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Performance in Initiating and Delivering Clinical Research exercise - Feedback process

Contents

The Performance in Initiating and Delivering Clinical Research submission is due to open. You are required to submit and publish Q1 2021-22 data by Friday 30 July 2021 at 5.00pm. The submission platform will open on Thursday 1 July 2021.

Please contact the CTP team at CTP@nihr.ac.uk with any questions or concerns.

Acronyms

Acronyms

Title

CTP

Clinical Trial Performance

DSC

Date Site Confirmed

DSS

Date Site Selected

FPR

First Participant Recruitment

HRA

Health Research Authority

MHRA

Medicines and Healthcare products Regulatory Agency

REC

Research Ethics Committee

SOP

Standard Operating Procedure

Purpose

This Standard Operating Procedure (SOP) describes the process of data feedback for the Performance in Initiating Clinical Research exercise which informs the NIHR performance metrics for providers of NHS services.

The intention of this SOP is to outline clearly and transparently the way in which the feedback process is applied to submitted clinical trials; to promote consistency of execution of the process and common mutual understanding of expectations and requirements. 

With the removal of the 70 day benchmark as of Q1 18-19, a feedback process to improve reporting accuracy will replace the previous adjustment process. The objective of the feedback process is to identify where NHS providers have reported delays in initiating clinical trials, but the explanation of these delays is unclear or incomplete.  These trials will continue to be used to evaluate the broader performance of the clinical research system both locally and nationally.

Audience

The primary audience of this SOP is the Clinical Trial Performance (CTP) Team at the NIHR Central Commissioning Facility to use during the analysis process following quarterly submissions. This document is also intended to help and support R&D Managers, R&D Data Managers and other R&D staff, both new to the exercise and those from established submitters, to complete their quarterly returns to the NIHR CCF in a way that achieves consistency within and across providers of NHS services.  

Background

The Government wishes to see a dramatic and sustained improvement in the performance of providers of NHS services in initiating and delivering clinical research.  The aim is to increase the number of participants who have the opportunity to participate in research and to enhance the nation’s attractiveness as a host for research. Performance in Initiating Clinical Research aims to assess the interval from the date the site is selected to recruitment of the first participant to a trial. The Department of Health places a contractual obligation on providers of NHS services contracted through the NIHR; to submit data and publish outcomes against the initiation of all clinical trials and delivery to time and to target for commercial clinical trials. More information and all related documents to support the submission process can be accessed on the submitting data on performance in initiating and delivering clinical research webpage.

Consistency in the feedback and analysis of data is important for providers to understand their quarterly performance against other providers, for the accuracy of publicly available published data.  Providers are responsible for the submission of complete and accurate information.

Term

Description

Date of First Participant Recruitment (FPR)

Means the date the first eligible participant consented to the study.

Date Site Confirmed

Date of the last contract signature of all the organisations involved (i.e. sponsor, site, 3rd party) or date of final written agreement of statement of activity (as applicable)

Date Site Selected

Date on the Sponsor email received by the site providing the minimum defined documents to enable site to commence arrangement and/or confirmation of local capacity and capability as applicable representing that the site has been selected to take part in the study. Where the Sponsor is also the site, this is the date of the HRA initial assessment letter.

Feedback process

Process by which trials which have reported delays are assessed for completeness and clarity.

Matched trial

Trial where the reason for delay and the source of delay are consistent with each other and with the durations between DSS and FPR.

Mismatched trial

Trial where the selected source of delay does not correspond to the reason for delay and/or the durations between DSS and FPR.

Need More Info

Term given to a trial where no reason and/or source of delay has been selected, or where the information given is not sufficient to match the trial.

Reason for delay

Relating to the list of possible reasons for delay to clinical trials initiation, cited by the provider of NHS services for each clinical trial where a delay has been noted. The list of possible reasons can be found in Appendix 1 of this document.

Source of delay

Indicates which party was responsible for the delay: NHS Provider/Sponsor/Both/Neither.

Submission period

The period (usually 30 days) between the end of the quarter and the submission deadline

Submission window

The timeframe for which data must be submitted by the provider

Feedback Process

The feedback process is now comprised only of a data quality assessment; this feedback is intended for providers to review their data in future submissions and not for in-quarter changes.  Because there is no longer a benchmark by which trials will be judged, records will not be removed from the analysis even if the delay was out of control of the NHS provider. The feedback will highlight where providers can give additional detail to create a clear and complete picture of delays. For any additional information about platform validation of data quality, please refer to the CTP Submission Platform Instructions.

Data Issue Type

Action

REC number not recognised

Feedback to trust; trials will not be excluded from the analysis solely on the basis of an unrecognised REC number

Incorrect date format

If the date is invalid or in a format which will cause formulae to fail, the dates and durations will be deleted. If the format of the date is incorrect but the information is clear, then the record is cleaned (i.e., 1-Jan-15 to 01/01/2015). For more information, please refer to the CTP Submission Platform Instructions.

Data outside the submission window

Usually occurring with Date of First Participant Recruitment; record will be cleaned to how it looked on the last day of the quarter (date of FPR deleted, duration from DSS to FPR deleted, “First Participant Recruited?” changed to ‘No’).

Data type mismatch

When numerical data appears in text fields or vice versa; these types of errors are usually picked up by the submission validation and are therefore quite rare. Where the intended information is clear (i.e., the inversion of two columns), the record will be cleaned; if there is any doubt about the intended information, the record will be excluded from analysis.

No source of delay and/or no reason for delay

Marked as ‘‘Need More Info’’, and included in the dataset.

First Participant Recruited? status is ‘Yes - Date Unavailable’

Trials will be treated as if a first participant has not been recruited, since the Date of First Participant Recruited will be blank.

HRA approval record not found

If the record cannot be matched to the HRA data using the REC or IRAS number, the following comments may be returned, depending on query results from the HRA: ‘Pre-HRA’, ‘Non-clinical trial’ or ‘Non-HRA approval’. ‘No Data’ comment will also be returned for HRA Submission Date / Date Study Initiated, HRA Country, HRA Approval Status, and HRA Approval Date if record cannot be matched to HRA data.

All trials carried forward from the previous quarter to the current quarter will be compared to the previous quarter's matching status and handled according to the following scenarios and actions:

Scenario

Action

Trial data not changed, trial previously reported delays

Matching as previous quarter

Trial data updated

Matching reassessed

Trial data not changed, but the feedback guidelines have changed and trusts have been notified at least 10 days before the end of the quarter

Matching reassessed

The following table describes the range of scenarios involving omission of data or the selection of a single delay reason, what is expected in the way of supporting information and the action in respect of match/mismatch:

Scenario

Sub-Category

Expected Source of Delay

Comments

Notes/Action

A - Relevant permissions delayed and not granted in time

HRA approval process not completed in time

Neither

Please briefly explain the reason for delay to permissions (i.e., the subcategory). Please briefly explain the nature of the delay and why the chosen source of delay is appropriate.

 

B - Suspended by Sponsor

 

Study suspended by sponsor at all sites

Sponsor

No comment required

 

Study suspended by sponsor at this site

Sponsor

No comment required

 
C - Closed by Sponsor 

Study closed by sponsor at all sites

Sponsor

No comment required 

 
Study closed by sponsor at this site Sponsor No comment required   

D - Sponsor Delays

 

 

 

 

 

Sponsor delay in provision of study documentation (e.g. pharmacy or laboratory manual)

Sponsor

Please briefly explain the nature of the sponsor delay (i.e., the subcategory) in the comments.

 

Sponsor delay in provision of IMP, device or equipment

Sponsor

Please briefly explain the nature of the sponsor delay (i.e., the subcategory) in the comments.

 

Sponsor delay through protocol or research application amendments

Sponsor

 Please briefly explain the nature of the sponsor delay (i.e., the subcategory) in the comments.

 

Sponsor delayed site initiation visit

Sponsor

Please briefly explain the nature of the sponsor delay (i.e., the subcategory) in the comments.

 

Sponsor delayed confirmation of study open to recruitment at site (i.e., green light)

Sponsor

Please briefly explain the nature of the sponsor delay (i.e., the subcategory) in the comments.

 

Planned and agreed later start or delay intrinsic in study design (e.g. planned later start, follow-on study, dependency on unpredictable event e.g. flu epidemic)

Sponsor

Please briefly explain the nature of the delay (i.e., the subcategory) in the comments.

 

E - Staff Availability Issues

 

 

 

NHS Provider staff availability (annual leave, sickness absence, staff issue / shortage)

NHS Provider

No comment required 

NHS staff issues such as annual leave, sick leave, maternity leave, etc. are expected to be within NHS provider's control.

NHS Provider training (e.g. GCP, protocol specific training, etc.)

NHS Provider

Please briefly explain provider training issue (i.e., the subcategory) in the comments.

 

Sponsor staff availability (annual leave, sickness absence, staff issue / shortage)

Sponsor

Please briefly explain sponsor staffing issue (i.e., the subcategory) in the comments.

Sponsor staff issues such as annual leave, sick leave, maternity leave, etc. are expected to be within sponsor's control.

Sponsor training (e.g. protocol specific training etc.)

Sponsor

Please briefly explain sponsor training issue (i.e., the subcategory) in the comments.

 

F – No Eligible Participants Seen

 

 

Participants screened but no eligible participants identified

Neither

Please indicate the reason no participants were seen (i.e., the subcategory) in the comments.

 

Strict participant eligibility criteria / Low recruitment target

Neither

Please indicate the reason no participants were seen (i.e., the subcategory) in the comments.

 

NHS Host Site's inadequate planning / feasibility arrangements to see participants

NHS Provider

 No comment required 

 

G – No Eligible Participants Consented

 

Eligible participants seen chose not to participate in study (e.g. Personal reasons, frequent study visits, reluctance to participate in placebo arm, preference of treatment choice, etc.)

Neither

 No comment required 

 

Eligible participants seen chose not to participate in study: NHS Host Site's inadequate planning /arrangements to consent participants

NHS Provider

No comment required 

 

H - Contracting Delays

Contracting / costing delays (including service support costing and excess treatment costing, etc.)

NHS Provider

Sponsor

Both

Neither

Please briefly explain the nature of the delay and why the chosen source of delay is appropriate.

 

I - Rare Diseases (Please see submission guidelines)

Rare or very rare diseases studies (as defined in the guidance)

Neither

No comment required 

 

J - Other

Other - specify in comment

NHS Provider

Sponsor

Both

Neither

Please only use other if no other reason explains the delay. Comments must always be included. Please briefly explain the nature of the delay and why the chosen source of delay is appropriate.

Trial will be marked ‘Need More Info’ if no comments are entered, or if the comments do not adequately explain the delay and the choice of source of delay.

Complex delays with multiple reasons for delay and/or sources of delay

It is important to capture all delays which occurred between DSS and FPR in order to gain a more complete understanding of why trials have not progressed as expected.  As indicated in the table above, please provide reasons for delay between DSS and DSC and between DSC and FPR, if applicable.

As the overall aim of the exercise is to reduce the amount of time to initiate clinical trials, it is important to capture delays which could have been avoided or mitigated in order to highlight opportunities for process improvement. If there are multiple reasons for delay, please include all of these reasons in the record.  Because reasons are not currently ranked or prioritised in the submission platform, it is not possible to objectively differentiate them in the analysis. However, providers are welcome (but not required) to indicate which reason or reasons contributed most significantly to the delay. Where there are also multiple sources of delay associated with these reasons, the CTP Team will accept in good faith the source of delay which the provider associates with the most significant reason for delay as long as the rationale is sufficiently explained in the comments.