We Can Make Clinical Trials Safer, Efficient With FDA ‘Best Practice’ Endorsement

Amid October’s pink ribbons is the story that some women have a type of breast cancer that’s difficult to treat, a problem we can only solve with more research. What if future clinical trials could be expedited with better-quality data, so we could get new, targeted therapies to everyone more quickly and save more lives, not just for breast cancer, but all types of diseases?

We already know how: Within the last decade, clinical research and technology companies have deployed a more efficient and effective quality-control process that can pinpoint with greater speed and accuracy the right information to protect patients and secure quality data much faster.

While I’m pleased the Food and Drug Administration has encouraged this new approach, called risk-based monitoring, for use in all clinical trials, it’s time to issue an official statement naming risk-based monitoring the gold-standard best practice. This would mean completely replacing older quality-control methods in most cases.

If we do that, pharmaceutical companies can submit stronger safety and efficacy data to the FDA, and patients can benefit even sooner from new therapies. Clinical trials can take up to eight years; if we can shorten that by even a year, it will make a tremendous difference.

Imagine you are responsible for a trial that enrolls 3,000 patients across 50 different locations. Your job is to watch over the entire operation, raising a red flag about any unusual findings, perhaps a higher-than-expected blood pressure reading.

How quickly can you notice that odd, needle-in-the-haystack result? How long does it take to identify the cause, whether it’s a data-entry error, an equipment malfunction or a potentially drug-induced rise in blood pressure that could endanger patients?

Risk-based monitoring is an effective solution that has gained popularity, but we can maximize its potential with the FDA’s endorsement. It’s the difference between the outdated protocol of sending a team of people to multiple trial sites every month to manually collect information, versus having a larger, bird’s-eye view of all sites on an electronic dashboard, instantly synthesizing data simultaneously and continuously.

Rather than combing through every piece of paper by hand, one by one, risk-based monitoring weeds out irrelevant information. For example, in most cases it wouldn’t impact a trial’s outcome if researchers recorded a patient’s height differently on different days, depending on whether they were wearing shoes. Instead of wasting time and brain power on that kind of detail, risk-based monitoring gets right to what matters.

In our survey of clinical research organizations, risk-based monitoring illustrated the potential for gathering better-quality data, for example, with 17 percent better detection of the type of significant deviations in trial data that would require attention. In one epilepsy trial, this approach alerted the sponsor to key differences in how investigators were tapering patients off the study medication. This could affect how the results were analyzed and submitted to the FDA and could even put patients at risk.

Risk-based monitoring can also be faster. One small biotech firm was able to cut down the data-review process from as many as 60 days to just five, dramatically slashing the time between when the last patient’s data was collected and when the database was finalized and submitted to the FDA.

As we work to create new advances for diseases such as breast cancer and beyond, clinical research and technology companies are committed to using risk-based quality monitoring. If the FDA declares it a best practice, everyone from small biotechs to large pharmaceutical companies will have the confidence to embrace it fully.

I urge the FDA to make a definitive statement in guidance that strongly encourages research sponsors, clinical research organizations and technology companies to fully adopt risk-based quality monitoring so that evidence-based new drugs can get to the patients who need them, sooner.


Doug Peddicord is executive director of the Association of Clinical Research Organizations, which represents the world’s leading clinical research and technology organizations.

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