Resources

Content and Methods Based Electives

FDA: Guidance for industry, investigators and reviewers: Exploratory IND studies

Uploaded 07 Jan 2019

This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. Alternative approaches can be used if the approach satisfies the requirements of the applicable statutes and regulations. Discussions of an alternative approaches can be scheduled by contacting the FDA staff responsible for implementing this guidance. If the appropriate FDA staff cannot be located, contact can be made using the telephone number listed on the title page of this guidance.

Content and Methods Based Electives

Guidelines to promote the wellbeing of animals used for scientific purposes (Website)

Uploaded 07 Jan 2019

This resource is to complement your learning, and introduce you to other perspectives on the topics under discussion.

These guidelines have been developed by NHMRC on advice from its Animal Welfare Committee to promote the wellbeing of animals used for scientific purposes and aim to minimise their experience of pain and distress. They advocate the consideration of an animal's "whole of life" experiences, argue the potential risk to the reliability/validity of research data from unintended pain or distress, and promote the 3R's (replacement of animal research with other types of research when possible, reduction of the number of animals used in research and refinement of research techniques to minimise pain and distress).

Content and Methods Based Electives

National Quality Use of Medicines Indicators for Australian Hospitals

Uploaded 07 Jan 2019

This resource is to complement your learning, and introduce you to other perspectives on the topics under discussion.

The National Quality Use of Medicines Indicators for Australian Hospitals (National QUM Indicators) is a set of process indicators developed for Australian hospitals and health professionals. 

Content and Methods Based Electives

NHMRC National Mutual Acceptance (Website)

Uploaded 07 Jan 2019

In 2013, the Victorian, South Australian and Queensland Departments of Health, and the New South Wales Ministry of Health signed a Memorandum of Understanding (MOU) for the National Mutual Acceptance (NMA) of ethics and scientific review of clinical trials conducted in each of the participating jurisdictions’ public health organisations. In December 2015, the scope of NMA was expanded beyond clinical trials to include all human research. In August 2016, the Australian Capital Territory joined the NMA and Western Australia will join in August 2017.

Content and Methods Based Electives

Promoting consistency in safety monitoring and reporting of Clinical Trials

Uploaded 07 Jan 2019

As part of the initiative to have more efficient research governance processes, NHMRC and the Therapeutic Goods Administration (TGA) are working to achieve a safety reporting system that is efficient and reflects contemporary reporting requirements.

Content and Methods Based Electives

Revised List of standard items for use in clinical trials in Australia

Uploaded 07 Jan 2019

This Chapter presents the revised List of standard items associated with the conduct of clinical trials. To put the List into context, it starts with a series of principles that should guide the use of the List, and a summary of the structure of the List. The full set of items in the revised List with proposed definitions is then presented. 

Content and Methods Based Electives

Development of a Good Practice Process for site assessment and authorisation of clinical trials (Website)

Uploaded 07 Jan 2019

To improve clinical trial start-up times, following extensive stakeholder consultation and under the guidance and leadership of the NHMRC Research Governance Working Group, NHMRC has developed the Good Practice Process for Site Assessment and Authorisation Phases of Clinical Trial Research Governance (the Good Practice Process).

Content and Methods Based Electives

New antibiotic development: barriers and opportunities

Uploaded 06 Jan 2019

Antibiotic resistance represents a serious threat to public health worldwide, leading to increased healthcare costs, prolonged hospital stays, treatment failures and deaths. To address the emergency of multidrug-resistance, the major international societies of infectious diseases and public health have developed strategies and guidelines to reduce unnecessary antimicrobial use as well as to incite the development of new antibiotics targeting multidrug-resistant pathogens. Even though pharmaceutical companies have been developing new antibiotics since 2010, the global situation is still worrisome. Indeed, the currently available data regarding new antibiotics are limited to microbiological activity and pharmacokinetic profile and their use for the treatment of life-threatening infections (i.e., sepsis) is often off-label. The aim of this article is to present the antibiotic molecules recently commercialized and with which clinicians will deal quite often in next years. We describe ceftolozane/tazobactam, ceftazidime/avibactam, eravacycline, plazomicin, dalbavancin, oritavancin and tedizolid in terms of mechanism of action, antimicrobial spectrum, trials behind the approval and possible indications for the future. In last few years, the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) approved many new antibiotic molecules but, unfortunately, they lack in biological innovation and in wide clinical indications. These agents show appealing properties for off-label use, as we propose in the article, but caution is still needed considering that high-quality clinical data are limited.

Content and Methods Based Electives

NHMRC: Principles for accessing and using publicly funded data for health research

Uploaded 03 Jan 2019

The Principles are a guide for researchers who are requesting access to wholly or partially publicly funded datasets, and for organisations that hold them. These Principles augment existing ethics and grant review practices as well as internal custodian processes. They do not dictate a particular process that must be followed, nor restrict an organisation from using its own data access policies. The Principles acknowledge that requests for data are made in the context of custodian’s core business requirements, the primary aim of which may not include support of research. Organisations holding relevant data that are not publicly funded, such as those conducting clinical trials, are also encouraged to consider and use the Principles.

Content and Methods Based Electives

Guidelines for the ethical use of digital data in human research

Uploaded 31 Dec 2018

The guidelines presented here have been developed to assist researchers who are conducting, and ethics committee members who are assessing, research involving digital data.