single compound or a mixture of many compounds. Their discovery is done for the benefits of the human, but they can also even harm the human body by side effects. Drugs are mostly developed from proteins, but sometimes DNA or RNA particles are also used. Normally, the process of drug discovery can take 12–14 years to complete the whole process. The pre-clinical phase takes 3–5 years and the clinical stage takes 4–6 years. Testing of the safety and effectiveness of drugs on human beings are very crucial before launching the drug in the market. Thus, five stages are used to develop an effective drug. These stages are stage 1: early drug discovery, stage 2: preclinical research, stage 3: clinical research, stage 4: FDA drug review, and stage 5: FDA post-market monitoring safety.

Stage 1- Early Drug Discovery: This first stage of drug discovery involves both the development process and the discovery of the drug. At first, scientists and industry collaborate to work together and try to find the insights of the disease such that the researchers can design the drug either to stop the disease or to just reverse it. Different chemical compounds are used to check their effects on various diseases. Using the existing treatments on the particular disease to predict the designing of the microorganism causing the disease is also done during the first stage. The development stage includes the acknowledgment of distribution, absorption, metabolism, and the excretion activities of the drug in the body. The mechanism of action and the beneficial rate are determined. The dosage and side effect of the drug are studied.

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Stage 2- Pre-Clinical Research: This stage involves the two-phase testing of the drugs on animals or microorganisms. These phases are in-vivo and in-vitro. This stage tries to evaluate the potential of the drug causing any serious harm in humans, like toxicity. This stage requires approval from the FDA and MHRA before proposing the Investigational New Drug Application (IND). The testing is done on the organism that resembles metabolic and genetic activities similar to the human. The drug should not be gender biased, as the drugs that are beneficial for the women may harm the male body. The information like the potency of the drug, its effect on the human body, and the reaction of the body toward the drug is described in IND.

Stage 3- Clinical Research: This stage involves the designing of the clinical trials and the study of phases of the clinical researches. Designing comprises personal information about human volunteers for drug testing, details like the number of people who will be involved, and how much time duration will be used to finish the research. Clinical research consists of three phases of testing. Phase-1 includes 20–100 healthy volunteers or those humans who were already diagnosed with the disease for which the drug is being tested. This phase nearly extends for several months. This phase is done for testing the dosage and the safety of a person. Nearly 70% of the drugs get approval for the next phase. Phase-2 includes people who are already suffering from the disease. This phase may take several months or up to 2–3 years and check the side effects or efficiency of the drug on humans. Around 34% of drugs are approved for the next phase. Phase-3 consists of more than 3000 humans diagnosed with the disease. This phase lasts for 4 years and is used to determine the efficacy or monitoring of the adverse reactions of the drug. The last phase is phase-4 in which only one drug gets approval. This phase also consists of testing on the 1000 people who are already suffering from the disease. The efficacy and safety is the prime concern of this stage.

Stage 4- FDA Drug Review: The New Drug Application (NDA) explains the details about the drug and whether it is safe. The FDA reviews the drug and its efficiency, and if they find the drug as safe to be used by humans, then they approve the drug.

Stage 5- FDA Post-Marketing and Monitoring Drug Safety: The FDA review does not give all the surety about the safety of the drug. Hence, this stage is used for reconsidering the supplemental applications, manufacturer inspections, INDs for marketed drugs, drug advertising, generic drug and then reporting problems, and finally active surveillance.

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