Adverse effects of a multicentre system for ethics approval on the progress of a prospective multicentre trial of cancer treatment: how many patients die waiting?

Abstract

The multicentre system of ethics approval has significantly delayed this multicentre trial and may delay advances in cancer care. Extrapolating this delay to determine an influence on improvements in cancer survival suggests that it may be responsible for 60 cancer deaths per year. A method for measuring the effect on the shape of the accrual curve is defined, and the term DIABOLECAL (Delays in Accrual Brought On Largely by Ethics Committee Activity Lag-time) is proposed to describe it. Attempts to overcome this problem have been introduced overseas.

Limited Chemotherapy and Shrinking Field Radiotherapy for Osteolymphoma (Primary Bone Lymphoma): Results From the Trans-Tasman Radiation Oncology Group 99.04 and Australasian Leukaemia and Lymphoma Group LY02 Prospective Trial

“…TROG and ALLG participating centers submitted the trial protocol to their ethics committees. The processes involved in ethics committee review for this trial were reviewed (13). Written informed consent was obtained from each patient.…”

Regulation--the real threat to clinical research

“…In a risk-benefit arena that is now heavily stacked towards perceived risk, the instigators of over-regulation must bear responsibility for the real and emerging risks of a failure to deliver the potential lifesaving benefits of clinical research promptly. 15 Contributors and sources: PMS has over 20 years' experience of undertaking clinical translational research and has witnessed first hand the threat to this activity from the increased regulatory burden. He has also been involved in UK government and medical charity research funding panels.…”

Impact of regulatory assessment on clinical studies in Brazil

“…Although not all clinical studies can save lives, each patient for whom participation in a clinical study is prevented as a result of these delays misses a significant opportunity to receive access to innovative treatments. 15 The ethical review was developed to ensure the protection of patients, but this precept is not always observed. As an example we can cite the ISIS-2 study on acute myocardial infarction, where the comparison between the requirements necessary in the USA and United Kingdom in the ICF of participants estimated around 10,000 unnecessary patient deaths attributed to factors that reduced recruitment.…”