We all know how important it is for clinical research organizations to have well-developed, clearly documented, standardized procedures (SOPs), with supporting technology, in order to conduct our business effectively. Despite SOPs often being derided, we don’t think anyone would disagree that these procedures and systems are a key part of ensuring that a sponsor’s clinical development and drug safety complies with regulatory and ICH requirements and standards. Equally importantly, SOPs and technology documentation serve as the backbone for training clinical research personnel, governing the day-to-day activities of each functional group within the organization.

Increased regulatory scrutiny (or the promise thereof) has further pushed the focus on SOPs, with information technology often playing a key role in facilitating and enabling this compliance. However, the interpretation of what “compliance” exactly requires can become lost in translation; the lengths to which some groups have gone to comply with regulations may become counterproductive, and at times even unnecessary. One might call it….obsessive.

Some clinical research groups make Herculean efforts to achieve a perceived level of quality in their work that, in the end, actually surpasses any true need or business benefit. In fact, rather than addressing a real need, adopting over-burdensome, unnecessary quality assurance procedures can actually create more problems by decreasing productivity, creativity and personal responsibility for quality work. Tied to that, of course, is the way that technology can be used (or mis-used) to enable this unhealthy focus on perfection. Indeed, information technology is often a prime forum for misplaced quality obsessions. Not only do quality assurance professionals often misunderstand the meaning of essential concepts of technology quality (like “systems validation” and “21 CFR 11 compliance”), but quality can be misused in ways which obstruct technology acquisition and implementation (and return on investment) without justification. Most disturbing of all is that IT professionals themselves, in some biopharmas, are witting accomplices to these misjudgments.

When bad things happen…

When you look at the SOPs that certain functional groups have developed, you can’t help but wonder if some event happened in the corporation’s “childhood” to make them almost obsessively concerned with achieving perfection – to avoid mistakes or errors at all costs. This past experience may trigger what we’re calling “Obsessive Quality Disorder”. Perhaps an organization can experience the same kind of reaction to a negative experience (for example, receipt of an FDA Notice of Violation or Warning Letter) as an individual or a family experiencing a life-changing trauma. The parallels can be instructive.

For an individual or a family, the reaction to a negative experience can take many forms. One example is when children revert to a younger stage of development in reaction to a family transition or crisis. For example, a family moves to a new town, leaving many friends behind. Immediately or shortly after the move, the four-year-old daughter starts to have temper tantrums, something she has not done since she was two. If parents are insecure, they will create more of a problem by becoming overly reactive and anxious. They might miss the obvious connection between the geographic move and the regression, and instead look needlessly for more complicated explanations and solutions.

In personal psychology, the problem can go further. The definition of Obsessive Compulsive Disorder (“OCD”) is when people have repeating doubts about whether a situation is safe. People with OCD respond by obsessing often about whether things are orderly and symmetrical. In order to reduce the anxiety that bad things my happen (again), someone with OCD will act in compulsive ways by creating rituals (“policies and procedures”) that are meant to keep the feared event at bay.

The parallel corporate behavior shows up in clinical development. For instance, clinical data management departments might respond to an auditor’s observed deficiency by putting elaborate, cumbersome procedures in place to guarantee this “traumatic event” (the observation) will never happen again. Departmental subgroups might be added to implement these processes, and organizational charts end up ballooning to accommodate a new workforce devoted to ensuring (obsessively) that no step in a given process will ever go unverified.

Drug safety departments in particular are susceptible to embracing highly-detailed, complex and redundant procedures that focus on ensuring “quality” (which they translate into “compliance”). It’s not unusual to find personnel in these groups spending an inordinate amount of their day checking, double-checking and sometimes triple-checking what someone has already done before them in the process, with no other justification than “assurance”.

If one is able to investigate the root cause of this behavior, the phrase you find that best summarizes things is: “we don’t trust them” – “them” being either another department, a subordinate, a partner company, or even the co-worker sitting in the next cubicle. This subliminal atmosphere of mistrust and pursuit of perfection can actually negatively affect individuals’ performance, when people are constantly in fear of being “caught” making an error.

This is also where “OQD” is most disruptive to technology innovation. Very expensive, resource-consuming clinical IT projects have been delayed for months or years because of the inherent mistrust we are describing. It is not technical design, vendor failings, or even resistance to change among users which ultimately delayed these projects, but rather an intractable mistrust based on equally well-meaning but dysfunctional motivations.

Road to recovery

When an organization has obsessively over-treated a problem, the first step to “recovery” is to recognize that a problem or unhealthy situation exists. Taking a big step back and re-examining a department’s process isn’t always an easy thing to do, especially when there is a set of beliefs about quality that has been deeply ingrained within the organization.

Equally difficult are situations where those in upper levels of management are not willing to re-consider that procedures are overly “quality burdened”. In these instances, a significant effort by correctly empowered personnel need to help upper management re-examine the big picture, and find the balance between responsibility and fear.

One way to find the right balance is to use the wisdom of the people who actually do the work to create the solutions, rather than imposing something on them from other departments or from on high. When solutions are co-developed with the people who carry them out, there is generally more buy-in and better outcomes. This is most dramatic when comparing the mindset of an auditor or even an IT department liaison to that of the actual user of the process or technology in real work.

Prevention is better than intervention

Healthy companies, like healthy families, are able to respond to problems in a secure, reflective way, looking at the strengths and abilities of the people and systems that are in place, capitalizing on them, and adding only practices which are necessary to perform correctly, or use their energy for innovation. Healthy personalities are willing to make changes, even dramatic ones, which are consistent with the end goals, but give up on short-term targets that are no longer useful.

Regularly re-examining your department’s approach to quality is important to ensure that some level of “Obsessive Quality Disorder” isn’t unnecessarily preventing IT innovation and other efficiency initiatives intended to improve compliant clinical research. A little family therapy can go a long way to helping your company’s productivity.