CRfocus on Twitter

Clinical research professionals can now keep up with CRfocus even more rapidly using the well-known web service Twitter. After several months of including CRfocus-related content on my personal Twitter page, I have now set up a dedicated CRfocus account (http://twitter.com/CRfocus).

You can visit that page for regular updates, see recent “tweets” on the main CRfocus page (www.crfocus.org) or ‘follow’ CRfocus through your own Twitter account.

It’s a great way to keep up with the fast-moving world of clinical research, particularly during the conference season…

From the issue: It’s not all work, work, work

To round off CRfocus each month, we look at the lighter side of clinical research. To make this work, we need your contributions of things related to clinical research, and medicine more generally, that make you laugh. Send your contributions to comment@crfocus.org. These are some of the items intended for February’s issue.

Hollywood goes pharma?

At some time or another, I’m sure all of us has daydreamed about being a film star. But if real film stars decided on a change of career into clinical research, what roles would they end up in?

• Meryl Streep would work in QA, delivering results with precision
• Mickey Rooney would be Operations Manager for a small university biotech spin-off: “Let’s do the show right here!”
• Sigourney Weaver would be an unflappable line manager, nurturing but able to be ruthless if necessary
• Quentin Tarantino would become famous as the fastest implanter of implantable medical devices… often faster and messier than the patients themselves might like!
• Will Smith would be the Project Manager everyone wants on their bid defence team. Joe Pesci would be brought out of retirement to turn round failing studies… or else!
• Wall-E would become a CTA, patiently clearing up the mess left by others before nurturing a study from green shoot to sturdy tree
• Renée Zellweger would be a CRA, doing what it takes to get the job done, before walking off into the sunset

Obama-bandwagon

The International Secret Society of Journalists and Editors (what do you mean you haven’t heard of them?!) has decreed that every newspaper or magazine published in 2009 must include an item or photograph including new US President Barack Obama. While we’ve been assured that he is an avid reader on CRfocus, we’ve yet to source a picture of him with our venerable journal. In the meantime, here is our prediction of what President Obama will accomplish for clinical research. We’ll be generous, and give him his first 100 days in office as a deadline:

• Patients will accurately diagnose themselves and assess the inclusion/exclusion criteria before pro-actively contacting investigation sites to volunteer.
• Data queries will vanish overnight as blood tests and patient-recorded outcomes are replaced by a hand-held ambient full-body scanner. The only drawback is that all doctors will be called “Bones”.
• The FDA will find a new algorithm to dramatically reduce the volume of evidence required to accurately assess a new medicine’s safety and effectiveness. All its decisions will be made within days of submission.
• The general public will realise that they’ve been wrong about the medicines development industry, and we’ll receive a round of applause every time someone takes a tablet or receives an injection.
• Hope will become the most effective placebo of all time, curing all acute conditions, and giving respite from chronic suffering… until the end of his term of office, or at least until the post-election euphoria wears off…

Another Ten Things…

This month, as we find ourselves solidly in 2009 and the meeting-fest restarts in earnest, we’re bringing you “Ten things not to say in a study planning meeting”:

10 Is there an attendance list? I’d like to action someone who isn’t here.

9 No, really: I think we could achieve double that recruitment in half the time.

8 Why can’t the first part of the second party be the second part of the first party… or is that the contract for a cross-over study?

7 … and that’s the point in the schedule when we meet to reschedule the rest of the project…

6 We’ve scheduled bloods every week for 6 months; can’t we just take one big sample at the end?

5 Okay, so the investigator who recruits most patients gets to name the drug…

4 We’ll just copy this whole section from the 1986 protocol on this indication…

3 Does taking copies of “ICH GCP for Beginners” to the site initiation meeting count as training?

2 We’ve had a very productive meeting… but this wasn’t it!

1 Nothing!

Moving this blog to a new host

This is the first CRfocus blog to be posted to its new home on WordPress. Having started blogging about clinical research on my personal blog over a year ago, I decided that the time has come to give this work a dedicated home. This will also let me do some cool new stuff… so watch out…

Reforming the Declaration of Helsinki: Who Needs It?

The World Medical Association (WMA) has embarked on an 18 month process to amend the Declaration of Helsinki in October 2008.¹ After a period of consultation to identify gaps and areas for improvement in the current text, a working groups is currently working on an initial draft to be circulated to National Medical Associations (NMAs) and other stakeholders around the end of this year. Comments from these groups will be considered for a second draft, which will be considered by the WMA’s Medical Ethics Committee and Council and again by the NMAs before being passed to the 59^th General Assembly (to be held in Seoul) for adoption.

This is a rigorous and relatively transparent process, but it omits two fundamental questions: whether a document such as the Declaration should exist at all, and if so, whether the WMA is the appropriate body to oversee it.

Do we need a universal standard for research ethics?

 

I’ve written previously² on the debate over whether a universal standard for research ethics is achievable or desirable. There are strong arguments on either side; on one hand, using anything other than universal standards to determine what is ethically permissible undermines the rights and dignity of those subject to lower standards than others elsewhere. On the other, different societies and cultures have reached their own consensus over time on practices they consider acceptable, and if the ‘universal’ standard is in reality a Western, Christian, liberal standard, then to impose it on other societies denies their right to autonomy.

If the Declaration of Helsinki didn’t exist, to misquote Voltaire, would it be necessary to invent it? This is a very difficult question. Fortunately, though, the situation we face is slightly different, so pragmatism can prevail: abandoning the concept of the Declaration would result in such ethical chaos and socio-political upheaval that there is no practical alternative but to keep it… or, at least, something like it.

Who should set the standard?

In my opinion, the more compelling question is whether the WMA is the right body to set the standard for whether a proposed clinical study is ethical. Physicians have no monopoly on ethical practice, and the Research Ethics Committees referring to the Declaration to give opinions on individual studies now comprise a far more diverse range of scientists and lay people than was the case in 1964. The 43-year history of the Declaration has seen it diverge from the opinions of other stakeholders to the extent that key documents such as the EU Clinical Trials Directive cite versions of the Declaration which the WMA considers superseded. Since the current version was adopted in 2000, it has twice been “clarified”, softening its position on placebo controls and post-trial access. While these clarifications were broadly welcomed, the fact that they were needed at all further undermines the current drafting and adoption process.

Clearly, to arrive at a document that will be complied with by all and incorporated into legal documents, a more inclusive drafting process is required. The current amendment process is certainly more inclusive and transparent than previous ones, but the final decisions still rest within the WMA. I would like to see a process involving the WMA, but also patient representatives, regulators, industry and professional ethicists on an equal footing. Representatives should come from developed and developing regions, for open debate without deference or power-politics.

Replaced, not now but soon

Of course, it is wholly impractical for this kind of new process to be completed by October 2008, but the current Declaration is creaking slightly and in need of attention. The WMA should continue on its course towards a 2008 revision, but then immediately set the scene for the creation of a successor to be drafted and adopted by a multi-disciplined body in 2010. With a new name and a broader mandate, this document should be free from the Declaration’s ‘baggage’, and acceptable and workable for all, to protect patients while facilitating the development of new medicines.

References

1. http://www.wma.net/e/ethicsunit/helsinki.htm
2. Smith A (2007): “Does One Size Fit All? Are Universal Standards of Research Ethics Achievable… or Even Desirable?” CRfocus 18(4), p4.