{"id":559,"date":"2017-02-22T12:58:19","date_gmt":"2017-02-22T17:58:19","guid":{"rendered":"http:\/\/waife.com\/home\/?p=559"},"modified":"2017-02-22T13:00:11","modified_gmt":"2017-02-22T18:00:11","slug":"it-aint-me-babe-its-my-culture-clinical-researcher-february-2017","status":"publish","type":"post","link":"http:\/\/waife.com\/home\/it-aint-me-babe-its-my-culture-clinical-researcher-february-2017\/","title":{"rendered":"It Ain\u2019t Me Babe, It\u2019s My Culture (Clinical Researcher, February 2017)"},"content":{"rendered":"

If pharmaceutical companies have a special Harry Potter \u201cDefense Against\u00a0the Dark Arts\u201d class for their management team, one of the first techniques they must be learning is the Culture Defense. When confronted with evidence of their reluctance to change, they are apparently taught to point their wands out in front of them and say, \u201cIt ain\u2019t me, it\u2019s the culture here.\u201d This turns out to be a marvelous, widely applicable spell\u2014the easiest way out of an uncomfortable situation. There\u2019s one problem: we are <\/em><\/strong>the culture.<\/p>\n

We can\u2019t all be the rebels, can we? If so, how would the \u201cculture\u201d ever form with beliefs different from our own? To claim that company culture is the reason that operational innovation fails to take root is to deny your own place in the company you work. Culture doesn\u2019t kill efficiency, people do.<\/p>\n

This common weakness of corporate organizations is particularly obstructive to the introduction of information technology because technology generates so much upheaval, especially in areas of clinical development still untouched, or merely grazed, by the productive use of software. Often standing in the way of that productivity is the Culture Defense.<\/p>\n

Let\u2019s look at the following examples of flawed process improvement where culture is often blamed as the cause of failure, and let\u2019s ask ourselves if there might be other reasons lurking.<\/p>\n

<\/h2>\n

The Ubiquitous Culture Defense<\/strong><\/p>\n

We\u2019re getting lousy data out of a great tool (an expensive enterprise clinical trials monitoring service [CTMS] for instance, or a state-of-the-art adverse event system). How does this happen? The old IT acronym, \u201cGIGO\u201d (garbage in, garbage out), applies. But why is it happening? Why are our staff waiting until the last minute to enter trial status information that is supposed to be feeding a highly accurate real-time CTMS? Or in the case of the adverse events system (AES), why are antique paper-based data flows being maintained, while the AES is an alien, unwelcome layer imposed on top. Why is this allowed to happen? The Culture Defense says, \u201cWell, we\u2019re not used to reporting data in real-time,\u201d or \u201cWe want to review and double-check the information before anyone sees it.\u201d Or in the safety case, \u201cWe won\u2019t risk the importance of safety surveillance to software which may not work.\u201d It\u2019s a culture thing. Really?<\/p>\n

Another example: A major process improvement project is organized into the ubiquitous \u201cworkstreams\u201d and comes up with a flood of recommended changes. Several of the most important changes require re-organizing staff, and while the net headcount will stay the same, some people will probably not fit the new skills required. Impossible! Why? Because \u201cwe don\u2019t (or can\u2019t) fire people here \u2013 it\u2019s our culture.\u201d<\/p>\n

And another example: We throw resources (human and monetary) at the database lock of our pivotal trial, with no restraint. At that moment, there is nothing more important to the company. If the data management processes are examined, however, you will likely find that the electronic data capture (EDC) tools you have used for years are being used sub-optimally and inefficiently. It\u2019s the culture. Perhaps it is, but is that a good thing? Does the Culture Defense make all other options moot?<\/p>\n

Yet another example: \u201cWe don\u2019t measure here.\u201d It\u2019s our culture not to measure, or if we do, we don\u2019t do it consistently, or with rigor, or learn from the results. There\u2019s probably loads of data \u2013 indeed too much data \u2013 for you to measure from, but it\u2019s not in the culture to act on this information. Is that culture or laziness or fear?<\/p>\n

More pervasively, it is common to see clinical development executives across the industry turn a blind eye to what really happens at the operational level. Executives announce an impassioned commitment to a particular process improvement initiative, and tiptoe out of the room\u2014leaving the implementation to middle management. In many companies, without the executive watching your back, there is little incentive for middle managers to execute on the vision. Is this disconnect a culture<\/em><\/strong> problem or a management<\/em><\/strong> problem?<\/p>\n

 <\/p>\n

It Is<\/u><\/em> You, Babe<\/strong><\/p>\n

If individual study teams, or even entire therapeutic areas, don\u2019t follow company- wide SOPs (but instead make up their own regulatory-compliant \u201cstandards\u201d), is that culture or the acts of individual managers? (It may be a justifiable action on the manager\u2019s part, but that\u2019s logic, not culture, at the source.)<\/p>\n

If we put training of the new CTMS tool in an e-learning environment (although most monitors won\u2019t really pay attention and only click through it to get certified), can we blame our culture for being anti-training? It\u2019s the individual who chose not to pay attention. If we rely on individuals\u2019 cooperation in using new tools appropriately, and people fail to do so, isn\u2019t that a series of individual decisions? If I fail to fill out all the fields in a template-based site visit report in my clinical trial management system (CTMS), isn\u2019t that my choice? The culture didn\u2019t make me do it, I chose<\/em><\/strong> not to do it.<\/p>\n

The damaging side-effects of the Culture Defense are legion: it enables us to drag our feet when it comes to changing the way we are used to working; it gives us permission to abdicate responsibility without penalty; it enables us to stand in the way of progress with impunity for whatever our personal motivation may be (e.g., we\u2019re overworked, we\u2019re jealous, we want our<\/em><\/strong> pet project to get all the attention, we\u2019re afraid of learning too many new process details).<\/p>\n

Psychologists will tell us that the most powerful realization victims of damaging habits can have is that they have a choice<\/em><\/strong> to change. The Culture Defense is designed to prevent<\/em><\/strong> choice, to prevent individual responsibility, even to preclude individual initiative. The Culture Defense is defeated by individuals who choose not to go along with the easy path, to see the executive direction as good for themselves as well as the company, to embrace change as the inevitable condition of modern business, to risk getting information that may reveal true operating conditions quicker because it is better to do so, and to risk measuring because objective data about how we work can make us better workers.<\/p>\n

We as individual pharmaceutical company staff, middle managers, and executives can choose<\/em><\/strong> to act in a manner that enables operational improvement to flourish. We can face down the Culture Defense so that our process redesigns are easily learned and pragmatic, so that our CTMS systems actually produce accurate, actionable data on clinical trial program performance, so that our CRO vendors are well managed; so that our technology investments are worth the effort to implement them; and so that our diverse and broadly skilled staff can be focused on productive work with urgency.<\/p>\n

 <\/p>\n

Walt Kelly, in his famous cartoon strip Pogo<\/em>, memorably exclaimed, \u201cWe have met the enemy and he is us.\u201d Culture isn\u2019t the enemy, we are. Facing up to this fundamental truth will begin to enable operational innovation to meet our expectations.<\/p>\n","protected":false},"excerpt":{"rendered":"

If pharmaceutical companies have a special Harry Potter \u201cDefense Against\u00a0the Dark Arts\u201d class for their management team, one of the first techniques they must be learning is the Culture Defense. When confronted with evidence of their reluctance to change, they are apparently taught to point their wands out in front of them and say, \u201cIt ain\u2019t me, it\u2019s the culture here.\u201d This turns out to be a marvelous, widely applicable spell\u2014the easiest way out of an uncomfortable situation. There\u2019s one problem: we are the culture. We can\u2019t all be the rebels, can we? If so, how would the \u201cculture\u201d ever form with beliefs different from our own? To claim that company culture is the reason that operational innovation fails to take root is to deny your own place in the company you work. Culture doesn\u2019t kill efficiency, people do. This common weakness of corporate organizations is particularly obstructive to the introduction of information technology because technology generates so much upheaval, especially in areas of clinical development still untouched, or merely grazed, by the productive use of software. Often standing in the way of that productivity is the Culture Defense. Let\u2019s look at the following examples of flawed process improvement where […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[50,54],"tags":[],"class_list":["post-559","post","type-post","status-publish","format-standard","hentry","category-recent-columns","category-recent-postings"],"_links":{"self":[{"href":"http:\/\/waife.com\/home\/wp-json\/wp\/v2\/posts\/559","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=559"}],"version-history":[{"count":1,"href":"http:\/\/waife.com\/home\/wp-json\/wp\/v2\/posts\/559\/revisions"}],"predecessor-version":[{"id":562,"href":"http:\/\/waife.com\/home\/wp-json\/wp\/v2\/posts\/559\/revisions\/562"}],"wp:attachment":[{"href":"http:\/\/waife.com\/home\/wp-json\/wp\/v2\/media?parent=559"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"http:\/\/waife.com\/home\/wp-json\/wp\/v2\/categories?post=559"},{"taxonomy":"post_tag","embeddable":true,"href":"http:\/\/waife.com\/home\/wp-json\/wp\/v2\/tags?post=559"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}