How Mesothelioma Clinical Trials Are Organized

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Mesothelioma clinical trial studies may be open at only one institution (commonly referred to as a single institution study), or may be open at many institutions (either regionally, nationally or internationally). National and international study protocols may be part of what is called a cooperative group, which is a national consortium of institutions whose mission is to investigate diagnosis, treatment and/or monitoring of disease. In the United States, many of the cooperative groups receive federal funding from the National Institutes of Health (NIH). International or national studies can involved multiple cooperative groups (often called an Intergroup study). Examples of cooperative groups that focus on cancer patients include:

  • Eastern Cooperative Oncology Group (ECOG)
  • Cancer and Leukemia Group B (CALGB)
  • Southwest Oncology Group (SWOG)
  • Radiation Therapy Oncology Group (RTOG)
  • American College of Surgeons Oncology Group (ACOSOG)
  • North Central Cancer Treatment Group (NCCTG)
  • European Organisation for Research and Treatment of Cancer (EORTC)

…and many others

In the United States, cooperative group study protocols are reviewed and approved at the federal level by the Cancer Therapy Evaluation Program (CTEP) before any institution has the opportunity to review and open the study protocol. Protocols that are approved by CTEP then become available for the institutional members (that wish to participate in the study) of the cooperative group(s) that submitted the protocol to CTEP. Some studies (including some cooperative group studies) may be fully or partially sponsored by drug companies. Drug companies may sponsor studies that are open at a single or multiple institutions. Other studies may be independently funded. The National Cancer Institute (NCI- a branch of the NIH) studies are available to any U.S. citizen who is eligible for that study; generally all treatments and diagnostic testing that are part of the study protocol are funded by the NCI, and only available at the NCI campus in Bethesda, Maryland.

Single institution studies generally plan to enroll 25-75 patients (though NCI protocols often plan to enroll >100 patients). A clinical study may only be available at select institution(s). Thus, informing your doctor of this study will not necessarily allow him or her to enroll you on the study if he or she is not part of that institution(s). There are many reasons for this:

• Firstly, the study must go through the Institutional Review Board of every participating hospital or cancer center, and cannot be ethically offered at an institution which has not reviewed the protocol.

• Secondly, an infrastructure must be in place to deliver protocol treatment. While any hospital or cancer center can open studies, some studies require pharmacists trained in how to handle certain drugs, nurses trained in administering certain drugs, nurses, doctors and research specialists trained at administering diagnostic testing or assessments and data managers.

If a study is of particular interest to you, your oncology team may be able to determine if you are eligible, and then may be able to facilitate you being assessed and possibly treated at the institution(s) offering the study.

Next, learn about the details of participating in a mesothelioma clinical trial.