Understanding the Scope of Clinical Research and What it Entails

Students

Jun 25

Clinical research can be defined as a study of illness and health in humans. This is how we find out ways in which we can prevent, make a diagnosis, and even treat illnesses. Usually, the focus is on the improvement of knowledge and coming up with the best diagnostic methods or new treatments to create better care.

Clinical research respects a study protocol that is very precise and organized. A clinical research can only be fully realized under specific conditions.

The research must:

 Collect the necessary consent from all participants of the research

 Obtain all the approvals as required by the law and ensure all the ethical steps are adhered to

 Take the necessary measures to protect everyone who joins in the research

 Be conducted by people who are competent

 Have the aim of growing medical knowledge

Types of clinical research

There are two types of clinical research that can be conducted:

1. Observational studies (epidemiology, cohort study)

2. Clinical trials or Intervention studies

1. Observational studies

This kind of research is aimed at the improvement of knowledge of a particular disease as well as how it has evolved over a period of time. Usually, they are conducted within a set framework where patients have follow ups in reference centers. Historical studies are also included here.

2. Clinical trials or Intervention studies

These aim at providing enough scientific evidence of the safety and effectiveness of new drugs, new illness management, or new care device. This is a step which is necessary before any molecule can be made a drug as well as a new medical device before it is brought to the market.

There are very strict steps that are involved in this case and they include:

 Administration to healthy humans

 Administration in the patients

 Therapeutic efficacy

 Marketing authorization or approval

 Evaluation and monitoring of the side effects

Clinical trials

Clinical trials fall under the clinical research umbrella. It is an experiment which is designed to address very specific questions regarding possible treatments or any new ways that can be used with existing treatments. They are done to determine if the treatments and new drugs are effective and safe. Clinical trials are usually a long and careful process that can take years before completion. The treatment has to be studied in a lab by qualified doctors.

Drugs and treatments need to be animal tested before any human testing.

Medical care and clinical research

It is common for people to confuse medical care and clinical research. In Medicare, a patient has a plan that is unique to their needs. The treatment plans have already been tested and proven safe and effective.

Everyone who wants to undertake clinical trials should be aware that it is an experiment. This means that while patients will have access to the newest technology, clinical trial may or may not benefit you.

In clinical research, there is usually a pre-determined set plan or protocol that the researcher and the subject have to follow. In a clinical trial, there are steps taken if someone starts feeling unwell during the trials, but the researcher is not allowed to make any adjustments to the plan to fit any particular subject. It is therefore important to have everything laid out with the researcher and your doctor.

Take courses from CCRPS and learn more on how to become a clinical research professional.

Exploring the World of Clinical Research: Understanding Its Significance and Processes

Courses:

Clinical Research Coordinator: Gain insights into the role of Clinical Research Coordinators in organizing and overseeing clinical research studies.
Pharmacovigilance Certification: Understand the importance of pharmacovigilance in ensuring drug safety throughout clinical research processes.
CRA (Clinical Research Associate): Delve into the responsibilities and duties of Clinical Research Associates in managing and monitoring clinical trials.
ICH-GCP: Learn about the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) guidelines essential for conducting ethical clinical research.
Clinical Trials Assistant Training: Acquire the foundational skills necessary to support clinical trial operations effectively as a Clinical Trials Assistant.
Advanced Clinical Research Project Manager Certification: Enhance your expertise in clinical research project management with advanced certification training.
Advanced Principal Investigator Physician Certification: Gain advanced certification tailored for Principal Investigator Physicians involved in clinical research studies.
Medical Monitor Certification: Explore the critical role of medical monitoring in ensuring the safety and integrity of clinical trials.