What to know before going for a clinical trial?

Clinical trials are carried out to verify or study whether a new intervention is safe and effective for humans in order to prevent, screen for, diagnose, or treat a disease, syndrome or condition and thereby adding results to medical knowledge.

Interventions being tested in clinical trial may include any of the following:

  • Medical strategy such as diet plan, medicines, vaccines or any lifestyle changes for a  particular disease condition.
  • Treatment procedure such as surgery or radiation therapy
  • Medical products, such as drugs or devices

Each trial has its own research plan or protocol about who are eligible participants. Some trials need volunteers with a certain disease. Some need healthy people while others want just men or just women.

Informed consent also known as heart of ethical practice is the process of agreeing to take part in a study or trial  based on access to all relevant and easily digestible information about what participation means, in particular, in terms of harms and benefits.

What to know before going for a clinical trial?

Anyone concerned about taking part in clinical trial should be aware of its pros and cons before making a decision of going for it or not. One should know as much as possible about the study by asking the research team queries about the study, the related procedures, and any expenses. One must read Informed consent document carefully as answers to some of these questions are included in it.

Some of the questions to be asked for making a informed decision are as follows:

  • What is being studied?
  • Why do researchers believe the intervention being tested might be effective? Why might it not be effective? Has it been tested before?
  • What are the possible interventions that I might receive during the trial?
  • How will it be determined which interventions I receive (for example, by chance)?
  • Who will know which intervention I receive during the trial? Will I know? Will members of the research team know?
  • How do the possible risks, side effects, and benefits of this trial compare with those of my current treatment?
  • What will I have to do?
  • What tests and procedures are involved?
  • How often will I have to visit the hospital or clinic?
  • Will hospitalization be required?
  • How long will the study last?
  • Who will pay for my participation?
  • Will I be reimbursed for other expenses?
  • What type of long-term follow-up care is part of this trial?
  • If I benefit from the intervention, will I be allowed to continue receiving it after the trial ends?
  • Will results of the study be provided to me?
  • Who will oversee my medical care while I am participating in the trial?
  • What are my options if I am injured during the study?

References and Further reading:

  1. http://www.rcn.org.uk/__data/assets/pdf_file/0010/78607/002267.pdf
  2. https://clinicaltrials.gov/ct2/about-studies/learn
  3. http://www.nlm.nih.gov/medlineplus/clinicaltrials.html

 

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Healthtard

Healthtard

Pradeep completed his Masters in Clinical Engineering from IIT Madras and he likes to share the care! To know about him and his projects click here!

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