What are they and why are they important?
A clinical trial is a type of medical or health-related study that investigates the safety and efﬁcacy of a new form of patient treatment. This may be a new drug, a device, a protocol or even a diagnostic tool. Clinical trials can vary in size and cost, and they can involve a single research centre or multiple centres, in one country or in multiple countries. Patient safety is of great importance when developing or conducting a clinical trial. To ensure that the highest standard of patient safety is met, all clinical trials conducted in Australia are thoroughly reviewed and approved by an external ethics committee.
“Why should I participate in a clinical trial?”
The main reason is that the patient may receive a current investigational treatment for their condition, gaining access to treatment options that are not yet commercially available. When patients participate in clinical trials at the Skin & Cancer Foundation Australia, they also receive expert medical care in a highly reputable health care facility (often free of charge). Patients also gain personal satisfaction from their contribution to medical science. “
“Is this treatment safe?”
It is important for patients to understand that in most cases clinical trials are very safe. For a test treatment to gain approval for use in a clinical trial, evidence from past research must be provided, demonstrating that the treatment is safe for humans. However, it is not always possible to guarantee that no unpleasant or unexpected side-effects will occur. At the Foundation, patient safety is our highest priority and we only choose to be involved in studies that we understand to be safe and that we believe will beneﬁt our patients in the future. Our patients are under no obligation to participate in any clinical trial at the Foundation. It will in no way affect the clinical care offered if a patient decides not to participate in a trial. We understand that participation in clinical trials is not for everyone. However, we like to give our patients the choice, so they can fully understand the treatment options available to them.
The clinical trial currently recruiting participants at the Foundation:
- Efﬁcacy and safety of a topical Gel in ﬁeld treatment of Actinic Keratosis on full face, balding scalp or on the chest. Principal investigator is Pablo Fernández Peñas and the trial is undertaken at our Westmead clinic.
The clinical trials currently in progress at the Foundation are listed below:
- Examining the safety of a new treatment for patients with locally advanced or metastatic basal cell carcinoma. Principal investigator for this study is Associate Professor Pablo Fernández Peñas and the trial is undertaken at our Westmead clinic.
- Evaluating the safety and efﬁcacy of a new biologic treatment for patients with moderate to severe plaque psoriasis. This trial is occurring at our Darlinghurst clinic and Dr Johanna Kuchel is the Principal Investigator.
- Evaluating the Efﬁcacy and Safety of a biologic treatment alongside an active comparator for the treatment of subjects with moderate to severe plaque-type psoriasis. This trial is occurring at our Darlinghurst clinic and Dr Johanna Kuchel is the Principal Investigator.