Clinical Trial Initiation and Clinical Trial Recruitment Transparency

The Government wants to see a dramatic and sustained improvement in the performance of providers of NHS services in initiating and delivering clinical research.

The Government’s Plan for Growth, published in March 2011, announced the transformation of incentives at local level for efficiency in initiation and delivery of clinical research. 

As part of this incentivisation, the Department of Health and Social Care requires, via the new NIHR contracts with providers of NHS services, publication on a quarterly basis of information on clinical trial initiation and on recruitment to time and target for commercial contract clinical trials.

Providers of NHS services are required to publish the following information on initiating clinical research on a publicly available part of their website:

• The Research Ethics Committee (REC) reference number
• The Integrated Research Application System (IRAS) Number
• The name of the clinical trial
• The date the site was invited
• The date the site was selected
• The HRA Approval date
• The date the site was confirmed by the sponsor
• The date the site was confirmed
• The date when the site is ready to start
• The date of the recruitment of first participant, and
• The source of the delay in recruiting the first participant into a trial (NHS Provider/ Sponsor/ Both/ Neither).

Plus, in the event that a trial initiation did not proceed to confirmation:

• The non-confirmation status.

Providers of NHS services are also required to publish the following information regarding commercial contract clinical trials, to meet the transparency commitment for delivering clinical research to time and target on a publicly available part of their website:

• The Research Ethics Committee (REC) reference number
• The Integrated Research Application System (IRAS) Number
• The name of the clinical trial
• Whether or not a target number of participants was agreed
• The minimum number of participants agreed to be recruited (if a range has been agreed; this will be the same as the maximum if a fixed number has been agreed)
• The maximum number of participants agreed to be recruited (if a range has been agreed; this will be the same as the minimum if a fixed number has been agreed)
• Whether or not a target date to recruit participants was agreed
• The date agreed to recruit the target number of participants
• The total number of participants recruited at the agreed target date
• The total number of study participants recruited
• The date that the trial closed to recruitment
• The reason for the closure of the trial.

We have published a list of providers of NHS services in receipt of a new NIHR contract and a link to their website where the above data is published. Note where a provider of NHS services has failed to provide a link to their performance data this is highlighted.