Gov’t delay could postpone usability, patient recruitment

By Melissa Fassbender contact

- Last updated on GMT

(Image: iStock/Shaiith)
(Image: iStock/Shaiith)

Related tags: Clinical research, Clinical trial

Several organizations have penned an open letter to NIH urging it adhere to 21st Century Cures deadlines that if missed, will affect improvements to – and ultimately, study start up.

The letter, signed by several organizations* representing various industry stakeholders, was addressed to Dr. Francis S. Collins, Director at the National Institutes of Health and Dr. Patricia Flatley Brennan, Director at the National Library of Medicine.

The letter was written in regards to Section 2054 of the 21st Century Cures Act​ and

According to the section, the Secretary of Health and Human Services should consult with relevant Federal agencies and other stakeholders “to receive recommendations with respect to enhancements to the clinical trial registry data bank … including with respect to usability, functionality, and search capability​,” no later than 90 days after the Act’s enactment.

This date would be March 13, 2017.

However, John J. Lewis, Senior Vice President, Policy and Public Affairs, at the Association of Clinical Research Organizations (ACRO), one of the organizations among the letter-writing group, told us they do not expect the deadline to be met.

It was one of the shorter deadlines in Cures and 90 days is not easy for regulators in the best of circumstances​,” he said.

Lewis explained the consequences of the missed deadline “would be more delay before is really usable for patients and physicians looking for clinical trials or for patient recruitment​.”

Consequently, he said patient recruitment will be delayed and as such, it will be “a contributing factor to longer study start up times​.”

We appreciate that we are in a period of transition and that the NIH has many new responsibilities placed on it by 21st Century Cures​,” the letter stated.

Nevertheless, we are writing to strongly encourage you to adhere to this timeline for the benefit of patients everywhere who are awaiting new treatments and cures​.”

When asked when he thinks the consultation will take place, Lewis said, "whenever NIH gets to it​."

*Association of Clinical Research Organizations (ACRO), Association of Clinical Research Professionals (ACRP), Society for Clinical Research Sites (SCRS), Coalition for Clinical Trials Awareness (CCTA), Research!America, and The Center for Information and Study on Clinical Research Participation (CISCRP).

Related topics: Clinical Development, Regulatory affairs

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