What is a clinical trial?

Clinical trials (also known as clinical studies) are conducted to learn about the safety and effectiveness possible biomedical interventions can have in the real world.

Clinical trials are essential to the development of new interventions. For example, without clinical trials, we cannot properly determine whether new medicines developed in the laboratory or by using animal models are effective or safe, or whether a diagnostic test works properly in a clinical setting. This is because computer simulation and animal testing can only tell us so much about how a new treatment might work and are no substitute for testing in a living human body.

Clinical trials are essential to the development of new interventions.

Clinical trials also permit testing and monitoring of the effect of an intervention on a large number of people to ensure that any improvement as a result of the intervention occurs for many people and is not just a random effect for anyone.

Most modern medical interventions are a direct result of clinical research. New interventions for most diseases and conditions have been developed through clinical research. Clinical trials often lead to new interventions becoming available that help people to live longer and to have less pain or disability .

Source: https://www.australianclinicaltrials.gov.au/what-clinical-trial

Phases of Clinical Trials

Clinical trials of biomedical interventions (new medications) typically proceed through four different stages, which are called "phases". In the early phases, the new intervention is tested in a small number of participants to assess safety and effectiveness. If the intervention is promising, it may move to later phases of testing where the number of participants are increased to collect more information on effectiveness and possible side effects. All new drugs must be tested in phase I, II and III studies before being approved for use by the public. Phase IV is done after the drug has been approved by the Therapeutic Goods Administration (TGA).

Sinclair Dermatology is committed to excellence in patient care, clinical research and to thedevelopment of new treatments that improve our patients' lives. We conduct trials at different phases.For more information on clinical trial phases, please visit: https://www.australianclinicaltrials.gov.au/what-clinical-trial/phases-clinical-trials

Types of clinical trials

Although there are different types of clinical trials, all must conform to strict rules set by country-specific regulatory. In Australia, the bodies responsible for the regulation for assessing and monitoring clinical trials are the Human Research Ethics Committees (HREC), the pharmaceutical companies running the clinical trials and the Therapeutic Goods Administration (TGA).

Sinclair DIRECT works with local and international pharmaceutical companies to conduct trials in a broad range of skin conditions. All research is conducted in accordance with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) guidelines. Ensuring the safety and comfort of all our trial participants is our upmost priority.

Sponsor-led trials

Sponsor-led trials are clinical trials that are initiated by drug or device companies who have developed a new treatment. The companies or also known as “Sponsors” engage a contract research organisation (CRO) to act on their behalf to ensure the trial runs smoothly and in accordance with ICH-GCP guidelines.

Investigator-led trials

Investigator-led trials are clinical trials initiated by individual or groups of health care practitioners such as doctors or medical research entities. These trials may be funded by a research organisation, grants from research funding bodies, or by the doctors themselves.

Sinclair DIRECT works with local and international pharmaceutical companies to conduct trials in a broad range of skin conditions. All research is conducted in accordance with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) guidelines.