The evolving value assessment of cancer therapies: Results from a modified Delphi study.

The move toward early detection and treatment of cancer presents challenges for value assessment using traditional endpoints. Current cancer management rarely considers the full economic and societal benefits of therapies. Our study used a modified Delphi process to develop principles for defining and assessing value of cancer therapies that aligns with the current trajectory of oncology research and reflects broader notions of value. 24 experts participated in consensus-building activities across 5 months (16 took part in structured interactions, including a survey, plenary sessions, interviews, and off-line discussions, while 8 participated in interviews). Discussion focused on: 1) which oncology-relevant endpoints should be used for assessing treatments for early-stage cancer and access decisions for early-stage treatments, and 2) the importance of additional value components and how these can be integrated in value assessments. The expert group reached consensus on 4 principles in relation to the first area (consider oncology-relevant endpoints other than overall survival; build evidence for endpoints that provide earlier indication of efficacy; develop evidence for the next generation of predictive measures; use managed entry agreements supported by ongoing evidence collection to address decision-maker evidence needs) and 3 principles in relation to the second (routinely use patient reported outcomes in value assessments; assess broad economic impact of new medicines; consider other value aspects of relevance to patients and society).

International Association for the Study of Lung Cancer Study of the Impact of Coronavirus Disease 2019 on International Lung Cancer Clinical Trials.

INTRODUCTION: To evaluate the effects of the global coronavirus disease 2019 (COVID-19) pandemic on lung cancer trials, we surveyed investigators and collected aggregate enrollment data for lung cancer trials across the world before and during the pandemic. METHODS: A Data Collection Survey collected aggregate monthly enrollment numbers from 294 global lung cancer trials for 2019 to 2020. A 64-question Action Survey evaluated the impact of COVID-19 on clinical trials and identified mitigation strategies implemented. RESULTS: Clinical trial enrollment declined from 2019 to 2020 by 14% globally. Most reductions in enrollment occurred in April to June where we found significant decreases in individual site enrollment (p = 0.0309). Enrollment was not significantly different in October 2019 to December of 2019 versus 2020 (p = 0.25). The most frequent challenges identified by the Action Survey (N = 172) were fewer eligible patients (63%), decrease in protocol compliance (56%), and suspension of trials (54%). Patient-specific challenges included access to trial site (49%), ability to travel (54%), and willingness to visit the site (59%). The most frequent mitigation strategies included modified monitoring requirements (47%), telehealth visits (45%), modified required visits (25%), mail-order medications (25%), and laboratory (27%) and radiology (21%) tests at nonstudy facilities. Sites that felt the most effective mitigation strategies were telehealth visits (85%), remote patient-reported symptom collection (85%), off-site procedures (85%), and remote consenting (89%). CONCLUSIONS: The COVID-19 pandemic created many challenges for lung cancer clinical trials conduct and enrollment. Mitigation strategies were used and, although the pandemic worsened, trial enrollment improved. A more flexible approach may improve enrollment and access to clinical trials, even beyond the pandemic.

The Menstrual Cycle, Sex Hormones, and Anterior Cruciate Ligament Injury.

OBJECTIVE: To determine if anterior cruciate ligament (ACL) injuries in female athletes occur randomly or correlate with a specific phase of the menstrual cycle. DESIGN AND SETTING: Female athletes who sustained ACL injuries reported the days of their menstrual cycles and provided saliva samples for sex-hormone determination. Salivary sex-hormone profiles were assessed to confirm the self-reported menstrual histories. SUBJECTS: A total of 38 female athletes (20 college, 15 high school, 1 middle school, 2 recreational) with recent ACL injuries participated in the study over a 3-year period. MEASUREMENTS: Athletes with recent ACL injuries completed a questionnaire defining the injury, the last menstrual cycle, prior knee injury, school, and type of birth control used (if any). Each subject provided a 30-cc saliva sample within 72 hours of injury. Saliva samples were placed into sealed containers and frozen at -20 degrees C. We obtained 13 additional control samples from uninjured females to test the correlation between saliva and serum sex-hormone levels. Progesterone and estrogen were assayed by radioimmunoassay. Physical examination, magnetic resonance imaging, or surgery confirmed the injury in all subjects. RESULTS: The correlations between saliva and serum estrogen and progesterone were 0.73 (alpha =.01) and 0.72 (alpha =.01), respectively. Ten of 27 athletes who reported their cycle day at time of injury sustained an ACL injury immediately before or 1 to 2 days after the onset of menses. We rejected the null hypothesis that such high frequency was due to random chance. CONCLUSIONS: A significantly greater number of ACL injuries occurred on days 1 and 2 of the menstrual cycle. Salivary sex-hormone levels correlated with the reported cycle day.