It seems straightforward: Clinical trial sponsors are required to enter information about their studies at ClinicalTrials.gov, the resource maintained by the U.S. National Library of Medicine (NLM) and designed to offer the public standardized, up-to-date information about ongoing and completed clinical studies. The government provides detailed instructions. Yet, as we discussed here in a previous post, sponsors often fail to comply. Even those with the best intentions can run afoul of the exacting standards.
To be specific, NLM has reported that just 23% of those sponsors attempting to register a trial were successful in their first go at it.
Why? What is so challenging about this?
The truth is, there are many ways to get it wrong.
You Need to Assign the Job to the Right Person
The first challenge for sponsors is to identify someone to take responsibility for the work. This is not simply an administrative task and if someone is assigned on that basis, you’re already on the wrong path. A strong candidate must meet all these criteria:
Be very close to the data and grasp any complexities quickly
Understand all the nuances of and background to the trial
Be extremely detail-oriented
Have excellent written communication skills, including the ability to explain difficult scientific issues clearly and accurately to the general public
Be well versed in and sensitive to the particular demands of the NLM standards
Have the necessary bandwidth to stay on top of the project for the entire duration of the trial
Often the people best qualified don’t have room on their plates for an additional task requiring this time commitment. While there may be a temptation to delegate to junior, less-qualified members of the sponsor’s team, this can lead to problems and avoidable mistakes.
Let’s look at a few issues in greater detail:
You Must Have an Excellent Grasp of English and be a Careful Writer
The QC process is very unforgiving when it comes to language that is less than clear or not sufficiently scientific. This is a common stumbling block for sponsors, particularly those who are not native English speakers. Accuracy and consistency of approach are critically important, too. Consider your entries to ClinicalTrials.gov as part of a manuscript that will be scrutinized by a very discerning editor.
As to specific content, sponsors are not to draw conclusions. The task is simply to post results, not suggest what they might mean. There is no allowance for interpretation to any degree.
It Requires Long-Term Attentiveness
Creating your account at ClinicalTrials.gov is quick and straight-forward, but that just steps one on a long journey. Sponsors need to monitor and regularly update their information to ensure it reflects what is actually going on in the trial. There are triggers that require specific updates, such as the trial’s primary completion date, and these must be reflected at ClinicalTrials.gov. The more sites and data the trial involves, the more difficult this task will be, especially if trial data is poorly organized.
You Must be in Tune with the NLM Standards
There are numerous rules and procedural peculiarities that must be complied with when entering your trial information in order to meet the rigorous standards of the NLM. If you don’t abide by their processes, you will fail the quality control (QC) assessment. A novice may face several rounds of failed QC review, which is not only frustrating but wastes time and resources.
Know that Your Failure to Measure Up will be Made Public
If you don’t pass the ClinicalTrials.gov quality QC process, your colleagues across the industry will know as the NLM recently established a policy of posting the results of its review process. This means that sponsors who are guilty of some error, deficiency, or inconsistency will be publicly called out. Even though the infractions might be minor, this could be a source of some embarrassment for sponsors.
What to do to Improve your Odds of Success
Engaging a consultant to help you navigate ClinicalTrials.gov, is an approach that can save sponsors a lot of time, money, and scrutiny. Not only will it avoid potentially embarrassing errors and financial penalties, but you will be guided through the process with a knowledgeable, strategic and commercial hand, ensuring you report your trial wisely and in a timely fashion. Remember that this is a very public display of your trial and results; it reflects your organization and potentially could be read by those very patients whom you hope to recruit. Finally, a knowledgeable consultant can also advise you on more nuanced issues surrounding registration, such as the business advantages inherent in the timing of registration.
TBG has broad and deep knowledge of the clinical trial process and is well qualified to help sponsors navigate every aspect of it, including the varied rules for compliance with ClinicalTrials.gov. Reach out to us for the input that will make all the difference!