The TIME Trial Network to facilitate rapid clinical trial activation, patient screening, and enrollment in molecularly targeted trials.

1563 Background: Clinical trials that require patients to have specific actionable mutations based on next generation sequencing (NGS) present unique problems, such as recruiting patients with rare mutations, low enrollment rates, and distance between patients and trial sites. Such barriers can slow the pace of trial enrollment and delay the development of new therapeutic options. Methods: Tempus Labs has partnered with experienced research sites and pharmaceutical companies with molecularly targeted clinical trials to create the TIME Trial Network. The study portfolio includes pharmaceutical sponsored phase I-III clinical trials across solid tumors and hematological malignancies, targeting actionable mutations. This network was established to ensure rapid just-in-time (JIT) activation of trials by streamlining start-up activities (i.e., execution of CTAs and study budgets/financial exhibits, regulatory paperwork, SIV planning and conduct, drug and study supply shipments, submission to the central IRB, and sponsor-specific requirements). Rapid activation begins upon receipt of an activation form from a site partner. “Site Activated” describes a site that has fulfilled all regulatory, documentation, contracting requirements, and has sponsor approval to screen and enroll patients. Results: In Q4 2020, JIT activations were completed for 6 unique interventional clinical trials across 10 sites in 8 US states in the TIME Trial Network. On average, sites were activated in 9.4 business days. Patients enrolled had rare NGS mutations and were from geographically diverse locations. In one urgent case, trial activation, patient consent, screening, and treatment were achieved in 5 business days. In total, 91.7% of patients consented to trial. The average timeline from activation to consent was 4.5 days (range 0 - 24 days), with half of patients consenting within 1 business day. 45.5% of patients who consented to trial received the study drug within 1 day of consent; 2 patients dosed on day of consent. Conclusions: Over a 3-month period, on average, TIME Trial sites were activated in 9.4 days (compared to the 20+ week industry-wide average), and patient consent was completed in 4.5 days. Rapid JIT activations through the TIME program provide significant improvements in trial enrollment timelines and increase access to therapies nationwide. JIT activations may be especially useful for rural, underserved communities, as sites can enroll diverse patient populations and help address the equity gap in clinical trials across ethnic groups.[Table: see text]

The Role of Discretion in Handling COVID-19

Indonesia is now experiencing national disaster called covid-19 or corona outbreak. This case will be a kind of history in the future to become a lesson for central or regional government in making public policy in emergency state. By facing the covid-19 outbreak, public officials must quickly resolve the problem. Discretion gives the opportunity for public officials to do free action to solve the urgent case. Public officials are given alternatives to reach the aim of public service by using discretion even though there is no regulation upon it. Moreover, we know that the implementation of discretion still remains several problems. This research used the literature study method with a qualitative research approach. It was based on several references in order to give the description of the discretion role in handling covid-19 outbreak. Theoretical reference in discussing discretion role was based on the study of journals, books, dan others. Being deeply studied, the discretion implementation of social distancing in big scale belongs to regulatory policy that needs social planning discretion. This type creates more different interests and contains a relatively high complexity. The result of study shows that the implementation of discretion is important because the main function of government is to serve the citizens in emergency state. Therefore, discretion becomes the effective and efficient choice. The integrity of discretion makers becomes one of the variable indicators in creating successful discretion. The government accountability needs to be explained to the society. Moreover, it can be studied more fairly.

Safety recommendations for dentists and maxillofacial surgeons during COVID-19 pandemic

Oral health professionals are at high risk of developing COVID-19 infection due to their practice of close proximity to the patients. Patients in daily dental practice can be seen with basic protection protocol. Routine and elective dental procedures should be cancelled during this pandemic situation and could be rescheduled when the situation eases. In practice, as of universal prevention strategy, all patients should be assumed as COVID-19 infected and treated accordingly. Adequate standards of hygiene and protection should be adopted for all patients to avoid potential transmission risks. During the COVID-19 pandemic, it would be crucial to categorize oral and maxillofacial surgery cases into: emergency case, urgent case, intermediate case and low priority cases. While there has been a growing literature suggesting the aspect of critical care associated in treating these patients, ample of evidence indicates how this COVID-19 pandemic will affect surgical practice. Here we highlight the current unfavorable situation due to COVID -19 and offer recommendations for changes to dental and maxillofacial surgical practices. J Bangladesh Coll Phys Surg 2020; 38(4): 197-204

Encoding Equality: The Case for Greater Regulation of Artificial Intelligence and Automated Decision Making in New Zealand

Automated decision-making systems, developed using artificial intelligence and machine learning processes, are being used by companies, organisations and governments with increasing frequency. The purpose of this article is to outline the urgent case for regulating automated decision-making and examine the possible options for regulation. This article will argue that New Zealand's current approach to regulating decision-making is inadequate. It will then analyse art 22 of the European Union's General Data Protection Regulation, concluding that this regime also has significant flaws. Finally, this article will propose an alternative regulatory solution to address the novel challenge posed by automated decision-making. This solution aims to strike a balance between the interests of organisations in capitalising on the benefits of automated decision-making technology and the interests of individuals in ensuring that their right to freedom from discrimination is upheld.

You Are What You Eat: The Relationship between Values and Organic Food Consumption

In current times, the man-made problems affecting our planet (climate change, loss of biodiversity, etc.) are making an urgent case for shifting towards a more sustainable kind of consumption. One of the ways these problems can be addressed is to promote organic agriculture, which means boosting levels of organic food consumption. This study examines the relationship between the number of organic foods consumed and the specific values that consumers look for in foods, in order to deepen the current knowledge regarding the behaviour of the organic food consumer. To this end, data was analysed from a face-to-face survey of 776 people in Spain through bivariate analysis techniques. Results show that organic food consumers have a different pattern of values from non-consumers and a greater level of involvement with food in general. Moreover, within the group of organic consumers, the effect of values on the quantity or variety of foods consumed is not as marked, although there are differences in favour of those that consume more frequently. Lastly, the main implication of the results obtained is that, in order to increase consumption, selfish values should be connected with altruistic ones. For this reason, instilling a specific value based on the term or concept “life” is proposed.