Category Archives: Uncategorized

A Query Named Matilda

Good Clinical Practice guidelines (VICH GL9) Section 8.3.1 requires that all raw study data, “whether handwritten or electronic, be attributable, original, accurate, contemporaneous, and legible.”

“Original and accurate means the raw data are the firsthand observations.”

“Contemporaneous means the raw data are recorded at the time of observation.”

“Legible means the raw data are readable and recorded in a permanent medium , e.g., ink for written records or electronic records that are unalterable.”

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Data Dilettantes

The success or failure of a clinical trial turns on the integrity of the data, i.e. whether it is complete, accurate, and contemporaneously-recorded. The integrity of the data depends on the diligence of those collecting and recording it. And that is where many clinical trials run into trouble.

Most investigators and other site personnel participating in clinical trials start out with the best of intentions. However, good intentions alone will not result in high quality data. They must be supplemented with comprehensive protocol training and frequent follow-ups to prevent the normal daily demands of a busy clinic from distracting the investigator and other site personnel from their important study responsibilities .

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I love Halloween … the pumpkins, the corn stalks, the hay rides, the hot apple cider and, of course, the trick-or-treaters.

From walking my two dogs, I have come to know most of the kids in my neighborhood. So, I enjoy matching each child to the character they have chosen to portray. Usually it’s fairly easy. Although, as I get older, I find that I am increasingly out of touch with current film and TV heroes.

However, at least once each Halloween, someone comes with a costume so elaborate or a mask so life-like that their identity is totally obscured. Most eventually tell me who they are but a few leave me wondering for the rest of the night. This year, there was one ghastly, ghostly, grim reaper who had me totally stumped. I still am unsure whether it was a boy or a girl behind that very scary mask with the articulating jaw.

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Band-Aids and Vaccines

My July 2015 article, “How to Cut Study Delays-Revisited;’ generated quite a bit of interesting feedback. However, since research has shown that 90% of all clinical trials experience significant delay, I was not surprised. Some people shared their version of one of the problems I had cited. Others called to recount their tales of clinical trials gone bad. A few offered solutions or strategies that I had not considered. What did surprise me was the concentration of troubled scenarios around one of two causes: incomplete protocol development or slow enrollment.

All clinical trials have a timeline, some more aggressive than others. However, I have yet to see one that did not increase the stress level of one or more members of the project team. When the inevitable problems occur, there is rarely enough time to pause all activities while the team determines the root cause. More often than not, a looming deadline reinforces the natural inclination to apply a Band-Aid and keep moving forward. The intention always is to revisit the situation at a later, less rushed date to develop a permanent solution — a vaccine, if you will — so that particular problem does not recur in future trials. Finding the time for that extra step in today’s pressured development environment is difficult.

The future dividends, though, make the effort a worthy investment. To further illustrate this point, I selected seven scenarios from those I received, together with the corresponding Band-Aid and my recommended vaccine.

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