From the new branch committee chair for multicenter clinical trials in undersea & hyperbaric medicine
The Undersea and Hyperbaric Medical Society will pursue a proposal that falls directly in line with its mission: To investigate post-acute sequelae of SARS-CoV-2 infection – PASC, aka long-haulers syndrome.
To accomplish this the UHMS will launch a multi-institutional cooperative research group patterned after oncology cooperative groups sponsored by the National Cancer Institute (NCI). Since 1955 the NCI has supported cooperative research groups with multi-institutional membership. The initial efforts were focused on childhood cancer research but quickly expanded to include study of adult malignancies. By the end of the 1990s there were four groups focusing on pediatric oncology and 11 groups focusing on adult malignancies. In an effort to re-energize the groups and introduce some needed efficiencies into the system, these existing groups were consolidated into the NCI National Clinical Trials Network (NCTN). This action was taken based on a report in 2010 by the National Academies of Science Institute of Medicine entitled “A National Cancer Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program.” The 15 existing groups were combined into six focusing on adult malignancies and two that focus on pediatric tumors.
We can learn from the NIH experience.
A lesson for our own embryonic efforts to establish a multi-institutional research cooperative is here: From time to time, goals, availability of resources and administrative procedures will need to be reviewed and revised. Nonetheless, the NCI-sponsored groups continue to enroll about 17,000 patients per year into trials and have been responsible for studies leading to an overall cure rate of about 90% in childhood acute lymphoblastic leukemias, a disease that was previously 100% fatal, and overall, about 80% in pediatric tumors.
Many landmark trials in adults notably include studies such as NSABP-06, which demonstrated that modified radical mastectomy is not superior to lumpectomy and breast radiation for most women with early breast cancer.
The effort to establish this research group is not meant to replace or conflict with the efforts of either the Multicenter Registry for Hyperbaric Oxygen Therapy (MCRFHO) or the US Wound Registry. These Registries are both open to our members who desire to participate in clinical research by utilizing the Registry approach. Drs. Jay Buckey and Caroline Fife head up the Registries named above. Dr. Buckey is also one of the co-chairs of the UHMS Research Committee. His experience in establishing the MCRFHO will be invaluable in providing guidance for the administrative structural components required to successfully initiate and operate our new group.
The aims and vision for this group.
In my vision for this new group, it will complement and be complemented by all of the available hyperbaric registries. Joint membership by individual institutions in both efforts seems desirable. The prior efforts of the Baromedical Research Foundation in enlisting several institutions to conduct hyperbaric research should also be noted. This group is responsible for the HORTIS (Hyperbaric Oxygen for Radiation Tissue Injuries) Trial that gave us a randomized controlled trial demonstrating that hyperbaric oxygen is effective in the treatment of radiation-induced proctitis.
We should also recognize the efforts and success of Dr. Lindell Weaver and his colleagues in conducting Department of Defense-sponsored studies investigating a potential role for hyperbaric treatment of traumatic brain injury in service members injured in the line of duty.
There is no question that the effort to establish a multi-institutional cooperative research group will be a daunting challenge. Our plans will need to address the following issues and many more:
• Unlike the NCI groups we have no initial federal funding, although an ambitious long-term goal will be to seek NIH funding. Start-up funds will be needed. The UHMS does not have deep pockets, and we will need individual and industry members to contribute to this cause.
• The administrative structure for the group will have to be established. We will need enlist an oversight committee to see that administrative issues are properly scrutinized.
• Qualifications for membership by applying institutions will have to be established. I believe that we should not restrict membership to academic institutions only. Many of our leaders in hyperbaric medicine come from community practitioners.
• I do not believe that we should restrict our membership to U.S. institutions. By using the aegis of the UHMS and its status as a 501(c)(3) organization we should qualify for many government-sponsored grant opportunities.
• Quality performance reviews will have to be conducted for member institutions to ensure compliance to the specific requirements of protocols for which they recruit and conduct participation.
• It will be essential that the group be able to secure adequate statistical support. Efforts to assist member institutions in data acquisition and entry will be vitally important.
• Procedures to acquire IRB (Institutional Review Board) approval will have to be addressed and simplified when and where possible.
Other committees will need to be created to review and prioritize protocols as they are submitted. I anticipate and welcome investigator-initiated trials, especially when they coincide with opportunities to compete for a grant from NIH or other funding agencies.
Some in our group will criticize these efforts as nothing more than a pipe dream. They will sit back and discuss the impossibilities of this proposal. To them I say: Recall the less than elegant statement, the origin of which is uncertain, that poses “no guts, no glory.”
We can never know whether success is possible until we try. I believe that almost all of you would agree that in hyperbaric oxygen we have a modality which is not a panacea, but which offers the potential for management of many uninvestigated disorders. The physiology of hyperbaric oxygen is unique, and our understanding of its effect on the human organism and the disorders, especially infectious and inflammatory that affect it, are understood only to a very primitive and incomplete extent.
I appeal for your help and your participation in this effort. I know this group. It is made up of many dedicated members who advocate for the best patient care possible. We can deliver this optimal care only when our referring colleagues can be persuaded that our efforts are based on sound and proven scientific principles. For those who struggle to be properly reimbursed for their clinical efforts, I ask: “How would you like to have at your fingertips well-conducted recent studies indicating sound supporting information and a cost advantage for hyperbaric oxygen?”
Our discipline, our specialty, has been in need of strong evidence to justify many of its applications since the inception of clinical hyperbaric medicine. This evidence can only come from us. To generate it, we must have a mechanism. I believe the establishment of this cooperative multi-institutional clinical trial group provides that mechanism.
I hope you agree.
JOHN FELDMEIER, DO, FACRO, FUHM • E: jfeldmeier@aol.com
A longtime UHMS member and supporter, Dr. Feldmeier has served in multiple capacities in the UHMS, including as Past President of the non-profit organization.
From UHMS’ open-access Pressure, available at: https://www.uhms.org/publications/pressure/viewdocument/4816/first-quarter-pressure-2021.html
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