Benjamin Franklin is often credited with this wise warning: If you fail to plan, you are planning to fail. When it comes to study startup (SSU), and site activation in particular, these words ring true, especially as the clinical trials sector embraces planning as key to boosting study quality. With the availability of workflow-based SSU tools, proactive planning is within reach for stakeholders who view this function as pivotal to improving quality, as measured by audit-readiness and the likelihood of passing regulatory audits.
FDA recently released a snapshot report showing the diversity of clinical trial participants in studies conducted in 2015 and 2016. Out of over 31,000 patients who participated in clinical trials for novel products in 2016, 48% of the study participants were women, which was an increase from 40% in 2015. An increase in clinical trial participation of African Americans was also observed from 2015 to 2016 (i.e., 5% in 2015 vs. 7% in 2016). However, Asian subject participation in clinical studies decreased 1% between 2015 and 2016 (from 12% to 11%, respectively). Overall, the trend towards increasing the diversity of clinical trial participants is encouraging, but a continued effort is needed to keep moving in the right direction.
From leisure activities, to our own health and wellness, to the industries in which we work — Big Data has transformed our world. Subscription-based content providers, like Netflix and Amazon Prime, are changing television programming by using detailed customer segmentation and viewing habits to rethink how new programming is funded, produced, and released to the market. Everyday items like Nest are transforming home heating and cooling by collecting and aggregating sensor data to automate thermostat changes.
The life sciences industry is repeatedly cited as the most at-risk for a major security breach. Many assume that the greatest threat comes from outside: malicious parties that are actively working to compromise company information. While this certainly reflects the new normal in cybersecurity - for example, see Pfizer's recent U.S. Securities and Exchange Commission (SEC) filing acknowledging that their IT systems are subject to frequent attacks – the unfortunate reality is that most information security breaches start with insecure data sharing.
This research study seeks to investigate two separate but related areas. Part 1, whose findings are described in this report, tries to identify the drivers of shareholder value creation from the merger and acquisition (M&A) activity of an extremely large sample of global publicly listed companies over the past 20 years. Part 2, examines the M&A strategies of an elite group of M&A-active corporate outperformers – companies that have demonstrated sustained, above average shareholder value creation (known as “excellent corporate portfolio managers”, or ECPMs) – to try to determine if this group share common attributes and behaviors, and to identify what those are.
Immunotherapies are being touted—both in scientific literature and the general media—as the most promising advances in cancer treatment in decades.
With the quality of data captured throughout a trial playing a crucial role for the success or failure of a study, clinical data management (CDM) is a key element of any research program. During a study lifecycle, data managers will deal with data from many sources such as MRI scans, ECG, lab data, as well as eCOA – all of which are equally important.
This paper isolates three specific areas that warrant close attention for app developers, clinical trials sponsors and CROs designing trials powered with mHealth app tools: technology considerations, data considerations and regulatory considerations. These areas are vital to developing a compliant trial that generates meaningful data for clinical development using mHealth sources.
Post-approval research studies are becoming increasingly large and complex in the clinical research landscape. These programs are often massive in scope, engaging thousands of physicians and tens of thousands of patients. Unfortunately, post-approval operational strategies have not kept pace with the needs and demands of post-approval (Phase IV) research.
Understanding patient reported outcomes (PROs) in oncology clinical trials enables researchers to develop more effective treatments for patients battling this illness. But if it isn't easy for patients to report their health data, they won't - so it must be accessible for them.
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