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Preclinical Workshop Report: Getting to the IND
1/06/2008
Issue Number: 125
This one-day workshop, held at the University of Queensland on Tuesday 13th May, was presented by Prof. Evan Siegel, CEO of Ground Zero Pharmaceuticals. The focus of the workshop was on FDA’s procedures for approval of phase I clinical trials under an Investigational New Drug Application (IND), and the challenges faced by small biopharmaceutical companies in getting to the IND. It was sponsored by TetraQ, Queensland Clinical Trials Network and Q-Pharm.
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ARCS Annual Congress Awards – the Best of the Best
1/06/2008
Issue Number: 125
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Developing Effective Patient Communication Campaigns – An International Report
1/06/2008
Issue Number: 125
Your time to market is ticking away, your clinical trial has stalled as patient enrolment is slowing, everything is in place but you can’t get the patients, what do you do? It’s a question asked by companies time and again when they realise that slow patient recruitment means their study is ‘in rescue’. Data from a CenterWatch survey revealed that in 40% of clinical studies, failure to achieve patient recruitment and retention targets was the biggest cause of delays. Problems such as this have been estimated to cost drug companies up to US$1 million a day in missed sales revenues.
This article was originally published by CRFocus (www.crfocus. org) in the UK (P. Westmacott and D. Cockerill; Developing Effective Patient Communication Campaigns - Communicating to Maximise Patient Recruitment; 18(10) p11-14).
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Adrian Bootes Elected Vice President of the ARCS Board
1/06/2008
Issue Number: 125
The vice-presidential role allows ARCS to have a more defined management structure at the Board level, and to me it is a very great honour. The Board has progressed markedly in its orientation and operation over the years culminating in a very successful external benchmarking assessment in 2007. However, not resting on our laurels, we do need to continue to take stock of our current situation, the evolving environment and to respond and grow. A stronger management team at the Board level will ensure that the organisation will thrive during this time of change.
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Increased Transparency for Corporate Sponsorship of Doctors’ Education
1/06/2008
Issue Number: 125
On 28 March 2008, Medicines Australia set a global precedent for the pharmaceutical industry by publishing its first report of medical education events held or sponsored by its member companies. The report shows that, during the six months to 31 December 2007, there were 14,633 educational events for healthcare professionals held or sponsored by Medicines Australia’s 42 member companies during the six months to 31 December 2007. The requirement for reporting arises from the Australian Competition Tribunal’s (“Tribunal”) decision to affirm a condition on authorisation of the Medicines Australia Code of Conduct (“the Code”) imposed by the Australian Competition and Consumer Commission (“ACCC”). The condition requires companies to submit sponsored event reports twice yearly. In the last edition, we provided readers with a summary of the background to the Tribunal’s decision and, in this edition, we provide a summary of Medicines Australia’s audit of the reports and the action taken by Medicines Australia in response to the key fi ndings. Of the 14,633 events held during the first six month reporting period, there were 52 events identified as potential breaches of the Code. These events have been referred to the Medicines Australia Code of Conduct Committee (“the Committee”) for investigation. Medicines Australia has said that the findings from the investigation will be made public.
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An Integrated Patient Recruitment Campaign: An Australian Case Study
1/06/2008
Issue Number: 125
An urgent advertising campaign was required to help reach the recruitment target for a study sponsored by Janssen Cilag. A number of sites were involved throughout Sydney, Brisbane and Adelaide for a study in reflux. The strategy of the patient recruitment campaign involved the implementation of an integrated advertising campaign to reach and penetrate the broad target audience quickly and cost effectively. The underlying objective of the advertising was to generate a response in individuals with reflux and heartburn to determine if they were eligible to participate in the study. A far greater level of noise and ‘breakthrough’ of the communication objective was achieved by combining radio and print advertising. This was reflected in the results achieved through the call centre. The call centre operated in real time and screened, qualified, referred and tracked eligible patients to augment recruitment of potential study participants. Qualified subjects were referred electronically on a daily basis to the respective study coordinators at the various sites. Details of the data captured and referrals executed by the call centre can be reviewed in the accompanying tables. As the campaign rolled out, further advertising was pursued (in waves) and a switch made to colour advertisements to generate a greater response.
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Clinical Trial Agreements in Western Australia
1/06/2008
Issue Number: 125
I was delighted to attend my first ever Grand Rounds recently, at Princess Margaret Hospital for Children in Perth. As an employee of Telethon Institute for Child Health Research (TICHR) managing a global investigator-initiated clinical trial, I attended with a keen interest the launch of the new Medicines Australia Clinical Trial Agreement, and Standard form of Indemnity, now to be used in all Western Australian Public Hospitals.
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Better Medicines for Children: The EU Paediatric Regulation
1/04/2008
Issue Number: 124
New legislation governing the development and authorisation of medicines for use in children was introduced in the European Union(EU) in January 2007 (Regulation (EC) No 1901/2006 as amended - the ‘Paediatric Regulation’). The aim of this regulation is to assist clinical development and ensure availability of high quality and appropriately tested medicines for children aged 0 to 17 years as well as improving information to prescribers on the use of medicines in children. However these aims are balanced against the need to ensure that there are no delays to the authorisation of medicines for adults or that children are subjected to unnecessary clinical trials. This short article provides a brief summary of this new regulation in Europe as well as its possible impact for Australia.
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Secrets to Using the Web to Stay Informed, Contribute, Network and Save Time and Money. Part II
1/04/2008
Issue Number: 124
Last issue we introduced some of the tools that exist to improve networking, communication and information retrieval, with some ideas for how these can support your business. In part II of this article, we will explore some different ways to improve efficiency and save money.
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Reporting of Sponsored Events: Increased Transparency for Corporate Sponsorship of Doctors’ Education
1/04/2008
Issue Number: 124
The first round of reports in relation to educational meetings and symposia held or sponsored by companies (“sponsored event reports”) was due to be submitted to Medicines Australia by its members at the end of March 2008. The Australian Competition Tribunal (“Tribunal”) affi rmed the decision by the Australian Competition and Consumer Commission (“ACCC”) to impose a condition on authorisation of the Medicines Australia Code of Conduct (“the Code”) which required companies to submit sponsored event reports twice yearly. In this edition, we provide readers with a summary of the background to the decision and in the next edition, we will report on the impact of the publication of the reports, including stakeholder feedback, and any issues that may arise from the publication.
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Factors Influencing Decisions to Participate in Clinical Research
1/04/2008
Issue Number: 124
This paper discusses some of the issues that influence decision-making by healthy volunteers and patients when invited to consent to participate in clinical research. It is through a better understanding of these issues that researchers will be able to appreciate why people consent, or not, to participate in clinical research and to consider options that might improve recruitment and retention to future studies.
This article was originally published by CRFocus (www.crfocus.org) in the UK (L. Gelling and G. Ellis; Factors Infl uencing Decisions to Participate in Clinical Research; 18(10) p5-10).
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ARCS and DIA: Benefits for Members and Opportunities for the Future
1/04/2008
Issue Number: 124
ARCS and the Drug Information Association (DIA), with headquarters in the USA, share many similarities in their structure and goals. Both are member based organisations which provide a neutral forum for discussions between regulators, researchers and industry on issues relating to therapeutics development and provide opportunities for education, networking and information sharing. Like ARCS, DIA is volunteer driven with Special Interest Groups (SIGs) covering a large set of disciplines and interests. Of course DIA is much larger and attracts approximately 8,000 delegates to its USA meeting in June each year and around 3,000 delegates to its European meeting in March.
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MIAA Changes Name to Medical Technology Association of Australia in Line with its Vision for the Future
1/04/2008
Issue Number: 124
After 26 years since its beginnings the Medical Technology Association of Australia (formerly the Medical Industry Association of Australia) has come of age and are focusing on the future of medical technology and its role in the Australian healthcare system. The new name is part of a bigger picture strategic plan for the association and the medical technology industry.
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New Zealand Association of Clinical Research (NZACRes) Update
1/04/2008
Issue Number: 124
NZACRes was formed from the clinical research focus group to foster and promote clinical research, and is the professional association for clinical researchers in New Zealand. NZACRes holds regular meetings to bring together members of the clinical research community, to discuss issues in the industry and to network amongst peers for over 240 members. We also run our annual NZ Clinical Research Conference where invited speakers from New Zealand and overseas present on topics of interest to researchers.
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New National Manager of the Therapeutic Goods Administration (TGA) - Dr Rohan Hammett
1/04/2008
Issue Number: 124
ARCS would like to welcome Dr Rohan Hammett as the New National Manager of the TGA. Rohan brings a number of important qualities to the role of TGA National Manager, including a distinguished career as a dedicated clinician and academic.
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When to Use a Call Centre in Patient Recruitment and Retention
1/02/2008
Issue Number: 123
An effective call centre can help to expedite subject recruitment and is usually the first critical contact point for a potential study participant. Essentially a call centre acts as a big funnel or filter. There is always significant attrition, however a call centre helps enormously by targeting prospective subjects and then ascertaining if they meet the inclusion criteria and are willing to commit to the study protocol. This article addresses some of the key questions raised when deciding whether to use a call centre to expedite patient recruitment.
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Professional Development Opportunities for Medical Writers Outside Australia
1/02/2008
Issue Number: 123
ARCS provides an excellent program to encourage members to become medical writers, and provides information on topics relevant to that profession (for example, this year the Medical Writing Education Subcommittee held evening seminars on ‘International Update on Industry Sponsored Publications’ and ‘The Right Writer for the Job’). In Europe, there is a large professional organisation specifi cally for medical writers called the European Medical Writers Association (EMWA), which holds professional development conferences in spring and autumn each year. The EMWA conference offers foundation and advance training in all aspects of medical writing, and workshops covering regulatory topics and fundamental writing skills. This article reviews my experience of this year’s EMWA Annual Conference.
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Important Techniques for Effective Networking
1/02/2008
Issue Number: 123
The electronic revolution of the last 15-20 years has seen an enormous change in the way we live and work. It now seems hard to imagine how we survived without email, mobile phones and the internet. Pharmaceutical companies and research centres pride themselves on being at the cutting edge of scientific technology and medicine, but how quickly have they embraced the opportunities the internet now provides to network, stay informed and work more effi ciently? In an age where environmental concerns see us striving to reduce paper use, projects are more regional/international and we are all asked to do more in less time, it seems reasonable to seek solutions from the electronic world, of which the internet is cornerstone. Do you know how to get the best out the functionality the web now provides? How could it help you or your business better network and save time and money? This 2-part article provides learnings from my own personal journey to become familiar with the vast wealth of resources the internet provides and how these can be used for personal and commercial advantage, particularly in the world of clinical research. Part 1 explores networking, blogs, wikis and forums whilst Part 2, next issue, delves into other tools that can be used to enhance efficiency.
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2nd ARCS TGA and Industry Day
1/02/2008
Issue Number: 123
The highly successful Therapeutic Goods Administration (TGA) & Industry Day was held for the second time in Canberra on the 9th November 2007, and was attended by 80 pharmaceutical and device regulatory representatives. The aim of the seminar was to provide an introduction to industry professionals who are new to the regulatory profession and give them an insight into the regulatory framework within several of the key TGA sections. It also provided overview of common deficiencies in quality data that these TGA sections have compiled over time. The TGA representation was from the Manufacturing Assessment Branch, Drug Safety Evaluation Branch (DSEB), Over the Counter Medicines (OTC), Complementary Medicines, Medical Devices and the Therapeutic Goods Analytical Laboratory (TGAL). There was also an opportunity, during the tea and lunch breaks, for delegates to meet with the TGA speakers.
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The Right Writer for the Job – ARCS Evening Seminar
1/02/2008
Issue Number: 123
Outsourcing of medical communications materials has become commonplace. However, in an increasingly competitive market, identifying the most appropriate agency to appoint may appear a difficult task. A recent ARCS seminar – organised by the Medical Writing Education Subcommittee, and chaired by Dr Peter Tobin (Roche Products) – A/ Prof. Karen Woolley (ProScribe Medical Communications) and Ms. Cathryn Berry (Meditech Media Asia Pacific Pte Ltd) provided practical insights into how to go about choosing the right agency for a range of medical writing projects. The key elements discussed included: understanding the outsourcing environment, defining needs, assessing resource capabilities and nurturing relationships. From Bridget Jones to briefs, the seminar proved both engaging and informative…
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The Pharmaceutical Benefits Scheme (PBS) - ARCS Education Seminar
1/02/2008
Issue Number: 123
A PBS education seminar was held in Canberra on 4th December, which was well attended by pharmaceutical and device company representatives, staff from the Department of Health and Ageing, other government agencies, Medicines Australia (MA) and ARCS. The aim of the seminar was to provide an introduction to all aspects of the PBS listing process. In doing so presentations were made covering the entire range of activities required in achieving PBS listing, from sponsor pre-submission meetings to deeds of agreement.
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The Role of the Administrative Appeals Tribunal in Reviewing Decisions of the TGA
1/02/2008
Issue Number: 123
The Administrative Appeals Tribunal (“Tribunal”) is an independent, impartial review body that has statutory power to review certain decisions of the Therapeutic Goods Administration. If you’ve ever wondered exactly what the Tribunal does and how it operates, look no further. This article provides a summary of the role of the Tribunal in reviewing administrative decisions and the procedural steps involved once an application for review has been lodged with the Tribunal.
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2007 ARCS AGEM Session Write Up - Clinical Research Updates
1/02/2008
Issue Number: 123
The Australian clinical research environment underwent significant changes during 2007 with the introduction of new processes, updated regulations and new/updated codes of conduct for researchers and industry. The 2007 ARCS AGEM provided the opportunity to review some of those initiatives and their impact, and look to the year ahead for what it might hold in store.