Increased pressure on successful regulatory submission

The updates are on the verge of finalization and release.?

The new guidelines will have a profound impact on how sponsors design, develop and implement their clinical trials. The ripple effect of these regulations will touch every level within the organization from regulatory affairs to finance.?

The updates will most likely result in:?

• Increased pressure on successful regulatory submission?
• Regulatory submissions taking longer to complete?
• More communication and coordination between different departments within the organization?
• An overall increase in the workload for everyone involved in the clinical trial process.?

There are three areas in which these new regulations could have the most impact: cost, time and resources necessary for compliance; increased burden on Investigators conducting clinical research; and potential for more delays in getting treatments to patients.?

What's driving these new regulations? In part, it's the recognition that the clinical trial process has become more complex, risk oriented, technologically enabled and expensive. The goal is to make sure that this process is as efficient as possible, while still protecting patients' rights and ensuring the quality of data.?

There are a few key things, sponsors should keep in mind as they prepare for these changes:?????????????????

1. Clinical trials are becoming increasingly globalized. With new regulations comes an?increased need for compliance with multiple regulatory bodies.?
2. The cost of clinical trials is rising, and sponsors need to be prepared to invest more in both the conduct of the trial and compliance with regulations.?
3. There is a greater emphasis on patient safety and informed consent. This means that sponsors need to have systems in place to track patients throughout the trial process and ensure they are fully informed of all risks involved.?
4. There is a heightened focus on data quality due to usage of advanced technology. New regulations will require Sponsors to put additional controls in place to ensure that data collected during a clinical trial is accurate and complete.?
5. Sponsors need to be prepared for increased scrutiny from regulatory agencies. With new regulations comes an increased risk of audits and investigations.?

As per the FDA Data standards Catalog, The eCTD is the standard format for submitting applications, amendments, supplements, and reports to FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER). To ease the submission, FDA shared the draft guideline on the submission of applications and other regulatory submissions in alternate electronic format without extensible markup language (XML).?

What do you think are the most important changes that sponsors should be aware of? Share your thoughts in the comments below.