Robert Califf: ChatGPT has a challenge for you

Dear Robert Califf,

Can you provide better regulatory arguments than a chatbot?

Thousands of clinical trial results remain missing in violation of the law, but FDA is refusing to take action. We asked ChatGPT to write a blog weighing in on the debate.

Precise instructions:

"Write a 700 word blog for an expert audience arguing that the FDA urgently needs to enforce FDAAA Section 801 clinical trial reporting requirements."

Below are ChatGPT's arguments.

TranspariMED now kindly invites you to write a blog in response.

Precise instructions:

"Write a 700 word blog arguing that the FDA's persistent foot-dragging on FDAAA enforcement is entirely justifiable and actually benefits patients."

Our readers look forward to hearing your arguments. Let the battle begin.

Best wishes,

The TranspariMED team

Blog generated by ChatGPT

Clinical trials are a critical component of the development of new medical treatments, as they allow scientists and regulators to evaluate the safety and efficacy of new drugs and medical devices. The results of clinical trials are used to make decisions about the approval of new treatments, as well as to inform clinical practice and medical research. However, the results of many clinical trials are not published, which can lead to incomplete and biased assessments of the benefits and risks of new treatments.

To address this problem, the U.S. Food and Drug Administration (FDA) has enacted the Food and Drug Administration Amendments Act (FDAAA) of 2007, which includes Section 801, which requires that certain clinical trials be registered and their results reported.

Despite the passage of FDAAA, however, many clinical trials are still not registered or their results reported, leading to a significant gap in our understanding of the benefits and risks of many treatments.

The results of clinical trials are critical to the evaluation of new medical treatments and to inform clinical practice. When the results of clinical trials are not reported, it can lead to incomplete and biased assessments of the benefits and risks of new treatments. This can have serious consequences for patient safety, as well as for public trust in the medical community and the regulatory system.

FDAAA Section 801 is designed to address this problem by requiring that certain clinical trials be registered and their results reported.

The reporting requirement applies to certain information about the trial, including its design, primary outcome measures, and summary results. This information must be submitted to ClinicalTrials.gov, a public database of clinical trials sponsored by the National Institutes of Health.

Despite the passage of FDAAA, many clinical trials are still not registered or their results reported, leading to a significant gap in our understanding of the benefits and risks of many treatments.

This is a major problem for several reasons.

• First, incomplete and biased reporting of clinical trial results can lead to incorrect conclusions about the safety and efficacy of new treatments. This can result in the approval of treatments that are not safe or effective, or the rejection of treatments that are safe and effective.

• Second, incomplete reporting of clinical trial results can undermine public trust in the medical community and the regulatory system. When the public is aware that the results of many clinical trials are not being reported, it is difficult to maintain trust in the medical and regulatory communities.

• Third, incomplete reporting of clinical trial results can prevent scientists and clinicians from learning from each other's work. When the results of clinical trials are not reported, it is difficult for scientists and clinicians to build on the work of others, which can slow the pace of medical progress.

• Finally, incomplete reporting of clinical trial results can harm patients. When patients are not aware of the full range of benefits and risks of new treatments, they are more likely to be harmed.

In light of these serious consequences, the FDA urgently needs to enforce FDAAA Section 801 clinical trial reporting requirements.

Note: We shortened ChatGPT's response by four sentences and added highlighting and bullet points. Otherwise ChatGPT's response is reproduced 100% verbatim above.