Salary Survey: The Age of COVID

With large shift to decentralized strategies, industry roles appear set for change Our 2022 Clinical Research Industry Salary and Employee Satisfaction Survey Report, a biennial survey of clinical trials professionals, conducted with our survey partner SCORR Marketing, shows no overwhelming deviations this year from previous years. In Figure 1 on the facing page, you can see the various functional areas and, expectedly, a higher proportion of clinical operations respondents, as that is our core content focus. [...]75% of the respondents do not receive non-cash compensation such as a car, stock options, or mobile phones. In the first five to seven years, employee value increases much more quickly than 3% a year (a typical merit increase). "Because the leaving and onboarding process is time-consuming and costly for employers, why not look to increasing the base pay via merit increases for current employees?

Trial Innovation Beyond the COVID-19 Pandemic

In this article from our June issue (https://bit.ly/2YVTxeH), we noted that the "newer methods" of patient-centric clinical trials trend toward home study visits, telemedicine, and remote patient monitoring, have been happening over the past few years, but uptake was slow. Tufts Center for the Study of Drug Development found no significant differences in the mean number of patients enrolled per site or by therapeutic area in 2019 versus 2012. During the pandemic, service providers offering safe patient access and decentralized model enablement, found increased interest in their business.

The Future of Remote Trials

According to a recent report from Frost & Sullivan, "Hybridization of Clinical Trial Designs Reviving Global CRO Market Post-pandemic;2019-2024" (https:// bit.ly/36Fquky), hybrid trials and remote patient monitoring are key trends driving the global CRO market. Frost & Sullivan further expects that revenue will be back to its original growth trajectory by 2024-2025, with a compound annual growth rate of 8.2% and $63.83 billion revenue by 2024, up from $43.03 billion in 2019. The report also suggested that adoption of hybrid trials by CRCs could increase their growth opportunities by enabling uninterrupted trials and cost savings of 15% to 20%;by focusing on long-term collaborations that offer substantial cost advantages with 8% to 13% savings across different trial phases;by leveraging new technologies, such as risk-based monitoring, eConsent, wearables, and telemedicine patient visits;and implementing direct-to-patient model clinical trial supplies.

Does Clinical Operations Need a Makeover?

Jim Reilly, VP of Clinical Strategy, Veeva Systems Reilly has led teams responsible for sales and delivery of clinical data standards and regulatory technologies at Accenture (formerly as part Octagon Research Solutions), and has extensive consulting experience from his time at Octagon Research, as well as HighPoint Solutions, where he led business process improvement and technology selection programs in clinical and regulatory operations at a number of large pharmaceutical organizations. [...]sites rely on sponsors and CROs to provide technology for managing trial activities and collaborating during a study. The resulting gains in efficiency, visibility, and quality will enable trials to run faster, simplify data sharing and collaboration, and ultimately, accelerate delivery of breakthrough drugs and treatments to the market amidst a more complex clinical trial environment." Some companies have clinical project leads, clinical trial leads, lead clinical research associates (CRAs), but ultimately, what a clinical operations makeover would truly look like depends on the size of the company and what the expectations are around the ClinOps role as well as the needs of the organization.

COVID Exposes the Cracks in Trial Problems

The primary one, at 67.3%, was suspension of enrollment;delayed initiation of planned trials followed at 18.4%, and slow enrollment at 14.4%. If sponsors now take a data-driven approach, by identifying high-performing sites or finding the most relevant CRO with a performance record in the indication under study, they could potentially avoid a trial destined for failure. Li uses the example of the number of recruiting sites in Crohn's disease that increased in the three years before COVID-19, from under 2,000 to more than 9,000, and without acknowledgment of the limited patient population.

From Present to 'Post': Holdover Trends to Watch

The article discusses on several topics which are trending in healthcare services including Telemedicine and receiving healthcare remotely was the basis of clinical trials and healthcare delivery during Covid, Community-based research, and workforce decline of clinical trials.

Sleep health among people with severe mental ill health during the COVID-19 pandemic: Results from a linked UK population cohort study

Objectives Sleep problems are a transdiagnostic feature of nearly all psychiatric conditions, and a strong risk factor for initial and recurrent episodes. However, people with severe mental ill health (SMI) are often excluded from general population surveys, and as such the extent and associates of poor sleep in this population are less well understood. This study explores sleep health in an SMI sample during the COVID-19 pandemic, using multiple regression to identify risk factors, including daily routine, wellbeing and demographics. Methods An existing cohort of people with an SMI diagnosis were sampled. Participants were invited to complete a self-report survey about their health and the impacts of COVID-19 and associated public health measures. Sleep duration, efficiency, and quality were measured using items from the Pittsburgh Sleep Quality Index (PSQI). Results Two hundred forty-nine adults (aged 21–84 years) completed the survey. Mean sleep duration and efficiency were similar to general population estimates, at 7 h 19 min and 78%, respectively. However, 43% reported “bad” sleep quality that was associated with being younger in age as well as disturbed routine and declined wellbeing. Indeed, 37% reported a disturbed routine during the pandemic. Conclusions High estimates of perceived poor sleep quality in the SMI population align with previous findings. Supporting people with SMI to maintain routine regularity may work to protect sleep quality and wellbeing. Future research should more closely examine sleep health in people with SMI, using accessible and scalable measures of objective and subjective sleep, examining longitudinal trends.

UK children's sleep and anxiety during the COVID-19 pandemic.

BACKGROUND: Sleep and mental wellbeing are intimately linked. This relationship is particularly important to understand as it emerges over childhood. Here we take the opportunity that the COVID-19 pandemic, and resulting lockdown in the UK, presented to study sleep-related behaviour and anxiety in school-aged children. METHODS: Parents and children were asked to complete questionnaires towards the start of the UK lockdown in April-to-May of 2020, then again in August of that year (when many restrictions had been lifted). We explored children's emotional responses to the pandemic and sleep patterns at both time points, from the perspectives of parents and children themselves. RESULTS: Children's bedtime anxiety increased at the start of the lockdown as compared to a typical week; however, by August, bedtime anxiety had ameliorated along with children's COVID-19 related anxiety. Bedtime anxiety predicted how long it took children to fall asleep at night at both the start and the end of the lockdown. Bedtime and wake-up time shifted at the start of lockdown, but interestingly total sleep time was resilient (likely owing to an absence of early school start times) and was not predicted by child anxiety. CONCLUSIONS: These findings further support calls for sleep quality (in particular, time taken to fall asleep) to be taken as a key indicator of mental health in children, particularly under usual circumstances when schools are open and sleep duration may be less resilient.

"Warm and Ready" Clinical Trial Sites

The article reports that need to support the development and long-term sustainability of an infrastructure that unites clinical research with clinical care. Topics include need to increase the number of sites, additional recommendations such as engaging more community-based institutions and networks;and disseminated findings from the Federal COVID-19 Response or Countermeasures Acceleration Groups to bring relevant therapeutics to use in the next public health emergency.

The Tangled Web of Large Outsourced Providers

The article focuses on the Tangled Web of Large Outsourced Providers. Topics discussed include CROs, as an industry, appear to be in a period of change, and the overall market for mergers and acquisitions since the year of COVID have needles moving in various directions;and CMO/CDMO space is looking to capitalize on the needed manufacturing capabilities for vaccines and biologics that are more prevalent in the drug development landscape.