Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, how many patients were recruited to participate in a phase (a) I, (b) II, (c) III and (d) IV clinical trial in each of the last five years.
Data is not available on the total number of patients recruited to participate in a clinical trial. Recruitment in England to clinical trials hosted by the National Institute for Health Research (NIHR) Clinical Research Network (CRN), and total recruitment in England to all trials and other well-designed studies hosted by the CRN is shown in the following table.
| 2009-10 | 2010-11 | 2011-12 | 2012-13 | 2013-14 |
Phase I | 70 | 85 | 151 | 5,363 | 931 |
Phase I/II | 283 | 305 | 808 | 185 | 279 |
Phase II | 3,874 | 2,268 | 2,913 | 3,306 | 3,234 |
Phase II/III | 2,729 | 2,578 | 3,041 | 2,517 | 3,237 |
Phase III | 31,363 | 33,027 | 33,812 | 35,140 | 28,595 |
Phase IV | 11,077 | 10,876 | 8,647 | 9,944 | 23,780 |
Total (trials) | 49,396 | 49,139 | 49,372 | 56,455 | 60,056 |
All trials and studies | 454,138 | 564,698 | 595,540 | 637,974 | 604,216 |
Recruitment in England to clinical trials hosted by NIHR-designated infrastructure for experimental medicine including NIHR biomedical research centres, NIHR biomedical research units, and NIHR clinical research facilities for experimental medicine (from 2012-13 onwards), is shown in the following table.
| 2009-10 | 2010-11 | 2011-12 | 2012-13 | 2013-14 |
Phase 0 | 0 | 530 | 1,275 | 255 | 1,046 |
Phase I | 2,185 | 2,178 | 2,471 | 2,827 | 4,390 |
Phase II | 5,423 | 3,923 | 3,169 | 8,467 | 7,893 |
Phase III | 5,003 | 5,228 | 7,276 | 8,930 | n/a |
Phase IV | 2,425 | 23,519 | 1,843 | 3,135 | n/a |
Total trials | 15,037 | 35,378 | 16,034 | 23,614 | n/a |