If you are not locking your database within 5 days after your “last subject is out” then something is wrong.
It is a well-recognized in clinical research that succeeding and/or failing quickly is critical to the ability to bring new therapies to market. There are many aspects of clinical research that are beyond our control, such as how will the drug compete against other therapies in efficacy, how will the drug interact with the physiology of the subjects, and will this yield a favorable safety profile? These are the questions we hope to answer by conducting clinical trials, but we don’t have any direct control over them until we get the data.
What we do have control over, is how we collect and analyze the data, and more importantly, how quickly we are able to obtain this data to arrive at that critical and expensive decision of whether or not to proceed further. Over many years working in the biopharma research industry, I notice how much discussion is spent on getting that first subject into the trial. But many would argue that a heavier focus should be placed on getting the trial completed, so that you have the data you need to make critical development decisions. The database lock timepoint, then, is the key step in arriving at a development go/no go decision.
I continue to be shocked when I ask at conferences and clients, “How many days, on average, after last patient out, do you lock your database?” and the responses are overwhelmingly “weeks to months”. There are those few companies that are doing this within 5 days, and to those I say congratulations! – you need not read any further. To the rest, if you are using electronic data capture (EDC) and you are not locking your database within 5 days of last subject out, then there is something broken in your process. This applies to both outsourced and insourced models, and to a large degree is independent of the EDC software you are using. To be fair, some software solutions may make this process a little easier with various built-in tools, but most of you can achieve this goal with your current EDC technologies.
So, you should ask yourselves about whether your procedures are preventing you from completing your trials in an expedited fashion; this is one of those components of clinical research that you have full control over, and there are many proven strategies and techniques to succeed at faster database lock processes. Often, as in most process analysis and correction, the solution is very specific to your particular circumstances of talent, policies, politics, compliance and history. If you are interested in updating your processes to take full advantage of the technology you have purchased and implemented, then please reach out to Waife & Associates at www.waife.com. Or to me directly at firstname.lastname@example.org. We have a proven track record over 25 years specializing in biopharma clinical development to address these types of issues. A 5-day database lock is a very real and achievable milestone, and if you are not achieving this performance in your Phase II and Phase III programs, then you are leaving opportunities and money on the table.