Australian Clinical Research Network

What are Clinical Trials?

Clinical trials are essential in the research and development of a new medication for future treatment of clinical illness and diseases.

Before a new medication gets and approval to be used in Australia, the said products has to go through a rigorous series of clinical trials and then endorsed by the Therapeutic Goods and Administration (TGA).

The sequence of clinical trials is divided into a various phases starting with phase 1, phase 2a, 2b, 2c and 3. Each of these phases will help to identify the suitability and possible side effects of the product. It is therefore very important to have your full support and commitment to make the whole process a successful one.

Prior to the trial being instituted, each study will have to be approved by the Ethics Committee of an institution to ensure that they do not subject any patients to any unnecessary risks. All the trials conducted by Australian Clinical Research Network are approved by the Ethics Committee prior to any patients being enrolled.

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Process of Conducting Trials

The process of conducting clinical trials is a complex one to say the least. It involves extensive planning, execution of the process in a timely and efficient manner to ensure the success of the projects. Team effort in the coordination is of utmost importance.

Before a project can get off the ground, an approval is sought from the Ethics Committee. Once the approval is obtained, the enrolment of eligible patients then commences.

The first stage involves the screening of the suitable patients. This is the time when suitable patients are selected with preliminary investigations (including blood tests, ECG, and the like). This is also the time to provide an opportunity for you to discuss any aspects raised include the length of participation, possible side-effects, ability to withdraw at anytime.

Once the screening is completed, the patients that are deemed to be suitable are then enrolled after a full explanation is given to the patients and consent forms are signed. The trials could run from anytime from 16 weeks to 5 years. We will always encourage all patients to complete the study but we do realize certain circumstances may preclude this. WE STRESSED THAT ANY PATIENTS HAVE THE RIGHT TO WITHDRAW FROM THE PARTICIPATION OF THE TRIALS AT ANY TIME but please discuss any issues with us prior to doing so.

In the initial study phase, you will normally be randomised to various medications or placebo according to the study protocol. Most of these studies are double blinded so it is very rare for anyone to know which arm of the study you are on till the completion when the data are analysed. However, in the exceptional circumstances the code may be broken with approval of the sponsoring company if your health is threatened.

Under Australian regulations, you will not be paid for your participation except in phase 1 trials. Certain reimbursements will be given to cover transport costs and other incidentals. Please check with your clinical research nurse.

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Our Privacy

This is of utmost important. Your identity will never be exposed and your details will not be released to anyone. You will only be identified by a code. Only your treating doctors and nurses know your treatment details.

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About Us

We are Australian company based in Sydney. The company is run by two executive directors, Drs Agus Brotodihardjo and Dr Mark Arya who also acts as Principal Investigators (PI) if not Co-Investigators (CI). The aim of the company is to conduct proper clinical trials in an ethical and professional fashion sponsored by various pharmaceutical companies and Clinical Research Organisations (CRO).

The company has two centres in Maroubra and Campbelltown. Each site is staffed by receptionists, medical typists, experienced clinical research nurses as well as doctors. The team is responsible for the supervision of your will being during the conduct and your participation in the clinical trials.

The company also utilizes many co-investigators who provide contract works to help in various subspecialty medical trials when their expertise are called upon. Certain general practice trials may also be conducted by various GP who specialises in their areas of the study.

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Staff Profile

*Dr Agus Brotodihardjo* Director and Principal Investigator		Dr Brotodihardjo graduated from the University of Melbourne in 1986. Since then, he had gone on to specialize in Internal Medicine and Gastroenterology. Besides conducting clinical practice in Gastroenterology, Dr Brotodihardjo has been extensively involved in various clinical trials both as PI and CI for the last 15 years. He has supervised many projects in various subspecialties of Internal Medicine with huge success. He is easily accessible by any of his enrolled patients on 24/7 basis should any problems arise. The projects that he has supervised post herpetic neuralgia, osteoarthritis of knees, reflux disease, inflammatory of bowel disease, diabetes, hypertension, sinusitis and the like.

Dr Mark Arya Director and Principal Investigator		Dr Mark Arya graduated from the University of New South Wales in 1989. He has been in General Practice since 1994 with work experience in Campbelltown, Maroubra, Crows Nest, Surry Hills, Broadway and Newtown. He has been the Medical Director of Maroubra Medical Centre since 1999. It is a large fully computerised Practice employing 14 GPs and has approximately 35,000 patients.

*Louise Hart-Brown RN* Study Coordinator		Louise completed her nursing training at Prince of Wales Hospital followed by an Intensive care degree at Guy’s Hospital London were she worked for many years before marry and having two children. For the last 7 years she has been working in various aspects of clinical research. Louise has been involved with trials in men and women’s sexual health and quality of life, diabetes, atrial fibrillation, menier’s disease and hypertension. In 2005 Louise started work for the Prostate Cancer Centre at St Vincent’s Hospital and the Garvan Medical Institute conducting research in Benign Prostate hypertrophy, prostate biopsies and the HIFU procedure for prostate cancer. In 2006 she joined Cancer Services at the RNSH to help establish a urology and prostate cancer database for the collection of clinical and pathological data including treatments and procedures in one central location. She also conducted a prostate cancer study in conjunction with the Garvan Medical Institute collecting tissue from biopsies and the prostate for research. Louise has just been recently awarded a scholarship with Latrobe University to complete a degree in prostate cancer care and has recently joined the team at the Maroubra Medical Centre to help coordinate our new clinical trials centre.
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Contact Us

Maroubra

Maroubra Medical Centre

Level 1/725 Anzac Parade

Maroubra NSW 2035

Tel: 02 9314 3400

Fax: 02 9314 3411

Mobile: 0414 798 281

Email: contactus@acrn.com.au

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Campbelltown

Suite 211, 4 Hyde Parade

Campbelltown NSW 2560

Tel: 02 4628 4905

Fax: 02 4628 4175

Email: contactus@acrn.com.au

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Australian Clinical Research Network Pioneering Clinical Research and Beyond in Australia
	Suite 211, 4 Hyde Parade Campbelltown NSW 2560 Tel: 02 4628 4905 Fax: 02 4628 4175	Maroubra Medical Centre Level 1/725 Anzac Parade Maroubra NSW 2035 Tel: 02 9314 3400 Fax: 02 9314 3411


What are Clinical Trials?	Trial Process	Our Privacy	About Us	Staff Profile	Contact Us