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Only 5% of clinical trials of new coronary therapies can give guidance? The acting director of the FDA co-issued a joint message

 Last Update: 2021-03-24
 Source: Internet
 Author: User

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COVID-19。COVID-19。，，、、。，FDAKevin BuginFDAJanet WoodcokNature Reviews Drug Discovery，。，，，（actionable information）。

Many clinical trials currently conducted by Nature Reviews Drug Discovery around the world may not be able to provide actionable information due to no randomization or insufficient number of patients participating in the trial.

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In this analysis, the FDA Center for Drug Evaluation and Research (CDER) evaluated clinical trials of potential new crown therapies registered on ClinicalTrials.

gov in the United States and the World Health Organization’s International Clinical Trial Registration Platform (WHO ICTRP).

The number of clinical trials continues to increase, and the distribution of treatment types has shifted

Researchers found that in the past year, the number of clinical trials testing new coronary therapy has continued to increase.

The number of trial arms has increased from 443 in March 2020 to 2,790 in November, an average monthly increase of 29%.
.

With the passage of time and the clinical information obtained during the pandemic, the distribution of the types of treatments tested in clinical trials has also changed.

In March 2020, most test groups tested antiviral drugs (31%) or immunomodulators (31%).

In this analysis, the FDA Center for Drug Evaluation and Research (CDER) evaluated clinical trials of potential new crown therapies registered on ClinicalTrials.

gov in the United States and the World Health Organization’s International Clinical Trial Registration Platform (WHO ICTRP).
The researchers collected information from more than 2024 clinical trials (including 2895 trial groups), which enrolled more than 500,000 patients.
This analysis is mainly aimed at testing interventional clinical trials of new crown drugs and antibody therapies.

Information on 2024 clinical trials (including 2895 trial groups), which enrolled more than 500,000 patients in total.

The number of clinical trials has continued to increase, and the distribution of treatment types has shifted.
The number of clinical trials has continued to increase, and the distribution of treatment types has shifted.

Researchers found that in the past year, the number of clinical trials testing new coronary therapy has continued to increase.

The number of trial arms has increased from 443 in March 2020 to 2,790 in November, an average monthly increase of 29%.
.

The number of trial arms increased from 443 in March 2020 to 2,790 in November, an average monthly increase of 29%.

With the passage of time and the clinical information obtained during the pandemic, the distribution of the types of treatments tested in clinical trials has also changed.
In March 2020, most test groups tested antiviral drugs (31%) or immunomodulators (31%).
However, by October, the proportion of antiviral drugs (17%) and immunomodulators (26%) had declined, while the proportion of neutralizing antibodies (9%) and other therapies (26%) had increased.
This change may be due to the fact that some early "old medicines and new use" studies did not find good efficacy, and the neutralizing antibody and the rehabilitated plasma therapy entered the stage of clinical evaluation.

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▲Changes in the number of clinical trials and the distribution of new crown therapy (picture source: reference [1])

Most clinical trials are under-enrolled or not randomized

From the perspective of regulatory agencies, even during a pandemic, their decisions still need to be based on scientific evidence.
Therefore, FDA scientists are concerned with whether these clinical trials are randomized trials and whether the number of participants can provide statistically valid information.
The information is analyzed.
Based on the COVID-19 disease stage targeted by potential therapies and the FDA's past experience on the number of people enrolled in clinical trials, researchers have set the threshold for the number of people enrolled in clinical trials to give statistically valid results.

The analysis results show that although the threshold standard can fluctuate to a certain extent, in general, the analysis of 2895 test groups shows that only 5% of the test groups achieve randomization at the same time and the number of patients enrolled can provide statistical power Information standards.
These clinical trials included 26% of the planned enrollment of patients.

▲Changes in the number of clinical trials and the distribution of new crown therapy (picture source: reference [1])

▲Changes in the number of clinical trials of new crown therapy and the distribution of treatments (picture source: reference [1]) ▲The number of clinical trials of new crown therapy and changes in the distribution of treatments (picture source: reference [1]) ▲The number of clinical trials of new crown therapy and changes in the distribution of treatments (Image source: Reference [1])

Most clinical trials are under-enrolled or not randomized

Most clinical trials have insufficient enrollment or no randomization.
Most clinical trials have insufficient enrollment or no randomization.

The analysis of 2895 test groups showed that only 5% of the test groups reached the criteria for randomization at the same time and the number of patients enrolled could provide statistically effective information.
These clinical trials included 26% of the planned enrollment of patients.

▲5% of the clinical trial group is randomized and the number of participants can provide statistically effective information (picture source: reference [1])

Some discussion

The author pointed out that in order to respond quickly and effectively to an unseen disease outbreak (such as COVID-19), the clinical trial ecosystem needs to have two key capabilities.
One is a powerful screening mechanism that allows researchers to quickly discover "old drugs" based on drug mechanisms or non-clinical information, and prioritize their ability to treat diseases.

The second requirement is that the clinical trial ecosystem should be able to quickly and efficiently generate deterministic and highly instructive information when evaluating the safety, efficacy, and target population of therapies.
The quality of this information should meet standards acceptable to regulators and expert groups.

The analysis of current clinical trial data shows that the clinical trial ecosystem still lacks in these two aspects.
The main finding is that due to the low randomization rate and the limited number of participants, many trial data may not provide interpretable results on the safety and effectiveness of the therapy.
It is worth mentioning that researchers have observed many repeated studies, and multiple small clinical trials are using similar interventions to treat similar patient groups.
This does not make the most effective use of patient resources.

▲5% of the clinical trial group is randomized and the number of participants can provide statistically effective information (picture source: reference [1])

▲5% of the clinical trial group is randomized and the number of participants can provide statistically valid information (picture source: reference [1]) ▲5% of the clinical trial group is randomized and the number of participants can provide statistical information Information on academic effectiveness (picture source: reference [1]) ▲5% of the clinical trial group is randomized and the number of participants can provide statistically effective information (picture source: reference [1])

Some discussion

Some discussion some discussion

To respond quickly and effectively to an unseen disease outbreak (such as COVID-19), the clinical trial ecosystem needs to have two key capabilities.
Powerful screening mechanism

Due to the low randomization rate and the limited number of participants, many trial data may not provide interpretable results on the safety and effectiveness of the therapy.
Not making the most effective use of patient resources.

▲Characteristics of the clinical trial group initiated before and after November 2020 (picture source: reference [1])

Fortunately, the researchers found that the quality of clinical trials has improved over time.
In the clinical trials initiated before November 2020, only about 5% of the clinical trials met the randomization and enrollment criteria, while in the clinical trials initiated after November 2020, nearly 30% of the clinical trials achieved randomization And the criteria for the number of people in the group.

The author stated that the FDA will continue to analyze relevant factors in clinical trials to provide insights into global efforts to fight the new crown epidemic.

▲Characteristics of the clinical trial group initiated before and after November 2020 (picture source: reference [1])

▲Characteristics of the clinical trial group initiated before and after November 2020 (picture source: Reference [1]) ▲Characteristics of the clinical trial group initiated before November and after November 2020 (picture source: Reference [1]) ▲Characteristics of the clinical trial group initiated before and after November 2020 (picture source: Reference [1])

In the clinical trials initiated before November 2020, only about 5% of the clinical trials met the randomization and enrollment criteria, while in the clinical trials initiated after November 2020, nearly 30% of the clinical trials achieved randomization And the criteria for the number of people in the group.

The author stated that the FDA will continue to analyze relevant factors in clinical trials to provide insights into global efforts to fight the new crown epidemic.

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