1. Rosenblatt M. The large pharmaceutical company perspective. N Engl J Med. 2017;376:52–60.
2. Schuler P, Heering C. What makes a good protocol better? In: Schuler P, Buckley B, eds. Reengineering Clinical Trials. London: Academic Press; 2015:137–144.
3. DiMasi JA, Grabowski HG. The cost of biopharmaceutical R&D: is biotech different? Manage Decis Econ. 2007;28:469–479.
4. Wampler S. Tackling protocol complexity. Good Clin Pract J. 2000;7:6–8.
5. Fast Track Systems. Index of clinical study complexity by year, phases I-IV. In: Mathieu M, ed. Parexel’s Pharmaceutical R&D Statistical Sourcebook, 2007/2008. Waltham, MA: Parexel International Corp; 2007:116.