ESMO Press Release: Regulators and hospital authorities called upon to avoid unnecessary delays in approving clinical trials - ESMO Commentary

Lugano, Switzerland, 28 January 2013 – The European Society for Medical Oncology (ESMO) hails the findings from a large international breast cancer study published today in The Oncologist, highlighting the need for regulators and hospital authorities to avoid unnecessary delays in approving clinical trials[1].

In the research paper, corresponding author Dr. Otto Metzger Filho, from the Dana-Farber Cancer Institute, and colleagues investigated the time that elapsed between the various regulatory steps, including approval from national regulatory authorities, ethics committees and review boards within participating institutions, before researchers could start treating patients in the Phase III ALTTO trial[2].

“As ALTTO is an almost global trial, it allowed researchers to undertake a differential analysis of how long the various approval stages took in different geographic and economic regions,” explains ESMO spokesman Prof Christoph Zielinski (Chair, Clinical Division of Oncology, Medical University Vienna, Austria).

“As expected from previous experience, the durations of time required from one step to the other were not only quite considerable, but also differed from one region to another.”

The study showed that the median approval time was longest in South America --where the regulatory processes took 236 days compared to 52 days in Europe, 26 days in North America and 62 days in the Asia-Pacific.

Overall, it took an average of 55 days for national regulators to give their approval to the trial protocol, 59 days for approval by ethics committees or institutional review boards, and 169 days from the ethics committee or institutional review board approval until the treatment of the first patient, the study shows.

“In all regions, a long time elapsed between approval by institutional review boards or ethics committees and the recruitment of the first patient,” says Prof Zielinski. “This obviously reflects the long time needed for negotiations between the organisations sponsoring the study and individual hospitals where the study was supposed to be performed, in addition to the time required for drug import regulations and perhaps the timing of initiation visits at individual sites.”

“Once trials were approved and started, recruitment was swift and very effective in almost all geographic regions,” ESMO spokesman notes. “This demonstrates the high interest of investigators and the high relevance of the trials for patients.”

Large scale clinical trials, especially those that are based on collaborations among cooperative groups, such as the ALTTO study, help oncologists make significant improvements in therapy and modify the standard of care, notes ESMO spokesman Prof Roberto Labianca (Director, Department of oncology and haematology, Ospedali Riuniti di Bergamo, Italy).

“Unnecessary delays in the approval of clinical trials mean patients can miss the advantages of a new active drug, a new combination of drugs or a novel therapeutic strategy, because oncologists will be compelled to use traditional and potentially sub-optimal treatments,” ESMO spokesman says.

“The ALTTO trial is large, and involves many countries. In my opinion, however, the findings reported in the paper are similar to those we could observe in trials for the treatment of other cancers with fewer patients,” Prof Labianca says. “The data generated in this new analysis show that regulatory and hospital authorities have to speed up their processes for study approval, as they obviously can constitute a major obstacle for study initiation, data generation and the translation of study results into everyday, high-quality clinical routine for the benefit of patients,” Prof Labianca says.

“Countries should undertake major efforts to set limits on the timeframe for regulatory assessment of clinical trial protocols, as well as the minimum speed of the various steps after a positive vote by individual institutional authorities,” agrees ESMO spokesman Prof Zielinski. “Only then will we be able to speed up the availability of results of clinical trials, which is ever more important at a time when more intricate and promising drugs with more attractive targets for individual malignancies are entering the field of clinical trials.”

Notes to Editors

[1] Metzger-Filho O, De Azambuja E, Bradbury I et al. Analysis of Regional Timelines to Set Up a Global Phase III Clinical Trial in Breast Cancer: The ALTTO Experience. The Oncologist doi: 10.1634/theoncologist.2012-0342 [epub ahead of print on January 28, 2013]

The full article can be accessed at www.TheOncologist.com.

[2] The ALTTO trial includes over 8,300 women with early-stage breast HER2-positive cancer in 44 countries. It aims to evaluate whether the drug lapatinib is effective in helping patients with early breast cancer survive longer after surgery without their cancer returning. Patients were enrolled in the trial between 2007 and 2011, and will be followed for a total of 10 years.

About the European Society for Medical Oncology

The European Society for Medical Oncology (ESMO) is the leading European professional organisation committed to advancing the speciality of medical oncology and promoting a multidisciplinary approach to cancer treatment and care.

ESMO’s mission is to advance cancer care and cure through fostering and disseminating good science that leads to better medicine and determines best practice.

ESMO’s scientific journal, Annals of Oncology, ranks among the top clinical oncology journals worldwide.

To find out more about ESMO, please visit: www.esmo.org

Information reported in the mentioned study does not necessarily express ESMO's point of view.