Clinical Research

Holdsworth House clinical research unit has participated in research since our Sydney practice was founded, and the semi-autonomous research unit has grown to become one of Sydney's most ambitious and comprehensive.

Holdsworth House Clinical Research has a long history of conducting studies in HIV and infectious diseases, and more recently have expanded our therapeutic areas to include dermatology, respiratory medicine, immunology and general medicine. Our Clinical Research team take pride in their high recruitment and retention rates and strive for optimal patient care and high quality standards at all times.

Our Areas of Research

The following types of clinical research studies are performed at Holdsworth House Medical Practice.

HIV Naive

For patients that have never commenced anti-HIV drugs

HIV Experienced

For patients that need to change their anti-HIV drugs

Dermatology

Psoriasis, Eczema, Rosacea and skin cancers

General Medicine

Cardiovascular disease and diabetes

Immunology

Vaccines and allergies

Respiratory Medicine

Asthma, COPD and LAM

Our Current Studies

Do you have high blood pressure?

Holdsworth House Medical Practice is now recruiting for a study for patients with high blood pressure, comparing the benefits of taking:

  • four low dose medications in one pill, versus
  • one normal dose pill

If you are over 18 and taking only one hypertension medication, or none at all, and your blood pressure is not well controlled you may be eligible for this study.

All study assessments and medication are supplied at no cost.

For more information please contact our Research department on 02 8038 1044 or email us at research@holdsworthhouse.com.au

Endometriosis pain?

You may be eligible for a clinical trial.

Do you have moderate to severe pelvic pain caused by endometriosis? Endometriosis affects
about 10% of women — approximately 176 million women worldwide — and has no known
cause or cure. We are currently participating in a clinical research study which is evaluating an
investigational non-hormonal medication to see if it is safe and effective in reducing moderate to
severe endometriosis-related pelvic pain.

You may qualify for this study if you:
• Are a woman who is 18 to 49 years old
• Have been surgically diagnosed (via laparoscopy or laparotomy) with endometriosis within the past 10 years
• Experience endometriosis-related pelvic pain, even when you are not having your period
• Have regular menstrual cycles of 24 to 38 days
• Meet additional requirements, which the study team will discuss with you

To learn more about the possible risks and benefits of participation or to see if you may qualify for this study, contact our Research department on 02 8038 1044 or email us at research@holdsworthhouse.com.au

rsv_research_trials

Have you been vaccinated against Meningococcal Disease?

The Holdsworth House Research team are currently recruiting for a study using licensed vaccines for meningococcal disease in the 18 to 50 years old age group.
If you have never had the meningococcal vaccines, weigh over 50kg and have a BMI under 32 you may be eligible.
There will be 4 or 5 visits over an up to 8 month period and participants will receive reasonable reimbursement for travel expenses.
For more information please contact our Research department on 02 8038 1044 or research@holdsworthhouse.com.au

Information for Patients

For any questions or information that is not provided below please contact our friendly research team.

Generally our research unit only take part in later phase studies where the drug or treatment has already been extensively tested in both laboratories and humans for side effects.

Before consenting to any clinical trial, potential participants are given very detailed information about what the study will involve and the possible risks and side effects. This information is approved by an independent ethics committee who ensure that the patient’s safety and care is considered above all study activities.

During a study participants see one of our Doctors at every visit and are monitored carefully for any ill-effects or reactions to the study treatment.
Sponsors respect the privacy of study participants and safeguard the confidentiality of their medical information in accordance with all applicable laws and regulations. While access to confidential medical records may at times be necessary to verify clinical information, no information that identifies individual participants is retained by Sponsors.
Participation in a clinical trial is completely voluntary and participants may withdraw from a study at any time.
In most cases, there is no cost to you to participate in a clinical trial. Your medication, treatment and medical appointments relating to the study will be free of charge. However, you will be required to attend the clinic at regular intervals and in certain instances there may be compensation available for time and travel expenses.

Information for Sponsors

We welcome enquiries from potential sponsors at any time. Please contact us for further information.

Our Clinical Research team consists of a dedicated team of study coordinators, research nurses and a clinical trial assistant. Drawing on many years of experience in clinical trials, our investigators include both general practitioners and clinical specialists, all of whom undergo regular training in GCP and specific study procedures.
Our Clinical Research Unit is conveniently placed within Holdsworth House Medical Practice. Our dedicated, secure space includes a temperature-controlled laboratory for processing and shipping of specimens and storage of investigational product. We have alarmed and monitored refrigerators and freezers, an incubator and a refrigerated centrifuge.

Our research staff are IATA certified and proficient in venepuncture, spirometry, ECGs and other clinical assessments. All staff are regularly trained in GCP and are competent in using various eCRFs, including INFORM, Oracle, iMedidata and Viedoc.

Facilities are available for CRAs to conduct their monitoring visits with access to computers and relevant study documents.
As an independent body, Holdsworth House Clinical Research can use a central ethics committee which allows for rapid submission and turn-around of applications and expedited study start-up. Our experienced study team are often called upon to be lead site for multi-site applications and can guarantee a fast and efficient submission process.

Our rapid response times also ensure that contract and budget negotiations are dealt with quickly and efficiently.