Involvement in a clinical trial is certainly a personal decision that only you can make. There are many reasons to participate, each one with valid benefits. However, you should always consult your personal physician before moving forward with the enrolment procedure.
Clinical trials cost nothing to the participant. In fact, many (not all) clinical trials provide varying degrees of monetary compensation for your time and travel.
During the informed consent process, potential trial participants are fully informed of the risks and benefits of study participation. A trial will not be approved if Ethics Committees determine that the risks outweigh the potential benefits. Each phase of the process is closely monitored by the study physician and all parties involved, and all study activities are reported to the Ethics Committee.
During the informed consent process, potential trial participants are fully informed of the risks and benefits of study participation. The Institutional Review Board (IRB) is established to review clinical trials in order to ensure that the rights and welfare of human subjects is protected. No clinical trial can proceed without a review and approval from an Ethics Committee. It is their duty to:
- Review the clinical study’s protocol for merits, risk/benefit ratio, and ethics
- Review any changes to the protocol
- Monitor the welfare of the subjects being studied
Informed Consent is a strict requirement of the clinical trial process in which a volunteer participant is briefed on the specifics of the study. Eligible candidates are thoroughly versed in every aspect of their involvement until it is clear that they understand the information presented. A study will not begin until the IRB has reviewed and approved the informed consent form. Even then, you would not be under obligation and can choose to quit the trial whenever you wish.
After you let Panoply know you’re interested in participating, you can expect to be screened by a representative about your medical history and your current health. You’ll be informed about any potential risks and side effects that may occur from the trial, as well as the parameters of the study. Next, a physical examination will be completed. This exam typically includes such things as a measurement of your height and weight, an electrocardiogram (simple test that measures the electrical activity of the heartbeat), blood and urine analysis, and any other tests required by the particular study. Upon acceptance, a representative will contact you to schedule the next step. An informed consent agreement will need to be signed before the trial begins. The results of your screening tests will be provided to you whether you qualify for the study at hand or not. In some cases, you may be asked to stay at the clinic during the duration of the trial. A study team will be assigned to provide you with care throughout the process. The team may include a variety of doctors, nurses, social workers and other healthcare professionals. You may or may not be asked to perform certain tasks or refrain from certain behaviours, depending on your unique study. Also, there is a chance that you may be administered a placebo instead of actual medication. The regulations of your specific study will be explained to you in advance. Your health will continue to be monitored throughout the duration of the study as well as after the clinical trial is complete, depending on your unique study.
A question that often comes up about clinical trials is whether or not the volunteer has the freedom to leave the study for any reason. The simple answer is ‘yes’. While it is important that participants continue the research study from beginning to end in order for the trial to be a success, it is essential that people remember that they have the right to withdraw from a clinical trial at any time during the duration of the study.
At the completion of a clinical trial, researchers will analyse the data to determine if the potential treatment was safe and effective. You can ask your clinical trial coordinator for more information on how to follow up on the results. If the potential treatment was found to be effective, researchers will submit their data for approval. Depending on the study, some participants can continue using a potential study treatment after the study is complete. If the study was for an alternate use of a pre-existing, approved medication, your doctor may be able to prescribe it for an off-label use, allowing you to continue receiving the medication after the study is complete. However, if it is an unapproved drug, you may not be able to use it after the study is complete, until it has been approved by the regulatory authorities. Your study doctor and research team will discuss your post-trial treatment options with you.
Whether you are a healthy individual who has volunteered to participate for research purposes OR you have a particular condition being studied in the clinical trial, it’s vitally important to keep in communication with your own GP. Here are a few reasons why:
- Your medical history: Researchers ask questions and thoroughly screen volunteers for health conditions that may affect or be affected by clinical trials. But your GP is typically much more familiar with your medical past and can provide information and insight that may be important for the study itself.
- Treating your other health care needs: Although clinical trials address the issues surrounding the medical condition or treatment in question, they are not designed to provide care for other medical conditions you may already have.
- Preventing Conflict: Your GP may be able to help ensure that the clinical trial will not interfere with other treatments or medications. They should help you put together a thorough history for the trial screener.
Click here to review the various studies going on in your area. If you see a medical condition that is affecting you or a loved one—OR if you see an unrelated study that is looking for healthy volunteers—click that link. You will be directed to an online form. Just follow the easy directions for each step of the application process. If you’d feel more comfortable going through the application process with someone over the phone, just call 0800 014 8897. Or click here to find the trial site nearest you where you can apply in person.
Interested in participating in a clinical trial?
Want to be contacted to participate in a clinical trial? We welcome you to join millions of other people who have registered as a potential trial volunteer. It’s fast, at no cost, and you are never obligated to join a trial, even if you qualify.
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