Understanding the scope of clinical research and what it entails

Clinical research can be defined as any kind of research that is conducted on human beings whether sick

or healthy. Usually, the focus is on the improvement of disease knowledge and coming up with the best

diagnostic methods as well as new treatments and medical devices to make sure that there is better

care of patients.

It respects a study protocol that is very precise and acts in a framed manner. A clinical research can only

be realized when there are some very specific conditions present. 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 so as to protect everyone who joins in the research

 Be conducted by persons who are competent

 Have the aim of growing any kind of 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 Interventional 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

are followed up while in reference centers. Historical studies are also included here.

2. Clinical trials or Interventional 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