Research Staff Perspectives on Cancer Clinical Trials and Barriers to Recruitment: A Qualitative Research.

Background Clinical trials are key elements of the processes that account for many of the recent advances in cancer care. Unfortunately, they are becoming more challenging to conduct. Furthermore, a large number of clinical trials in oncology close early due to poor accrual. To identify opportunities for continued improvement in clinical trial enrollment, we sought to identify the obstacles encountered by our clinical trial research staff in these activities. Methods This is a prospective qualitative study, using Grounded Theory Methodology that was concluded at Stephenson Cancer Center (SCC). SCC has been the lead accruer to National Cancer Institute-Lead Academic Participating Sites (NCI-LAPS) trials over the past three years, and in addition, fields investigator-initiated and industry-sponsored trials. We conducted a survey of our research staff including all research nurses and disease site coordinators who participate in recruitment, screening, consenting, data collection, and compliance for interventional clinical trials. We then performed a follow-up meeting with our research coordinators to clarify responses. The study objectives were to highlight common barriers to recruiting adult cancer patients, encountered by research coordinators from all disease sites and to propose effective solutions to identified barriers. Results We are reporting our results of investigating barriers to clinical trials enrollment from a new perspective. The most commonly reported obstacles for clinical trials enrollment from our research staff's perspective were categorized into five themes: clinical trials protocol, communication barriers and cultural beliefs, financial barriers, patients' comorbidities and performance status, and physicians' commitment. Conclusions Although assessing barriers encountered by clinical research staff is an infrequently used metric for improving clinical trial enrollment, it provides an important perspective in the field. Implementing interventions to improve clinical trial feasibility and accrual is critical to improving cancer care.

Edetate Disodium as a Polysorbate Degradation and Monoclonal Antibody Oxidation Stabilizer.

Polysorbates are frequently used in biotherapeutic formulations. Interest in assessing their stability, in particular the impact of their degradation products on the stability of therapeutic proteins, has been steadily growing in the past decade. The work presented summarizes a case study of a monoclonal antibody formulation that demonstrated a simultaneous loss of polysorbate and an increase in methionine oxidation. Spiking studies were conducted to determine both the cause and a potential mitigation for the monoclonal antibody (mAb) oxidation and polysorbate 80 (PS80) loss. The results indicated that a different source material exhibited different rates of mAb oxidation and PS80 loss and that in all evaluated materials, the addition of edetate disodium to the formulation mitigated both observed issues. The mAb was assessed for the presence of lipases and lipoprotein lipase was detected at low levels. It is proposed that edetate disodium was effective in mitigating the mAb oxidation and PS80 loss by chelating calcium in the formulation and therefore decreasing the activity of the lipases.