What are clinical trials?
Clinical trials are medical research studies involving people. All new medical treatments need to be thoroughly tested in the laboratory before being tested in voluntary participants. Clinical trials look at risks, causes, prevention, diagnosis and treatment of various diseases and conditions. Some trials are for establishing side effects of current medication and some are for the purposes of introducing better treatment for the public.
At East Sydney Doctors we conduct all phases of clinical trials, ranging from phase 1 to phase 3.
Phase I studies of a new drug are usually the first that involve people. The main reason for doing phase I studies is to find the highest dose of the new treatment that can be given safely without serious side effects. Although the treatment has been tested in lab and animal studies, the side effects in people can’t always be predicted. These studies also help to decide on the best way to give the new treatment.
If a new treatment is found to be reasonably safe in phase I clinical trials, it can then be tested in a phase II clinical trial to find out if it works. The type of benefit or response the doctors look for depends on the goal of the treatment. It may mean the health condition of the participant improves, the health issue altogether disappears or the benefit may be an improved quality of life.
Phase III clinical trials compare the safety and effectiveness of the new treatment against the current standard treatment.
Clinical trials at East Sydney Doctors
East Sydney Doctors has been historically involved in HIV and infectious disease studies and more recently the trials team has been involved in respiratory, dermatology, and gynaecology studies.
Our main recruitment source is ESD’s vast database of loyal and longstanding patients, and we pride ourselves in high participant recruitment and retention rates.
East Sydney Doctors is involved in many different areas of research – HIV, Hep C, gynaecology, dermatology, respiratory and many more.
Some of the major national and international studies that the practice has been involved with to date, are START and EPIC Prep which have led to major findings in HIV prevention and treatment.
Current studies at the practice range from phase 1 studies in women diagnosed with CIN II/III to a new antibiotic treatment for treatment of Uncomplicated Urogenital Gonorrhea.
Clinical Trials Team
The trials team at East Sydney Doctors are experienced, knowledgeable and extremely passionate and caring towards all patients and always working towards improving the patients’ journey throughout the trial.
Information for sponsors
East Sydney Doctors has a dedicated clinical trials team, consisting of experienced GPs, nurses and clinical trial coordinators with a strong interest and years of experience in trials. We work with a central private ethics committee that allows for a fast turnaround for applications.
There is a dedicated space within the East Sydney Doctors building where clinical trials are conducted and there is restricted access to all clinical trials materials. The space includes temperature-controlled storage facilities such and fridge and freezer. There are experienced and ICH-GCP trained nurses on site where needed, with a pathology on site for blood collection and processing. The close proximity to St Vincent’s Hospital in case of an emergency, or in case of referral for any specific tests that are only available in a hospital setting, is also an advantage.
SOME OF OUR AREAS OF RESEARCH
HIV: HIV-Naïve and experienced patients in need of anti-HIV drugs
HEPATITIS C: Hepatitis C infection in people living with HIV
SEXUAL HEALTH: treatment of gonorrhoea & UTIs
RESPIRATORY MEDICINE: Prevention and treatment of respiratory illness
DERMATOLOGY: People affected by atopic dermatitis (eczema), Rosacea and plaque Psoriasis
GYNAECOLOGY: women with high grade cervical (CIN2/CIN3) lesions
Our Current/Recruiting Trials
What are the risks involved?At East Sydney Doctors, our GPs mainly get involved in later stages of clinical trials where the investigational product has already been extensively tested. As part of a clinical trial, at every trials visit, patients get to see the GP and get assessed for any possible side-effects or reactions to the study treatment. Patients can thoroughly read the consent form before participating in the study and receive all the details and information about the study drug and its background. They have the opportunity to ask questions and discuss course of their treatment with their treating Dr and the trials team.
Can I withdraw at any time during the study?Participation in clinical trials is voluntary. Participants are free to withdraw at any time during the course of the study.
How is my personal private information protected?Conducting clinical trials is under the guidelines of Good Clinical Practice (an internationally accepted standard for the designing, conducting, recording and reporting of clinical trials). Personal information of the study participants remain de-identified and anonymous throughout the study and as a result the identity of the participants remain confidential.
Will I be compensated for my time?There is no monetary reimbursement for participation in clinical trials; however volunteers can be reimbursed for their travel fees.