Drug Makers - Avoid the Data Disaster

Surprisingly, drugs are not the main thing pharmaceutical companies produce. From early discovery to post-marketing, they are in the business of producing data. Data open doors to investment and regulatory approval and determine the fate of every therapeutic program. The right dataset, sometimes shockingly small, can allow novel therapies to reach patients desperate for treatment; on the business side, data can be worth billions of dollars.

With data being the cornerstone of drug development, why do some organizations lose focus? We have seen this often – companies eager to initiate new programs, but unable or unwilling to apply adequate resources to ensuring the quality of their clinical data.

Mark Twain’s quote sums this up well:

“Behold, the fool saith, "Put not all thine eggs in the one basket" - which is but a matter of saying, "Scatter your money and your attention"; but the wise man saith, "Pull all your eggs in the one basket and - WATCH THAT BASKET.”

A key basket worth watching is your CRFs (case report forms). CRFs are the mechanism by which data are collected from the clinical sites. If the CRFs are designed poorly and not adequately thought through, then critical data may never even enter the database. Perhaps you are interested in capturing the details associated with prior therapy to really highlight the severity of disease in your patient population. If the CRFs don’t allow these data to be specifically and systematically entered, then you will end up with inadequate data; no data, no story.  

Another basket to be watched is your evolving database. With a typical study being conducted across dozens of clinical sites, often around the globe, it’s expected that there will data entry errors. Many companies fall behind on their data cleaning, which requires experienced clinical scientists and/or medics assisting the data managers to systematically and regularly review the database and flag obvious errors. Too often the cleaning of clinical data is left until the end of the study, which may not allow enough time to correct mistakes before an eminent filing. Aggressive timelines for submissions exacerbate these late pushes for data cleaning resulting in incomplete cleaning or unanticipated delays.

Overall, leaders at drug-makers would be best served to re-think what their business is – they are data makers first and foremost. Without quality data, their drugs will never reach their intended patients. As such, their teams should be built to ensure they maintain the highest quality data.    

Justin McLaughlin

CEO, Acumen Medical Communications