A Study of Regulatory Challenges of Pediatric Oncology Phase I/II Trial Submissions and Guidance on Protocol Development.

The purpose of this study was to identify key deficiencies in pediatric oncology early phase clinical trial protocols in Germany and to provide guidance for efficient trial protocol development. A systematic review of the response letters of German competent authorities (CAs) and Ethics Committees to phase I/II pediatric oncology trial submissions in the period from 2014 to 2019 was performed. Documents were requested from all five Society for Paediatric Oncology and Haematology in Germany (GPOH) phase I/II trial networks plus all nine German Innovative Therapies for Children with Consortium Cancer (ITCC) centers. A blinded dataset containing aggregated data from 33 studies was analyzed for validation. All deficiencies were reviewed, listed, and weighted using a structured matrix according to frequency, category, significance, and feasibility. In total, documents of 17 trials from 6 different sites were collected. Two hundred fifty deficiencies identified by the CAs were identified and categorized into eight categories. "Toxicity and safety" was the most prominent category (27.6%), followed by "Manufacturing and Import" (18%). The majority of deficiencies were categorized as minor and potential measures as easy to address, but an important group of major and difficult to implement deficiencies was also identified. The blinded validation dataset confirmed these findings. The majority of the EC deficiencies could be resolved by changing the wording in the patient-facing documents. In conclusion, this study was able to detect a pattern of key deficiencies. Most of the shortcomings can be anticipated by minor changes in the protocol and increased awareness can prevent time-consuming revisions, withdrawals, or even rejections. A corresponding guideline describing key regulatory aspects is provided.

Exploring the Needs of Cancer Survivors When Returning to or Staying in the Workforce.

Purpose Cancer survivors have strong personal desires to resume work to feel productive and meet financial needs. However, they may be faced with physical and psychological challenges. This research addresses the question: "What are the needs of cancer survivors when returning to or staying in the workforce?" by (i) examining cancer survivors' perspectives on supports needed when returning to or staying in the workforce and (ii) exploring personal and employment factors that influence the return to work process. Methods An exploratory qualitative design was used. We conducted focus groups and one-on-one semi-structured interviews with cancer survivors (n = 15). Inductive thematic analysis was used to analyze the data. Results Four key themes were identified as significant aspects of the return-to-work process for cancer survivors: (1) changing perspectives on self and work; (2) managing work and social systems; (3) determining disclosure and accommodation; and (4) the importance of supports for return to work and daily life. Conclusions There is a growing interest in developing targeted interventions to improve work outcomes for cancer survivors. This study informs cancer rehabilitation research by developing an understanding of the supports and strategies that should be implemented to help cancer survivors return to work successfully and improve quality of life.

The prevalence and determinants of return to work in head and neck cancer survivors.

PURPOSE: To determine the prevalence of and factors associated with the reduction or complete cessation of employment following treatment in head and neck cancer survivors. METHODS: This cross-sectional study was conducted among head and neck cancer survivors visiting outpatient clinics at the Princess Margaret Cancer Centre over a period of 18 months. Participants at any point along their survivorship course completed a survey that included demographic information, the Radiation Therapy Oncology Group (RTOG) Work Status Questionnaire, the Functional Assessment of Cancer Therapy-Head and Neck (FACT-HN), the M.D. Anderson Symptom Inventory-Head and Neck (MDASI-HN), the Cancer Survivors' Unmet Needs Measure (CaSUN), and the EuroQol EQ-5D-5L utility scale. RESULTS: Among 130 participants, 64 were employed at diagnosis. At the time of study, 31 (48%) had reduced their work, among whom, 21 (32.8%) had not returned to work at all following treatment. Pre-treatment employment status, cancer-related symptoms, quality of life, and health utility were associated with employment outcomes. CONCLUSION: A high proportion of head and neck cancer survivors reduced their work capacity and many did not return following cancer treatment. Further research is needed to understand the barriers to work return in these survivors and to explore strategies to encourage resumption of employment and employment satisfaction.