More changes in clinical trials since 2000

Our previous article discussed some of the most important changes in clinical trials in the past 17 years. So much has changed that it wasn’t possible to cover all the major points in a single article, so this second piece follows on where the previous one left off. Advances in technology again feature, as do changes in regulations that impact on clinical trials.

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More studies are being conducted

According to industry figures, 1,667 studies were registered 17 years ago. 22,876 were registered in 2014. That is a dramatic increase in less than two decades, and one of the main factors behind this surge is believed to be the decision by the International Committee of Medical Journal Editors to make registration one of the conditions of publication. This move took place in 2005 and the effect has been dramatic since then.

In addition, the Food and Drug Administration Amendments Act was enforced for the first time in 2007, and this made it a legal requirement for applicable clinical trials to be registered. According to the FDA, the Act aims to “provide significant benefits for those who develop medical products, and for those who use them.”

With more trials and paid research studies taking place, the importance of the work conducted by professional organisations such as Trials4us has become increasingly recognised by researchers requiring guidance through the study process.

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Electronic submissions have been enhanced

The introduction of electronic submissions has had a huge impact on clinical trials. Submissions to the FDA were traditionally paper-based, but this became less and less practical, as submissions became increasingly complex. Aside from anything else, the sheer volume of paper that makes up a single submission meant storage was a problem. Electronic submissions have changed all that, and they bring with them some important advantages. While the first electronic submissions took place in the 1980s, there was no single strategy set up, so things were slow to get off the ground. Even in the 1990s, submissions tended not to be uniform and were based on more ad-hoc designs. Everything changed in 1999, however, when guidance was issued paving the way for a formal push to replace paper with electronic submissions.

The process towards electronic submissions as standard was difficult and lengthy, but has undoubtedly been worth it.

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