Conducting Clinical Research

Time to play catch up with the blogging as the year begins to wind down.  The fall term at UC Santa Cruz will finish next week and I have no more conferences booked till January. 

A couple of weeks ago I attended and presented at MAGI West Conference on Clinical Research in San Francisco.  The event was neatly sandwiched in between the end of baseball pennant series' and the World Series, in which my beloved San Francisco Giants prevailed for the first time in, well, my whole life.  San Francisco was a very orange place to be during these days, and as a lifelong baseball fan left heartbroken by my team twice before in my adult life, it was a glorious time to be in the city. 

But this blog is not about baseball.  The MAGI conference was well attended by over 500 people, many more than had attended the same event last year in San Diego (on the last day of the baseball 2009 regular season, in case anyone is keeping track).  MAGI (Model Agreements and Guidelines International) so far is offered on either coast - in the east in spring and the west in the fall - and I think it is rapidly becoming one of the must-attend meetings on the yearly calendar for clinical research professionals, especially as the scope of the conference gradually expands from its origins in contracts and agreements to its current goal of "establishing best practices for clinical research operations, business and regulatory compliance".  The quality of speakers that I heard was uniformly quite high with little variation, although a couple stood out in both directions.  As the conference becomes larger it is also becoming an important networking opportunity and my LinkedIn connections have expanded significantly as a result of the acquaintances I made and renewed during the two days I attended.

One of the people I reconnected with in San Francisco is Dr Judy Stone of Maryland, the author of "Conducting Clinical Research", a newly revised quite complete how-to guide primarily written for investigators and would-be investigators to help them understand their role in the clinical research enterprise, particularly as relates to pharmaceutical industry-sponsored research, which is ultimately for profit.  Dr Stone has done her homework and produced an excellent reference that, while geared toward investigators, also offers new insights to the sponsor and CRO sides of the industry for those who might have a look.  It is always a good idea to remember to see things from the investigator's perspective, and Dr Stone has done this very well.  I plan to recommend this volume to my GCP students as adjunct reading material starting in the next term.

At the conference I was fortunate to participate on a panel entitled "Are Sponsors Re-evaluating Globalization of Clinical Sites?", moderated by Joan Chambers of Centerwatch.  In my next post I will review some of the key points of the discussion with the panel and audience. 

I close this post with the acknowledgement that our world became a great deal poorer last week when our friend Kate Allen died of gastric cancer.  She was 44.  She was a good teammate, colleague and friend, and she left many friends and loved ones behind who will miss her for the rest for our lives.

New Year, New Challenges

The new year has hit the ground running hard and many colleagues are just trying to hang on. The good news is that though we are still in the midst of some hard times, we are starting to see an upturn in movement of money, new clinical programs under development, and jobs. Enrollment is up in the UC Santa Cruz certificate programs where I have taught for the last 10 years and in honer of the winter term just getting underway, I posted a picture from my most recent trip to India of a woman walking her children to the school bus in Bangalore.

The conference season is in full swing. I just came back from the Indian Society for Clinical Research's excellent 3rd annual national conference at the Hotel Leela Kempinski in Bangalore. Attended by 500 participants from all over India and beyond, the conference featured many of the most influential people in the Indian clinical research field as well as many young CRAs and project managers, and it was a fantastic opportunity to listen and learn from the people who know the region best.

This week I will be attending and presenting at Outsourcing in Clinical Trials West Coast in San Francisco, on the topic of Offshoring to Emerging Countries: Navigating Uncertain Waters. I gave a similar talk last week as an advance for the Partnerships in Clinical Trials event to be held in Orlando in April. I'm told a podcast of last week's talk is forthcoming and I will make it available to anyone who contacts me for it. This week I am also presenting in a webinar entitled Biotech and the Global Marketplace for the US Commercial Service. My task is to discuss clinical trials in emerging markets and opportunities for US biotech companies to enter into co-development projects with sister companies in these regions.

My partner and I were recently featured in a blog post over at goBalto.com about the Indian clinical trial market- see it here.

I receive regular updates from Audrey Erbes, who is a faculty colleague of mine at UC Santa Cruz extension and teaches in the biosciences certificate program. I took her 2 day course on business development and highly recommend it. Here is her excellent blog where she freely shares huge amounts of information from her network including job postings with students and colleagues alike. Highly worth subscribing to in your reader.

2010 represents my 30th year in the clinical research field. Next year I will have to rename my blog to '3 Decades, Full Stop'.

Focuses for the Upcoming Term

This tide marsh is located behind the building I where I work Monday through Thursday, on the east side of the San Francisco bay. It is close enough to walk to, and it has long flat dirt paths to run on when I feel energetic. On a clear day, such as we had this week, you can identify individual buildings in the downtown San Francisco skyline. Most days there is a haze on the water that precludes even seeing the mountains of the peninsula on the other side. I like to go out there during the day to clear my head or to think. Sometimes if I don't have early morning calls I stop by the marsh before heading into the office to watch the great white herons, snowy egrets, mallard ducks and other shorebirds make their living. I find the movement of the tides calming. The water of the bay has a different personality every day; sometimes calm, flat and glassy, sometimes grey and choppy. But the water in the marsh, seen here at high tide, is always smooth and tranquil.

The focus of this week has been building my network of experts in the field of clinical trials in emerging markets. I'm starting to do some research into the area of informed consent in emerging markets: what does signing a form mean to the patient, why are we shoving 15+ page consents down people's throats, and why do the ethics committees let us? I will be contacting my Indian, Eastern European and other connections in the developing world (although they don't know it yet) in the coming weeks to get their perspectives for the next iteration of the emerging markets course, to be offered in the spring term.

The winter term at UC Santa Cruz starts for me next week. It's been about an 8 week break since the fall term ended. Good Clinical Practices, my flagship class, begins Wednesday evening Jan 21 from 6-9pm, and runs for 10 weeks. I've improved (I hope) the curriculum for this term, updating some older information and including references to recent events in the NY Times, NPR, and other sources.