PFD report

Carl Anthony Schmidt · Prevention of Future Deaths report

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Issued 11 Sep 2019•West Yorkshire Eastern

Report record

Published report and response evidence

This page connects the concerns raised in this report with statements found in recipients’ published responses. A link shows a clear evidence connection; it does not assign responsibility.

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Concerns
1

Raised in this report

Recipients
1

Named on the report

Responses found
1

Of 1 recipient

Stated actions
2

Described in responses

Recipients and published responses

Source document

Full report text

This is the full text from the original published report.

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Concerns and recipient responses

Select any concern, action or position to view the source wording.

Concerns raised1

  1. Neurological damage from the form of chemo radiotherapy
Responses linked to these concerns

Each statement is shown once, even when linked to more than one concern.

Actions described in response An action is something a recipient says it has done, is doing, or plans to do in response to a concern raised.2

  1. Action

    Suspend recruitment into Arm 3 pending investigation into the circumstances of the death.

    Stated by University of BirminghamStated completedThe respondent said that this action was complete when they made their response on 22 November 2019.
  2. Action

    Review Arm 3’s trial operation, risk mitigation, treatment, dosage and radiotherapy plans, and safety information through the Trial Management Group and Data Monitoring Committee.

    Stated by University of BirminghamStated completedThe respondent said that this action was complete when they made their response on 22 November 2019.

Respondent positions A position is what a recipient says about a concern when it does not describe a specific action.2

  1. Position

    The experimental Arm 3 radiotherapy was not considered likely to have caused the death; alternative causes were considered more likely.

    Stated by University of BirminghamDisputes the concernThe respondent disagreed with part of the concern or the basis for it.

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Neurological damage from the form of chemo radiotherapy

Wider context from the report

“(1) The form of chemo radiotherapy provided in the clinical trial potentially exposes the patient to neurological damage. (2) The mechanism by which the radiotherapy/chemotherapy treatment probably causes injury needs to be further investigated to establish whether this occurs directly or indirectly by affecting the immune system. ”

Is this part of a recurring concern?

No recurring-concern membership is currently published.

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Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Suspend recruitment into Arm 3 pending investigation into the circumstances of the death.

Verbatim wording from the response

“The CRCTU was notified of the outcome of the subsequent inquest by the Trial site at St James’ Institute of Oncology Leeds on 9th September 2019. This was a few days prior to receipt of the Regulation 28 Report dated 11th September. As the Chief Investigator, Professor ████████ immediately reviewed the situation with CRCTU and on 12th September 2019 arranged suspension of recruitment into Arm 3 of the Trial pending further investigation being undertaken around the circumstances of the death of the patient. He notified the TMG who were in agreement and he informed the chair of the DMC. The MHRA were sent a follow up report on 12th September and were notified of the suspension by telephone on 13th September and in writing on 16th September 2019. At the date of this Response, recruitment continues to be suspended.”

Source location

2019-0358-Responses_Redacted.pdf
Page 3 · response
Published 22 November 2019

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Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Review Arm 3’s trial operation, risk mitigation, treatment, dosage and radiotherapy plans, and safety information through the Trial Management Group and Data Monitoring Committee.

Verbatim wording from the response

“In the light of the outcome of the Inquest and receipt by Professor ████████ of the Regulation 28 Report, a number of actions were undertaken to review the activity under the Trial.”

Source location

2019-0358-Responses_Redacted.pdf
Page 3 · response
Published 22 November 2019

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Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

The experimental Arm 3 radiotherapy was not considered likely to have caused the death; alternative causes were considered more likely.

Verbatim wording from the response

“The DMC (and notably the radiotherapy oncology expert) reviewed all the available information (both the dosage plan and the radiotherapy outlining plan) and did not conclude that the patient’s symptoms or death were caused by direct damage from the radiotherapy on the local peripheral nerves. The reason for this is that the patient had polyneuropathy bilaterally including contralateral (left) arm and bilateral vocal cord palsy (i.e. including contralateral recurrent laryngeal nerve), whereas the high dose radiotherapy only affected the right recurrent laryngeal nerve and the right C5 root.”

Source location

2019-0358-Responses_Redacted.pdf
Page 4 · response
Published 22 November 2019

Open published response

Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Further suspension of Arm 3 recruitment was not considered necessary because the review identified no reasons to continue it.

Verbatim wording from the response

“The University has thoroughly reviewed the risk mitigation processes and operation of the Trial, the treatment provided, the potential benefit to patients, and the circumstances of this particular case. For the reasons mentioned above, the University does not believe that the experimental treatment given in Arm 3 is likely to have been the cause of death. Accordingly, and as the review has not identified reasons for continued suspension of Arm 3, the University (in consultation with the TMG and DMC) believes that resumption of recruitment into Arm 3 would be justified.”

Source location

2019-0358-Responses_Redacted.pdf
Page 4 · response
Published 22 November 2019

Open published response
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Information checked against the published report and official responses · Data reviewed 7 Sep 2026 · About data quality and limitations

Data last updated 7 September 2026