Clinical Trials Essentials: The Different Drug Development Stages

Clinical Trials

The process of new drug development can take upto 15 years to complete. The early drug development stage usually begins with screening potential drug compounds that may have a therapeutic effect on a disease population. Once a potential therapeutic compound is identified, it moves to the next step in the drug development timeline. Data suggests that only one in 5000 potential drug compounds reaches the market approval stage. Moreover, only 250 out of 10000 identified drug candidates make it to the initial pre-clinical phases. Hence, the drug development cycle is challenging and requires robust testing alternatives for its success.

Bioanalytical methods such as Meso Scale Discovery immunoassay are crucial for analyzing analytes in complex study matrices. Validating Meso Scale Discovery (MSD) assays are vital for the success of pre-clinical and clinical studies. Besides, MSD biomarker and cytokines assays have become the primary choice of assay type for studying immune responses. Hence techniques such as MSD platforms provide crucial safety and efficacy data for drug development studies.

The current article highlights the four fundamental stages of the drug development process. Let us dive into each of these stages individually.

Early drug discovery

The primary aim of the early drug discovery process is to identify potential leads and convert them into specific targets. Generally, the lead compound must produce a therapeutic response against the intended disease. Researchers employ several biochemical assays and animal studies to test the efficacy of the potential lead compound. The processes involved in early drug discovery are as follows:

  • Identifying the target
  • High throughput screening
  • Hit identification
  • Screening and assay development
  • Hit to lead
  • Lead generation
  • In vitro and in vivo assays.

Pre-clinical phase

Once a potential compound is identified during early drug discovery, researchers conduct pre-clinical studies to optimize and test the drug compound in several laboratory and animal studies. Sponsors aim to acquire adequate efficacy and safety data to procure permissions for clinical studies. Besides, pre-clinical studies are crucial for identifying early drug doses for subsequent human trials. Moreover, the pre-clinical phase also focuses on the production process, as clinical studies will require a larger quantity of the candidate drug for large-scale clinical studies.

Clinical phase

The clinical trial study consists of 4 phases: Phases I, II, III, and IV. Phase I clinical trials focus on testing the safety and efficacy of the drug candidate in a small healthy population. Once the efficacy and safety data are tested in healthy subjects, sponsors conduct Phase II studies in a more extensive target disease population. Here, the drug dose is refined to examine its tolerability, efficacy, and safety in the disease population. In the final stage, Phase III studies, researchers test the drug product in thousands of patients to assess its safety and effectiveness in treating the patient population. 

Regulatory approval

After completing clinical studies, sponsors submit the data to regulatory authorities for approval. Only after the concerned regulatory authorities approve a drug it can then be marketed to the general patient population.. Besides, sponsors continue with phase IV studies, also called post-marketing surveillance trials, to collect additional safety and efficacy data for assessing the long-term effects of the drug product.

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