{"id":247,"date":"2014-02-05T21:50:17","date_gmt":"2014-02-06T02:50:17","guid":{"rendered":"http:\/\/waife.com\/home\/?p=247"},"modified":"2014-02-17T19:29:03","modified_gmt":"2014-02-18T00:29:03","slug":"the-best-we-can-monitor-may-2012","status":"publish","type":"post","link":"http:\/\/waife.com\/home\/the-best-we-can-monitor-may-2012\/","title":{"rendered":"The Best We Can? (Monitor, May 2012)"},"content":{"rendered":"

\u201cWhenever we say we\u2019re doing the best we can, it means something has gone wrong\u201d<\/strong><\/p>\n

 <\/p>\n

How often do you hear, from someone who has just failed you, that \u201cwe\u2019re doing the best we can\u201d? It is the universal response of auto repair shops, phone companies, catalog merchants, hospital nurses \u2013 just about anyone who has not delivered the service you expected. Instead of an apology, or a promise to improve, we are meant to believe we are getting the best there is. It is a universal and automatic expression, and also almost certainly a lie. The worst of it is, those who say it probably believe it.<\/p>\n

 <\/p>\n

A Story<\/strong><\/p>\n

 <\/p>\n

Here\u2019s a true story. I was supposed to receive a time critical, very important package one morning from Fedex. Ten-thirty AM came and went, and no package. I found the tracking number and going online, I instantly found out that the package would be on time! Except that it wasn\u2019t. So I picked up my phone and called Fedex, seeking a human rather than a database explanation. After the usual keypad entries and insipid hold music, and various transfers, I found myself speaking to a very kind and enthusiastic representative who told me there had been strong storms in the Midwest the night before, most packages were delayed, and delivery could not be estimated. When I pointed out that their website said it was \u201con time\u201d, she had no explanation other than, \u201cwe\u2019re doing the best we can\u201d.<\/p>\n

 <\/p>\n

Really? Was Fedex that day actually doing the best they could? Employing one of the most sophisticated worldwide tracking and communication systems in commercial use, could they not have done something other than post out-of-date, incorrect information? Could they have added a message alerting users to expect delays? Could they have had a recording on their customer service line? Could they have promised delivery within one additional day, rather than not having any prediction at all? Could they have looked at a weather forecast the day before? Could they have offered a partial refund? I\u2019m sure you can think of many more things Fedex could have done, and then ask yourself, did they do the best they could?<\/p>\n

 <\/p>\n

Best of What?<\/strong><\/p>\n

 <\/p>\n

I worry that this phrase is not just an expression, a habit of speech, or even just a feeble attempt at placating customers. I think it is a reflection of two key aspects of our daily work:<\/p>\n

1) we\u2019re always told how good we\u2019re doing and how hard we\u2019re trying; and therefore<\/p>\n

2) we settle for the status quo, believing that since we work long hours, we must be doing the best we can.<\/p>\n

What this means for clinical research is very important: we ignore the opportunities, and avoid the cost and time, for improving how we work \u2013 and how our suppliers work \u2013 because it is daunting to think of changing it. It is so much easier to think we\u2019re doing as well as we can.<\/p>\n

 <\/p>\n

Let\u2019s review a few of the opportunities for improvement in front of us:<\/p>\n

\u00a7 A large majority of our trials are behind their enrollment targets.<\/p>\n

\u00a7 Clinical staff change study protocols repeatedly, even after study start.<\/p>\n

\u00a7 Ethics committees\u2019 reviews routinely cause months of startup delay.<\/p>\n

\u00a7 A new study team rarely has the information to learn operational improvement from past study teams, nor do they seek this information.<\/p>\n

\u00a7 Service providers routinely charge substantial amounts in change orders, in part because of misguided contractual terms insisted on by sponsors.<\/p>\n

\u00a7 Joint steering committees between sponsor and service provider are neither truly \u201cjoint\u201d nor \u201csteering\u201d anything.<\/p>\n

\u00a7 EDC, ePRO, eTMFs and all the other \u201ce\u2019s\u201d are surrounded with paper, negating their cost savings.<\/p>\n

\u00a7 A focus on quality and oversight has turned into an endless loop of mistrustful triple-checking.<\/p>\n

\u00a7 Outsourcing requires more in-house management resources than insourcing did.<\/p>\n

And so on.<\/p>\n

 <\/p>\n

Clearly, in this 21st century world of clinical research, we are not doing the best we can. And yet, do we move through our days thinking about all the stupid things we do, or instead are we thinking about how we should stop and fix the stupid things we do? And let\u2019s not shy away from an important new reality in clinical research: it is even harder to stop doing stupid things when we are paying outsiders to do them, at our direction!<\/p>\n

 <\/p>\n

Building the Airplane in the Sky, and Other Moronic Metaphors<\/strong><\/p>\n

 <\/p>\n

The typical, and possibly most potent, argument for saying we are doing our best (insert shrug here), is that we can\u2019t stop the pace of clinical research to fix it. Pick one:<\/p>\n

\u00a7 We are building our airplane in the sky.<\/p>\n

\u00a7 We are trying to change the tire on a speeding car.<\/p>\n

\u00a7 We are trying to work on a speeding train.<\/p>\n

True enough. But here we have once again a case of the pharmaceutical industry somehow thinking they invented business adversity (regulations, the unpredictability of research, recouping capital-intensive development, requiring a highly skilled workforce) and no one has ever faced such novel problems. Which is very silly. Think of the number of enormous (and ultimately successful) transformations the automobile industry has undergone in every aspect of their business, while they still built and sold cars. Think about journalism, entertainment, the computer industry. They\u2019ve all had planes in the sky and trains on the track, but learned (eventually and sometimes painfully) how to change and execute at the same time.<\/p>\n

 <\/p>\n

Biopharma desperately needs to recognize when it is not doing the best it can, and figure out how to improve its operations other than mergers or outsourcing. Society needs our best; it is critically important that we find it.<\/p>\n

 <\/p>\n

It is a perverse use of the language that whenever we use this phrase, we\u2019re doing the best we can, that it always means something has gone wrong. Our \u201cbest\u201d is apparently never enough. When we\u2019ve done something great, why don\u2019t we ever stand up and say, truthfully: \u201cwe\u2019re doing the best we can\u201d? Shouldn\u2019t that be the better — and only — time to say it, rather than mumbling it as an excuse for shortcomings? Let\u2019s hope that someday, your organization, and even all of clinical research, can say this proudly.<\/p>\n","protected":false},"excerpt":{"rendered":"

\u201cWhenever we say we\u2019re doing the best we can, it means something has gone wrong\u201d   How often do you hear, from someone who has just failed you, that \u201cwe\u2019re doing the best we can\u201d? It is the universal response of auto repair shops, phone companies, catalog merchants, hospital nurses \u2013 just about anyone who has not delivered the service you expected. Instead of an apology, or a promise to improve, we are meant to believe we are getting the best there is. It is a universal and automatic expression, and also almost certainly a lie. The worst of it is, those who say it probably believe it.   A Story   Here\u2019s a true story. I was supposed to receive a time critical, very important package one morning from Fedex. Ten-thirty AM came and went, and no package. I found the tracking number and going online, I instantly found out that the package would be on time! Except that it wasn\u2019t. So I picked up my phone and called Fedex, seeking a human rather than a database explanation. After the usual keypad entries and insipid hold music, and various transfers, I found myself speaking to a very kind and […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[50],"tags":[],"class_list":["post-247","post","type-post","status-publish","format-standard","hentry","category-recent-columns"],"_links":{"self":[{"href":"http:\/\/waife.com\/home\/wp-json\/wp\/v2\/posts\/247","targetHints":{"allow":["GET"]}}],"collection":[{"href":"http:\/\/waife.com\/home\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"http:\/\/waife.com\/home\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"http:\/\/waife.com\/home\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"http:\/\/waife.com\/home\/wp-json\/wp\/v2\/comments?post=247"}],"version-history":[{"count":2,"href":"http:\/\/waife.com\/home\/wp-json\/wp\/v2\/posts\/247\/revisions"}],"predecessor-version":[{"id":410,"href":"http:\/\/waife.com\/home\/wp-json\/wp\/v2\/posts\/247\/revisions\/410"}],"wp:attachment":[{"href":"http:\/\/waife.com\/home\/wp-json\/wp\/v2\/media?parent=247"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"http:\/\/waife.com\/home\/wp-json\/wp\/v2\/categories?post=247"},{"taxonomy":"post_tag","embeddable":true,"href":"http:\/\/waife.com\/home\/wp-json\/wp\/v2\/tags?post=247"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}