Should ICH GCP be reviewed and revised?

ICH guideline E6 (ICH-GCP) is, along with the Declaration of Helsinki, arguably the most important document in clinical research. Although neither has any direct status in the legislation of most countries where clinical research is conducted, their principles (and in many cases more substantive details) set the tone for how pretty much everyone conducts clinical research. Since its adoption in 1996 (in Europe; 1997 in the USA and Japan), ICH GCP has been the ‘bible’ for CRAs, auditors and other clinical research professionals worldwide.

Since 1996…

The world of clinical research has moved on quite some way in the past 13 years, and even more so when you consider the period of several years that was taken for the drafting, consulting, reviewing and negotiating prior to the guideline’s finalisation. Other guidelines (most notably the Declaration of Helsinki) have been updated several times in the past decades, and have a timeline for regular review every few years.

So, following a remark made by a speaker at the ICR Annual Conference earlier this year, we wondered whether ICH E6 should be reviewed and potentially revised. We put a poll on the front page of the ICR website, and were rather surprised by the result: over 80% thought that it should be reviewed (although from an admittedly small sample). We are currently undertaking a qualitative survey, asking what elements of the guideline should be updated and/or what should be added that did not exist in 1996. We hope to publish this in September’s issue of CRfocus magazine. If you would like to share your thoughts on this, and contribute to our article, please send your comments to andrew.smith@crfocus.org no later than August 10th 2009.

Of course, this is to an extent a purely academic exercise: many of the assorted national legislations, EU Directive etc. are subtly different, and the feasibility of renegotiating such a complex document with so many stakeholders (not least the more recently research-active countries that are outside the formal ICH process) is highly questionable. Indeed, some contend that the national legal arrangements have become so much more formal and sophisticated than they were in the 1990s that any thought of change to a founding guideline like ICH GCP is futile.

Still, it is useful to consider what aspects of contemporary clinical research are poorly served by the current fragmented global network of regulation and guidelines, and how different ICH GCP would look if it were being created in 2009. I’m interested to hear what you think…

CCRA 2009 reception at the House of Lords

I’ve seen from my blog admin dashboard that some readers have been looking at the post I wrote around this time last year, to say that I was going to the CCRA‘s annual reception at the House of Lords. Once again, I’ll be going there this evening, and am looking forward to catching up with the CCRA team and this year’s crowd of association members and their guests. Doubtless many interesting conversations will ensure, but I doubt I’ll report them here specifically. Instead, I hope that at least some of them will make it through to interviews or articles for future issues of CRfocus.

End of term reports?

You can tell it’s summer! In the latter part of July, large parts of the clinical research establishment evidently winds down for a summer recess. In the past few days, three substantial and (to a greater or lesser extent) significant reports have thudded onto my desk (metaphorically, of course – I read them as PDFs…)

• Life Sciences Blueprint – A Statement from the Office for Life Sciences (July 14th)
• The Case for Globalisation: Ethical and Business Considerations in Clinical Research (July 21st)
• Appraising the Value of Innovation and Other Benefits: A Short Study for NICE (July 22nd)

I would like to be able to give a detailed analysis of each of these documents, discussing which of their many recommendations seem to be the most feasible and/or helpful. However, arriving so close together (and as we’re getting the August issue of CRfocus to print) I have only had time to skim them so far, so the best I can do is suggest that you take a look at them yourself.

As one early aside, it might be worth considering the OLS Blueprint (an action plan to re-energise and optimise the UK’s innovative pharmaceutical industry) in the context of PICTf, which was a series of reports, workstreams and metrics that ran in the first half of this decade. Much of what has made UK clinical research what it is today had its source in the PICTf work programmes, so it remains to be seen how much of the Blueprint builds on those developments, and how much re-addresses topics that PICTf initiatives didn’t quite manage to resolve. Also, with a UK General Election less than a year away, and a change of government certainly not beyond the realms of possibility, it might be interesting to wonder how many of the report’s 12 key action points would withstand a shift from Labour to Conservative.

Perhaps more likely to maintain its relevance should the Conservatives win power next year is the report by Professor Sir Iain Kennedy’s report on how NICE might better handle the valuing of innovation in its analysis of the economic impact of new health technologies. Although it sticks with the basic ICER/QALY framework, it makes some strong recommendations on what further research is needed and on a pilot scheme for  innovation might be rewarded. This chimes with the “Innovation Pass” idea in the OLS Blueprint, which was initially portrayed in the media as something of a snub to NICE, but is perhaps more an anomoly of publication timings.

If these two reports are quite UK-specific, the middle one is definitely global in scope. Commissioned by the ACRO (the US trade body for CROs, representing the head offices of many of the world’s major contract research organisations) the report aims to demonstrate that clinical research in the “pharmerging” countries is of a comparable standard of safety and ethics of the traditional countries (ie, USA, western Europe etc.) and speed, scale and reduced cost present a compelling case for embracing the shift of larger clinical trials to these new regions rather than railing against it. From my initial reading of the report, this seems something of a tautology: because the studies are commissioned by western sponsors, often conducted by local affiliates of western CROs and designed to collect data to support western registration with the FDA, EMEA etc. is it really surprising that the standards achieved are broadly similar. Still, it’s important for the rest of society to recognise this if they hadn’t already (much of our industry realised this some years ago).

For all three reports, there is then the question of momentum. By the time the world starts getting back to speed in September, we might have had time to ponder some of their more complex recommendations, but others might have forgotten about them entirely! So, let’s make the effort and read them now…

EFGCP workshop on a single clinical trial application for pan-national studies

I’ve just worked out how long it’s been since I posted something here that hadn’t already been published elsewhere (ie, reportage or fresh comment rather than the Table of Contents of the current issue of Clinical Research focus). Things have been a bit manic here in the CRfocus office, with CRfocus and other ICR tasks (mostly related to our website and our 2010 conference) taking priority over blog-only posts. Hopefully, as the summer holiday season gets into full swing, I’ll be able to blog a bit more…

Ironically, today’s the day when I really would have preferred to reporting from Brussels on the EFGCP’s latest workshop, building on the ICREL workshop in December 2008 to discuss possible routes towards a single clinical trial application for multinational clinical studies. This could be of huge benefit to the efficiency of setting up large-scale clinical trials in Europe, and some of the contenders (eg, the “Voluntary Harmonisation Procedure” currently being piloted by the Clinical Trials Facilitation Group (CTFG) of the Heads of Medical Agencies) are very exciting indeed.

Unfortunately, my schedule is such that I couldn’t make it there without some incredibly long-winded travel plans that would have doubtless resulted in substandard reporting anyway…

I’m very supportive of this event, and this project overall. While I’m not able to report on it first-hand, I’m hoping to publish a brief report from someone else who is there today, and possibly arrange an interview or two with key participants over the coming weeks. This is too important a project not to do everything we can to engage everyone in the process.

CRfocus: Table of Contents of July 2009 issue – 20(7)

CRfocus 20(07) – July 2009

This is the Table of Contents of Clinical Research focus 20(07) for July 200. Members of ICR can click the links below and log-in to read the full text of these articles

Outsourcing

The Evolution of Outsourcing: Contract Management Coming of Age

Andy Parrett

The contract management role in clinical development outsourcing is still a relatively young profession. The nature of the role can vary significantly between pharmaceutical companies. Andy Parrett, Chair of the Pharmaceutical Contract Management Group (PCMG) suggests that the most exciting developments in the role are occurring in today’s small to mid-sized companies, and looks at how the processes surrounding outsourcing and its successful management are being developed.

Features

EudraCT Upgrades to Version 7

Andrew Smith

An information day was held by the EMEA at the end of April, bringing together representatives of national Competent Authorities (CAs), pharma companies, CROs and non-profit stakeholder groups. The purpose of the day was to communicate the features and development timelines of the next few versions of the EudraCT database of clinical trials in the European Economic Area (EEA), which went live in mid-June. Andrew reports, based on blog postings made on the day of the meeting.

CDISC European Interchange 2009: Conference Sketch

Adam Jacobs FICR CSci

CDISC (the Clinical Data Interchange Standards Consortium) is a relatively new player in the world of clinical research, having been founded in 1997, but it is rapidly gaining in importance, and is here to stay. To keep up with some of the latest developments in the CDISC world, Adam reports from the European CDISC Interchange, held in Budapest in April 2009.

Quality Assurance: Friend or Foe? A Survey

Jan Robinson MICR CSci

No-one questions the need for quality assurance of clinical trial activities but as someone at the receiving end have you ever been asked your opinion of the process? In your view, is audit a positive force for improvement? Are they the best means of advancing best practice or should we be taking a different approach? Jan invites you to take part in a short survey, to be reported in CRfocus and at the BARQA annual conference later this year.

Writing Protocols: Collaboration & Compromise or Conflict & Confusion? ICR/EMWA Joint Symposium

Alex Dedman & Andrew Smith

The challenges of developing clinical trial protocols were the topic of the second annual symposium jointly hosted by the European Medical Writers’ Association (EMWA) and The Institute of Clinical Research (ICR) on 24 February 2009. Around 60 delegates discussed the difficulties associated with developing protocols that both meet sponsors’ scientific and regulatory requirements, and facilitate the practical conduct of the study. Alex and Andrew report for CRfocus and The Write Stuff, the EMWA members’ journal.

People

Why You Should Care About the Innovative Medicines Initiative: An Interview with Jackie Hunter

Edward Blair MICR

The EU Innovative Medicines Initiative (IMI) was established in 2007 and issued its first call for proposals in 2008. Funding for the successful proposal has been allocated and the work kicks off in June this year. So, the IMI is for real and is beginning to deliver, but how well known is it and why will it change the pharmaceuticals industry in ways that will benefit ICR members? To get a first-hand insight into the aspirations of the IMI, CRfocus talked to Dr Jackie Hunter of GlaxoSmithKline, who has seen the IMI develop from a twinkle in the eye of EFPIA into the operating entity that it is now.

Conference

We are pleased to include two more session reports from the ICR Annual Conference, which space prevented us from including in last month’s issue.

International inspections

Fergus Sweeney & Gunnar Danielsson

Reporter: Judit Varkonyi-Sepp MICR CSci

Organ Transplantation: Past, Present & Future

Prof. James Neuberger & Mr Simon Bramhall

Reporter: Ali Zataar MICR CSci

Regular update

The Board of Directors: Who Are They & What Do They Do?: Message from the Chair

Janette Benaddi MICR Csci

The Institute of Clinical Research has a legal status of “a company limited by guarantee” and this means that it has to be managed by a Board of Directors. As members, you may wonder from time to time what the ICR Board of Directors do, who they are and how they add value to ICR members. Janette answers these questions, explains how the Board operates, and confesses her early (now-achieved) professional ambition to be a Board Director herself.