It has been approximately 10 years since Bayer’s medicine Nexavar was approved for the treatment of advanced hepatocellular (liver) cancer. Despite all of the research and money put into this effort since then, there has not been another drug approved for this disease. However, in April 2017, patients did finally see a new treatment (Stivarga) approved by FDA.
There are so many challenges around designing clinical trials that it can often be difficult to decide where to focus your efforts and resources to improve the process. Based on our recent surveys of clinical trial participants, we see that early engagement with patients can change the course of a study for the better — and research shows it can directly impact the cost of conducting the trial as well.
Earlier this year, three members of the U.S. House of Representatives introduced H.R.1234, the Domestic Research Enhancement Act of 2017. The partisan legislation would amend the Internal Revenue Code of 1986, enabling CROs to claim a portion of the Research & Development Tax Credit for qualified research conducted in the United States. Currently, pharmaceutical and biotech (sponsor) companies that outsource clinical research projects only claim 65 percent of the R&D tax credit; the new bill would make CROs eligible for the other 35 percent, which is unused.
In 2014, TransCelerate BioPharma launched an initiative dedicated to creating a common protocol template (CPT), with a vision of addressing the increasing complexity of clinical trial protocol development and supporting the pursuit of protocol quality through a practical, harmonized and adoptable approach. Several weeks ago, the U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH) released a final version of its own common protocol template — noting that it was in alignment with TransCelerate’s CPT, specifically, the new enhanced technology-enabled edition. They, like TransCelerate, recognized that the clinical trial protocol deserved renewed attention and modernization.
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.
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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. CDM is the process of collecting, cleaning, and managing subject data in compliance with regulatory standards, with the aim of generating high-quality, reliable, and statistically sound data.
The International Council for Harmonization (ICH) efficacy guideline on Good Clinical Practices (GCP) aims to help sponsors keep up with these major shifts and implement improved practices in the industry. This article discusses how the ICH has changed with the recently approved Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) and outlines some of the major areas where sponsors can develop more efficient approaches in the design and conduct of their clinical trials.
Ebola struck three West African nations in 2014, mobilizing the World Health Organization and bringing doctors from around the world to the affected areas. The following year, the Zika virus spread throughout major portions of Latin America. Events like these have led to calls for expedited approvals of vaccines and drugs undergoing clinical trials in order to nip these and future outbreaks in the bud.
Multi-country clinical trials have risen in recent years, and new regions have emerged as today’s most promising venues for clinical trials. The major forces behind these changes include the varying degrees of regulatory friendliness and access to patient populations in different countries around the world. Of course, cost plays a major role as well, as researchers have become increasingly attracted to developing regions where the cost of conducting a trial are considerably lower.
With the myriad of technology advances available and proven to overcome the challenges of paper based approaches, the methods used to conduct and support clinical trials can be cutting edge. However, some sponsors and their CROs continue to operate based on error-prone manual processes and siloed databases that extend development timelines and inflate costs. This article explores why so many continue to collect, aggregate and report clinical trial data manually when automated solutions are proven to streamline operations, yield better results and reduce trial costs and timelines.
