SRA's number for the day: 37, 000
This article was originally published in SRA
A report on how to improve the regulatory landscape for regenerative medicines in the UK provides as an example of the bureaucracy involved in setting up clinical trials a case whereby one trial involved the need to prepare over 37, 000 pages of documentation1,2.
The House of Lord, science and technology committee says in its Regenerative Medicine Report: "We heard ample evidence that more could be done to support clinical trial set-up." Commenting on the need for additional support for clinicians and academics in setting up trials, the report notes that there are “huge numbers" of forms and documentation required. Also, the skills to conduct administrative preparations required for clinical trials were “not normally found within academic or small company settings”.
References
1. House of Lords, Science and Technology Committee, Regenerative Medicine Report, 1 July 2013, www.publications.parliament.uk/pa/ld201314/ldselect/ldsctech/23/23.pdf
2. UK Govt suggests 24 ways for improving regenerative medicine regulations, Scrip Regulatory Affairs, 3 July 2013