Long time no blog, as they say. Usual excuses about being too busy, traveling etc. But the real reason is that things have been in such flux the last weeks that I haven't had the singleness of purpose to write. I've been too busy trying to stay present with all the changes. Some are seasonal and mundane: end of school term, posting of grades and the full-on arrival of summer (which in the SF bay area feels like spring just about everywhere else - as my friend Mary says, there is a reason why we pay prices this high for houses this small). Some are big and all-consuming, like travel in June to start my new business - more on that shortly.
Some of the most mind-spinning transitions have been in the lives of others, the kind you can only stand by and watch in helpless awe. One friend recently had surgery to remove cancerous lesions from his tongue, acquired most likely from radiation therapy for his previous three bouts with lymphoma. My oldest friend's 18 year old daughter has been fighting against a tumor wrapped around her thalamus. Last week they were told all options are exhausted and they are looking at about 6 weeks. Another friend died about 5 weeks ago after her breast cancer returned and metastasized into her bones. My father will undergo an open heart valve replacement procedure next week, a risky move in an 89 year old, to say the least.
But I am back. Here are a couple of links of note this week. ClinPage has a write up on some survey results taken by J&J in the wake of their rather public flogging in 2006 at the hands of the BBC. The piece in question is in my opinion poorly reported, long on sensation and speculation but short on balance and does nothing to actually educate the viewer about clinical trials. Nevertheless, J&J reacted and put together a group to look at the problems identified in their consent forms and to make some suggestions, and unveiled the results at June DIA meeting in San Diego. I hope this is the beginning of a trend in the industry. Consent forms have become too long and too filled with language intended to protect the sponsor and investigator, to limit their liability instead of to inform the subject.
The first thing we do, to paraphrase the Bard, is get the lawyers out of the process. The next thing is to stop worrying about people writing headlines. We should simplify the consent process to include the most important elements - research, risk and voluntariness - in the first page and stop trying to rewrite the entire protocol in the rest of the consent.
I also came across this blog whose author draws a comparison between Sasha Baron Cohen's new film Bruno and the research consent process. Worth a look.
Now for the news. With my partner in India I have opened a new clinical trials consulting business: Anhvita BioPahrma Consulting. Our aim is to connect the right clinical services in India and other emerging markets to sponsors in the US and Europe. It is all about bridging gaps and that is what 'Anhvita' means in Sanskrit. We are also developing professional training components for clinical research professionals in India and elsewhere to increase the emerging markets' capacity to handle the burgeoning clinical trial market, which hit US$50 bn last year and is growing. Watch this space for more information as we explore this market together.
And that's the way it is. RIP Walter Cronkite, narrator of all the nation's major events during my youth.
