25 C
Wednesday, September 23, 2020

Stages of Clinical Trials and the Importance of Clinical Trial Registry

- Advertisement -

Is very important you have clinical trial registry if involving humans as subjects. It’s based on the declaration of Helsinki, which says that every clinical trial must be registered in a publicly accessible database before recruitment of the first subject.

- Advertisement -

One of the purposes of the registration of research involving human subjects is that all the data can be stored and used by the parties concerned to conduct further research.

The intent and purpose of these Articles is merely providing enlightenment, knowledge and understanding for us all to learn how, difficult, expensive and long time needed to launch a medicine for the human beings.

Test Clinic

Basically clinical trials to ensure the effectiveness, safety and adverse-event that often arise in humans due of a medicine. The clinical trial consisted of a phase I up to phase IV.

Clinical Testing First Phase

This phase is the testing of a new medicine for the first time in humans. It is usually performed in healthy volunteers. The first objective of this phase is to determine amount of a single dose and ensuring not cause serious effects.

Clinical Testing Phase II

In this phase the medicine tested for the first time on a small group of patients who would be treated with the medicine candidate. The goal is to see whether the pharmacologic effects seen in the first phase for ensuring the treatment is useful or not.

Phase II was carried out by people who are experts in their respective fields. They are having had a role in making the research protocol to be assessed first by the local ethics committee. The study protocol should be followed strictly, patient selection must be careful, and each patient should be monitored intensively.

Clinical Testing Phase III

Phase III clinical trials conducted to ensure that a new medicine is really efficacious and to determine position and compare with standard medicines. This research also will answer questions about the effect when it is used widely, other effects that have not been seen in phase II, and the impact of use in patients.

When the results of the phase III clinical trials show that a new medicine is reasonably safe and effective, the medicine can be allowed to be marketed. Number of patients included with this third phase at least 500 people.

Clinical Testing Phase IV

This phase is often referred to as post- marketing medicine surveillance is an examination of the medicine has been marketed. This phase aims to determine patterns of medicine use in the community as well as the pattern of effectiveness and safety in actual use.

- Advertisement -

Phase IV studies are epidemiologic survey about the effects and effective’s medicine. In phase IV can be observed  the low frequency effects or arising after use of the medicine for years , the effectiveness of the medicine in patients with severe disease or double disease , expectant, children or the elderly , or after repeated use in the term length, medicine abuse, the problem overuse, and others.

Clinical trial
  • Save
- Advertisement -

Disclaimer: This article is purely informative & educational in nature and should not be construed as medical advice. Please use the content only in consultation with an appropriate certified medical or healthcare professional.

Editorial Staffs at Healthtian, A team of Writers.
- Advertisement -

Trending Now

What are the Reasons for Implementing an Occupational Health and Safety Program?

Occupational health is defined as a comprehensive approach to health focusing on everyone at a workplace. This includes the workers and the visitors, including...
- Advertisement -

Skin Rashes: Causes, Symptoms and Effective Home Remedies

Skin rashes are common skin problems experienced by millions of people worldwide; it is characterized by a visible change in the color...

Atis Fruit: 10 Health Benefits of Eating Sugar Apple

Sugar apple (Atis fruit), is the Annona squamosa fruit belonging to the natives of West Indies and to the tropical Americas like Peru, Mexico,...

How to Increase Sodium Levels in Your Blood?

Levels of sodium in the blood is often a misunderstood topic and it is extremely necessary that we as individuals understand the meaning and...

Spider Bites: Symptoms, Treatment & Identification

Spider bites in the United States are often annoying but they are rarely fatal. If a person gets bitten by a black...

Hole in the Heart: Causes, Symptoms and Treatment

Normally, the heart is divided into two parts - left and right - which are separated by a septum (which separates the two upper...

Oral Surgery Recovery – What Foods to Eat

Had oral surgery? Then it’s very hard to have foods while in recovery. An oral surgery makes you feel weak and nauseous. So it’s...

7 Types of Disability and Examples

For disabled people life is a lot different than the rest of us. They don’t lead normal lives like we do and need assistance...

8 Ways to Remove Dandruff Without Washing Hair

There are about 50 million Americans are diagnosed with dandruff which is an alert problem. Dandruff not only cause damage to your...

What Causes Pain Between Shoulder Blades?

Shoulder blade is in the upper side of your back, the scapulae, which become prominent if you pull your elbows close to your trunk...

Exercise During Pregnancy: Everything You Need to Know

Regular exercise during pregnancy can promote health, reduce the chances of excess weight gain, and conceivably make childbirth easier. Exercise during pregnancy...



Nurture yourself with health tips, wellness advice, and more.

- Advertisement -

Related Posts

5 Simple Home Remedies for Sleep Apnea

Sleep apnea is a sleeping disorder, which affects the respiratory function during the sleep. This disorder can affect your way of breathing when you...

Legionella Risk Assessment and Testing: What Are a Landlord’s Responsibilities?

In the UK health and safety law requires that landlords take responsibility for matters concerning the safety and well-being of their tenants. Part of...

Diseases Caused By Your Workplace

Initially, asbestos was used almost everywhere in the United States. It is a mineral that naturally exists in the form of fibers...

Bladder Stones – Causes, Symptoms, and Treatments

As days go by, there are lots of things that cause damages to our system even some things we know nothing about. Bladder stones...


Please enter your comment!
Please enter your name here

This site uses Akismet to reduce spam. Learn how your comment data is processed.

Clinical trial
Copy link
Powered by Social Snap