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CLINICAL RESEARCH - OVERVIEW
Our Medical Research Unit works hand-in-hand with our GP’s,
specialists, practitioners and counsellors. Its work
enables participants in clinical trials to benefit from
new treatments before they are approved for wider use
HHMP decides to participate in a trial, based on
the scientific merits of the proposal and the possible
benefits of the treatment to patients. At this point
participants are recruited through the practice, or
via external advertising. HHMP’s doctors are
briefed on the requirements of the study, and suitable
patients may be invited to participate. The doctors
remain the patients’ main point of contact during
the trial, and they answer any questions or concerns
the participants may have.
The patients who are being provided with the trial
treatment are carefully monitored by their doctor,
counselled about the effects of the drug, instructed
on the methods for taking it, and advised about their
continuing health care.
HHMP’s clinical research staff coordinate the
trials, liaising between the doctors and the pharmaceutical
companies to ensure the objectives of the studies
are being followed. The research staff monitor the
progress of the trials, answer queries, supervise
recruiting, and keep track of interim analyses and
final outcomes.
Clinical Trials Design
Medicines Australia members conduct clinical trials based on scientifically designed protocols that balance potential risks to the trial participant with the possible benefit to the participant and to society. Scientific, ethical and clinical judgments must guide and support the design of the clinical trial, particularly those aspects directly affecting the trial participants such as inclusion/ exclusion criteria, endpoints, and choice of control, including active and/ or placebo comparator.
Selection of Investigators
HHMP Investigators are selected based on qualifications, training, research or clinical expertise in relevant fields, the potential to recruit trial participants and ability to conduct clinical trials in accordance with good clinical practices and applicable legal requirements.
Training of Investigators
HHMP Investigator and clinical trials staff are trained on the clinical trial protocol, pharmaceutical product, procedural issues associated with the conduct of the particular clinical trial, and their key responsibilities as investigators under the ICH GCP guidelines.
Human Research Ethics Committee (HREC) Review
Prior to commencement, each clinical trial is reviewed by one or more HRECs that have independent decision-making authority.
- The HREC has the responsibility to protect trial participants and is responsible for monitoring the conduct of clinical trials.
- The HREC is provided relevant information from prior trials, the clinical
protocol, and any materials developed to inform potential participants about the proposed trial.
- The HREC may disapprove, require changes, or approve the clinical trial protocol
- The HREC can ask any question of the sponsor and will not approve a clinical trial protocol unless satisfied with the answers.
- The HREC must give written approval before any participants are enrolled at the institution or other trial site for which it has responsibility.
- The HREC will recommend to the Approving Authority at the institution or proposed trial site whether the trial should be conducted.
- The HREC may also be the Approving Authority for a particular trial site.
Informed Consent
HHMP is under strict guidelines to ensure that our clinical investigators obtain and document informed patient consent, freely given and without coercion, from all potential trial participants.
Clinical Trials Monitoring
Clinical Trials are monitored using appropriately trained and qualified individuals. The sponsor will have procedures for these individuals to report on the progress of the trial.
Privacy and Confidentiality of Medical Information
Sponsors respect the privacy of trial 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.
Quality Assurance
Procedures are followed to ensure that trials are conducted in accordance with good clinical practices and that data are generated, documented and reported accurately and in compliance with all applicable requirements.
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