Participating in a Clinical Trial

Who can participate in a clinical study?

                  Depending on the study, and its needs, various factors are taken into account in terms of participants. There is typically an outline in the protocol calling for particular persons for particular studies. Some may require participants have a certain illness or condition, or that they be perfectly healthy. Some may call for underweight persons, smokers, or those with an addiction in order to target the effectiveness of a particular item being tested.

There are certain factors as well that are used to disqualify an individual from taking part in a particular study as well, such as age, race, gender, pre-existing health condition or otherwise. In clinical studies, factors for eligibility or disqualification are not personal, they are based on the needs of the researchers to maximize the observation of the efficacy of the product being tested, and where as you may be disqualified for one, you may be uniquely qualified for another. The general needs of study participants are made aware to any applicants prior to obtaining a position within the study.

How are participants protected?

All participants are protected via the informed consent protocol of the testing phase. No participant shall go into a study without knowing what they are getting into. As a study member you have the right to access of information considering your expectations as a study member, and what you can expect to take part of. Prior to giving your consent you will be given information regarding your participation, and also have the opportunity to raise any questions or concerns at that point.

As a member of the study, your well being is still of the utmost importance to the research group, and your consent can be retracted at any point in which you feel unsafe, or uncomfortable. If you believed you had a firm grasp of your expectations at the date of signing, but came to realize later that you were unprepared for the actual study, you are not locked in to completion simply because you said you were at the beginning. Terms of retraction from the study if need be, should also be discussed prior to signing your informed consent form.

Relationship to usual healthcare.

Typically you will still have access to your usual healthcare provider. In clinical study, the product being tested will be integrated into your normal daily life, and so therefore into your normal healthcare. In continuing to see your doctor, they essentially join the research team in monitoring your effects, and how the product is implemented with any previous medical routine or medications.

Considerations for participation.

By participating in a clinical study, you are helping with the advancement of medical knowledge. Every drug you have ever heard of has gone through the rigorous testing phases that are still continued today. There was an individual in your shoes many years back to be the first to attempt the polio vaccine, to take the first pain reliever, and to use the first pacemaker. Those partaking in clinical studies are pioneers, willing to brave the unknown for the chance at great success, and to help many, many other down the road.

With risk for reward though, comes risk for failure. Some products may not work, and others may carry side effects ranging from unpleasant, to potentially fatal. By stepping into the unknown, you can never be sure where your foot will land. And so that is why it is vitally important to ensure that you are fully informed going into any clinical study, and to arm yourself with as much information as you can. The best preparation for a journey, is to be informed beforehand.

Ensuring that you fully understand the potential risks in advance to participating in a clinical study is an important first step in the process for both yourself and for the researcher. Each study, and each individual is carefully crafted to be ensure the chance for success.