Jessica Wapner of Slate explains how the pendulum may have swung a bit too far in this piece on the value of industry sponsored medical education, here.
The latest in the Pfizer/Trovan saga comes down from the US Supreme Court today. The Supremes have kicked the entire mess back to the lower courts by ruling today that it won't stop Nigerians from suing Pfizer in the US. Technically they didn't rule so much as declined to hear Pfizer's appeal of the lower court ruling from last summer. We have run down this story a couple of times on this blog, here and here. Pharmalot's take is here.
Wednesday, June 30, 2010
Friday, June 25, 2010
Career Question
A former student wrote to tell me she had a chance to take a year long consulting job at a very big stable company, although it would mean leaving her current job that she had held as a headcount for a long time, and she asked my advice. Here is an excerpt of my reply.
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The question you are asking yourself is exactly the right one: do I leave something comfortable and reasonably secure for the possibility of an even better job, knowing that I am stepping into the unknown and could eventually lose more than I gain?
In rock climbing, going from handhold to handhold is one thing. But sometimes the next hold is far enough away that you actually have to jump to it, meaning you have to let go of the rock for a split second to get where you want to go, risking a serious fall. This is called a 'commitment move', and that is a good analogy of where you find yourself right now.
Sometimes we think in terms of 'secure' versus 'not', as though having a headcount job now means that job or the next one will be there as long as we want it. But that is often not true: the job that seems solid now can disappear in a flash if the company goes into protect mode. No company, even the good ones, is so loyal to its employees that it will sacrifice its financial health to keep its employees secure. If there is a choice between the company or the employees, the company will survive. They can always get new employees; it is a buyer's market. So the choice is not as black and white as secure versus the unknown. There is risk in staying, too. That might make it easier to think about.
In addition to your taste for risk, think about your long-term career goals. Where do you see yourself in 2 years, 5 years? What job would you like to be doing, and does your current position provide you with a path to that goal? Have you had that conversation with your manager? Does going to a large company as a consultant take you closer to that goal? Are you okay with being content, or do you want to check out the grass on the other side of the fence?
And a final thought: your current position is in a smaller organization. Where you are thinking of going is the very definition of a giant organization, and it is quite different to work in that culture. That is part of its security, but it can come at the cost of some autonomy in the job role: every decision gets processed through a long chain before it can be acted on, and that can be frustrating. You may not know how you feel about that until you've worked in it for a while, but it is something to think about nevertheless.
This is all more than you really asked - you happened to catch me in a moment of transparency. To sum up: For the most part, clinical consultants in the Bay Area do pretty well, and taking a full time contractor role at a bigger company is about as safe as it gets in the consulting world. Most people are betting that the job market in our industry will continue to improve slowly over the coming year - the number of deals announced this week alone seems to support that - and in the unlikely event that your contract is not renewed after the year, your resume would probably be richer for having spent the year there getting the big company experience.
*********************
The question you are asking yourself is exactly the right one: do I leave something comfortable and reasonably secure for the possibility of an even better job, knowing that I am stepping into the unknown and could eventually lose more than I gain?
In rock climbing, going from handhold to handhold is one thing. But sometimes the next hold is far enough away that you actually have to jump to it, meaning you have to let go of the rock for a split second to get where you want to go, risking a serious fall. This is called a 'commitment move', and that is a good analogy of where you find yourself right now.
Sometimes we think in terms of 'secure' versus 'not', as though having a headcount job now means that job or the next one will be there as long as we want it. But that is often not true: the job that seems solid now can disappear in a flash if the company goes into protect mode. No company, even the good ones, is so loyal to its employees that it will sacrifice its financial health to keep its employees secure. If there is a choice between the company or the employees, the company will survive. They can always get new employees; it is a buyer's market. So the choice is not as black and white as secure versus the unknown. There is risk in staying, too. That might make it easier to think about.
In addition to your taste for risk, think about your long-term career goals. Where do you see yourself in 2 years, 5 years? What job would you like to be doing, and does your current position provide you with a path to that goal? Have you had that conversation with your manager? Does going to a large company as a consultant take you closer to that goal? Are you okay with being content, or do you want to check out the grass on the other side of the fence?
And a final thought: your current position is in a smaller organization. Where you are thinking of going is the very definition of a giant organization, and it is quite different to work in that culture. That is part of its security, but it can come at the cost of some autonomy in the job role: every decision gets processed through a long chain before it can be acted on, and that can be frustrating. You may not know how you feel about that until you've worked in it for a while, but it is something to think about nevertheless.
This is all more than you really asked - you happened to catch me in a moment of transparency. To sum up: For the most part, clinical consultants in the Bay Area do pretty well, and taking a full time contractor role at a bigger company is about as safe as it gets in the consulting world. Most people are betting that the job market in our industry will continue to improve slowly over the coming year - the number of deals announced this week alone seems to support that - and in the unlikely event that your contract is not renewed after the year, your resume would probably be richer for having spent the year there getting the big company experience.
Friday, June 11, 2010
Updates to 1572 Guidance
The FDA has finally released a final FAQ, representing their 'current thinking' on 1572s. The guidance in the form of question and answer runs for 17 pages and covers, among other things, how to fill it out, who should be listed in item #6, whether it is required to be submitted to the FDA, and under what circumstances an investigator needs to sign a new one. Makes for surprisingly interesting reading.
In this FAQ the 1572 is describes as having two purposes: one) to provide the sponsor with information about the investigator's qualifications and the suitability of the site for clinical trial purposes, and two) tho inform the investigator of his/her obligations and to obtain the investigator's commitment to discharge those obligations according to the regulations. This clearly defines the document as a two-way communication tool in addition to a statement of undertaking. The parties involved in the communication flow are the sponsor and the investigator. Notice that the FDA is not among those sharing in this conversation. The guidance makes it clear that sponsors are not required to submit the 1572 to the IND, although it acknowledges that most sponsors do because it is a convenient collection tool for all the information that sponsors must submit to the FDA under 21 CFR 312.23(a)(6)(iii)(b). This is a small but potentially important distinction: the 1572 itself is not required to be submitted, just the information contained. A sponsor could submit that information on a separate sheet of paper and be fully in compliance. Most regulatory folks both of sponsors and CROs have always insisted that the 1572 itself must be submitted, yet I never found a regulations supporting the policy. It's nice to know what the requirement actually is.
Former FDAer and blogger Carl Anderson has an excellent run-down on one of the other new provisions of the guidance, namely that study coordinators should now be listed on the 1572:
“Generally, a research coordinator has a greater role in performing critical study functions and making direct and significant contributions to the study data. For example, a research coordinator often recruits subjects, collects and evaluates study data, and maintains study records. Therefore, the research coordinator should usually be listed in Section #6 of the 1572.”
This represents a major shift from the draft 1572 guidance dated July 2008, where it was recommended that study coordinators be listed if performing "critical study functions". The change appears to acknowledge not only that study coordinators play a consistently critical role in study conduct, but also that they take a significant role in recruiting subjects.
Notice also the non-committal use of words like "should" and "generally", but don't be mistaken: The FDA considers their guidances and FAQ's to be a close to regulation as you can get without going through the full process, so as Carl says, might be a good idea to update your 1572s to include study coordinators.
However after you get all your 1572s updated to reflect this guidance, the FDA says you shouldn't be revising them and having the investigator re-sign them any time something changes during a study, like new sub-investigators or a change in lab. The guidance says that 1572 needs to be completed and signed by the principal investigator on only two occasions: when participating in a new protocol under the IND or when he is being added to an existing protocol under an IND (question 7, page 6). One hopes that this will cut down on some of the paper chase that goes on throughout long studies when people think they have to update the 1572 every time some item on it changes. The FDA says we can simply include these changes during routine informational updates to the IND.
Use of Foreign Investigators
The FAQ also has a lot of guidance on the requirements of foreign investigators vis-a-vis the 1572, use of foreign data in support of submissions, foreign investigators obligations with respect to local versus US laws, and so one. I did not know for example that multinational studies may include domestic sites under the IND and foreign sites not under the IND. In that case the non-US investigators would not be required to sign the 1572, which is sometimes a sticking point with them as they don't wish to be obligated to US law, and the sponsor could use similar rather than exactly identical protocols to allow for differences in medical practice yet still result in pool-able data. If this is a change it is a good one.
It was mango season.
In this FAQ the 1572 is describes as having two purposes: one) to provide the sponsor with information about the investigator's qualifications and the suitability of the site for clinical trial purposes, and two) tho inform the investigator of his/her obligations and to obtain the investigator's commitment to discharge those obligations according to the regulations. This clearly defines the document as a two-way communication tool in addition to a statement of undertaking. The parties involved in the communication flow are the sponsor and the investigator. Notice that the FDA is not among those sharing in this conversation. The guidance makes it clear that sponsors are not required to submit the 1572 to the IND, although it acknowledges that most sponsors do because it is a convenient collection tool for all the information that sponsors must submit to the FDA under 21 CFR 312.23(a)(6)(iii)(b). This is a small but potentially important distinction: the 1572 itself is not required to be submitted, just the information contained. A sponsor could submit that information on a separate sheet of paper and be fully in compliance. Most regulatory folks both of sponsors and CROs have always insisted that the 1572 itself must be submitted, yet I never found a regulations supporting the policy. It's nice to know what the requirement actually is.
Study Coordinators Now Should be Listed Routinely
Former FDAer and blogger Carl Anderson has an excellent run-down on one of the other new provisions of the guidance, namely that study coordinators should now be listed on the 1572:
“Generally, a research coordinator has a greater role in performing critical study functions and making direct and significant contributions to the study data. For example, a research coordinator often recruits subjects, collects and evaluates study data, and maintains study records. Therefore, the research coordinator should usually be listed in Section #6 of the 1572.”
This represents a major shift from the draft 1572 guidance dated July 2008, where it was recommended that study coordinators be listed if performing "critical study functions". The change appears to acknowledge not only that study coordinators play a consistently critical role in study conduct, but also that they take a significant role in recruiting subjects.
Notice also the non-committal use of words like "should" and "generally", but don't be mistaken: The FDA considers their guidances and FAQ's to be a close to regulation as you can get without going through the full process, so as Carl says, might be a good idea to update your 1572s to include study coordinators.
Sign It Once and Done
However after you get all your 1572s updated to reflect this guidance, the FDA says you shouldn't be revising them and having the investigator re-sign them any time something changes during a study, like new sub-investigators or a change in lab. The guidance says that 1572 needs to be completed and signed by the principal investigator on only two occasions: when participating in a new protocol under the IND or when he is being added to an existing protocol under an IND (question 7, page 6). One hopes that this will cut down on some of the paper chase that goes on throughout long studies when people think they have to update the 1572 every time some item on it changes. The FDA says we can simply include these changes during routine informational updates to the IND.
Use of Foreign Investigators
The FAQ also has a lot of guidance on the requirements of foreign investigators vis-a-vis the 1572, use of foreign data in support of submissions, foreign investigators obligations with respect to local versus US laws, and so one. I did not know for example that multinational studies may include domestic sites under the IND and foreign sites not under the IND. In that case the non-US investigators would not be required to sign the 1572, which is sometimes a sticking point with them as they don't wish to be obligated to US law, and the sponsor could use similar rather than exactly identical protocols to allow for differences in medical practice yet still result in pool-able data. If this is a change it is a good one.
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How about a photo? Here is one from a recent project management workshop that we led in Bombay. 
It was mango season.
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