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Clinical Trials

Clinical trials are sets of tests in medical research and drug development that generate safety and efficacy data. Trials provide the basis for the development and marketing of new drugs, biological products, and medical devices. Trials are conducted only after satisfactory information has been gathered on the quality of the nonclinical safety, and health authority/ethics committee approval is granted by the government.

Sometimes, the safety and the effectiveness (or more specifically, information about adverse drug reactions and adverse effects of other treatments) of the experimental approach or use may not be fully known at the time of the trial. Some trials may provide participants with the prospect of receiving direct medical benefits, while others do not.

Most trials involve some risk of harm or injury to the participant, although it may not be more than the risks related to routine medical care or disease progression. Many trials require participants to undergo additional procedures, tests, and assessments based on the study protocol. These will be described in the informed consent document for a particular trial.

 http://clinicaltrials.gov

HFA does not recommend any specific trials. We do encourage potential trial participants to be clear in their understanding of any trial before agreeing to participate and discuss in advance with your usual health care provider.

Be Informed! Some Questions to Ask

Know as much as possible about a clinical study and feel comfortable asking the research team questions about the study, the related procedures, and any expenses. The following questions might be helpful during such a discussion. Answers to some of these questions are provided in the informed consent document you will sign prior to participating.

  • 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 in the trial?
  • What are my options if I am injured during the study?
 Source: http:///clinicaltrials.gov

 

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