An example of implementing a safety protocol in remote intervention and survey research with college students.

INTRODUCTION: This article draws attention to the need for open evaluation and reporting on safety protocols in survey and intervention research. We describe a protocol for responding to those who indicate increased risk of self-harm (i.e. suicidality or potentially lethal alcohol use) as an example and report on the outcome of our procedures. METHODS: Participants were first-year college students (n = 891) participating in an intervention trial for binge drinking. We describe the protocol, provide descriptive outcomes, and examine whether participant sex, attrition, or study intervention condition were related to endorsing items that indicated risk for suicidality or potentially lethal alcohol use. RESULTS: Of the 891 participants, 167 (18.7%) were identified as being at risk in one or more study wave. Of those, we were able to successfully contact 100 (59.9%), 76 (45.5%) by phone, and 24 (14.4%) by email. Of those 100, 78 accepted mental health resources as a result of outreach. Participant sex, attrition, and intervention condition were not related to risk. DISCUSSION: This article may aid other research teams in developing similar protocols. Strategies to reach an even greater proportion of high-risk participants are needed. A body of literature documenting published safety protocols in research and the associated outcomes would help to identify opportunities for improvement.

In India, most principal investigators have run very few trials over the years.

Background: In the past, clinical trials run in India have been the subject of criticism. Among other steps to improve the trial ecosystem, for some time the government limited the number of trials that a Principal Investigator (PI) could run to three at a time. We were interested to know how many trials PIs in India tend to run at a time. Methods: We accessed the 52,149 trial records hosted by the Clinical Trials Registry-India in April 2023. Of these, we shortlisted trials that had run in India, were interventional, and involved certain interventions such as drug, biological etc. We used multiple parameters, such as email ID, phone number etc. to determine whether one name always represented the same PI and whether two names corresponded to the same PI. We then determined how many trials each PI had run. Results: We found that 3,916 unique PI names were associated with 6,665 trials. Of these, 2,963 (75.7%) PIs had run a single study. Only 251 (6.4%) had run more than three trials. A mere 14 PIs had run 20 or more trials. The 14 PIs were affiliated with local pharma companies (6), local or global contract research organizations (4), multinational pharma companies (3) and the Central Council for Research in Homeopathy (1). The maximum number of trials run by a single PI was 108. Of these, the largest number run in a single year, 2022, was 53. Conclusion: Each PI name needs to be connected to a unique ID that does not change with time, so that it is easier to track the number of trials that a given PI has run. The number of studies run by a given PI at a given time must not be excessive and needs to be monitored more actively. The government needs to consider whether a cap on the number of trials that a PI runs at a time is required and what infrastructure needs to be in place to facilitate higher numbers of trials. Trial registry records need to be updated more regularly. Other countries may wish to do likewise.

Safety risks and ethical governance of biomedical applications of synthetic biology.

Background: In recent years, biomedicine has witnessed rapid advancements in applying synthetic biology. While these advancements have brought numerous benefits to patients, they have also given rise to a series of safety concerns. Methods: This article provides a succinct overview of the current research on synthetic biology's application in biomedicine and systematically analyzes the safety risks associated with this field. Based on this analysis, the article proposes fundamental principles for addressing these issues and presents practical recommendations for ethical governance. Results: This article contends that the primary safety risks associated with the application of synthetic biology in biomedicine include participant safety, biosafety risks, and biosecurity risks. In order to effectively address these risks, it is essential to adhere to the principles of human-centeredness, non-maleficence, sustainability, and reasonable risk control. Guided by these fundamental principles and taking into account China's specific circumstances, this article presents practical recommendations for ethical governance, which include strengthening ethical review, promoting the development and implementation of relevant policies, improving legal safeguards through top-level design, and enhancing technical capabilities for biocontainment. Conclusion: As an emerging field of scientific technology, synthetic biology presents numerous safety risks and challenges in its application within biomedicine. In order to address these risks and challenges, it is imperative that appropriate measures be implemented. From a Chinese perspective, the solutions we propose serve not only to advance the domestic development of synthetic biology but also to contribute to its global progress.

Conducting a supportive oncology clinical trial during the COVID-19 pandemic: challenges and strategies.

The coronavirus disease 2019 (COVID-19) pandemic resulted in severe interruptions to clinical research worldwide. This global public health crisis required investigators and researchers to rapidly develop and implement new strategies and solutions to mitigate its negative impact on the progress of clinical trials. In this paper, we describe the challenges, strategies, and lessons learned regarding the continuation of a supportive oncology clinical trial during the pandemic. We hope to provide insight into the implementation of clinical trials during a public health emergency to be better prepared for future instances.Trial registration: ClinicalTrials.gov, a service of the US National Institute of Health (NCT03030859). Registered on 22 January 2017.

Managing clinical trials during COVID-19: experience from a clinical research facility.

There is a dearth of literature on best practices for managing clinical trials, and little is understood on the role of the clinical trial manager. The COVID-19 pandemic has brought this into focus, and the continuance of clinical trials worldwide has been catapulted into a state of uncertainty as countries enter lockdown to manage the spread of the virus. Participant retention is an ongoing issue in clinical trials, and the concern is that in the current pandemic environment, attrition will be an issue which could potentially jeopardise trial completion. The current situation has necessitated timely problem solving by the trial manager to ensure trials remain open, and most importantly, that participant safety, paramount in clinical trials, is monitored. The purpose of our study is to highlight key issues arising in the management of clinical trials during a pandemic from first-hand experience in a clinical research facility managing both academic and commercial clinical trials. We offer some practical guidance on solution implementation.

Online Research Participant Communication: Balancing Benefits and Risks.

Online communication has emerged as an important vehicle for participant interaction during the course of clinical research. At the same time, such communication has been identified as a source of risks both for participants and the scientific integrity of clinical trials. Although strategies for mitigating these risks have become a focus in the research community, missing from the discussion has been a sustained and sympathetic effort to understand the various benefits of online communication for participants themselves. In this article, we provide a taxonomy of the benefits of online communication for participants and argue that attempts to mitigate the risks of online communication by discouraging or placing limits on such communication are generally unadvisable. Instead, we advance a context-sensitive approach that emphasizes education and several actionable recommendations for preserving the benefits of online participant communities while mitigating the risks.