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Dear section members,

A recent publication in the JBS (Journal of biopharmaceutical statistics),   that section members and many others may find useful. I'm honored to be a co-author with a group of very  talented statisticians. The topic is clinical trial disruptions, foremost recent example were the disruptions worldwide of many clinical trials due to the Covid pandemic. The citation

The above publication work arose from the --- Ingram Olkin Forum Series on Unplanned Clinical Trial Disruptions --- sponsored by the NISS (National Institute of Statistical Sciences). I recommend section members sign on to the NISS email list for announcements and consider attending upcoming NISS sponsored seminars. 

As I'm assume has happened to some section members, more than once in my career, I had experience with significant clinical trial disruptions, at a time when we were uncertain as to specific steps to take in the statistical analysis of those clinical trials.  In my career, we experienced a  massive disruption of the corporate  Headquarters (Palo Alto) function and Northern California area clinical sites operations due to the 1989 Loma Prieta Earthquake. I have vivid recollection of the impact of the quake in Palo Alto. At the time, I had just started the new job. And arrived to my new company to hear that the regulatory (FDA etc.) record keeping rooms filled with 4 and 6 drawer lateral files, had tipped over, often times spilling the contents of many records on the floor. Weeks of refiling was required after that.  My office partner had been attending Game 3 of the world series at Candlestick park when the quake occurred. No serious or life threatening  injuries at my corporation (Syntex) that I was aware of at the time. In California that led to recommendations, changes in building codes, and legislation. One example was that furniture was to be bolted to the walls.

Several years later I was working on clinical trials when there was  a major disruption of New Orleans Area clinical sites due to Hurricane Katrina in 2005. Some clinical sites were flooded or underwater and could not be visited or contacted. And tragic reports from NOLA of laboratories and freezer storage inundated with water and years of biological tissue and other sample collection ruined. 

Dear section members,

A recent publication in the JBS (Journal of biopharmaceutical statistics),   that section members and many others may find useful. I'm honored to be a co-author with a group of very  talented statisticians. The topic is clinical trial disruptions, foremost recent example were the disruptions worldwide of many clinical trials due to the Covid pandemic. The citation

The above publication work arose from the --- Ingram Olkin Forum Series on Unplanned Clinical Trial Disruptions --- sponsored by the NISS (National Institute of Statistical Sciences). I recommend section members sign on to the NISS email list for announcements and consider attending upcoming NISS sponsored seminars. 

As I'm assume has happened to some section members, more than once in my career, I had experience with significant clinical trial disruptions, at a time when we were uncertain as to specific steps to take in the statistical analysis of those clinical trials.  In my career, we experienced a  massive disruption of the corporate  Headquarters (Palo Alto) function and Northern California area clinical sites operations due to the 1989 Loma Prieta Earthquake. I have vivid recollection of the impact of the quake in Palo Alto. At the time, I had just started the new job. And arrived to my new company to hear that the regulatory (FDA etc.) record keeping rooms filled with 4 and 6 drawer lateral files, had tipped over, often times spilling the contents of many records on the floor. Weeks of refiling was required after that.  My office partner had been attending Game 3 of the world series at Candlestick park when the quake occurred. No serious or life threatening  injuries at my corporation (Syntex) that I was aware of at the time. In California that led to recommendations, changes in building codes, and legislation. One example was that furniture was to be bolted to the walls.

Several years later I was working on clinical trials when there was  a major disruption of New Orleans Area clinical sites due to Hurricane Katrina in 2005. Some clinical sites were flooded or underwater and could not be visited or contacted. And tragic reports from NOLA of laboratories and freezer storage inundated with water and years of biological tissue and other sample collection ruined.