Participating in a clinical trialPParticipating in a clinical trialParticipating in a clinical trialEnglishNeonatologyPremature;Newborn (0-28 days);Baby (1-12 months)NANANAPrenatal Adult (19+)NA2009-10-31T04:00:00ZJonathan Hellmann, MBBCh, MHSc, FCP(SA), FRCPC9.0000000000000055.0000000000000763.000000000000Flat ContentHealth A-Z<p>Learn about a difficult decision some parents face: whether to agree to allow their premature baby to participate in a clinical trial. </p><p>It can be a difficult decision deciding whether to allow your premature baby to participate in a clinical trial. Before making any decision, make sure the doctor or research nurse addresses all your questions and worries. Consider the advantages and disadvantages of clinical trials.</p><h2>Key points</h2> <ul><li>There are several questions you should ask before allowing your premature baby to participate in a clinical trial so that you can understand the advantages and disadvantages for your baby.</li> <li>Saying no to a clinical trial or other research will not have any negative impact on the care or treatment your baby receives.</li></ul>
Participation à un essai cliniquePParticipation à un essai cliniqueParticipating in a clinical trialFrenchNeonatologyPremature;Newborn (0-28 days);Baby (1-12 months)NANANAPrenatal Adult (19+)NA2009-10-31T04:00:00ZJonathan Hellmann, MBBCh, MHSc, FCP(SA), FRCPC9.0000000000000055.0000000000000763.000000000000Flat ContentHealth A-Z<p>Renseignez-vous sur la décision difficile que certains parents doivent prendre : soit de permettre que leur bébé prématuré participe à un essai clinique.</p><p>Il peut être difficile de permettre que votre bébé prématuré participe à un essai clinique. Non seulement vous avez à composer avec la maladie sérieuse de votre bébé, mais on vous demande de prendre une décision additionnelle afin qu’il participe à une étude.</p><h2>À retenir</h2> <ul><li>Vous devriez poser plusieurs questions avant de permettre à votre bébé de participer à une étude clinique afin que vous puissiez comprendre les avantages et les inconvénients pour votre bébé.</li> <li>Refuser de participer à une étude clinique n’aura aucune conséquence négative sur les soins ou les traitements administrés à votre enfant.</li></ul>

 

 

Participating in a clinical trial1831.00000000000Participating in a clinical trialParticipating in a clinical trialPEnglishNeonatologyPremature;Newborn (0-28 days);Baby (1-12 months)NANANAPrenatal Adult (19+)NA2009-10-31T04:00:00ZJonathan Hellmann, MBBCh, MHSc, FCP(SA), FRCPC9.0000000000000055.0000000000000763.000000000000Flat ContentHealth A-Z<p>Learn about a difficult decision some parents face: whether to agree to allow their premature baby to participate in a clinical trial. </p><p>It can be a difficult decision deciding whether to allow your premature baby to participate in a clinical trial. Before making any decision, make sure the doctor or research nurse addresses all your questions and worries. Consider the advantages and disadvantages of clinical trials.</p><h2>Key points</h2> <ul><li>There are several questions you should ask before allowing your premature baby to participate in a clinical trial so that you can understand the advantages and disadvantages for your baby.</li> <li>Saying no to a clinical trial or other research will not have any negative impact on the care or treatment your baby receives.</li></ul><p>Whether to agree to allow your premature baby to participate in a clinical trial can be a difficult decision. Not only must you deal with your baby having a serious illness, but you are also asked to make an additional decision about joining a study. </p> <p>Some parents worry that their doctor is only interested in research and that their baby is not the primary concern. The reality is that no patient, including your baby, is secondary to research. Medical progress is made in the long term by establishing evidence for "best practices". No patient is ever knowingly put at risk to establish this evidence.</p> <p>It is true that treatment studies can be based on randomization, meaning your baby will get one of two treatments based on chance. Parents worry that their baby may get into the “wrong” group. The fact is, there is no known "wrong" group. Studies use this method to try to determine if one treatment is better than another treatment or no treatment at all. The point is, they do not yet know and finding out is the purpose of the study. </p> <p>Parents should also understand that their baby is almost certainly benefiting from previous studies about premature babies other parents consented to in the past. </p> <p>Before making any decision, make sure the doctor or research nurse addresses all your questions and worries. Consider the advantages and disadvantages of clinical trials. </p> <h2>Questions to ask about a clinical trial</h2> <p>If you are asked to allow your premature baby to participate in a clinical trial, you should ask the staff in charge of the study the following questions: </p> <ul> <li>What is the purpose of the study? </li> <li>What is involved in the study? </li> <li>What are the benefits of participating? </li> <li>What are the risks of participating? </li> <li>Is there any information about how other premature babies have responded to the same treatment? </li> <li>What are the side effects, both in the short-term and long-term? How will the side effects be prevented or managed? </li> <li>Are any extra diagnostic tests required? </li> <li>How will participating in the trial affect my premature baby’s daily life? </li> <li>What effect might this have on other family members? </li></ul> <p>When you have the answers to these questions, feel free to take some time to think about whether you want to allow your premature baby to participate. You may want to take a day or two to think it over, especially if the study will involve invasive procedures or take a lot of time. </p> <h2>How will my premature baby be protected if we agree to join a clinical trial?</h2> <p>There is a system in place to protect babies, children, and adults who participate in clinical trials. First, the protocol must be approved by a review committee and research ethics board. During the clinical trial, these committees make sure the research protocol is being followed. Participants must be told in detail about the treatments, tests, possible benefits, and risks of the trial. This is called informed consent. Then they can make a decision. At any time, they may withdraw from a clinical trial. </p> <p>Trials are also independently monitored to ensure that safety is not compromised and that protocols are being followed. </p> <h2>What if we don’t agree to join a trial?</h2> <p>You are free to decline to allow your premature baby to participate in a clinical trial or other research. There is no penalty for not participating. Your premature baby will receive excellent care either way. </p> <h2>What are the advantages and disadvantages of putting my premature baby in a clinical trial?</h2> <p>Here are some general advantages and disadvantages to consider and talk to your doctor about.</p> <h3>Advantages</h3> <ul> <li>Your premature baby gains access to new treatments that are not otherwise available. </li> <li>Your premature baby will obtain expert, state-of-the-art medical care. </li> <li>Participation contributes to medical research and may help others in the future. </li></ul> <h3>Disadvantages</h3> <ul> <li>Your premature baby may need to have more tests or other complex drug requirements. </li> <li>Depending on the phase of the trial, the result may not be known and the treatment may not work. </li> <li>There may be unknown side effects or reactions. </li></ul> <p>Remember, participating in any kind of research is your choice. You should take all the time you need to decide. Your premature baby’s care will not be affected, whether or not you choose to participate.</p>Participating in a clinical trial

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