If your trials rely on research participants with a track record of taking part in a number of clinical trials, it might be worth taking a second look and examining them a bit closer. Building on past research findings that found high fabrication rates by frequent study participants, or “professional patients,” two universities recently collaborated to study the prevalence of deception used by these subjects.
Those who have been involved with emerging technologies for any length of time will recognize the Hype Cycle – the realization that technologies often go through expectation peaks and valleys on their way to widespread acceptance and adoption.
Mobile health (mHealth) technology holds the promise to improve the quality of life of us all, so hype is virtually built-in. When you combine the Internet of Things with people, you’re bound to find lots of coolness and lots of interest. Have you checked your step count recently?
As with most businesses, a big concern for clinical trial sites is paying the bills. Sites typically receive payments for work performed about four months late while bills are due upfront. Keeping clinical sites happy is every sponsor’s goal, and paying them on time goes a long way. What would happen if the average employee received a paycheck for their work four months late?
ACRP’s Terri Hinkley Discusses How to Help Clinical Research Associates Adjust to Risk-based Monitoring
Terri Hinkley, the interim executive director of ACRP, recently shared her thoughts with us on the current changes facing clinical research professionals. In the clip, Terri discusses how sponsors and the industry can help clinical research associates (CRAs) become more comfortable with risk-based monitoring.
The U.S. House of Congress recently passed the 21st Century Cures Act, which aims to revise the drug development and approval process and increase funding for the U.S. National Institutes of Health and the FDA. Dr. Janet Woodcock, MD, PhD, the director of the U.S. FDA Center for Drug Evaluation and Research is optimistic about the bill’s impact on incorporating the voice of the patient in drug development and believes “patient-focused drug development has the potential to become the most transformational piece of this bill.”
With the government’s reauthorization of the Prescription Drug User Fee Act in 2012 (PDUFA V), the FDA is trying an experiment to gather patient input by disease group rather than an individual treatment. The program launched for 20 disease areas, in which meetings take into account the current state of drug development, the specific considerations of the FDA review division, and the needs of the patient population by eliciting patient perspectives on their disease and treatment approaches.
In the fast-moving healthcare industry, it can be easy to forget the powerful back stories and longstanding dedication that drive our colleagues and motivate them to become exceptional leaders in the field. Each year, PharmaVOICE recognizes the top 100 folks in the industry whose exceptional work and innovative approaches motivate and inspire their peers and colleagues. This year, we are particularly proud of our own Steve Smith and Kara Dennis, two of the 2015 PharmaVOICE 100.
If you were the CEO of a major pharma company, how would you increase mHealth use in clinical trials?
If you’ve ever thought about this sort of thing, you’re not alone. We recently caught up with Jeff Kasher, a Ph.D. in pharmacology whose track record includes working at Eli Lilly for more than 28 years and is now president of Patients Can’t Wait, and chatted with him about his thoughts on adding mHealth technology to clinical trials.
In the quick video segment above, Jeff shares some of his thoughts on how using mHealth technology in clinical trials can make it easier to participate for patients as well as what he would do differently if he were the head of a major pharma company. Among other things, Jeff suggests including at least one mHealth device in every Phase II and III clinical trial as well as greater communication with regulators.
Interested in some of Jeff’s other thoughts? Check out the video clip above! And while you’re at it, don’t forget to check out our work in the evolving clinical research space.
ACRP (Association of Clinical Research Professionals) Interim Executive Director Terri Hinkley recently took a few minutes to chat with us about the groundbreaking initiative of the Joint Task Force for Clinical Trial Competency and where she sees the initiative leading in a few years.
In the clip, Terri discusses the exciting work the Joint Task Force for Clinical Trial Competency has done in defining the competencies required of clinical research professionals. She explains how ACRP is taking steps to move away from the traditional two-year experience requirements to become a monitor and is instead looking at the actual competencies needed for entry-, mid-level and experienced professionals.
What knowledge and competencies do clinical research professionals need to possess for their specific roles? As the initiative continues to move forward, she hopes to see even greater involvement and participation from all clinical research professionals.
How Do iComply? A Look at Regulatory Topics Surrounding the Use of mHealth Technology in Clinical Trials
The U.S. National Institutes of Health (NIH) Consensus Group has defined mHealth as “the use of mobile and wireless devices to improve health outcomes, health care services and health research.” The mHealth landscape is expanding with over 97,000 apps (mobile applications) as of 2013. Yet the vast majority of these apps have not been through the FDA medical device review process. Full stop? Not necessarily. A quick search on Clinicaltrials.gov reveals 131 interventional trials are in someway relying on mHealth technology (over 1,000 trials when searching on “mobile health”). Add in the splash of the Apple ResearchKit announcements and mHealth beckons further consideration by the research community. (more…)
Life science companies are continuously looking for ways to advance clinical research while simultaneously improving the understanding of drugs they are developing. One of the biggest issues for researchers is the high failure rate of new drugs during clinical development. The stakes are high in a global pharma market that is expected to exceed $1.2 trillion by 2018.
We recently caught up with James Moon, a biostatistician at the Fred Hutchinson Cancer Research Center. Moon works on the Lung-MAP clinical trial, or the Lung Cancer Master Protocol, which uses an innovative trial design meant to improve drug development.
Lung-MAP seeks to match the biomarkers of individual patients’ lung cancer tumors with specific medicines in hopes that a more tailored approach will create more benefit. The trial is an example of the emerging field of “precision medicine” that takes the individual patient’s unique genetic makeup into account.
The Lung-MAP “master protocol” refers to the single protocol (trial) to test four drugs at once rather than the traditional method of testing four drugs in four trials. There is growing interest in such trial designs, also known as “platform trials,” as a way of accelerating drug development.
The Lung-MAP clinical trial uses Medidata’s Rave for electronic data capture (EDC).
What do you think the next step will be in the ongoing evolution of clinical trial design?
- Five Considerations For Wearable Devices In Clinical Trials
- First Steps in Adding mHealth Technology to Clinical Trials
- Providing Clarity on the Definitions of Source Data Verification (SDV) and Source Data Review (SDR)
- ACRP’s Terri Hinkley on the Changing Roles of CRAs
- mHealth in Clinical R&D: Getting Around the Hype Cycle
If your trials rely on research par ...mHealth in Clinical R&D: Getting Ar ...
Those who have been involved with e ...An Easy Problem to Solve: Speeding ...
As with most businesses, a big co ...ACRP’s Terri Hinkley Discusses Ho ...
https://youtu.be/CC94q44__z0 Terri ...21st Century Cures Act and Improvin ...
The U.S. House of Congress recent ...
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