About Clinical Trials
- Are clinical trials safe?
- What happens in a clinical trial?
- What’s the difference between Healthy Volunteer and Patient clinical trials?
- Gain access to new medications
- Participants’ health is monitored by Doctors and nurses at no cost
- Medication is provided at no cost
- Help advance medical research
- Travel expenses are often reimbursed
- Some clinical trials compensate for time and inconvenience to participate in the trial
Trialfacts provides a link between medical research and patients wanting to understand all of their available options. There are many misconceptions surrounding clinical trials, and many people have no knowledge of trials they could be eligible for. Available resources present trial information in a manner which is difficult for patients to comprehend, and advertising of trials in the media usually provides little information.
It is Trialfacts’ mission to demystify clinical trials, and to provide detailed, relevant and easily digestible information about specific trials to aid in patients’ decision making processes. Where someone decides they would like to know more about a specific trial, Trialfacts provides a conduit for them to register their interest and for medical staff to get in touch to provide further information.
The prime method Trialfacts uses to inform patients about specific trials is via our email mailing list. Patients simply provide their contact details and choose which types of trials they would like to be notified about, and they will receive an email as new trials for which they may be eligible begin recruitment.
We place great importance on presenting information about clinical trials in an unbiased, ethical and honest way. The information we present about each trial is first approved by an independent ethics committee to ensure that it is correct and is not written in a manner which is ambiguous or induces anyone to participate. We strive to provide all relevant information in a simple to understand and accessible manner.
New scientific innovations like medications, medical devices, therapies and other treatment procedures constantly emerge from pharmaceutical, biotechnology, academic, not for profit and other research organisations. Before these advancements are available to the general public they undergo three phases of clinical trials. Generally, phase 1 trials assess safety, phase 2 trials assess effectiveness and continue to monitor safety, and phase 3 trials confirm effectiveness in a larger group of people and continue to monitor safety.
All Clinical Trials are conducted only after the approval of Ethics Committees and must follow the International Guidelines for Good Clinical Practice. Participation is always voluntary and a patient or volunteer must read and agree to the Informed Consent document, which outlines what will happen in the trial and all risks associated with advertising. Participants can also ask questions to the medical staff, and of course can consult with their own Doctor.
Before trials are conducted on humans, new medications or treatments have usually undergone extensive examination in laboratories and are tried on cells and animals grown in labs. The ones with positive results are then approved for testing in human trials. The treatment then progresses through the three phases of clinical trials outlined above.
All clinical trials are conducted only after the approval of Ethics Committees and must follow the International Guidelines for Good Clinical Practice. Participation is always voluntary and a patient or volunteer must read and agree to the Informed Consent document, which outlines what will happen in the trial and all risks associated with participating. Participants can also ask questions to the medical staff, and of course can consult with their own Doctor.
Patients or volunteers also have the right to leave the clinical trial at any time.
Each clinical trial varies significantly, but there are some common elements. Most (but not all) trials involve taking a medication or undergoing some form of treatment. The patient or volunteer will first undergo screening to determine that they fit the medical eligibility criteria for the particular trial, and then be given the study medication or treatment. The patient or volunteer typically returns to the research centre a number of times to measure their response.
Some trials require volunteers who are generally healthy, while other trials require patients with a particular medical condition. Healthy volunteer trials usually provide a reimbursement or compensation to the healthy volunteer for participating. Many patient trials do not provide compensation, but often do provide reimbursement for travel expenses. Patients are often not compensated in patient trials as they receive the medication or treatment and medical care at no cost.
If you’d like to learn more about clinical trials you can download this 12 page document with more detailed information.
Often with clinical trials, research organisations are trialling new therapies to provide improved care for sufferers of conditions and improve patient outcomes and quality of life. For information relating to a specific trial please ask the clinical staff conducting the study to provide more information.
Through the course of the clinical study, subjects are closely monitored and provided with professional care. This usually commences with your first visit to the trial site where an examination is performed and then is ongoing throughout the clinical trial. Please ask the clinical staff conducting the study to provide more information about patient care.
Clinical trials are about providing novel/improved healthcare therapies and patients are closely monitored at all times to ensure that they receive appropriate medication.
The media and public are often misinformed when it comes to clinical trials. The fact is, if we do not have new research, we do not achieve improved and new therapies which can provide optimised medications and potential new cures. This is never an overnight result, it is a process that costs pharmaceutical companies billions of dollars and can take more than 10 years just to bring a new therapy to the pharmacy shelf. Before a therapy can be used in a clinical trial it must pass through many thorough preclinical processes to prove that it is safe in humans. The industry is very highly regulated to a very high standard.
Most clinical trials will compensate patients for their costs to travel to and from the trial site to ensure that patients are not financially disadvantaged by their participation in the clinical trial. Please ask the clinical staff conducting the study to provide more specific information.
Most trials involving healthy volunteers are financially compensated. It is also not uncommon for patients to be compensated for their time where a trial may require repeated visits or long periods of observation including overnight stays. This is not always noted in the study information, as there are sometimes restrictions on publicising this information. Please ask the clinical staff conducting the study to provide more information.