With the rising importance of high-quality research in the field of wound care and healing, there is a need for key players from all disciplines across the wound care spectrum to collaborate. Writing for iWounds News, editorial board member Thomas E Serena (Cambridge, Massachusetts, USA) discusses the ongoing work of the SerenaGroup Research Foundation (SGRF) and how cooperation can be leveraged to improve clinical trials, provide education, and allow for the utilisation of new technologies.
Investigators have partnered together to create cooperative groups in most fields of medicine, and the first wound healing cooperative group formed under the aegis of the SGRF, a not-for-profit corporation based in Cambridge, Massachusetts, USA. This group has brought together nearly 100 clinical investigators at 60 sites across the globe to address the inconsistencies and lack of standardisation in wound healing clinical trials.
Today, the SGRF Cooperative conducts numerous multi-centre clinical trials solely within its network. Teamwork, progressive trial design, and technological advances in both data collection and analysis have revolutionised clinical trials in the areas of diabetic foot, venous leg and pressure ulcers, as well as in diagnostics and biomarkers.
The brainchild of a circle of thought leaders that first met in Cambridge in 2003, the Cooperative Group concept struggled for more than a decade. A breakthrough, though, arrived when I gathered a small collection of experienced researchers and began conducting clinical trials.
This group formed the nidus of the SGRF Cooperative. As clinicians, regulatory agencies and payers began to demand high quality trials, the SGRF Cooperative blossomed and, today, a central regulatory office manages ethics committee submissions for the sites. The burgeoning foundation drafts protocols, selects sites for trials, negotiates budgets and provides education for study coordinators and investigators.
In 2019 the SGRF Cooperative participated in clinical trials in all-patient care settings, from the outpatient clinic to skilled nursing facilities. The research included cellular or Tissue-based Products for Wound Care (CTP), topical oxygen in diabetic foot ulcers, pharmaceutical investigations in venous leg ulcers, genetically modified tissues, biomarkers, wound imaging, biofilms, phototherapy and bacterial load in the ulcer bed. In addition, this year saw the SGRF Cooperative move from single-device trials to studies evaluating a combination of multiple modalities. An equally robust slate of trials is planned for 2020.
The SGRF Cooperative’s experience has led to the development of unique trial designs for diagnostics and biomarkers, much needed standardisation for diabetic foot ulcer studies, and protocols that meet the reimbursement requirements for the Centers for Medicare Services.
It has to be said, however, that challenges exist. SGRF must meet the educational needs of the growing Cooperative, which is why a research pre-conference is planned for Wound Week (16–19 April, 2020, Milwaukee, USA). Interested investigators can learn more by contacting myself at [email protected]. In addition, SGRF has scheduled a series of conferences focused on the principles of conducting trials and the unique aspects of wound healing research.
The development of a cooperative group in the field of wound care has shown promise in enrolling patients in studies, supporting investigators and sites, improving trial design and raising the quality of research in wound healing.
Thomas E Serena is the founder and medical director of The SerenaGroup, a family of wound, hyperbaric and research companies, and is a Phi Beta Kappa graduate of The College of William and Mary Williamsburg, USA) and Penn State Medical School (Hershey, USA). He completed his residency in Surgery at the Milton S. Hershey Medical Center (Hershey, USA) and maintains certification in Surgery.
