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12 Things You Didn’t Know About How Medicine Gets Approved

Discussion in 'Pharmacy' started by Ghada Ali youssef, Jan 10, 2017.

  1. Ghada Ali youssef

    Ghada Ali youssef Golden Member

    Dec 29, 2016
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    Practicing medicine in:

    Everything you should know — but don’t! — about the contents of your medicine cabinet.

    1. Medicine spends YEARS (!!!) in testing and development before it reaches you.
    Did you know the development of a new medicine can take more than 10 years? Although long, this length of time is vital to ensure each medicine is tested rigorously.

    2. That lengthy testing process is made up of multiple research studies called “clinical trials.”
    A clinical trial is a scientific study in people that helps to determine if (and how!) a drug or therapy works. Clinical research helps doctors and scientists answer specific questions about new medicines, such as: Is it effective? Is it more effective than an existing treatment? Is it safe and/or what are its side effects?

    3. Clinical trials are really important — and for more reasons than you might think.

    Clinical trials obviously provide critical information about a new medicine’s safety and effectiveness, but just as importantly, clinical trials also generate a lot of in-depth data that can lead to the creation of other innovative new treatments.

    4. People participate in clinical studies for all sorts of different reasons.

    There are many, many reasons why people take part in clinical research studies. Some people want to assist in the discovery of new treatments and medicines. Others want to learn more about their own individual health issues. Everyone is different and choosing to participate is, ultimately, a personal decision.

    5. Every clinical trial has its own Inclusion and Exclusion Criteria, aka rules about who can and cannot participate.
    These rules are usually based on things like age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Inclusion and Exclusion Criteria are developed with a lot of thought and consideration because they help prove whether the medicine being tested actually works for the patient population it is intended for.

    6. As with everything, the risks and benefits of joining a clinical trial are different for everyone.
    Since clinical trials are experiments, the exact risks and benefits can be difficult to predict. And because all clinical trial participants are different, they will experience these risks and benefits in different ways. For example, one participant may experience a side effect that another participant does not. The study doctor will explain this to you to help you weigh the pros and cons of participation.

    7. The health, safety, and well-being of clinical trial participants are always taken extremely seriously…
    Caring for participants is one of the main responsibilities of the medical professionals who run clinical trials. These professionals may go by unfamiliar titles such as principal investigator or study coordinator, but they are also doctors, nurses, and trained research professionals. It’s part of their job to monitor participant safety and well-being. Sometimes that means adjusting care and coordinating with a participant’s personal physician and health care team; sometimes that means withdrawing them from the clinical trial altogether. It all depends on what they feel is in the participant’s best interest.

    8. …so seriously, in fact, that every clinical trial is overseen by doctors, an Ethics Review Board, and the FDA to ensure participants are being properly cared for and their rights are being protected.
    Everyone conducting a clinical trial has strict regulatory and ethical duties. To ensure these duties are carried out and participants are treated well, an Ethics Review Board (aka a team of people who aren’t involved with research conduct) reviews the clinical trial before anyone joins and periodically after the study starts. Study doctors, and ultimately the FDA, ensure appropriate steps are being taken to protect the rights and welfare of study participants.

    9. Participants are always free to drop out of their clinical trial at any time, for any reason.
    Participants can drop out of a clinical trial even after they have agreed to participate. And they do not need to give a reason. No matter what stage of a clinical trial, participants have the right to change their mind.

    10. Clinical trials take place in a lot of different settings.

    Clinical trials can be conducted in a variety of places, including hospitals, universities, doctors’ offices, and community clinics all around the world!

    11. The majority of people who participate in clinical trials would recommend it!
    According to a 2013 survey by the Center for Information and Study on Clinical Research Participation, 95% of clinical trial participants would consider enrolling in another clinical trial. And 91% thought the experience they had in their clinical trial was “Excellent” or “Good.”

    12. Finding new and improved medicines is only possible because of people like you.
    In order to learn if a new treatment works, doctors and scientists need to test it on real people in the real world. Over 2 million brave people take part in clinical trials every year (meet four of them here!), testing new treatments that may make life better. Without their help, clinical research — and all the valuable discoveries and insights it generates — wouldn’t exist.


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