Participating makes me proud.
- Can I change my mind?
Yes, you are free to withdraw from a trial at any time, without giving any reason, and without your medical care or legal rights being affected.
- Is it safe?
The participant’s safety is paramount and beyond the public and scientific interests of the trial. All participants are under continuous care of qualified clinical teams during the trial period. The Clinical Trial follows a protocol, which includes a trial plan that describes what researchers will do in the trial. As the Clinical Trial progresses, all results are reported to scientific meetings, medical journals, and to Independent Review Boards (IRB) and the FDA. The names of the participants will remain secret and will not be mentioned in any reports.
- Can anyone take part in a clinical trial?
All clinical trials have guidelines about who can participate. Before joining a clinical trial a volunteer must qualify for the trial. The factors that allow volunteers to participate in a clinical trial are called' inclusion criteria' and the factors that disallow participation are called 'exclusion criteria'. These criteria can include age, gender, the type and stage of a disease, previous and current treatments and other medical conditions.
- What do the different phases mean?
Clinical trials are usually conducted in three phases (I,II and III). Only a small number of volunteers, usually so called 'healthy volunteers’, participate in phase I trials, while the later phases involve a larger number of patient volunteers. At Accellacare, we focus on what’s known as “late phase” clinical trials. These studies look into the effects the treatments being researched have on the conditions they were designed to treat and all will have undergone some earlier phase testing.
- Who regulates a clinical trial?
A clinical trial can only be offered to our trial patients once it has been approved in the U.S. by the FDA, as well as an independent review boards (IRB) who look to ensure that the rights and wellbeing of all trial patients are not being compromised. Many trials, particularly phase III studies are conducted worldwide with a large number of patients participating in them. They will have to be approved by the regulatory agencies in their countries (e.g the FDA in the United States) and the results collected from all trial participants globally are monitored closely during the trial process. Our clinical trials are also rigorously monitored by both internal and external audits along with regulatory inspections throughout.
- What are the benefits of taking part in a clinical trial?
Volunteers in a clinical trial participate in the development of medical therapies that may offer better treatments for life threatening and chronic diseases. The possible benefits for volunteers include:
- Playing an active role in your health care.
- Gaining access to research treatments before they become available, if approved.
- Obtaining quality medical care at our dedicated research center during the trial.
- Receiving regular monitoring at clinic visits and the results of any investigations such as XRays, MRIs, blood tests, etc being forwarded to your primary care physician.
- Helping future generations with new treatments by contributing to medical research.
However, the possible and/or potential side effects and risks must also be considered. These are always fully documented in the Patient Information Sheet. We ask you to take time to discuss these and any other questions you may have with our research team.
- What does informed consent mean?
When a person decides to participate in a Clinical Trial, they must sign an “Informed Consent” document containing information about the Clinical Trial. The physician then provides information about possible risks and benefits and what is required by the participant during the Clinical Trial. The participant then decides whether to or not to sign the Informed Consent. It is very important to emphasise, that the Informed Consent is not a contract and that the participant may withdraw from the trial at any time, without giving any reason.
- Will I get paid?
A third-party, unbiased review board (IRB) must approve all payments to patients. It is usual for all reasonable travel expenses to be paid. Some clinical trials make patient inconvenience payments to volunteers for their participation in trials and this will be summarized in the Participant Information Sheet for each trial. All trial assessments, investigations and the investigational treatment will be provided to you at no cost.
- What is a placebo?
A placebo is an inactive product used to assess the investigational treatments' effectiveness. The volunteer, the doctor and research team may not know which volunteer receives placebo and which receives the active treatment. Not knowing which participants are receiving the active treatment allow the research team to objectively observe the volunteers during the trial. However, regardless of which treatment the volunteers’ receive, the level of medical care and attention is the same. All procedures eg. Blood tests, X-rays, MRIs etc, as required for the trial, will be conducted for all volunteers and they will attend all visits for the trial.
- Will my taking part in this trial be kept confidential?
Your data will be coded and collected on a paper record and it will be kept confidential. To make sure the information collected in the trial is accurate, it will need to be checked by researchers and authorized persons working on behalf of the pharmaceutical company and for government health departments. You are asked to give permission for these authorized people to see your medical records, who will keep the information confidential.
- What happens at the end of a clinical trial?
About 12 - 18 months after the trial ends your doctor will then be able to tell you which of the treatments you were taking during your trial participation. You can be given a copy of the results once they are publicly available, if you want a copy. Any report that is published about the trial will not identify you or any other patient taking part.