Tags clinical trialsdrug makerspatients Glen de Vries We are well into the era of the engaged consumer. By now, many companies have recognized that traditional selling tactics like advertising and discounting only take them so far. Consumers want deeper connections, and companies ranging from Amazon and Apple to Spotify and Zappos have been happy to oblige. Using predictive algorithms that prioritize consumer preferences, these companies are finding inventive new ways to engage customers with games, stories, and sharing tools sent to their mobile devices.Pharmaceutical companies should be doing the same thing. But many of them aren’t, or aren’t doing it well. For 16 years, I’ve witnessed their halting efforts to engage consumers from my vantage point as the cofounder and president of a cloud technology company that helps life science organizations better design, manage, and execute clinical trials.A clinical trial is often the first chance that a pharmaceutical company has to engage with individuals who may one day be their customers. Many companies ignore this opportunity. By doing so, they fail to gather invaluable information about the effectiveness and safety of their products and the responsiveness and progress of the people taking them.advertisement By Glen de Vries April 5, 2016 Reprints In a clinical trial, what does an engaged consumer look like? He or she feels confident of having an open, consistent dialogue with doctors and clinicians; intimately understands the purpose of the trial and his or her role in it; and is committed to following study protocols, making follow-up visits, and ultimately completing the trial.Few pharmaceutical companies do enough to help study participants meet this level of engagement. Consider these facts about clinical trials: The average dropout rate is around 30 percent, and about 80 percent of clinical trials don’t finish on time. A key contributor to both of these problems is poor patient engagement. Some participants drop out of trials for reasons a sponsor can’t control, like negative reactions to a treatment. Far more often, the sponsors aren’t doing enough to educate participants, make it easy for them to follow the study protocols, or motivate them to stay engaged.advertisement About the Author Reprints Some drug companies have taken baby steps toward engagement by launching patient-focused apps after getting approval for their drugs. By then, it’s too late.Fortunately, technologies available today have enormous potential to improve the quality of clinical research and the level of patient engagement. Devices like Fitbit or Jawbone can do a lot more than tell you how many steps you’ve taken or how well you are sleeping. They can also provide a more precise understanding of how an individual responds to treatment during a clinical trial. Meanwhile, emerging software platforms like Apple’s CareKit will help developers and health care professionals create new interactive health care-related apps.These tools can make it easier for clinical trial sponsors to improve engagement, whether it’s making participation easier by reducing the need for trips to a clinic or providing reminders for taking medicines in the right dose at the right time.Clinical trials are the perfect environment in which to identify and focus on successful patient engagement strategies. For any pharmaceutical company or clinical trial sponsor looking to improve patient engagement, three priorities are key:Act now. The FDA requires that all new therapeutics be tested in a rigorous, three-phase process. Engagement should be baked into this process from the start. The best time to study patients’ habits, preferences, and behaviors is during a trial as participants use the new drug, not after it has been approved.Be objective. Clinical trial research often ignores objective measures about participants’ quality of life and instead relies on subjective data collected in surveys. Today’s mobile technologies let researchers continuously collect consistent, reliable, objective information about things that are meaningful to participants, such as the quality of their sleep or their ability to walk through the grocery store without fatigue.Go with what works and what patients know. Pharmaceutical companies needn’t completely reinvent the customer engagement experience. People are increasingly and habitually using tools such as smartphone apps and activity trackers. The challenge for pharmaceutical companies is to keep up with the pace of digital innovation and understand the way new technologies can be used to reduce the burden that a clinical trial can place on participants.To combine emerging digital technologies with traditional clinical measurements and techniques, existing hardware and software must be adapted for clinical use. There is clearly a lot of work to be done, but we already have the tools to increase patient engagement for new drugs. The key is to start early in the process.Glen de Vries is president and cofounder of Medidata, which provides a cloud platform and data analytics for life science organizations conducting clinical research. First OpinionWhy every clinical trial should have an app for participants @CaptainClinical APStock
Andrew Joseph About the Author Reprints [email protected] Related: Paraplegics who learned to control an Iron Man-like exoskeleton with their thoughts appeared to regain some feeling and function in their legs as a result of the training regimen, according to a new study.The study, published Thursday in the journal Scientific Reports, describes how a year of training enabled participants with spinal cord injuries to recover some sensation, voluntary muscle contraction, and control over bowel function — evidence of neurological recovery that the authors were not expecting.Four of the eight participants had their paralysis reclassified to a less severe level, although they still do not have control over most of their leg muscles.advertisement Tags brainneurologyparalysis Related: The training relied on what is known as a “brain-machine interface,” which decodes the brain’s signals into outputs aimed at enabling movement.advertisement A dogged quest to fix broken spinal cords pays off with new hope for the paralyzed @DrewQJoseph General Assignment Reporter Andrew covers a range of topics, from addiction to public health to genetics. Paralyzed, yet walking againVolume 90%Press shift question mark to access a list of keyboard shortcutsKeyboard ShortcutsEnabledDisabledPlay/PauseSPACEIncrease Volume↑Decrease Volume↓Seek Forward→Seek Backward←Captions On/OffcFullscreen/Exit FullscreenfMute/UnmutemSeek %0-9 facebook twitter Email Linkhttps://www.statnews.com/2016/08/11/paraplegics-exoskeleton-brain-training/?jwsource=clCopied EmbedCopiedLive00:0000:4300:43 The participants in the study were injured three to 13 years ago. The goal of the project is to develop and refine the thought-controlled exoskeletons.The training started with participants practicing moving an on-screen avatar with their thoughts. Electrodes captured their brains’ signals and translated them through a computer so that when participants imagined walking, the avatars walked. The participants also trained with a harness-like system that helped them stand and walk on a treadmill, and eventually, worked their way up to controlling the exoskeletons.But as the participants trained, they regained some sensation in their lower limbs (although they could not sense changes in temperature) and some ability to voluntarily control muscles below the site of their injuries. Some of the participants saw improved bowel function and advances in their independence at home, such as being able to move themselves from their wheelchairs to the toilet. (The improvements in bowel and bladder control could also have come as a result of the participants being upright and out of their wheelchairs more often during the training program, not solely as a result of the interface training itself.)The advances made by the participants are likely possible because some of the nerves at the site of their injury survive, as other research has shown. And with the intensive training, the brain’s cortex restarted firing the signals it once did to command the muscles in the legs to contract, reigniting the nerves at the site of the injury. Those nerves then relayed the messages onward to nerves in the legs.“Something may have survived the original trauma, even if it were years ago,” Nicolelis said. By Andrew Joseph Aug. 11, 2016 Reprints The training described in the paper took place mostly in 2014, but Nicolelis said the participants who have kept up with some level of training have continued to show progress. The recovery seen in one participant who left the study waned after several months.Nicolelis’s approach is one of several that scientists are pursuing to restore mobility in patients with spinal cord injuries. Scientists are trying to reroute the brain’s signals around the site of injury, while others are trying to electronically stimulate a spinal cord. Still others think injecting new cells into the injury site could restore the cord’s function.For now, Nicolelis said the new research amounts to a demonstration of a technology that deserves further study. But he said he and his colleagues are wondering how they could make the technology accessible if the results hold up.“We’re already thinking about ways of disseminating this protocol,” he said. A shattering crash, an online chronicle, and an unexpected twist The study, which took place in Brazil, is not going to immediately change the course of therapy for the thousands of people with paraplegia around the world. The eight participants together took part in more than 2,000 training sessions to achieve small and what might not be sustainable gains.But the results suggest that by using their thoughts to control an external device, participants were also jumpstarting some long-dormant nerve networks and connections in the brain and spinal cord.“All this machinery is reactivated and you start bombarding the spinal cord — what’s left of it — with information,” Nicolelis said.Brain-machine interfaces have been used to allow people who are paralyzed to move robots, trigger hand movements via electrodes on the arm, and, in the case of Nicolelis’s study, control an exoskeleton. At the opening of the 2014 World Cup in Brazil, a paraplegic participant kicked a ball while wearing the exoskeleton — a movement caused by the participant’s own thoughts routed through electrodes on his head to a computer to the exoskeleton.In those cases, the interface acted as an assistive technology, helping patients control external devices. But the new study indicates that the interfaces might also serve as a therapeutic technology, restoring some level of function that the body had lost, said Dr. Elliot Roth, the medical director of the patient recovery unit at the Rehabilitation Institute of Chicago. Roth, who also chairs the physical medicine and rehabilitation department at Northwestern University Feinberg School of Medicine, was not involved in the study.The results of the study need to be reproduced and researchers need to think how the technology could be applied to patients broadly, Roth said. But he called the study “an exciting first step.” Brain implant helps quadriplegic move his hand — and play Guitar Hero In the LabWith brain training and an exoskeleton, paraplegics seem to regain some feeling in their legs In 2014, researchers in Brazil unveiled a brain-controlled exoskeleton that allows paraplegics to walk again. Today, something unexpected is happening to longtime users of the technology. Alex Hogan/STAT Related: “It turned out that six months into the training of these patients … we started realizing that the patients were experiencing an improvement in their neurological function,” said Dr. Miguel Nicolelis, a Duke University neurobiologist and senior author of the paper.
Pharmalot Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED In what some observers are calling a misguided effort, Arizona has become the first state in the nation to pass a law allowing drug makers to promote their medicines for so-called off-label uses — so long as the information given doctors is truthful.Interestingly, the law was hatched by the Goldwater Institute, the same think tank that spearheaded the controversial Right to Try laws designed to give patients early access to experimental medicines. And the think tank is vowing to duplicate that campaign by introducing off-label bills around the country. [email protected] By Ed Silverman March 29, 2017 Reprints APStock Ed Silverman Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. What’s included? STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. Log In | Learn More GET STARTED About the Author Reprints What is it? Arizona is first state to pass a law allowing drug makers to promote off-label uses @Pharmalot Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. Tags pharmaceuticalspolicySTAT+
Pharmalot Tags hospitalsMedicarepharmaceuticalsSTAT+ [email protected] @Pharmalot Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. By Ed Silverman Nov. 16, 2017 Reprints STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. Paul Beaty/AP What’s included? Ed Silverman What is it? About the Author Reprints GET STARTED A group of lawmakers introduced a bipartisan bill to reverse a Trump administration rule that would cut Medicare reimbursement for medicines purchased under the federal 340B Drug Discount Program, which was designed to boost revenues for hospitals that primarily serve low-income patients. The cut is estimated to save Medicare and its beneficiaries about $1.6 billion next year.The sponsors were among dozens of lawmakers who two months ago wrote the Centers for Medicare and Medicaid Services to argue that cutting reimbursement is a “misguided policy” that would limit the ability of hospitals to serve vulnerable patients. They further maintained the move would not reduce drug costs, as the pharmaceutical industry has suggested. Unlock this article — plus daily coverage and analysis of the pharma industry — by subscribing to STAT+. First 30 days free. GET STARTED Lawmakers push bill to reverse a Trump rule over Medicare drug discounts Log In | Learn More
Health What is it? Testing the tests: If two liquid biopsies deliver different results, can they both be right? Adobe [email protected] Unlock this article — and get additional analysis of the technologies disrupting health care — by subscribing to STAT+. First 30 days free. GET STARTED STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. GET STARTED Log In | Learn More The question had come from his boss. It was around the beginning of 2017, and the director of research for the Brady Urological Institute at Johns Hopkins asked Dr. Gonzalo Torga, a postdoctoral fellow, which of two genomic tests they should offer to their prostate cancer patients as a way of determining eligibility for certain drugs. Torga wasn’t sure, so his boss suggested they test the tests: Order a liquid biopsy from both companies for a number of patients, and then compare the results.Their findings, the Hopkins scientists say, were disconcerting: In many cases, the two tests gave conflicting results for the same patient. They published their comparison in JAMA Oncology in December, arguing that they needed to warn other clinicians that these tests don’t give standard results. But the companies in question retort that this warning is based on sloppy study design and could mean that patients don’t get offered potentially helpful tests. By Eric Boodman Jan. 19, 2018 Reprints What’s included? Eric Boodman General Assignment Reporter Eric focuses on narrative features, exploring the startling ways that science and medicine affect people’s lives. Tags cancerdiagnosticsSTAT+ About the Author Reprints @ericboodman
Health Tech Health apps collecting sensitive data need more transparent terms of service, law experts argue [email protected] Tags Health ITmedical technologySTAT+ Reporter, Morning Rounds Writer, Intern Coordinator Shraddha writes the Morning Rounds newsletter and covers health and medicine. What’s included? By Shraddha Chakradhar Feb. 13, 2020 Reprints We’ve all been there. We’ve downloaded a new app or visited a website that requires us to enter personal data and immediately been presented with a long agreement that we have to agree to before using the service.And every so often, we may have been asked to reaffirm our consent to these terms of service, which outline what the company does with our data, including sharing it with third-party users for research or with their own internal teams to improve the quality of their product. @scchak STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. GET STARTED What is it? Shraddha Chakradhar About the Author Reprints Adobe Unlock this article — and get additional analysis of the technologies disrupting health care — by subscribing to STAT+. First 30 days free. GET STARTED Log In | Learn More