CRfocus: Table of Contents of June 2009 issue

CRfocus 20(06) – June 2009

This is the Table of Contents of Clinical Research focus 20(06) for June 2009. Members of The Institute of Clinical Research can click on the links to read the full text of each article.In previous years, we have endeavoured to publish reports on all conference sessions in this issue. However, due to constraints on page space and available reporters, we have decided to publish a balanced selection of reports in print, with others (and extended versions of printed reports) becoming available here during June.

Conference photo-gallery

Photos uploaded during the meeting, plus many additional images

Plenary sessions

Lively Debates & Votes:Day One Plenary Sessions

• Niall Dickson, Prof. Karol Sikora, Prof. Nick Bosanquet, Francis Crawley & Colin Miller FICR CSci
• Reporter: Suheila Abdul-Karrim MICR Csci

Pharma 2020: VirtualR&D

• Kate Moss
• Reporter: Andrew Smith

Lively Debates & Votes: Day Two Plenary Sessions [online only, coming soon]

Sharing knowledge

Off-Shoring in ClinicalResearch [extended version, online only]

• Prof. David Jefferys & Paul Wathall MICR
• Reporter: Wendy Tomlinson MICR

Stem Cells: Current Advances & Applications

• Prof. Peter Andrews & Prof. Malcolm Alison
• Reporter: Jane Pelly MICR Csci

Contracts in Global ClinicalTrials

• Rebecca Sergeant & Sarah Watts
• Reporter: Judit Varkonyi-Sepp MICR Csci

Electronic Data Capture (EDC): Issues & Practical Solutions [online only, coming soon]

The A-Z of Adaptive Study Design [online only, coming soon]

Fundamentals of PIPs [online only, coming soon]

Therapeutics

Oncology Care in the Future [extended version, online only]

• Prof. Angus Dalgleish, Prof. Nicholas James, Prof. Jonathan Waxman & Prof. Will Steward
• Reporter: Shethah Morgan MICR Csci

The Heart of Cardiology

• Dr Mike Mullen & Dr Marcus Flather
• Reporter: Sue Jackson RICR

The Heart of Cardiology [extended version, online only coming soon]

Organ Transplantation: Past, present & future [online only, coming soon]

Raising standards

The Impact of theDeclaration of Helsinki

• Eva Nilsson Bagenholm MD & Bev Holt MD
• Reporter: Rachael Winter RICR

Quality & Productivity:Can You Have Both?

• Alison Messom MICR & Andrew Borrisow
• Reporter: Wendy Tomlinson MICR

Evidence for Good Quality:The Hidden Cost of Inspection

• Prof. Richard Gray & Joan Perou HonFICR
• Reporter: Suheila Abdul-Karrim MICR Csci

International Inspections [online only]

• Fergus Sweeney & Gunnar Danielsson
• Reporter: Judit Varkonyi-Sepp MICR CSci

Putting a Price on Patient Value [online only, coming soon]

Inspectors: Why Do They Do It? [online only, coming soon]

Developing professionals

Medical Devices Workshop [online only, coming soon]

Image in Business: It’s Personal [online only, coming soon]

Project Management Workshop [online only, coming soon]

Leadership Workshop [online only, coming soon]

Regular updates

Session Reports from theICR Annual Conference: Message from the Chair

• Janette Benaddi MICR Csci

CRfocus: Table of Contents of May issue

This is the Table of Contents of Clinical Research focus 20(05) for May 2009. Members of The Institute of Clinical Research can click on the links to read the full text of each article.

Features

Strengthening Protection of Research Subjects: The 2008 Revision of the Declaration of Helsinki

John Poland FTOPRA

The Declaration of Helsinki was developed to underpin the ethical conduct of human clinical research. Eight years after its previous major update, which prompted two clarifications on contentious points, the Declaration was revised late in 2008 after a process lasting nearly 2 years. John Poland provides a detailed view of the latest revisions, which have provoked mixed responses from regulatory, ethics and clinical communities.

Lost in Translation? Challenges in Preparing Participant Information for Multilingual Studies

Nicky Dodsworth MICR CSci & Efraim Roe

An increasing number of studies are being performed in parts of the world whose first language is not English. There are challenges in translation and communicating science in a multilingual world dominated by the de facto language of English. Nicky and Efraim look at the issues surrounding translation of the patient information and informed consent forms.

People

A Career Championing UK Clinical Research: An Interview

Richard Tiner

Richard Tiner steps down as Medical Director of the Association of the British Pharmaceutical Industry (ABPI) at the end of May, after nearly 13 years in the post. Over that time, he has been a prominent speaker at ICR events, and was the first person we interviewed for CRfocus. As he prepares to move on, he reflects on the changes in the UK clinical trials landscape since the mid-1990s, in which he has been instrumental.

National update

Local & National Perspectives on Streamlining R&D: ICR Scottish Forum

Mary Mumford RICR

Mary reports on the October 2008 meeting of the ICR Scottish Forum. At the meeting, Dr Janet Messer, Deputy Director of the NHS R&D Forum, gave an overview of the initiatives to integrate and streamline R&D activities throughout the NHS, while Brian Rae, R&D Manager of the Greater Glasgow & Clyde NHS Trust, spoke about the successes and challenges in developing world-class clinical research structures in one of the most health-challenged regions of the UK.

Professional development

Spice Up Your Interview Technique

Shanoo Singh

Being interviewed can be a nightmare. Interviewing skills have been rapidly and continuously changing over the past decade. Having been both a candidate and an interviewer on many occasions, Shanoo reaches out to everyone, particularly those seeking their next strategic positions, and offers some tips on how to perform at your best in an interview situation.

Viewpoint

Always Compete on Value; Never on Cost

Andrew Smith

When the economic upturn comes, the individuals, organisations and indeed countries that will be best placed to succeed will be those that have continued developing through the lean times. As an industry, we’ve become very good at working costs out of our processes. However, focusing solely on this risks neglecting importance of creating additional value for companies, shareholders and society as a whole. The relative risk of trying to leap ahead through strategic innovation is actually lower now than in ‘boom’ years, those that innovate and survive will secure their place at the forefront of the industry for a generation.

Devices, Drugs, Directives & Directors

John Kolthammer HonFICR

To recognise that our new Chair of the ICR Board of Directors has a background in medical device development, John Kolthammer, former CEO of ICR, offers a respectful and somewhat light-hearted reminiscence to draw attention to the some of the interesting issues that have always been present at the interface between pharmaceuticals and medical devices.

Regular update

Uncertainty & Opportunity: Message from the Chair

Janette Benaddi MICR Csci

Janette inspires us to remain optimistic and look harder than we have ever done for opportunities, despite any current financial insecurities or media-fuelled gloom. To add personal despondency to this will surely reduce our individual ability to cope, and will probably also make the wider recession both longer and deeper. It’s challenging to look on the bright side, but she believes that there is a bright side for many of us, if we care to search for it.

It’s Not All Work, Work, Work…

Compiled by Andrew Smith

Our regular look at the lighter side of clinical research, including “Ten innovations that won’t add value to sponsors, shareholders or society” and engaging with patients in language that is a bit more “street”…

FDA ‘Drops the Second Shoe’ on Helsinki

In the international news section of June’s issue of CRfocus, we report the decision of the US Food & Drug Administration (FDA) to amend its regulation 21CFR312 on the acceptance of foreign clinical studies not conducted under an investigational new drug (IND) application as support for an IND or application for marketing approval for a drug or biological product in the USA.¹ This new rule marks a further distancing from the text of the Declaration of Helsinki.²

The rule replaces the requirement that non-IND these studies be conducted in accordance with ethical principles stated in the Declaration of Helsinki, with a requirement that “the studies be conducted in accordance with GCP, including review and approval by an independent ethics committee”. Having continued to refer to the 1989 version despite two subsequent major revisions (in 1996 and 2000) this development is hardly surprising, and was arguably only a matter of time. Over the past 20 years, there has been an increasing divergence of opinion between the World Medical Association (WMA) and the FDA (and much of the broader regulatory community). The landscape is very different now to how it was in 1989, not to mention in 1964 when the Declaration was launched, with the various ICH guidelines (particularly E6, on good clinical practice³) giving more detailed and specific activities and responsibilities in conducting high quality clinical research. This is one of the main reasons given by the FDA requiring compliance with GCP rather than the Declaration. In addition, this period has seen an increase in specialist clinical research statisticians, ethicists and other professionals outside the medical community, diluting the authority of the WMA to have the final word in this area.

As I’ve previously reported in CRfocus,⁴ there is an ongoing process to redraft the Declaration for adoption at the WMA’s next General Assembly. In its supplementary information, the FDA notes that “the Declaration is a document that is subject to change independent of FDA authority and, therefore, could be modified to contain provisions that are inconsistent with US laws and regulations… [which] might be confusing for sponsors.” The WMA will meet in Seoul only 10 days before the FDA amendment comes into force on October 28^th 2008. One could speculate about this timing, and what the FDA might expect to see included in a revised Declaration that it would not wish sponsors to confuse with its own position. However, this work goes back over several years, with a proposed amendment being published as long ago as June 2004.

The real question, though, is whether this change will actually make anything more than a symbolic difference! Most ‘flavours’ of GCP refer to the Declaration (ICH GCP 2.1 states that “Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki…”³), the independent ethics committee called for in the amended regulation will almost certainly be founded upon its principles, and all investigators are indirectly bound by it through membership of their national medical associations.

So, the effective decision processes will remain basically the same. However, at the same time, the impact of any radical changes to the Declaration will be softened. Quite how important this last point will be, we’ll see in October…

References

1. US Food & Drug Administration (2008): “Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application”, available via www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&o=0900006480537f08 [Accessed May 23^rd 2008]
2. World Medical Association (2004): “Declaration of Helsinki”, available via www.wma.net/e/ethicsunit/helsinki.htm [Accessed May 23^rd 2008]
3. International Conference on Harmonisation (1996): “E6(R1): Good Clinical Practice: Consolidated Guideline”, available via www.ich.org/cache/compo/475-272-1.html#E6 [Accessed May 23^rd 2008]
4. Smith A (2007): “Reforming the Declaration of Helsinki: Who Needs It?” CRfocus 18(10) p4

Related posts

Blog by John Daly

Anything to Declare, Doctor?

It seems that transparency and public accessibility is all the rage these days. For the past decade or more, concerns among journalists, medics, politicians and (to a much lesser extent) the general public have been calling for greater transparency around the biomedical research process, from summaries and protocols of proposed and ongoing studies through to reports of finished studies and even for raw datasets for re-analysis. Under the thought-leadership of the International Committee of Medical Journal Editors (ICMJE) and the Committee on Publication Ethics (COPE), registration systems such as the International Standard Randomised Controlled Trial Number (ISCRTN), EU projects like EudraCT and EudraPharm, and the US-based www.clinicaltrials.gov, the bar has been raised and the infrastructure put in place for information about every study to in the public domain.

This is a good thing, although the debate continues about what information should be made public when, and how much you can discuss your work and still have it accepted for a prestigious journal. The most important thing for all of us is that the biomedical science community and the general public have increasing confidence in the accuracy and applicability of the evidence provided by clinical trials. In the absence of documented evidence to the contrary, the social climate is such that it is all too easy for allegations of wrongdoing by the pharmaceutical industry to be believed even if these cannot be proved. This is not least because of a few ‘horror stories’ of studies that were conducted but not reported (particularly by industry, and thus prominently reported in the media) or reported but not conducted (mostly by individual medics, and thus barely reported at all!)

There has been a great deal of brouhaha (and rightly so) about who should or should not be listed as an author: ‘guest authors’ have been widely deprecated, while ‘ghost writers’ should be ghosts no more, with the important contribution made by medical writers to the clarity and structure of a good paper being increasingly recognised. However, there is one area about which I’ve heard no calls for greater transparency and compulsory registration: the space at the end of each paper in a medical journal, where the authors (or, better, ‘contributors’) are required to list their conflicting interests. This is dangerous for two reasons: there is no independent mechanism to verify these statements are complete and accurate and, more importantly, it is left to the judgement of the individual contributor to decide what conflicts with their contribution to the paper.

If the world of industry can sometimes be an ethically messy place, the same is certainly true of academia, with professional jealousy and one-upmanship playing as much of a role as commercial interests such as consultancy fees and the potential for spin-out businesses. The precise details of such a system would need to be worked through, and a suitable body found to oversee and enforce it (perhaps the World Medical Association?) but it is unrealistic to think that this is the one area where subjective judgement should be accepted as rigorous. As the English saying goes, “what’s sauce for the goose is sauce for the gander”…