Recurring concern

Unreliable clinical-trial safety information and unblinding processes

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First reported 1 Jul 2014•Latest report 4 Aug 2022

Definition

What this concern includes

Includes failures in the dedicated clinical-trial safety-information and unblinding process, including reporting suspected adverse events, assigning responsibility for initiating or considering unblinding, communicating trial involvement and suspected trial-related events to receiving clinicians, using formal referral routes, and preserving transparent inter-hospital communication.

Not included

Excludes general hospital referrals, clinical handovers or information-sharing failures where clinical-trial involvement or trial-related safety information is not material.
Excludes failures in the underlying trial design, treatment efficacy or participant consent unless they directly concern the safety-information or unblinding process.
Excludes clinical assessment or treatment failures after relevant trial and adverse-event information has been reliably communicated.
Excludes generic incident-reporting or adverse-event systems unrelated to clinical trials and their unblinding arrangements.

Reports: 2
Individual concerns: 4
Date range: 2014–2022
Stated actions: 1

Reports over time

Reports about this concern issued each year.

* 2026 is projected from reports observed to 7 Sep 2026.

Most frequent recipients

Reports about this concern sent to each recipient.

Health Research Authority1

Medicines and Healthcare products Regulatory Agency1

National Patient Safety Agency1

University Hospitals Sussex NHS Foundation Trust1

Concerns and responses across reports

Only concerns grouped under this recurring concern are included. Select any concern, action or position to view the source wording.

4 Aug2022
Derby and Derbyshire
Concerns raised2
1. Absence of a formal referral system for reporting adverse events and triggering consideration of unblinding
2. Lack of a clear system and protocol for responsibility and procedure in triggering consideration of unblinding
This report raised 1 other concern. They are not shown here because they do not form part of this recurring concern.
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
Actions described in response 1
1. Action
  Publish guidance defining trial contact, out-of-hours coverage, emergency unblinding and testing arrangements.
  Stated by Medicines and Healthcare products Regulatory AgencyStated completed
Respondent positions 2
1. Position
  Existing patient information, emergency cards and documented contact arrangements sufficiently enable adverse-event reporting and unblinding without a formal referral system.
  Stated by Medicines and Healthcare products Regulatory AgencyExisting arrangements considered sufficient
1. Position
  Existing participant contact details, investigator responsibilities and trial protocols sufficiently enable emergency clinical-trial unblinding, so no further action is required.
  Stated by Medicines and Healthcare products Regulatory AgencyExisting arrangements considered sufficient
AI-generated summary

Roy DRAPER · Prevention of Future Deaths report

This summary was generated using AI from the published report. Please read the original report for the complete account.

Report summary

Roy Draper, who had mesothelioma linked to occupational asbestos exposure, became unwell after chemotherapy in a clinical trial, later developed bronchopneumonia and suffered a massive stroke, and died in hospital on 13 February 2020. Concerns were raised about the lack of a clear process and responsibility for requesting unblinding when a clinical-trial patient became acutely unwell at another hospital, and about the absence of a formal referral system for reporting adverse events to the trials team.

Read the report on judiciary.uk
Source evidence
How this individual concern was interpreted
PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation
Absence of a formal referral system for reporting adverse events and triggering consideration of unblinding
Wider context from the report
“The matters of concern arise in the context of patients who are undergoing a clinical trial but who become acutely unwell and are admitted to another hospital for treatment. In such circumstances the treating hospital wishes to know further information about the trial as it may be relevant to treatment decisions. At inquest the evidence was unclear as to whom bears responsibility for initiating unblinding requests and what the process is. The evidence was conflicting as to whether the treating hospital understood that unblinding requests were considered by the clinical trials team once they were notified of a suspected adverse event whereas the clinical trial hospital believed that unblinding would only be considered once a formal request was made from the treating hospital. 1. There is a lack of a clear system and protocol on whose responsibility it is to trigger consideration of the unblinding process and the correct procedure that should be followed by the treating hospital. If such a protocol in fact exists, then it does not appear to have been sufficiently disseminated. 2. There is no formal referral system for the treating hospital to use to report adverse events to the trials team and trigger consideration of the unblinding process. This means that conversations about the process between hospitals are not transparent. ”
Source location
Roy DRAPER · Prevention of Future Deaths report
Page 2 · concerns
Open source report
Source evidence
How this individual concern was interpreted
PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation
Lack of a clear system and protocol for responsibility and procedure in triggering consideration of unblinding
Wider context from the report
“The matters of concern arise in the context of patients who are undergoing a clinical trial but who become acutely unwell and are admitted to another hospital for treatment. In such circumstances the treating hospital wishes to know further information about the trial as it may be relevant to treatment decisions. At inquest the evidence was unclear as to whom bears responsibility for initiating unblinding requests and what the process is. The evidence was conflicting as to whether the treating hospital understood that unblinding requests were considered by the clinical trials team once they were notified of a suspected adverse event whereas the clinical trial hospital believed that unblinding would only be considered once a formal request was made from the treating hospital. 1. There is a lack of a clear system and protocol on whose responsibility it is to trigger consideration of the unblinding process and the correct procedure that should be followed by the treating hospital. If such a protocol in fact exists, then it does not appear to have been sufficiently disseminated. 2. There is no formal referral system for the treating hospital to use to report adverse events to the trials team and trigger consideration of the unblinding process. This means that conversations about the process between hospitals are not transparent. ”
Source location
Roy DRAPER · Prevention of Future Deaths report
Page 2 · concerns
Open source report
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
Publish guidance defining trial contact, out-of-hours coverage, emergency unblinding and testing arrangements.

Verbatim wording from the response
“The MHRA has published the following information in the MHRA Good Clinical Practice Guide (2012) – section 11.4.8 Contact Details and Out-Of-Hours Arrangements and 11.4.9 Emergency Code Breaking:”

Source location
Response from MHRA
Page 2 · response
Published 30 September 2022
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
Existing patient information, emergency cards and documented contact arrangements sufficiently enable adverse-event reporting and unblinding without a formal referral system.

Verbatim wording from the response
“The MHRA propose that no action is required in relation to either of the matters of concern raised. A detailed response is provided for each point explaining the systems in place for unblinding of clinical trials and the responsibilities for executing those processes.”

Source location
Response from MHRA
Page 1 · response
Published 30 September 2022
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
Existing participant contact details, investigator responsibilities and trial protocols sufficiently enable emergency clinical-trial unblinding, so no further action is required.

Verbatim wording from the response
“The MHRA propose that no action is required in relation to either of the matters of concern raised. A detailed response is provided for each point explaining the systems in place for unblinding of clinical trials and the responsibilities for executing those processes.”

Source location
Response from MHRA
Page 1 · response
Published 30 September 2022
Open published response
1 Jul2014
Brighton and Hove
Concerns raised2
1. Failure to communicate trial involvement and suspected trial-related events to receiving clinicians
2. Failure to record suspected trial-related causes in hospital notes
This report raised 6 other concerns. They are not shown here because they do not form part of this recurring concern.
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.

No linked response statements
No respondent-stated action or position is linked to these concerns in the published data.
AI-generated summary

John Henry ADAMS · Prevention of Future Deaths report

This summary was generated using AI from the published report. Please read the original report for the complete account.

Report summary

John Henry Adams died following multiple complications of an appropriate cardiac intervention after being recruited to a cardiac trial just before the procedure. Concerns included whether there was sufficient time for informed consent, the suitability and preparedness of the trial operator, and the recording and communication of the trial’s possible relevance to the cardiac tamponade and subsequent death.

Read the report on judiciary.uk
Source evidence
How this individual concern was interpreted
PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation
Failure to communicate trial involvement and suspected trial-related events to receiving clinicians
Wider context from the report
“(8) One of the organisers of the Trial has written in Mr. Adams' notes that he has been notified of what has happened to Mr. Adams but he makes no mention of what is believed to have occurred as a result of the Trial. Why not? Why was the Trial not mentioned to Kings College Hospital in the Referral letter dated the 1st February 2014? ”
Source location
John Henry ADAMS · Prevention of Future Deaths report
Page 2 · concerns
Open source report
Source evidence
How this individual concern was interpreted
PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation
Failure to record suspected trial-related causes in hospital notes
Wider context from the report
“(6) The Hospital notes for Mr. Adams admission on the 30th do not mention the view (apparently formed within an hour or so of surgery), that it was the pacing wires; which was the extra requirement of the Trial; which caused the cardiac tamponade. Why not? Why was this information effectively concealed? ”
Source location
John Henry ADAMS · Prevention of Future Deaths report
Page 2 · concerns
Open source report

Data last updated 7 September 2026

What this concern includes

Not included

Reports over time

Concerns raised2

Absence of a formal referral system for reporting adverse events and triggering consideration of unblinding

Lack of a clear system and protocol for responsibility and procedure in triggering consideration of unblinding

Actions described in response An action is something a respondent says it has done, is doing, or plans to do in response to the concern raised.1

Respondent positions A position is what a respondent says about the concern when they do not describe a specific action.2

Concerns raised2

Failure to communicate trial involvement and suspected trial-related events to receiving clinicians

Failure to record suspected trial-related causes in hospital notes

Actions described in response 1

Respondent positions 2