The Trickett Wendler Right To Try (RTT) Act was introduced in May 2016 by Sen Ron Johnson (R-Wis). According to Johnson, the bill would ensure terminally ill patients, their doctors, and pharmaceutical manufacturers were allowed to administer investigational treatments where no alternative treatment exists. But for all the fanfare around RTT and the slow federal drug approval process, would the RTT legislation actually help patients?
How many of the clinical trials that your company has conducted have met the initial recruitment timelines? How often have you seen recruitment issues increase costs or cause delays in your company’s operational objectives? Nearly 80 percent of clinical trials experience delays or even early termination due to recruitment issues.1 These delays not only negatively affect the sponsor company but also keep patients from getting potentially life-saving treatments in a timely manner (if at all).
Consumers today are asked to make increasingly complex decisions around their healthcare. They have access to so much information, yet the level of detail and potential for confusion is only increasing. At the same time, social media has fundamentally changed the way people gather information and relate to each other.
Back translation is a powerful tool for ensuring that a clinical trial document has been accurately translated without loss of meaning; however, it is not the right QA tool for every project. The alternative is quality assessment performed by a professional translator, which will not be dealt with in this article but is important to mention as an option.
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.
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Adaptive clinical trial design in oncology research represents an intersection of two major industry trends. One of these is the current prevalence of cancer clinical trials. Last year, Clinical Leader cited a GBI Research report that declared oncology the largest therapeutic area in the pharmaceutical industry pipeline. And the promise of immunotherapy continues to galvanize investigations into new cancer treatments. The other trend is the increasing popularity of adaptive trial designs, which have helped the industry neutralize major inefficiencies in their research - not to mention all the discussion and debate they have sparked among industry bloggers and thought leaders.
It’s a time of great evolution for clinical research. Recent years have seen a major expansion in the size and scope of industry operations. It’s increasingly common for clinical trials to cross borders, oceans, and continents. Studies and datasets are bigger, and protocols are more complex. All of this makes for a more intricate research environment than previous generations of sponsors and CROs ever imagined. Navigating that intricacy without jeopardizing study timelines is one of the definitive industry challenges today.
Thinking about using wearable devices (activity trackers, smart watches, etc.) in your clinical trial? Learn about some of the scientific and operational factors to consider that will help meet your objectives and what can lead to a smoother roll out, a higher likelihood of success, and potentially significant improvements in efficiency and accuracy during new drug research and development.
Global recruitment for clinical trials is far from a “one-size-fits-all” proposition. Enormous language, cultural, political, and socioeconomic differences exist in many of the countries that are becoming primary outsourcing locations for clinical research. Regional variations and cultural understanding of clinical research need to be taken into account when recruiting patients in these emerging markets.
Most Patient Recruitment Organizations (PROs) have essentially been doing the same thing for many years. Raising awareness of clinical trial opportunities and encouraging enrollment, their basic functions include: trial advertising and marketing communications, site support materials, study websites, and limited metrics tracking.