Clinical studies are the backbone of drug development.
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 various government agencies, like Ethical Committees, the Medicine Agency and others. 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.
Who regulates a clinical trial?
A clinical trial can only be offered to our trial patients once it has been approved by the regulatory agencies in that country (i.e. MHRA ,FDA, SAHPRA), as well as an independent ethics committee who look to ensure that the rights and wellbeing of all trial patients are not being compromised. All our clinical trials are fully approved by both national and local ethics committees. Many trials, particularly phase III studies are conducted worldwide with a large number of patients participating in them. 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 clnical 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 to:
- Play an active role in your health care.
- Gain access to research treatments before they become available, if approved.
- Obtain medical care at our dedicated research centre during the trial.
- Regular monitoring at trial visits and the results of any investigations such as XRays, MRIs, blood tests, etc being forwarded to your GP/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.
Will participating in a clinical trial disrupt my day-to-day life?
To participate in a clinical trial, you will need to attend visits with a clinician to administer the study drug or to check your health throughout the duration of the trial. Each trial requires a different schedule of visits, to properly dose the study drug and ensure your safety. Visits may occur at a clinical site or at home with the help of a an in-home nurse that works closely with the study team. Our goal is to make the trial regimen as convenient as possible for patients- this may involve a concierge, travel arrangements to and from site visits, wearable devices to check certain measurements remotely, or completing visits in your home when possible.
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?
An Ethics committee 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 summarised in the Participant Information Sheet for each trial. All trial assessments, investigations and the investigational treatment will be provided to you at no cost.