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?
There’s a lot of talk about patient centricity in the clinical trial arena these days, and for good reason — hearing the voice of patient and incorporating patient perspectives into trial design can pay huge dividends for all stakeholders involved. But what does it mean to be patient centric, practically speaking? What tactics are leading pharma companies employing to make centricity a reality in their trials?
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.
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.
Welcome to Clinical Leader, the premier online community that helps streamline clinical research by connecting trial sponsors and cutting edge service providers. Clinical Leader is part of the Life Science Connect media group. The vision of Life Science Leader and Life Science Connect is to help facilitate connections and foster collaborations in pharmaceutical and medical device development to find ways to get more life-saving and life-improving therapies to market. Connect, Collaborate, Contribute.
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The clinical trials sector is highly regulated, and justifiably so. Biopharmaceuticals that patients need and depend on must be safe and effective, which is why international regulations for Good Clinical Practice and an array of regulatory guidances zone in on how clinical trials should be conducted. But study startup (SSU), one of the most complicated and challenging parts of the clinical trials process, has surprisingly few guidelines.
There is intense pressure to speed clinical trials and restrain costs, and given the burden of this duality clinical project managers are expected to make smarter decisions on intelligence derived from clinical trial data - at a faster pace, while sponsors and contract research organizations (CROs) are looking for ways to incorporate business intelligence (BI) into the eClinical systems they are using to empower oversight—turning raw trial data into actionable information.
In November 2016 the FDA released final guidance on Non-Inferiority Clinical Trials to Establish Effectiveness providing researchers guidance on when to use non-inferiority trials to demonstrate effectiveness along with how to choose the non-inferiority margin, test the non-inferiority hypothesis, and provide interpretable results. The guidance does not provide recommendations for how to evaluate the safety of a drug using a non-inferiority trial design. This article provides background on a non-inferiority trial design along with assumptions and advantages and disadvantages of the trial design.
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.