PERFORMANCE IN INITIATING CLINICAL RESEARCH (PI) CLINICAL TRIAL FEEDBACK PROCESS HRA APPROVED TRIALS

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1 PERFORMANCE IN INITIATING CLINICAL RESEARCH (PI) CLINICAL TRIAL FEEDBACK PROCESS HRA APPROVED TRIALS Version Control New document 1

2 Acronyms CTP DSC DSS FPR HRA MHRA REC SOP Clinical Trial Performance Date Site Confirmed Date Site Selected First Patient Recruitment Health Research Authority Medicines and Healthcare products Regulatory Agency Research Ethics Committee 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 Q , 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 patients 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 patient 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 at 2

3 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 Date of First Patient Recruitment (FPR) Date Site Confirmed Date Site Selected Feedback process Matched trial Mismatched trial Need More Info Reason for delay Source of delay Submission period Submission window Description Means the date the first eligible patient consented to the study. 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 on the 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 is also the site, this is the date of the HRA initial assessment letter. 1 Process by which trials which have reported delays are assessed for completeness and clarity. Trial where the reason for delay and the source of delay are consistent with each other and with the durations between DSS and FPR. Trial where the selected source of delay does not correspond to the reason for delay and/or the durations between DSS and FPR. 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. 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. Indicates which party was responsible for the delay: NHS Provider//Both/. The period (usually 30 days) between the end of the quarter and the submission deadline 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 1 3

4 additional information about platform validation of data quality, please refer to the CTP Submission Platform Instructions. 2 Data Issue Type REC number not recognised Incorrect date format Data outside the submission window Data type mismatch No source of delay and/or no reason for delay First Patient Recruited? status is Yes - Date Unavailable HRA approval record not found Action Feedback to trust; trials will not be excluded from the analysis solely on the basis of an unrecognised REC number 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. 2 Usually occurring with Date of First Patient 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 Patient Recruited? changed to No ). 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. Marked as Need More Info, and included in the dataset. Trials will be treated as if a first patient has not been recruited, since the Date of First Patient Recruited will be blank. 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 Trial data not changed, trial previously reported delays Action Matching as previous quarter Trial data updated 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 Matching reassessed 2 ons%20published.pdf 4

5 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 Please briefly explain the reason for A - Relevant delay to permissions (i.e., the permissions delayed HRA approval process not subcategory). Please briefly explain and not granted in completed in time the nature of the delay and why the time chosen source of delay is appropriate. B - Suspended by Study suspended by sponsor at all sites Study suspended by sponsor at this site C - Closed by Study closed by sponsor at all sites Study closed by sponsor at this site D - Delays delay in provision of study documentation (e.g. pharmacy or laboratory manual) delay in provision of IMP, device or equipment delay through protocol or research application amendments delayed site initiation visit delayed confirmation of study open to recruitment at site (i.e., green light) sponsor delay (i.e., the subcategory) in sponsor delay (i.e., the subcategory) in Please briefly explain the nature of the sponsor delay (i.e., the subcategory) in sponsor delay (i.e., the subcategory) in sponsor delay (i.e., the subcategory) in 5

6 Scenario Sub-Category Expected Source of Delay Comments Notes/Action Planned and agreed later start or E - Staff Availability Issues F No Eligible Patients Seen delay intrinsic in study design (e.g. planned later start, followon study, dependency on unpredictable event e.g. flu epidemic) staff availability (annual leave, sickness absence, staff issue / shortage) training (e.g. GCP, protocol specific training, etc.) staff availability (annual leave, sickness absence, staff issue / shortage) training (e.g. protocol specific training etc.) Patients screened but no eligible patients identified Strict patient eligibility criteria / Low recruitment target NHS Host Site's inadequate planning / feasibility arrangements to see patients delay (i.e., the subcategory) in the Please briefly explain provider training issue (i.e., the subcategory) in the Please briefly explain sponsor staffing issue (i.e., the subcategory) in the Please briefly explain sponsor training issue (i.e., the subcategory) in the Please indicate the reason no patients were seen (i.e., the subcategory) in Please indicate the reason no patients were seen (i.e., the subcategory) in NHS staff issues such as annual leave, sick leave, maternity leave, etc. are expected to be within NHS provider's control. staff issues such as annual leave, sick leave, maternity leave, etc. are expected to be within sponsor's control. 6

7 Scenario Sub-Category Expected Source of Delay Comments Notes/Action G No Eligible Patients Consented H - Contracting Delays Eligible patients 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.) Eligible patients seen chose not to participate in study: NHS Host Site's inadequate planning /arrangements to consent patients Contracting / costing delays (including service support costing and excess treatment costing, etc.) Both delay and why the chosen source of delay is appropriate. I - Rare Diseases (Please see submission guidelines 1 ) Rare or very rare diseases studies (as defined in the guidance) J - Other Other - specify in comment Both 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. 7

8 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 8