COVID-19 challenges in clinical trials

Clinical research involves working with human subjects to answer questions relevant to their well-being in an ethical manner. The current scenario from the past one year has drastically changed the face of the clinical trials. The present COVID prevalence and simultaneously conducting the research with all the regulations and the precautions has been the difficult task for the contract research organisations (CRO).

Collaboration between academics and industry in clinical trials: cross sectional study of publications and survey of lead academic authors

Objectives To determine the role of academic authors, funders, and contract research organisations in industry funded trials of vaccines, drugs, and devices and to determine lead academic authors’ experiences with industry funder collaborations. Design Cross sectional analysis of trial publications and survey of lead academic authors. Eligibility criteria for selecting studies The most recent 200 phase III and IV trials of vaccines, drugs, and devices with full industry funding, at least one academic author, published in one of the top seven high impact general medical journals ( New England Journal of Medicine , Lancet , JAMA , BMJ , Annals of Internal Medicine , JAMA Internal Medicine , and PLoS Medicine ). Results Employees of industry funders co-authored 173 (87%) of publications; 183 (92%) trials reported involvement of funders in design, and 167 (84%) reported involvement of academic authors. Data analysis involved the funder in 146 (73%) trials and the academic authors in 79 (40%). Trial reporting involved the funder in 173 (87%) trials and academic authors in 197 (99%). Contract research organisations were involved in the reporting of 123 (62%) trials. Eighty (40%) of 200 lead academic authors responded to the survey. Twenty nine (33%) of the 80 responders reported that academics had final say on the design. Ten responders described involvement of an unnamed funder and/or contract research organisation employee in the data analysis and/or reporting. Most academic authors found the collaboration with industry funder beneficial, but 3 (4%) experienced delay in publication due to the industry funder and 9 (11%) reported disagreements with the industry funder, mostly concerning trial design and reporting. Conclusions Industry employees and academic authors are involved in the design, conduct, and reporting of most industry funded trials in high impact journals. However, data analysis is often conducted without academic involvement. Academics view the collaboration as beneficial, but some report loss of academic freedom.

EYE ON CHINA

China’s 2018 Future Science Prize winners announced. China tops world in alcohol-related deaths. Nanotech to inhibit wheat sprouting. New antibacterial hydrogel for wound healing. Genetically modified Zika virus vaccine to treat brain tumour. Semi-elastic nanoparticles to deliver drugs. Chinese stent for heart disease reported safe in European patients. First China-developed drug for colorectal cancer approved in China. More medicines added to the national list of essential medicines. Recent revisions in Chinese regulations open new doors for contract research organisations.

Putting contract research organisations on the radar

There is a trend for pharmaceutical companies to contract third parties to conduct the clinical trials that are needed to test their drugs. This trend is referred to as outsourcing, and the companies that carry out the work are called contract research organisations. In addition, clinical trials are increasingly conducted in non-traditional trial regions, which are mainly low-and middle-income countries. This trend is called offshoring. The combination of outsourcing and offshoring poses serious risks for the ethical treatment of participants in clinical trials.

Networks of dedicated biotechnology and service firms in Vancouver

Survival and growth of firms depends on their relationships to other organisations, including key suppliers, customers, supporters and competitors. This study compares geographic aspects of the networks of biotechnology firms (DBFs) and contract research organisations and service firms (CROs) in Vancouver, Canada. We find that for DBFs the key actors (organisations and individuals) that they network with are globally located (ie not local), despite the DBFs having originated from a local university. In contrast, CROs are more likely to network with local actors, and with actors on the same continent. Of the DBFs providing performance data, the distribution of their performance is consistent with recent developments in structural embeddedness theory (ie network coupling theory). This suggests that their performance may be inhibited if they are under- or over-embedded in their network, with the greatest opportunity for success in a medium range of coupling.