How do clinical trials work and who can participate?

Clinical trials are done according to some protocols. These protocols highlight those patients who are eligible to take part in the trials. There are different trials like treatments, prevention trials, screening trials, etc. Different institutions and labs provide clinical research services at affordable rates


How Clinical Trials Work? 


Clinical trials are executed in phases. Every phase is there to retrieve relevant information about the patient's history. To protect the safety of patients, good clinical practices are followed. Every study has its own rules, like deciding who can or can't participate. The eligibility of people depends upon some factors which include overall health, disease stage, treatment, and medical conditions. 


What are the phases of clinical trials?


Clinical trials are conducted in the labs. The researchers here test the treatment on the animals before proceeding with that on humans. When these become promising for animals, then they move with humans. The following are the phases of research trials: -

Phase 1 -In this phase, the testing process ensures whether the clinical trials can be conducted on humans or not.

Phase 2- Here, how much the drug is effective is considered. Moreover, it takes several months to years. There are hundreds of participants here.

Phase 3- There can be up to thousands of patients here. Here, in this, the trial side effects are depicted.

Phase 4- This phase is also called Post Marketing Surveillance Trials. It comes after the drug gets approval. Pharmaceutical companies monitor how effective the drugs are. Also, it gets compared with existing drugs in the market. Apart from that, the cost factor is also determined in this phase.


In a clinical trial, the following information is necessary:

  • Total patients, who will be participating in the trial?
  • The number of eligible candidates
  • What kind of data is gathered?
  • How will the information be checked and measured?


Who Can Participate?


There are specific guidelines regarding who can participate in the clinical trials. Some organizations only accept candidates who are in good health. while the other organization enrolls those who have minor issues such as the common flu.

 Before hiring the right candidate for a clinical trial, the organization uses inclusion as well as exclusion criteria. Several factors are considered in this, like gender, age, disease, medical conditions, etc.

The things which allow one to participate are called inclusion criteria. Exclusion criteria, on the other hand, are those that prevent or disqualify someone from participating.


What is Informed Consent and why it is needed to get signed? 


Informed consent is very much needed when you are participating in a clinical trial. 

In this study, researchers inform you about the benefits, alternatives, and risks associated with the study. There are some verbal instructions and printed materials, either in the form of a questionnaire or something else. When you are curious about the trial, you can ask questions of the researchers. 


After all, if you still want to be a part of this trial, then you need to sign a document. In this document, the risks, benefits, etc are mentioned. This is just a document, not any kind of bond or contract. The main purpose of this consent is to protect your information.

Publicado en Health en septiembre 17 at 06:00
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