INTRODUCTION TO CLINICAL RESEARCH

The process encompasses a complex and lengthy cycle from discovery to the processing of a new drug into the market. Several people are involved, including statisticians, clinicians, data managers, scientists, and SAS programmers, in registering a drug for marketing and in the process of drug making.

On average estimation, the drug-making process might take 10 to 12 years from Research to reach the market. Pharmaceutical companies and research agencies primarily carry out the drug-making process.

The demand for drugs is crucial for many purposes, so this market remains stable and competitive. Due to the proliferating demand for drug usage, pharmaceutical companies discover new drugs efficiently and quickly.

Drug Development Process 

It is a unique stage that can be classified into:

Drug Discovery

Drug Development

Clinical Trials

Manufacturing

Marketing Approval 

The primary purpose of discovering a drug is to cure a specific disease. Based on the diseases, the drug-making process varies, but the drug will undergo various chemical or biological compound testing. 

The drug testing process is performed in test tubes (laboratory, in vitro) and on animals (in vivo) to check how they affect the biological systems. This development 

The development process includes pharmacological studies of the lead compound and its effects on toxicity, carcinogenicity, mutagenicity, and reproductive development. 

These steps are crucial in determining whether the drug is safe, effective, and has the lead compound and potential. In drug testing, thousands of compounds are screened and tested before being finally released into the market as drug products. In this testing process, only a few drugs are approved, and others are rejected. 

Clinical Research

Clinical Research is a subfield of medical science that evaluates the efficacy and safety of drugs, equipment, diagnostic supplies, and treatment plans intended for human consumption.

Clinical Research includes: 

Research in medicine and behavior involving volunteers 

Study and analysis are carefully carried out; every investigation stage will be recorded.

The identification and testing are processed to prevent, diagnose, treat, and understand human disease.                                    

Drugs released in the market have come across various stages of testing and help treat new diseases.

Drug processing is a long-term study.

Strict scientific guidelines 

Ethical and regulatory constraints must be considered when designing and carrying out a clinical trial. Ethical principles must be followed before a drug is submitted for a clinical trial to protect participants. The United States National Institutes of Health (NIH) has stipulated seven ethical requirements:  

1. Social value 

2. Scientific validity 

3. Fair subject selection 

4. Informed consent 

5. Favorable risk-benefit ratio 

6. Independent review 

7. Respect for human subjects 

Clinical Trials

Clinical trials are research studies that evaluate the safety and effectiveness of medical treatments, interventions, drugs, devices, or therapies in humans. They are crucial steps in developing new treatments or improving existing ones. Clinical trials help determine whether a new intervention is safe, how well it works, and whether it offers any advantages over currently available treatments.

Randomization, control groups, and blinding techniques are often employed to maintain objectivity and minimize bias in the trial's results. Rigorous data collection, monitoring, and analysis are conducted throughout the trial to evaluate the intervention's impact on participants' health.

Clinical Research Process

Pre-clinical testing

Investigational New Drug Application (IND)

Phase I (assess safety)

Phase II (test for effectiveness)

Phase III (large-scale testing)

Licensing (approval to use)

Approval (available for prescription)

Post-marketing studies (special studies and long-term effectiveness/use)

These are the eight phases of the clinical research process. In the next blog, we will discuss these processes in detail. 

In conclusion, clinical research is a cornerstone of medical advancement, offering a systematic approach to understanding and improving healthcare interventions. It encompasses many studies, from observational research to randomized controlled trials, to evaluate the safety, efficacy, and real-world impact of treatments, drugs, therapies, and medical devices in human subjects. Clinical research is indispensable in evidence-based medicine, informing healthcare decisions and regulatory approvals. This introduction serves as a gateway to explore the intricacies of clinical research, its phases, ethical considerations, and its pivotal role in shaping healthcare's future.