Understanding why I might not qualify

Ever wondered why not everyone who volunteers is eligible to take part in a clinical trial? A clinical trial is strictly controlled  and needs to follow some very important rules:

All approved studies have a Protocol. What is a Protocol?

  • A document that clearly outlines how the study will take place
  • Who may take part (inclusion criteria)
  • Who may not take part (exclusion criteria)
  • Ensures that the trial participants safety and well-being is ALWAYS the most important
  • Makes sure that the data collected is 100% accurate

What are inclusion criteria?

To be able to take part in a clinical trial you need to meet the required inclusion criteria

Why you ask?

Quite simply because:

To have reliable results you need to compare apples with apples.

To achieve the purpose of the research.

How is that done in a clinical trial?

That is where the inclusion criteria  comes in. In order to be considered you need to meet CERTAIN inclusion criteria as stated in the PROTOCOL.

Let’s give you a practical example. Inclusion criteria for a particular study are as follows:

18-75 years of age/male and female/high cholesterol/Type 2 diabetes/Previous heart attack, stroke or stent

So the logical question would be: If I meet most of the inclusion criteria above would I automatically qualify?

The simple answer is: Unfortunately not.

Tests will need to be done to see what your total cholesterol levels are as well as testing your blood HbA1c levels which will show how well your diabetes is controlled. The PROTOCOL provides ranges for both that you need to be within in order to be considered. If your levels are higher or lower than the range stated in the protocol you CANNOT be considered for the study. A type 1 diabetic would also not be eligible according to the inclusion criteria example above. Anyone younger than 18 or older than 75 would also not be eligible.

What are exclusion criteria?

Exclusion criteria are what excludes you from being considered to take part and for good reason.

Why would exclusion criteria be important?

  • To protect your own safety
  • Current medication that you are taking can affect the trial treatment
  • Certain medical conditions can increase your risk when exposed to the treatment being provided during the trial

What are examples of exclusion criteria?

  • Already taking part in a clinical trial (you may only take part in one trial at a time)
  • Age
  • Pregnant or breast feeding women
  • Uncontrolled conditions i.e. hypertension, diabetes, thyroid disease etc
  • Certain medical conditions i.e. carpal tunnel syndrome, HIV, liver disease etc
  • Certain medications that you are currently taking i.e. cannabis

Important points to ALWAYS remember

  • All clinical trials are approved by the South African Health Products Regulatory Authority (SAHPRA) and relevant ethics committee prior to it starting – THIS IS TO PROTECT YOUR RIGHTS AND SAFETY
  • The protocol is always strictly followed – NO EXCEPTIONS
  • The inclusion and exclusion criteria differs from one trial to another
  • One thing that is never compromised ever – YOUR SAFETY AND WELL-BEING
  • Do not take your exclusion from a trial as personal – There is a VALID reason for it
  • You may not take part in more than one clinical trial at a time
  • Inclusion and exclusion criteria are there for a reason and are very important

 

 

 

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