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Type II Diabetes
Clinical trials are the most important part of clinical research and at the heart of all medical advances. In a clinical trial, participants receive a specific intervention, according to a research plan (or protocol), which is assigned to them by a suitably qualified investigator. These interventions can range from medicine to changes in diet to a new medical device. Investigators then try and determine the safety and efficacy of these interventions, usually by measuring certain outcomes, and it is this knowledge that drives modern medical advances.
- By participating in clinical trials you will have access to Doctors, Nurses and Dieticians resulting in additional medical check -ups, laboratory tests and dietary or nutritional advice.
- The new drug may improve your illness/condition (however these medications are still in testing phase and there are no guarantees that your condition will improve).
- Often, you will learn more about you condition allowing you better understanding and the ability to make informed decisions.
- By participating in a trial you are making a significant contribution to science, furthering our understanding of medicine and health which may indirectly help others with same condition/illness in the future.
- There will be no cost to your participation in the trial and all out of pocket expenses (travelling and meals costs) will be reimbursement.
- Remember that it is the doctor’s responsibility to protect your health, privacy and dignity and that regardless of signing a consent form you will have the final say with regards to your participation in or continuation of the clinical trial.
This will depend on the type of trial and the phase of testing. Every trial is aimed at a certain illness/disorder and thus comes with an inclusion/exclusion criteria list. The inclusion /exclusion list is essentially a medical questionnaire that a Doctor will discuss with you to assess your eligibility for a study together with your medical history and laboratory tests. These criteria are often very strict and every patient needs satisfy all inclusion criteria and none of the exclusion criteria to be able to participate safely in a study.
The informed consent document is a summary of the clinical trial explaining outcomes, procedures, risks, benefits and alternative treatment options available. By signing the document you are agreeing to participate in the trial, however, this document is not binding and the patient can at any point, without reason, withdraw consent and stop participation which will in no way influence any future medical treatment you may receive. The consent process is ongoing throughout the duration of the trial and patients may need to sign more than one consent form to receive updated information regarding the trial and any amendments to the trial protocol.
Risks: Due to the fact that these are unregistered drugs still in the testing phase there will be risks involved. Participating in a trial may result in unpleasant side effects; additionally the treatment may not be effective. However, for a sponsor company to be able to test a drug at a clinical trial stage the benefits of the drug must outweigh the risks. Ethics review boards and medicine councils closely monitor efficacy and safety of a drug.
Benefits: Benefits of participating in clinical trials are vast and include additional medical health care and assessments (at no extra cost), access to investigational products before they become widely available, and opportunity to assist in scientific research as well as help others.
The safety of a participant is the number one priority for every clinical trial. Before a study drug proceeds to the clinical trial stage it goes through a number of preclinical stages testing its safety and efficacy. When entering the clinical stage, the drug is closely monitored by Investigation Research Boards (IRB) to confirm that risks are as low as possible. A detailed protocol prompts doctors to conduct the study according to strict safety guidelines. Additionally, all patient information remains private and confidential.
Before participating in a clinical trial the patient needs to consider the risks and benefits involved. It is also important for patients to consider transport and transport costs to and from the site (even though these are remunerated) and their ability to take leave from work. Patients also need to consider the importance of the trial and their role in the trial, acting in adherence to protocol, maintaining drug compliance, maintaining the suggested exercise and diet regime and keeping to scheduled visits. Accurate, credible results from the study depend largely on the patients.
Yes. Regardless of having signed an informed consent form, patients are free to withdraw from the study without needing to give an explanation. However, in the interest of patient safety and trial protocol, medical staff will need to do follow up telephone calls for an underdetermined period of time to establish that the patients is not suffering from any side effects.
A placebo is essentially a sugar tablet that is identical in appearance, smell and taste to the study drug and is used to maintain the double blind and avoid treatment bias. The placebo will have no clinical/beneficial effect and is essentially used to establish a control or baseline in comparison with the experimental/investigational drug.
Experiments are mainly divided into 2 groups namely; an experimental and a control group. The two groups are very similar with the only difference being the treatment they are receiving (i.e. placebo/standard vs. experimental drug). The experimental group will receive the active drug/compound whereas the control group will not receive any additional treatment or they will receive a placebo. In this way, the control group is used to establish a baseline to be compared with the investigational drugs’ safety and efficacy results upon evaluation.