by Lee M. Krug, MD
At the International Mesothelioma Interest Group Meeting in Boston, a group of investigators convened at a Clinical Trials Design Workshop to discuss the challenges of conducting trials in this disease. The rarity of mesothelioma poses various issues with regards to proper study design, accrual, and interest by pharmaceutical companies. One theme that emerged from that workshop was the need to establish a clinical trials consortium. This concept has been quite successful with other rare cancers such as pediatric tumors and sarcoma. I propose that the Meso Foundation would provide the optimal mechanism to initiate such a consortium for mesothelioma trials.
The Meso Foundation Trials Consortium (MFTC) would offer the following advantages:
- It would provide scientific input to ensure that the trials are scientifically sound. The investigators involved in the Consortium best understand the biologic underpinnings of the disease. They would have important insight into the optimal design of the trials. Trials could be prioritized based on scientific merit and promise. This would ensure that valuable resources would not be wasted on trials unlikely to be successful.
- It would establish an international network of participating institutions with the highest volume of mesothelioma patients. This would have drastic effects on speeding accrual to complete trials in a timely fashion. The vorinostat phase III trial took over 5 years to complete enrollment, despite enlisting 125 institutions in 23 countries. The majority of those sites enrolled only 1 or 2 patients over that time. Typically, pharmaceutical companies hire Contract Research Organizations (CROs) who identify sites to conduct trials and collect the data. CROs do not know which institutions will have the appropriate patients for the trial.
- It would offer a referral mechanism to boost accrual. Patients look to the Meso Foundation as the primary source for medical advice, so they could be steered toward institutions that are participating in the designated studies.
Of course, the Meso Foundation does not have the resources to conduct clinical trials itself. The funding will initially need to come from the pharmaceutical industry. The process would work as such: Pharmaceutical companies interested in conducting large trials in mesothelioma would formulate an agreement to work with the Meso Foundation. Their protocols would be reviewed by a subcommittee of the Science Advisory Board who would provide feedback on the design and technical aspects. The Meso Foundation would solicit key institutions with strong research programs and high patient volumes to open the trial at their sites. Patients would be preferentially referred to these studies for participation. Once the success of this mechanism has been established, other companies will surely look to the Foundation for assistance. Ultimately, investigator-initiated trials could even be considered.
This year, more pharmaceutical companies than ever are planning clinical trials for patients with mesothelioma. This heightens the urgency to develop this consortium. As a research community, we cannot wait any longer. Let’s work together to make this happen.
Lee M. Krug, MD, is an Associate Attending Physician in the Division of Thoracic Oncology, Department of Medicine at Memorial Sloan-Kettering Cancer Center in New York, NY. Dr. Krug is also the Director of the Mesothelioma Program at Memorial Sloan-Kettering Cancer Center and Chair of the Science Advisory Board of the Mesothelioma Applied Research Foundation.
