Background and aim Time allowed for independent ethics committees (IECs) and administrative offices to assess and activate clinical trials is regulated by law. This study aims to describe time spent activating two multicentre non-profit trials supported by the Italian Medicines Agency (AIFA). Five non-AIFA supported (NAS) trials were used as a benchmark.
Methods The two AIFA-supported trials were FATA-GIM3 (optimal adjuvant hormonal treatment for breast cancer) and TOSCA (duration of adjuvant FOLFOX in colorectal cancer). The five NAS trials focused on lung or ovarian cancer. The following were measured for all trials: date of submission of trial documentation to peripheral IEC, date of IEC opinion and date trial contracts were signed. Times are reported in months.
Results 106 centres applied to participate in FATA-GIM3 and 137 in TOSCA. An IEC opinion was issued by 100/106 (1 negative opinion) and 137/137 (2 negative opinions) centres, with a median time from submission of 3.6 months (range 0.1–60.2). After a positive IEC opinion, the median time before signing the trial contract was 3.3 months (0.1–59.2). Contracts were signed with 93/99 and 135/135 centres, with a median time from submission of study documentation of 8.4 months (0.5–61.1). Times for NAS trials were not substantially different.
Conclusions FATA-GIM3 and TOSCA centres were opened after a median of 8 months, consisting of nearly 4 months each for IEC opinion and administrative signature, similar to the NAS trials. The process of trial activation in Italy remains inefficient and takes far longer than legally allowed.
- Clinical Ethics
- Ethics Committees/Consultation
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.
Read the full text or download the PDF:
Other content recommended for you
- Impact of recent legislative bills regarding clinical research on Italian ethics committee activity
- Surgical ovarian suppression for adjuvant treatment in hormone receptor positive breast cancer in premenopausal patients
- Young adults' opinions of Philip Morris and its television advertising
- Multicentre trials review process by research ethics committees in Spain: where do they stand before implementing the new European regulation?
- Research ethics committee decision-making in relation to an efficient neonatal trial
- SYMptom monitoring with Patient-Reported Outcomes using a web application among patients with Lung cancer in the Netherlands (SYMPRO-Lung): study protocol for a stepped-wedge randomised controlled trial
- Factors that influence attitude and enforcement of the smoke-free law in Turkey: a survey of hospitality venue owners and employees
- What do research ethics committees say about applications to conduct research involving children?
- Research ethics committees in Europe: implementing the directive, respecting diversity
- Absent progesterone receptor expression in the lymph node metastases of ER-positive, HER2-negative breast cancer is associated with relapse on tamoxifen