{"id":231,"date":"2014-02-05T21:42:47","date_gmt":"2014-02-06T02:42:47","guid":{"rendered":"http:\/\/waife.com\/home\/?p=231"},"modified":"2014-02-05T21:42:47","modified_gmt":"2014-02-06T02:42:47","slug":"the-path-of-most-resistance-monitor-2011","status":"publish","type":"post","link":"http:\/\/waife.com\/home\/the-path-of-most-resistance-monitor-2011\/","title":{"rendered":"The Path of Most Resistance (Monitor, 2011)"},"content":{"rendered":"

Sometimes, when the resistance is greatest, the treasure being guarded is the most valuable.<\/em><\/p>\n

 <\/p>\n

\u201cThe path of least resistance\u201d is a seductive phrase. It is used so often by those made nervous by change, or those who simply want to avoid conflict. It is seductive because it sounds wise, mature, even efficient. And sometimes I suppose it is. But often as not, the path of least resistance is very winding, indirect by definition, filled with backtracks, detours and roundabouts. It may have the least resistance, but sometimes it is the slowest path, without any guarantee that you won\u2019t come to a dead end.<\/p>\n

 <\/p>\n

Boulders Aplenty<\/strong><\/p>\n

The path we take to arrive at change \u2013 in a process or strategy or the tools we use \u2013 is a key determinant of success. The resistance that we usually seek to avoid can take innumerable forms, and so these seem like daunting boulders in our way. Let\u2019s list just a few:<\/p>\n

\u00a7 Inertia, the immutable law that states that an employee entrenched tends to stay entrenched<\/p>\n

\u00a7 Lack of a perceived demand for change, or \u201cwhat\u2019s everyone so upset about?\u201d<\/p>\n

\u00a7 Distractions, as in \u201cI\u2019m too busy figuring out how the latest merger affects my retirement plan\u201d<\/p>\n

\u00a7 Alternative priorities (\u201cI have my own agenda, thanks very much\u201d)<\/p>\n

\u00a7 Compliance, as in \u201cI\u2019m not sure which one, but I\u2019m sure the regs don\u2019t allow that\u201d<\/p>\n

\u00a7 We have a process for that, where \u201cprocess\u201d means bureaucracy<\/p>\n

\u00a7 We have channels for that, as in \u201cgo see the contracts office\u201d<\/p>\n

\u00a7 Personalities (take your pick, from passive or hostile to know-it-all)<\/p>\n

\u00a7<\/b><\/b>\u00a0And the ultimate boulder, the budget (\u201csorry, we didn\u2019t budget for that this decade\u201d).<\/p>\n

 <\/p>\n

When faced with this landscape, no wonder we typically look for less resistance, but if we try to miss all the boulders, how will we ever find our way?<\/p>\n

 <\/p>\n

Examples Aplenty<\/strong><\/p>\n

Throughout clinical development there are many boulder-strewn pathways to greater efficiency. Let\u2019s think about just two examples: reducing source data verification (SDV) and improving protocol feasibility. First let\u2019s look at the paths of least resistance.<\/p>\n

 <\/p>\n

SDV is a sacred cow milked by data management, monitoring, statistics and QA. And time-and-materials-based CROs endorse the labor-intensive policy wholeheartedly. The path of least resistance will lead us past these pools of quicksand on a route that nods empathetically to each of the resistant constituencies. We will concede that once you start looking at one field on the eCRF, you might as well look at them all. We will let statistics throw more queries on the truck. We won\u2019t try fighting QA\u2019s fears by taking the time to read the regulations more carefully. And we will give in when the CROs warn how expensive it will be if they have to change their SOPs just for us. The path of least resistance will lead us to a minor reduction in SDV, with virtually no efficiency benefit, but lots of arguments avoided.<\/p>\n

 <\/p>\n

With improving protocol feasibility as our destination, the path of least resistance will take a very wide turn around the medical affairs staff who just joined industry from academia yesterday, abdicating our responsibilities as clinical operations professionals. We will go miles out of our way to accommodate key opinion leaders essential to research paper authorship, but out of touch with patient populations and their health behaviors. And we will take the superhighway to the advertising agencies who will \u201crescue\u201d our study after infeasible enrollment targets are missed.<\/p>\n

 <\/p>\n

There\u2019s Gold in Them Thar Resistances<\/strong><\/p>\n

We cannot base our work on the paths of least resistance. Of course we want to work without acrimony, arguments, and escalations. But our industry is suffering from this ingrained fear. Complacency and inertia have led to a degree of ineffectualness that triggers executive dismissal of the clinical development function. So far, that means simply transposing the inefficiency from internal resources to external ones. A better analysis would recognize that sometimes, when the resistance is greatest, the treasure being guarded is the most valuable.<\/p>\n

 <\/p>\n

Facing the resistance should not be corporate suicide; instead it can take the lid off of hidden misunderstandings and past grudges. For instance, challenging traditional SDV policies head-on, if done correctly, generates a healthy debate that puts the issue in the context of modern realities instead of 1990\u2019s assumptions. Similarly, maintaining weak protocol evaluation practices to protect interpersonal scientific relationships will only cost us time and money we do not have. A direct comparison of expert opinion with properly collected data on patient populations, distribution and attitudes can have a lasting improvement on clinical development performance.<\/p>\n

 <\/p>\n

If we can get past entrenched self-interests defending the current SDV policy, by confronting the boulders head on, we will discover remarkable reductions in necessary data monitoring effort. If we face the rock cliff of infeasible protocol designs at the first gate, and dare to say that climbing it is more important than ego, then we may find a much shorter path to full enrollment on the other side.<\/p>\n

 <\/p>\n

The path of most resistance may be arduous at first, but as with all pathfinding, the more we travel it, the smoother and faster the path will become.<\/p>\n

 <\/p>\n","protected":false},"excerpt":{"rendered":"

Sometimes, when the resistance is greatest, the treasure being guarded is the most valuable.   \u201cThe path of least resistance\u201d is a seductive phrase. It is used so often by those made nervous by change, or those who simply want to avoid conflict. It is seductive because it sounds wise, mature, even efficient. And sometimes I suppose it is. But often as not, the path of least resistance is very winding, indirect by definition, filled with backtracks, detours and roundabouts. It may have the least resistance, but sometimes it is the slowest path, without any guarantee that you won\u2019t come to a dead end.   Boulders Aplenty The path we take to arrive at change \u2013 in a process or strategy or the tools we use \u2013 is a key determinant of success. The resistance that we usually seek to avoid can take innumerable forms, and so these seem like daunting boulders in our way. Let\u2019s list just a few: \u00a7 Inertia, the immutable law that states that an employee entrenched tends to stay entrenched \u00a7 Lack of a perceived demand for change, or \u201cwhat\u2019s everyone so upset about?\u201d \u00a7 Distractions, as in \u201cI\u2019m too busy figuring out how the […]<\/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-231","post","type-post","status-publish","format-standard","hentry","category-recent-columns"],"_links":{"self":[{"href":"http:\/\/waife.com\/home\/wp-json\/wp\/v2\/posts\/231","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=231"}],"version-history":[{"count":1,"href":"http:\/\/waife.com\/home\/wp-json\/wp\/v2\/posts\/231\/revisions"}],"predecessor-version":[{"id":232,"href":"http:\/\/waife.com\/home\/wp-json\/wp\/v2\/posts\/231\/revisions\/232"}],"wp:attachment":[{"href":"http:\/\/waife.com\/home\/wp-json\/wp\/v2\/media?parent=231"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"http:\/\/waife.com\/home\/wp-json\/wp\/v2\/categories?post=231"},{"taxonomy":"post_tag","embeddable":true,"href":"http:\/\/waife.com\/home\/wp-json\/wp\/v2\/tags?post=231"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}