Helping You Understand Clinical Trials



every day thousands of new drugs are being researched and developed by scientists around the world but only a few will ever be approved why because what works in their laboratory doesn't necessarily work in a human being and that's where clinical research studies come in clinical studies allow us to test how safe and potentially effective investigational drugs are when given to human volunteers in general investigational drugs pass through three types of clinical study we call these types phases phase one and Phase two focus on safety and look for early side to potential effectiveness these studies are fairly small usually recruiting less than a few hundred volunteers if the results of these look promising phase three studies can begin these are much bigger often recruiting hundreds or thousands of volunteers these large numbers allow us to test the safety and potential effectiveness of the investigational drug much more accurately every study follows the carefully designed plan called a protocol this explains why the study is needed what volunteers will have to do and how their health status will be monitored independent review teams or ethics committees must approve this protocol before the study can begin it's their job to protect the volunteers safety and rights of course volunteers must carefully consider the pros and cons of joining a clinical study before they participate for example during a study volunteers will have regular check-ins to monitor their health status this may allow them to learn more about their condition through their discussions with the study team but participating in these trials does take time and requires a commitment to regular appointments and tests and while joining a study may allow access to study related drugs and lab tests volunteers could also experience unwanted side effects from the investigational drug it's also important to note that often not all volunteers will receive the investigational drug sometimes a group is given a comparator instead this may be an already approved medication or it could be a placebo a placebo is something that looks exactly like the investigational drug without containing the active drug ingredient and is given in the same way by comparing the investigational drug to a placebo scientists can see whether any changes are due to the investigational drug for all these reasons it's important that volunteers think carefully about whether taking part is right for them after all participation is entirely voluntary in fact even if a volunteer signed up but then changes their mind they are free to leave at any time the study team may ask him to stop by for a voluntary final health status check clinical research studies are at the heart of all medical advances and they wouldn't be possible without the help of volunteers if you take part you could be contributing enormous e to the understanding of the disease this could potentially benefit you and others like you in the future you

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