Over the past few years, clinical research and clinical trials have seen a rapid rise with prompt advances in medical science, growing demand for newer treatments, and the emergence of personalized medicine. With the increasing incidence of chronic diseases, the growth of biotechnology firms and pharmaceutical industries, and support from regulations for accelerated drug approvals and clinical research related job roles has emerged as the most desired profession. New technologies like AI, big data analytics, and decentralized clinical trials are transforming the industry, streamlining trials to make them cost-efficient, and accessible trials.
As a result, the demand for skilled clinical research professionals ranging from clinical research operations to pharmacovigilance, regulatory affairs, and medical writing are at a higher level than ever, giving exciting career opportunities for healthcare professionals, doctors and research scientists around the world. Many of us are unsure what is the difference between clinical research and clinical trials? Let us explore this CareerInPharma article to gain a better understanding.
What is Clinical Research?
Clinical research is the broad field with all types of various medical research involving human subjects to improve the medical knowledge and patient care to protect human health. It involves
Observational studies: An observational study (non-interventional study) is used to answer a research question based purely on what the researcher observes. There is no interference or manipulation of the research subjects, and no control and treatment groups.
(e.g., epidemiological research, case studies)
Interventional studies: An Interventional study is used to conduct a clinical trial on a human subject. There is interference or manipulation of the research subjects, control groups and treatment groups.
(e.g., clinical trials)
What are Clinical Trials?
Now you will have an idea about the difference between clinical research and clinical trials. Yes, Clinical trials are one of a subset of Clinical Research-Interventional Study. It involves testing new drugs, treatments, or medical device interventions in human participants to assess the safety, efficacy, and dosage of a new treatment before it is approved for public use under different trial Phases. There are four trial Phase (I-IV) along with Preclinical studies and Phase (0) zero which involves the innovation of molecules and animal tests. Before knowing about clinical trial phases let learn about preclinical studies and phase (0) Zero also.
Preclinical studies:
The first drug tests to be done on human cells or animal cells that are grown in a lab dish or a test tube to see if it might work or not works. If it works then the researcher will have an idea how safe the new drug treatment is in a living animal creature. If the pre-clinical studies are completed and the drug treatment still seems promising, the regulatory body must give permission before the treatment can be tested on people.
The investigational new drug (IND) application:
Before a clinical trial can be started, the research must be approved. An investigational new drug or IND application or request must be filed with the regulatory bodies when researchers want to study a drug in humans.
Phase 0:
It is also known as Microdosing Study. Phase 0 studies are very small, often with fewer than 15 people, and the drug is given only for a short time like weeks. They might test whether the drug reaches the target cell, how the drug acts in the human body, and how the target cells in the human body respond to the drug.
Clinical Trial Phases:
Phase I:
It is also known as Pharmacology trials. Phase I studies are done to find the highest dose of the new drug that can be given safely without causing severe side effects. Tests in a small group of people from (minimum 20 and below 100) for the first time to determine a safe dosage range and identify side effects. This trial lasts for several months.
Phase II:
It is also known as Therapeutic exploratory trial Study. Phase II studies (Randomized double-blind) randomly assign people to different treatment groups. Tests involve a larger group of people (several hundred). These groups may get different doses or get the drug in different ways to see which provides the best balance of safety, efficacy and response. This phase lasts for several months to 2 years.
Phase III:
It is also known as Therapeutic Confirmatory Trials. Phase III is often done in many places across the country (or even around the world) at the same time. Study involves a large group of people (from several hundred to several thousand) by comparing the standard or experimental drug as well as to monitor adverse effects, and to collect information that will allow the drug to be used safely. This phase lasts for 1- 4 years.
New drug application (NDA):
When phase III clinical trials (or sometimes phase II trials) show a new drug is more effective or safer then, a new drug application (NDA) is submitted to the regulatory bodies for approval and its ready to launch in the market.
Phase IV:
It is also known as Post-Marketing Surveillance (PMS) Study. Phase IV studies look at drugs that have already been approved by the regulatory body. The drugs are available for doctors to prescribe for patients, but phase IV studies might still be needed to answer important questions. It involves thousands to lakhs of people and to collect information about any adverse effects associated with widespread use and here comes pharmacovigilance to analyse the adverse effects data.
NOT ALL CLINICAL RESEARCH INVOLVES CLINICAL TRIALS BUT ALL CLINICAL TRIALS ARE CLINICAL RESEARCH
Conclusion
In conclusion, now you understand the difference between clinical research and clinical trials. Those serve different purposes and functions in the healthcare and pharmaceutical industries but they are interrelated to each other. Both are equally important for medical progressions, ensuring that new drugs or treatments are effective with data evidence and also safe for public usage. Whether you are a researcher, healthcare professional, life science graduate or aspiring to enter this field, CareerInPharma helps you understand these differences through more detailed clinical research courses, which allows you to navigate career opportunities and contribute effectively to the pharma industry.
FAQs About Clinical Research vs. Clinical Trials
1. What career opportunities are available in clinical research and clinical trials?
After completing the CareerInPharma Clinical research courses you can enrol in pharma and healthcare industry as the clinical research associate, clinical research coordinator, medical writer, regulatory affairs and specially under clinical trials you can get roles like clinical trial manager, principal investigators, data manager, drug safety associates and so on.
2. What is the main difference between clinical trials and clinical research?
Clinical research involves studying diseases, treatments and improving medical knowledge while clinical trials test new drugs or treatment for the human diseases and evaluate safety and effectiveness.
3. How can CareerInPharma help you to start a career in clinical research or clinical trials?
CareerInPharma offer expert-led courses, practical exposure, Assisting for Prestigious certifications: ICH-GCP Certification – from NIH (National institute of health, USA) WHO Uppsala Certification, Job updates for Career Growth (6 months), also Job Assistance for Top Placements with Life time course and CIP app access to help secure roles in this field.
4. What certifications can enhance your career in clinical research?
CareerInPharma offers industry-recognized training to help you gain these certifications like Good Clinical Practice (GCP), and advanced training Certification in Clinical Research and pharmacovigilance.
5. Are online training programs in clinical research effective for career growth?
Yes, CareerInPharma offers comprehensive online courses with practical case studies, training flexibility, industry-relevant knowledge, and access to expert mentors which making it easier for you to transition into the pharmaceutical industry.
