A new study published in The Oncologist emphasizes the critical need for regulatory authorities, pharmaceutical clinical trial sponsors, collaborative research groups, and other interests to work together to expedite study approval for clinical trials in cancer research on a global scale.
Dr. Otto Metzger Filho of the Dana-Farber Cancer Institute and a team of international colleagues reviewed the time taken to set up the Adjuvant Lapatinib and/or Trastuzumab Treatment Optimization (ALTTO) trial, a Phase 3 clinical breast cancer trial covering more than 8,300 patients in 44 participating countries.
The research team evaluated different aspects of ALTTO activation across different geographic and economic regions, measuring time intervals for regulatory approval, ethics approval, protocol amendments, and times for patient enrollment. Although some of these time periods did vary in different regions, the study’s primary finding was that significant delays and bottlenecks occurred across all regions.
“Improving the efficiency of the activation process would speed up the ability to gather scientific knowledge and evaluate its applicability,” said corresponding author Dr. Metzger Filho. “Most importantly, it would ultimately benefit the many patients who volunteer to participate in clinical trials. This is the only way to improve treatments for patients with cancer.”
“While the study’s focus on ALTTO means its findings cannot be generalized to make definitive statements about a region’s clinical trial proficiency, its main finding of consistently lengthy timetables should spark a global discussion about the need to improve the efficiency of all cancer trials,” Dr. Metzger Filho said.
“We hope that this study will help investigators in different regions to identify the bottlenecks in activating multinational trials and to address the problem of clinical trial participation,” he said.
The European Society of Medical Oncology (ESMO) heralded the study. Prof Roberto Labianca, Director, Department of Oncology and Haematology, Ospedali Riuniti di Bergamo, Italy, an ESMO spokesman, described the importance of these findings: “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.”
“These findings emphasize the obvious need to expedite, and harmonize, the process for review and approval of new trials across continents. Large studies are increasingly being conducted on an international basis. The delays in implementation of these trials not only deprive patients of access to drugs, but delay their completion and ultimately, regulatory approval. No one wins, least of all the patient,” said Dr. Bruce A. Chabner, Editor-in-Chief of The Oncologist and Director of Clinical Research, MGH Cancer Center, Massachusetts General Hospital.
Date: January 30, 2013
Source: The Oncologist