Bibliography on Clinical Trial Procedures

In this section we would like to present manuscripts published in peer-reviewed journals that provide data on clinical research procedures, classified according to their topic.

Please send us additional manuscripts to ecro@esmo.org in order to improve and update this collection.

Administrative procedures

1. Rule S, LeGouill S. Bureaucracy is strangling clinical research. BMJ 2019. doi:10.1136/bmj.l1097.
2. Gobbini E, Pilotto S, Pasello G et al. Effect of Contract Research Organization Bureaucracy in Clinical Trial Management: A Model From Lung Cancer. Clin. Lung Cancer 2018; 19(2):191–198.
3. Steensma DP, Kantarjian HM. Impact of Cancer Research Bureaucracy on Innovation, Costs, and Patient Care. J. Clin. Oncol. 2014; 32(5):376–378.
4. Cardone C, Martinelli E, Troiani T et al. Exploratory findings from a prematurely closed international, multicentre, academic trial: RAVELLO, a phase III study of regorafenib versus placebo as maintenance therapy after first-line treatment in RAS wild-type metastatic colorectal cancer. ESMO Open 2019; 4(4):e000519.
5. Roberts DA, Kantarjian HM, Steensma DP. Contract Research Organizations in Oncology Clinical Research: Challenges and Opportunities. Cancer 2016 15; 122: 1476-82.
6. Ramirez AG, Chalela P, Suarez L, Muñoz E, Pollock BH, Weitman SD, Gallion KJ. Early Phase Clinical Trials: Referral Barriers and Promoters among Physicians. J Community Med Health Educ. 2012; 2: 1000173.

Inclusion criteria

1. Clisant S, Clermont A, Adenis A, Penel N. Inflation in the number of eligibility criteria for industry-sponsored phase II cancer clinical trial: illustration over a 20-year period. Contemp Clin Trials 2012 May;33(3):459.
2. Penel N, Lebellec L, Vanseymortier M. Reappraisal of eligibility criteria in cancer clinical trials Curr Opin Oncol. 2018 Sep;30(5):352-357.
3. Jin S, Pazdur R, Sridhara R. Re-evaluating eligibility criteria for oncology clinical trials: Analysis of investigational new drug applications in 2015. J. Clin. Oncol. 2017; 35(33):3745–3752.
4. Kim ES, Bruinooge SS, Roberts S et al. Broadening eligibility criteria to make clinical trials more representative: American society of clinical oncology and friends of cancer research joint research statement. J. Clin. Oncol. 2017; 35(33):3737–3744.
5. Gore L, Ivy SP, Balis FM et al. Modernizing clinical trial eligibility: Recommendations of the American society of clinical oncology-friends of cancer research minimum age working group. J. Clin. Oncol. 2017; 35(33):3781–3787.
6. Garcia S, Bisen A, Yan J et al. Thoracic Oncology Clinical Trial Eligibility Criteria and Requirements Continue to Increase in Number and Complexity. J. Thorac. Oncol. 2017; 12(10):1489–1495.

Informed consent

1. Bleiberg H, Decoster G, de Gramont A et al. A need to simplify informed consent documents in cancer clinical trials. A position paper of the ARCAD Group. Ann. Oncol. 2017; 28(5):922–930.

Research biopsies and molecular testing 

1. Penel N, Lebellec L, Smis P, Lebitasy MP. Management of tumor tissue in cancer clinical trials: An ethical perspective. Bull Cancer 2019 Nov;106(11):1064.
2. Lim C, Sung M, Shepherd FA et al. Patients with Advanced Non–Small Cell Lung Cancer: Are Research Biopsies a Barrier to Participation in Clinical Trials? J. Thorac. Oncol. 2016; 11(1):79–84.
3. Adam V, Dooms C, Vansteenkiste J. Lung cancer at the intensive care unit: The era of targeted therapy. Lung Cancer 2015; 89(2):218–221.
4. Vrancken A, Lepers S, Peeters L et al. The challenge of molecular testing for clinical trials in advanced non-small cell lung cancer patients: Analysis of a prospective database. Lung Cancer 2016; 102: 96-100.

Trial activation, study monitoring and follow-up

1. Martinez DA, Tsalatsanis A, Yalcin A, Zayas-Castro JL, Djulbegovic B. Activating clinical trials: a process improvement approach. Trials. 2016; 17: 106.
2. Mckane A, Sima C, Fleck S, Weiss GJ. Examining the Effect of Teleconferences on Oncology Phase 1 Trials. J Cancer. 2013; 4: 464-467.

Electronic trial procedures

1. Perez RP,Finnigan S, Patel K, Whitney S, Forrest A. Clinical Trial Electronic Portals for Expedited Safety Reporting: Recommendations from the Clinical Trials Transformation Initiative Investigational New Drug Safety Advancement Project. JMIR Cancer. 2016 Jul-Dec; 2(2): e16.
2. Uren SC, Kirkman MB, Dalton BS, Zalcberg JR. Reducing Clinical Trial Monitoring Resource Allocation and Costs Through Remote Access to Electronic Medical Records.  J Oncol Pract. 2013 Jan; 9(1): e13–e16.

Inclusion in clinical trials

1. Mahmud  A, Zalay O, Springer A, Arts K, Eisenhauer E. Barriers to participation in clinical trials: a physician survey Curr Oncol 2018 Apr;25(2):119-125.
2. Vickers A. Do we want more cancer patients on clinical trials If so, what are the barriers to greater accrual. Trials. 2008; 9: 31.
3. Kristian D. Stensland, Russell B. McBride, Asma Latif, Juan Wisnivesky, Ryan Hendricks, Nitin Roper, Paolo Boffetta, Simon J. Hall, William K. Oh, Matthew D. Galsky. Adult Cancer Clinical Trials That Fail to Complete: An Epidemic? Journal of the National Cancer Institute, 2014; 106: 1-6