Highlights
- •Regulatory aspects regarding clinical trials increased substantially over time.
- •These regulations seem to cause information overload and ineffective bureaucracy.
- •Information overload and bureaucracy may distract from essential safety information.
- •We give insight in clinical trial regulations, evaluating practical consequences.
- •We propose specific improvements for optimal clinical trial conduct.
Abstract
Performance of clinical trials has led to major therapeutic developments and substantial
improvements in the field of medical oncology. To ensure patient's safety, regulatory
aspects for proper clinical trial conduct have been increased over the past two decades but
seem to cause information overload and ineffective bureaucracy, possibly even impacting
patient safety. To put this in perspective, after the implementation of Directive
2001/20/EC in the European Union, a 90 per cent increase in trial launching time,
a 25 per cent decrease in patient participation and a 98 per cent rise in administrative
trial costs were reported. The time to initiate a clinical trial has increased from
a few months to several years in the past three decades. Moreover, there is a serious
risk that information overload with relatively unimportant data endangers the decision-making
processes and distracts from essential patient safety information. It is now a critical
moment in time to improve efficient clinical trial conduct for our future patients
diagnosed with cancer. We are convinced that a reduction of the administrative regulations,
information overload, and simplification of the procedures for trial conductance may
improve patient safety. In this Current Perspective, we give insight in the current
regulatory aspects of clinical research, evaluate the practical consequences of these
regulations, and propose specific improvements for optimal clinical trial conduct.
Keywords
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References
- Progress in cancer survival, mortality, and incidence in seven high-income countries 1995-2014 (ICBP SURVMARK-2): a population-based study.Lancet Oncol. 2019; 20: 1493-1505
- Main changes in European clinical trials regulation (No 536/2014).Contemp Clin Trials Commun. 2018; 11: 99-101
- Impact of cancer research bureaucracy on innovation, costs, and patient care.J Clin Oncol. 2014; 32: 376-378
- Steps and time to process clinical trials at the cancer therapy evaluation program.J Clin Oncol. 2009; 27: 1761-1766
- Information overload in the information age: a review of the literature from business administration, business psychology, and related disciplines with a bibliometric approach and framework development.Bus Res. 2019; 12: 479-522
- Equipoise lost: ethics, costs, and the regulation of cancer clinical research.J Clin Oncol. 2010; 28: 2925-2935
- A systemic review of toxic death in clinical oncology trials: an Achilles’ heel in safety reporting revisited.Br J Cancer. 2012; 107: 1-6
- Information overload in healthcare: too much of a good thing?.Z Evid Fortbild Qual Gesundhwes. 2015; 109: 285-290
- Recovering from information overload.2011
- Information overload in emergency medicine physicians: a multisite case study exploring the causes, impact, and solutions in Four North England National Health Service Trusts.J Med Internet Res. 2020; 22e19126
- Effects of workload, work complexity, and repeated alerts on alert fatigue in a clinical decision support system.BMC Med Inform Decis Mak. 2017; 17: 36
- Information overload and missed test results in electronic health record-based settings.JAMA Intern Med. 2013; 173: 702-704
- Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the member states relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.Med Etika Bioet. 2002; 9: 12-19
- Costs of clinical trials with anticancer biological agents in an Oncologic Italian Cancer Center using the activity-based costing methodology.PLoS One. 2019; 14e0210330
- N Engl J Med. 1964; 271: 473
- Consequences of Directive 2001/20/EC for investigator-initiated trials in the paediatric population – a field report.Eur J Pediatr. 2007; 166: 1169-1176
- Effect of contract research organization bureaucracy in clinical trial management: a model from lung cancer.Clin Lung Cancer. 2018; 19: 191-198
- Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on Clinical trials in medicinal products for human use and repealing Directive 2001/20/EC.Off J. 2014; 158: 1022
- Good clinical trials by removing defensive interpretation of good clinical practice guidelines.Br J Clin Pharmacol. 2021; 87: 4552-4559
- 21 Code of federal regulations part 11-compliant digital signature solution for cancer clinical trials: a single-institution feasibility study.JCO Clin Cancer Inform. 2020; 4: 854-864
- ESMO clinical research observatory (ECRO): improving the efficiency of clinical research through rationalisation of bureaucracy.ESMO Open. 2020; 5
- Clinical research in Europe: who do we do all that for?.J Cancer Pol. 2020; : 23
- Streamlining adverse events reporting in oncology: an American society of clinical oncology research statement.J Clin Oncol. 2018; 36: 617-623
- The majority of expedited investigational new drug safety reports are uninformative.Clin Cancer Res. 2016; 22: 2111-2113
- Patient safety issues from information overload in electronic medical records.J Patient Saf. 2022; 9900https://doi.org/10.1097/PTS.0000000000001002
- Treatment-related mortality with bevacizumab in cancer patients: a meta-analysis.JAMA. 2011; 305: 487-494
- A need to simplify informed consent documents in cancer clinical trials. A position paper of the ARCAD Group.Ann Oncol. 2017; 28: 922-930
- American society of clinical oncology road to recovery report: learning from the COVID-19 experience to improve clinical research and cancer care.J Clin Oncol. 2021; 39: 155-169
Article info
Publication history
Published online: January 27, 2023
Accepted:
January 20,
2023
Received in revised form:
January 17,
2023
Received:
December 1,
2022
Identification
Copyright
© 2023 Published by Elsevier Ltd.
