Coronavirus Vaccine: Phases of clinical trials

A vaccine trail is a clinical trial that aims at establishing the safety and efficacy of a vaccine prior to it being licensed.



Developing vaccines requires special consideration because vaccines 
  • Are given to healthy individuals to prevent disease and help contribute to heath and well-being of society as a whole 
  • Demand a high safety threshold to achieve approval 
  • Are highly complex substance derived from living materials that require specific manufacturing process 
  • Require specialized testing to assure quality and safety in all vaccine distributed  
How are new vaccines Developed
The development cycle of a vaccine includes 
  • Exploratory stage 
  • Pre-clinical stage 
  • Clinical development 
  • Regulatory review and approval 
  • Manufacturing 
  • Quality control 
What are clinical trials
Clinical trials are research studies involving human volunteers that often evaluate the safety and efficacy of preventative measures or treatment products such as vaccines, medicines or medical devices 

Clinical trials also:
  • Provide important insight into disease vaccine can help prevent or medicines can help cure 
  • Are a critical step to support the approval of vaccine or medicine and medical devices by regulatory bodies 
How are clinical trials designed 
In order to produce the required data, clinical trials need to be designed based on number of parameters
  • The population to be studied 
  • Products to be investigated 
  • Goals or endpoints
  • Methods by which the trail will conducted 
Studies vary in their endpoints, the number of participants involved, and the study design, however all clinical studies follow criteria to protect the participants and ensure proper evaluation of product. 

Phases of clinical trials
A clinical trials is only done when there is good reason to believe that a new test or treatment may improve the care of patients. Before clinical trials, tests and treatments are assessed in pre-clinical research. Pre-clinical research is not done with people. It assesses the features of a test or treatment. 
After pre-clinical research, tests and treatments go through a series of clinical trials. Clinical trials assess if tests or treatments are safe for and work in people. Clinical trials have five phases. The phases are described next.


Phase 0: 
Phase 0 trials are the first clinical trials done among people. They aim to learn how a drug is processed in the body and how it affects the body. In these trials, a very small dose of drug is given to about 10 to 15 people.

Phase I
Phase I trials aim to find the best dose of a new drug with fewest side effects. The drug will be tested in small group of 15 to 30 patients. By giving very low doses of the drug to a few patients. Higher doses are given to other patients until side effects become too severe or desired further effect is seen. The drug may help patients, but phase I trials are to test a drug's safety. If drug to be find safe enough, it can be tested in phase II clinical trials 

Phase II 
Phase II trials further assess safety as well as if a drug works. Phase II trials are done in larger groups of patients compare to phase I trials. Often, new combinations of drugs are tested. Patients are closely watched to see if the drug works. However, the new drug is rarely compared to current (standard of care) drug that is used. If a drug found to work, it can be tested in Phase III clinical trial.

Phase III
Phase III trials compare a new drug to the standard of care drug. These trials assess the side effects of each drug works better. Phase III trails enroll 100 or more patients 
This are Randomized. Randomization is method based on chance by which study participants are assigned to different treatment groups. 
Randomization allows researchers to comparably test different treatments in similarly groups.
Every patient in phase III trials study will be stopped early if side effects of new drug are too severe or if one group has much better results.

Phase IV 
Phase IV trials test new drugs approved by the authorities(like FDA). The drug is tested in several hundreds or thousands of patients. This allows for better research on short lived and long lasting side effects and safety. Some rare side effects may only be found in large group of people.

In conclusion 
Vaccines are developed, tested, and regulated in a very similar manner to other drugs. In general, vaccines are even more thoroughly tested than non-vaccine drugs because the number of human subjects in vaccine clinical trials is usually greater. In addition, post licensure monitoring of vaccines is closely examined by the centers for Disease Control and the FDA.

Comments

Post a Comment

Popular posts from this blog

Hypothyroidism, Causes, Diagnosis and Laboratory Evaluation, Signs and Symptoms, Management

Image
Hypothyroidism Hypothyroidism results from under section of the thyroid gland Click here to know more Thyroid gland and Regulation of Thyroid hormones Hypothyroidism is classified as follows  Primary hypothyroidism: Failure of thyroid gland  Secondary hypothyroidism: Due to pituitary failure  Tertiary hypothyroidism: Due to hypothalamic failure  Causes of Hypothyroidism Worldwide, hypothyroidism resulting from iodine deficiency remains an all too common problem  In non-endemic areas or Iodine sufficient areas, Hishimoto thyroiditis, a choronic autoimmune disease, is the most common cause of primary hypothyroidism  Other causes are  Surgical removal of the thyroid gland  Thyroid gland ablation with radioactive iodine  A biosynthetic defect in iodine organification  Replacement of the thyroid gland by tumor  Drugs such as lithium or interferon  Pituitary and hypothalamic disease  Hashimoto's Thyroiditis Hashimoto's thyroidit...
Read more

Best Hand Sanitizers to Protect You From COVID-19, Cold, and Flu Germs in 2020

Image
Best Hand Sanitizers to Protect You From COVID-19, Cold, and Flu Germs in 2020 Combined with wearing a mask and practicing social distancing, keeping your hands clean is essential in preventing the spread of the novel coronavirus, as well as other germs that can cause the common cold and flu. Of course, washing your hands is the gold standard, but hand sanitizer is great option if don’t have access to soap and water. As we head into cold and flu season (and an eventual second wave of COVID-19), a bottle of hand sanitizer is a must-have. But choosing the right brand isn’t always simple. What to look for in an effective hand sanitizer Hand sanitizer is just alcohol suspended in a hand rub, which neutralizes germs that might be lurking on your hands, including SARS-CoV-2, the novel coronavirus that causes COVID-19. The Centers for Disease Control and Prevention (CDC) recommends hand sanitizers that contain at least 60% ethanol (ethyl alcohol) or 70% isopropanol as active ingredients. Coro...
Read more

Testosterone: Signs and Symptoms of low and high testosterone, laboratory testing of Testosterone

Image
 Testosterone Testosterone is main male sex hormone. In males (Human) testosterone plays a very important role or we can say key role in development of male reproductive tissues such as testes and prostate as well as helping in promoting secondary sexual  characteristics such as increased muscle and bone mass, and the growth of body hair. Testosterone is most often associated with sex derive, and plays a vital role in sperm production. The way men store fat in the body, and even red blood cell production. A men testosterone levels can also affect his mood. Testosterone is a hormone found in humans, as well as in other animals Testicles primarily make testosterone in men  Women's ovaries also make testosterone, in very small amount Chemistry of testosterone Testosterone is a potent steroid hormone whose chemical formulation is C19-H28-O2. Testosterone is also known as 17-beta-hydroxy-4-androstene-3-one. How testosterone produces The hypothalamus is decision maker. It puts ...
Read more