He pointed out that the highest number of amendments per year during Reid's tenure came in 2007, the Nevada Democrat's first year leading the Senate.
On average, each REC studied 39 protocols, 39 revisions and 37 amendments per year, representing an annual workload of 934 hours (480.50 hours for administrative tasks and 453.25 for expertise tasks, on a monthly basis respectively 40 and 38 hours) including neither committee meetings nor training of the members since there is too much variability across committees.
The experts panel estimated that the expertise process required 6 hours per protocol, 3.25 hours per revision and 2.5 hours per amendment.
required 4.5 hours per initial protocol recording, 4.5 hours per revision and 3.5 hours per amendment (table 2).
An average of 1.2 reasons per amendment was cited.
A further dose level, 75 mg kg−1, was included per amendment, as there was DLT in >2 out of six patients at the 90 mg kg−1 dose level.
Around 57% of pharma research costs are spent on the conduct of clinical trials [ 2], and yet this stage of drug development contains significant avoidable costs, such as protocol amendments due to recruitment delays [ 3] (costing around $0.5 million per amendment).
Public Policy Polling has been tracking this issue, and has seen the percentage of likely voters who say they support the amendment drop from sixty-one per cent to fifty-four per cent in the last six months.
These figures show, per year and per month respectively, an estimated administrative workload of 480.50/40 hours and an estimated expertise workload of 453.25/38 hours per REC (based on observed mean annual activity per committee: 39 protocols, 39 revisions and 37 amendments on average per REC and per year).
For biochar concentrations below 10%, higher biochar concentrations provide an increasingly greater enhancement of water holding capacity per unit amendment, suggesting a better value from higher concentrations.
In all, 29% of patients on OxCap+cetuximab started on the reduced dose of capecitabine as per protocol amendment.
