Pfizer made a big splash back in 2011 with its announcement of the first “virtual” clinical trial. This news was significant because, for the first time, patients would have the opportunity to be screened, enroll, and ultimately participate in a trial entirely via internet-connected devices — in other words, without setting foot on a clinical trial site. In an expensive industry where increased efficiency and patient convenience correlate with profits, this attracted significant (if somewhat skeptical) attention.
Some of that skepticism was warranted. According to Michal Orri, Senior Director of Clinical Sciences at Pfizer, the trial initially failed to recruit enough patients. Was this virtual, patient-centered approach a failed model? Hardly: despite the imperfect outcome of this first trial, the Pfizer study has ignited intense interest in virtualization. Today, virtual trials are increasingly common and may, in fact, revolutionize the Pharma industry.
Pfizer believes that their initial trial was unsuccessful, incidentally, because it didn’t cater enough to patients. As Outsourcing-Pharma notes, their online process was overly complicated and confusing from the outset. However, after simplifying online enrollment and adding a patient-oriented call center, the trial made appreciable enrollment gains. In fact, the FDA has since requested that they validate their final procedures for more widespread adoption.
The essential advantage of virtual trials is that they enable patients to enroll on their own terms; mobile health, e-platforms, remote monitoring devices, wearable technology, and telemedicine all make it simpler, and more inviting, for patients to consent to and participate in trials.
Clinical sponsors and CROs will have to employ digital strategies with a measured approach, ensuring that these strategies meet rigorous thresholds for cost-efficiency and usefulness. Even so, most clinical researchers are cautiously optimistic, because such tech tends to allay the skepticism of the most important group of all — the patients.
GlaxoSmithKline Plc has started a rheumatoid arthritis study using Apple Inc.’s ResearchKit, marking the first time a drugmaker has used the health system for the iPhone to conduct clinical research.
Glaxo wants to record the mobility of 300 participants over three months and will also ask the patients to input both physical and emotional symptoms, such as pain and mood. The app Glaxo created from ResearchKit comes with a guided wrist exercise that uses the phone’s sensors to record motion, giving the drugmaker a standardized measurement across all users. The company will use the results to help design better clinical trials.
The success of the study could help determine the pharmaceutical industry’s future appetite for using Apple’s products to conduct research. Drugmakers have to balance the lower costs of using the app with their ability to gather accurate, reliable data. Risks include that test subjects will tire of entering information into the app, and, given the iPhone’s $399 starting price, the sample may be skewed toward wealthier demographics.
Merial, la division santé animale du groupe Sanofi, vient de lancer l’application FleaTickRisk qui évalue en temps réel par localisations géographiques les risques d’infestation ou de piqûre par les puces, les tiques, et certains insectes volants tels les moustiques et les moucherons piqueurs (phlébotomes).
Apple fuses technology with design. IBM invests in research that is often a decade ahead of its time. Facebook “moves fast and maintains a stable infrastructure” .Each of these companies, in its own way, is a superior innovator. But what makes Google (now officially known as Alphabet) different is that it doesn’t rely on any one innovation strategy, but deploys a number of them to create an intricate — but powerful — innovation ecosystem that seems to roll out innovations by the dozens. A look at their machine learning team.
The same debates we’re having today about new technologies were being had over inventions such as the printed word or cellphones, argues Calestous Juma.Innovation and Its Enemies shows that resistance to new technologies is heightened when the public perceives that the benefits of new technologies will only accrue to a small section of society, while the risks are likely to be widespread. This is why technologies promoted by large corporations often face stiff opposition from the public.
For decades, medical meetings have been a place for doctors, patients, researchers and advocates to engage with each other and share information about the latest advances in treatments and science.
That engagement level has exploded over the last few years, however, with the rise of social media. Now, attendees can talk not only to others in the meeting hall but also in every corner of the globe.
How important has social media grown to become at medical meetings? Consider: The 2013 American Society of Clinical Oncology (ASCO) Annual Meeting saw 4,352 different people tweet 21,861 times using the #ASCO13 hashtag throughout the year. Two years later, the #ASCO15 meeting was mentioned in 81,273 tweets from 16,664 people – a nearly four-fold increase.
AstraZeneca once again will participate in major meetings in our therapeutic areas this year, including ASCO, AHA, ACC, ADA and several others. In addition to our live presence at the meetings, we hope to accomplish the following through our social engagement:
Conduct live, authentic dialogue with those in attendance as well as those following along virtually.Share our messages and resources with an informed, engaged audience.Continue conversations begun face to face in the meeting halls.Glean key areas of focus of those affected by the diseases being studied to better inform our efforts as a company.
It is increasingly crucial for all players in healthcare to be engaged in social media, as more and more Americans use these platforms.
Une culture d’entreprise peut-elle être un frein à la transformation digitale? Une chose est sûre : transformation digitale et culture d’entreprise doivent évoluer de concert pour que ce soit réellement bénéfique pour l’entreprise. La transformation digitale est un sujet à l’agenda des dirigeants de beaucoup d’organisations depuis quelques années. Il …
Five years of exclusivity is provided for drugs which do not contain active molecules that have appeared in previously-approved drugs.
This is one of the longest exclusivity terms provided by the FDA. Only orphan drugs receive a longer term of exclusivity, although the five years granted under the Generating Antibiotic Incentives Now (GAIN) Act may be added in addition to other exclusivities, giving it an effetively longer span.
This chart shows the companies which have received the most new chemical entity exclusivities in the past five years.