18
Apr

The Apple Research Kit : What does it mean for clinical trials?

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Smartphones are ideal and convenient tools to collect data in fast-paced and dynamic environments, making them perfect for use in medical research. New mobile apps are being developed with ResearchKit, Apple’s open-source software framework that supports medical and health studies. Clinical trials, surveys, and studies of any size can be performed around the globe with objective data gathered directly through an iPhone or a synced wearable device. With the added ability to link with HealthKit, researchers can access relevant data for their studies, such as calorie counts, daily steps taken and heart rate. What if collected data could help doctors and scientists study and find treatments to diseases, such as asthma, breast cancer, diabetes and Parkinson’s? ResearchKit allows for researchers to recruit participants for studies that are not limited to small regions, demographics or populations.

Tracking Health Metrics and Triggers Lead to Better Treatment

Impacts on the evolution of clinical trials are visible through the apps that are being developed. The Asthma Health app from the Icahn School of Medicine at Mount Sinai is just one example.
The app helps its users track data such as weight, blood pressure, glucose levels and asthma inhaler use. All of the gathered data syncs with AppleHealth and displays the collected information on a comprehensive dashboard.
In addition to gathering that data for research use, the Asthma Health app is also designed to help patients by providing them with education and self-monitoring. The app essentially helps track symptom patterns and potential triggers for exacerbation. Researchers can then use this information to learn new ways to treat asthma, and patients can use this information to help predict and monitor their condition.

iPhones Take the Place of Office Visits for Around the Clock Monitoring

The mPower app, powered by ResearchKit, gives patients with Parkinson’s disease a mean of better tracking their coordination. The app can track the patient’s gait and finger dexterity (for example) throughout the day. Being able to identify dexterity trends with this kind of critical data tracking may help researchers better understand the disease. It may also contribute to finding new treatments.
In the past, doctors relied on measurements taken at the time of an office visit, which does not reflect the patient’s overall health throughout the course of the day. Now physicians will have access to continuous daily data and a range of factors in their patient’s life, to help them make better treatment and recovery plans.

ResearchKit Helps to Connect Trials and Participants

Participation in clinical trials and determining a patient’s eligibility have been a daunting task for both patients and health providers. Physicians are given clinical trial information on a regular basis, but it’s impossible for them to know about every trial that is taking place, and which of their patients may qualify for the study. Websites such as ClinicalTrials.gov are a good reference tool, but reading the fine print can hinder participation.
Clinical trials can now reach patients directly through a device that they almost always have on hand, their iPhone. Recruiting participants for studies make the recruitment field much larger, as over 2 billion people own smartphones.
It is always recommended that participants consult their physician, before beginning a clinical trial.

Iphone is not the only tool to gather data

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With the recent popularity of wearable technology, patients have become more engaged with tracking their own health. Devices connected to smartphones such as watches (Apple Watch for instance), allow continuous data gathering without effort. They can track patients’ steps, sleep patterns and eating habits. An Android version of Apple’s ResearchKit, called ResearchStack, is under development. The first version came out April 15th 2016 so researchers can reach an even broader audience and so most devices can be compatible.

Should Patients Worry About Data Security?

Patient privacy is a huge concern in the healthcare industry. So how will collecting patient data from a smartphone affect patients’ privacy? Apple believes the transfer of data is secure through the apps as the data is sent anonymously when it leaves the phone. However, there are no traditional HIPAA documents to complete to create an app that gathers such data, so it is up to developers and researchers to closely follow federal privacy regulations. Patients’ privacy relies on the integrity of the institutions creating the apps and receiving the data. Some researchers and professors fear that this data will eventually end up in the hands of health insurances or drug companies that will use it for profit only. But so far, not only several features in the apps allow patients to control what information to share but also the app informs study participants about the scope of the study and the type of data that will be collected, to ensure a maximum transparency and privacy.

ResearchKit based apps are available on the App Store at appstore.com/researchkit

7
Apr

Infographic: Top eClinical Trends Report

ClinCapture empowers CROs, Pharmaceuticals and Medical Device companies to build their studies themselves, lower their clinical trials costs and streamline their data capture processes. Start creating your study at clincapture.com

16
Mar

Infographic: EDC System ClinCapture By The Figures

infographic-cc-by-the-figures

ClinCapture empowers CROs, Pharmaceuticals and Medical Device companies to build their studies themselves, lower their clinical trials costs and streamline their data capture processes. Start creating your study at clincapture.com

24
Feb

Big Data In Clinical Trials: Myths and Hopes

Billions of clinical measurements are recorded every day, generating stores of medical data beyond what anyone could have imagined just a few decades ago. The contents are called big data and the clinical research industry, although slow to see its potential, is now eager to put to use electronic versions of everything from notes doctors jot down about patients to clinical trial results.

“With enormous data come enormous opportunity,” reads the line in bold on the website of Nicholas Tatonetti, an  expert in biomedical informatics, an interdisciplinary field that combines information technology and medicine,

It’s an optimism shared widely across the healthcare industry and researchers imagine a revolution within clinical trials.

Big Data in Clinical Trials: The Hopes

“In the big-data era, the mysteries of many chronic diseases will be revealed,” said Stephen Wang, the founder of a Chinese bioscience publishing house.

Likewise, in oncology, clinicians see the possibility of using personal medical and population genomics data to improve clinical trials. For example, they can better recruit subjects likely to respond to treatments and exclude those likely to have side effects.

That could help improve the rate of drugs that make it through expensive, time-consuming clinical trials, and improve outcomes for cancer patients.

The optimism also extends to finances. McKinsey & Co. analysts estimated that using big data to make more efficient decisions could generate up to $100 billion in value annually across the US health-care system.

Big Data in Clinical Trials: The Myths

With so much hype about big data it can be difficult to weed out fact from fiction.

The data itself can cause misunderstandings. Perhaps the simplest way to define big data is as a collection of data that’s approximately bigger than one terabyte and/or is too big to handle using standard software and analytical processes.

To put that into context, by one estimation, a terabyte of data requires about 1400 CD-ROMs , 220 DVDs or 40 single-layer Blu-ray Discs. Now consider that by 2020, the overall amount of the amount of digital bits we produce is expected to equal the number of stars in the universe.

The question then becomes “how to find the gold among the dross?”

Artificial intelligence and machine learning are driving the development of tools that can process that amount of information. Supporting these efforts is the $200 million President Barack Obama invested in a National Big Data and Research and Development Initiative.

But big data is not so big that flaws become irrelevant to an accurate analysis, especially in a clinical trial where good information is critical to participants’ safety and the validity of results.

Even the solutions can have drawbacks. Take storage for example. Cloud technology (using off-site servers to store data) has developed in tandem as a place to keep the ever-growing amount of data being collected. In clinical trials, cloud technologies are also offer a way to bring down skyrocketing costs and streamline the process. But, trial investigators cite data privacy and security as major concerns about storing sensitive data in the cloud, which can be more vulnerable to cyber break-ins than off-line servers, especially if staff are not trained to understand the technology’s weaknesses.

For all the buzz, even the staunchest champions understand the limitations of big data in the complex infrastructure of a clinical trial. The idea is that big data will make the process more efficient with better results. And, as Tatonetti points out, even when trials fail they produce valuable data ready to be mined for further analysis.

“Each one of these experiments,” he said, “is a window into the human system, creating the most comprehensive and diverse medical data set ever imagined.”

Interested in the Cloud for Clinical Trials? We invite you to sign up for free for ClinCapture, our cloud-based eClinical system at clinovo.com/clincapture

10
Feb

Top 5 Digital Health Tech at CES

170,000 attendees. 2.2 million net square feet of exhibit space. +3,500 exhibiting companies. CES is the world’s largest consumer technology conference.

In the recent years, the CES track dedicated to digital health has been steadily growing in terms of number of sessions, gadgets, and demos presented, showing how technology is transforming health care, blurring the line between “patients” and “consumers”.

We wanted to share with you a variety of interesting devices presented in the digital health category, from vital signs monitoring, to smartphones apps, to medical devices for diabetic patients, or biointegrated sensors.

What does it mean for a company like ours? As the leading provider of eClinical software ClinCapture, we realize the importance of organizing and streamlining the data collection process from a growing number of sources. Behind ePRO systems that are already empowering patients to report outcomes in user-friendly mobile platforms, a new generation of biosensors and monitors is emerging. This added information could complement the current clinical trial process, better inform decisions and possibly prevent negative outcomes. We believe that the ability to integrate clinical data from disparate devices in real-time is a key driver in the future of eClinical systems.

Let’s take a closer look at the CES innovations.

Silver Mother

Silver Mother is a set of sensors to help monitor the health of seniors: To make sure medication is never forgotten, monitor daily living habits, sleep quality, temperature, water drinking habits, and even track the front door. The company behind this line of sensors is called Sen.se. The founder Rafi Haladjian says “every family can decide what is relevant for their loved one” and use the sensors in ways that are most appropriate.

silver-mother-ces

VisioMed’s Bewell Connect App + Meter

VisioMed, a French company, introduced the Bewell Connect system. It is composed of an app that communicates with medical devices such as a glucose meter, thermostat, blood pressure monitor, and blood oxygen sensor.

Presented as a “virtual checkup” toolset, it allows users to send the information to their physician by the push of a button on the app. The app will also locate nearby health care providers.

Qardio Heart Monitors

Qardio brings a new generation of heart monitors to the market. The company offers a “better way of tracking health that fits effortlessly into your life”. They presented a series of clinically-validated devices to continuously monitor blood pressure and heart rate. They also offer a way to conduct an electrocardiogram at home.

The company also offers the ability to feed all the data via a secure platform to a designated physician, giving the cardiologist or primary-care doctor the ability to track trends over time and react to quick changes.

qardio-ces

Medtronic and IBM

Medtronic showcased its partnership with IBM Watson Health at CES this year. IBM’s CEO Ginni Rometty delivered the event keynote, presenting IBM Watson, a “cognitive computing intelligence” paired with devices for medical and consumer use. The idea behind the system is to make sense of the growing influx of healthcare data from devices (medical or not) to enable consumers, patients, or their caregivers to take better informed decisions.

Medtronic CEO Omar Ishrak demoed a new app that has the capability to predict hypoglycemia three hours in advance of it occurring (it is currently reviewed by the FDA).

Watson will synthesize information from Medtronic insulin pumps and CGM devices — detailed information like the rate of insulin delivered, the constantly fluctuating glucose level and carbohydrate intake information. The app may also integrate information sources like wearable activity trackers, digital scales, geo-location data, calendar details and even the weather, to develop more valuable and personalized insights.

medtronic-ces

Long-term Biointegrated sensors

Biointegrated sensors for long-term, continuous tracking of body chemistry may make health and disease monitoring as easy as turning on your smart phone. Unveiled by Profusa, tiny bioengineered biosensors will soon enable real-time detection of our body’s unique chemistry, providing action­able, medical-grade data for personal and medical use for as long as two years at a time.

According to Dr. Hwang, the company’s biosensors will have applications for consumer health and wellness, as well as the management of chronic diseases such as Peripheral Artery Disease (PAD), diabetes, and Chronic Obstructive Pulmonary Disease (COPD).

While many of us may struggle to maintain our fitness, others are faced with diabetes and other chronic diseases that affect more than 70 million individuals in the U.S., accounting for more than 75 percent of our healthcare expenditures — that’s $2 trillion, according to the National Health Council. This is putting the nation’s healthcare under even more pressures, with greater calls for consumers to become more health conscious, and the key driver for why the mobile health market alone is expected to reach $41 billion by 2020.

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9
Feb

Where in the World is SAS Visual Analytics?

I get a lot of inquiries about the SAS Visual Analytics geo-mapping features. Typically, customers are interested in knowing how specific the plotting can get. Many are concerned that the product is focused mainly in the US and thus probably doesn’t go any deeper – but that’s not true. In this post I’ve assembled landmarks from around the world to give you an idea of ... This post appeared first on BI Notes for SAS Software Users. Go to the site to subscribe or view more content.

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28
Dec

Top eClinical Trends of 2015

Clinical research is well on its way to transforming its paper-driven model to an all things electronic format. During the past year, the clinical trial industry has made considerable progress in adopting technology as a way to streamline data collection, transmission, and monitoring.

Among the latest developments- adoption rates are higher for EDC, eSource, and eClinical integration, as the focus is now on capturing real-time data as a continuous stream. These trends are partially the result of high-tech devices, sensors and wearables entering the clinical trial industry, as well as the FDA embracing technology and opening up a dialogue with experts on how to best channel this revolution in order to advance clinical research. Here is a closer look at the most recent trends.

Higher EDC Adoption

smart doctorThe move to conduct clinical trials from paper to Electronic Data Capture (EDC) has accelerated over the past 10 years in an overall effort to increase data quality, regulatory compliance and to reduce cost. This trend has grown because of the need to share real-time data and facilitate strategic decisions to be made during the study based on its progress.

According to a newly released report, the healthcare cloud computing market is expected to grow from $3.73 billion in 2015 to $9.48 billion in 2020. The eClinical solutions market, including cloud-based solutions, is projected to grow 14% by 2020, reaching an estimated $6.52 billion, up from $3 billion in 2014.

Different sources of data present many data management challenges, which is why cloud solutions are quickly gaining popularity. Cloud-based technology brings efficiency and cost-effectiveness in managing clinical data, and works for both pharma companies and their CROs. Utilizing cloud infrastructure scales and streamlines data, improving its quality and allowing for a simple, seamless experience.

According to a recent report by the Industry Standard Research (ISR), in 2013 two providers accounted for more than 50% of EDC service. This year, five EDC providers accounted for over 50% of the market share, which shows that the market for these services is growing. The same report also shows that EDC has become standard practice with approximately 88% of Phase 3 clinical trials initiating use of the technology.

However, as recent Clinical Ink research points out, volumes of paper still delay clinical trials due to reliance on 100% source document verification (SDV). Risk-based monitoring (RBM) is also advancing at a high pace while sponsors and study teams don’t have the right eClinical solutions to generate real-time data. This explains the emergence of the next trend on our list- electronic source documentation (eSource).

 

esource eSource on the Rise

Two years ago, in an effort to move away from paper inefficiencies, the U.S. Food and Drug Administration (FDA) issued its final guidance on Electronic Source Data in Clinical Investigations. In this guidance, the agency promotes capturing source data in electronic form to assist in ensuring the reliability, quality, integrity and traceability of data from electronic source to electronic regulatory submission.

According to the Food and Drug Administration (FDA) eSource Guidance of 2013: “Electronic source data are data initially recorded in electronic format. They can include information in original records and certified copies of original records of clinical findings, observations, or other activities captured prior to or during a clinical investigation used for reconstructing and evaluating the investigation”. In other words, this is data that is entered directly into a digital format without having to first record it on paper and then transfer it to an electronic data capture solution.

Investigators like the flexibility and versatility of pen and paper, and they perceive computerized systems as a drain on their productivity. The Internet is not always easily accessible from the clinical sites, especially overseas. This is why new eSource solutions are built on tablets that can address these two hurdles. Tablet applications are designed to “look and feel” just like paper, but they offer the efficiency of an electronic document. Unlike case report forms (CRFs), which only capture the data necessary for analysis, eSource documents encompass the much broader goal of providing affirmative documentary evidence related to a subject case history and site audit, and allow for random, ad-hoc comments.

Other benefits of eSource documents include increase in clinical data quality through validation checks and the removal of unnecessary duplication of data, as well as the reduction of monitor site visits by eliminating source document verification (SDV) and enabling remote document review. However, despite the many benefits, esourced documents can still be challenged from a GCP compliance perspective.

One way for e-source solutions to comply with regulations and guidelines is to make the first data recording on paper or keep the source data in the clinical investigator’s control by entering it in a medical record or a medical record system. The FDA doesn’t regulate EMR, therefore it is not subject to 21 CFR Part 11 requirements. Collected data can be entered into eCRFs directly on the condition that it meets all regulations. If the clinical data is transferred to an eCRF from an EMR, then that EMR is considered the source. The FDA has made it clear that clinical trial monitors and auditors should have access to verify the data in the EMR.

Electronically collected data can be kept on or off-site. On-site storage can present many logistics challenges such as data corruption or loss, SOPs, software validation plan, restricted access and many others. Data not store locally should be under the control of the investigator in order for it to be compliant. Thin-client architecture, which delivers e-sourced data straight into the CRO’s remote server, can sometimes also be GCP non-compliant.

The FDA has made substantial efforts in supporting the use of electronic data solutions in the past couple of years. Among the many benefits, eSourcing helps control fraud as it is far more difficult to fabricate electronic records compared to paper ones.

 

eTMFRecord Adoption of eTMF

A 2015 report by Cutting Edge Information shows that adoption of eTMF is expected to reach 88% by 2020. Currently, only about 54% of TMF is electronic-based. The report also indicates that updating paper documents to an electronic platform is more time-consuming than building new TMFs in an electronic system. To overcome the challenges associated with eTMF platforms, many surveyed teams reported executing eTMF strategies in waves. For example, teams may start by building new TMFs into an electronic system as part of a paperless pilot program, before updating paper documents from older studies.

Another recent study done by an eTMF provider also claims a drastic spike in eTMF adoption this year. The Veeva 2015 Paperless TMF Study (Veeva is the provider of Vault eTMF) surveyed 50 international CROs and found that 38% use electronic trial master file (eTMF) applications in comparison to 21% just one year ago—a sudden, 17 percentage point increase, striking especially for a market that traditionally moves more gradually. The same report also claims that, as compared to 2014, greater numbers of CROs now exchange TMF documents with sponsors via eTMF applications (36% today, up from 24%), and are much less reliant on paper (46%, down from 65%).

 

RBMChanges in RBM Trends

Recent trends in RBM were discussed at the November 2015 CBI Conference on risk based trial management. Among the topics were the changing roles of study monitors, as well as the way RBM is changing how clinical trials are conducted. Even though some CRO and sponsors aim for 100% SDV, the path to RBM has been forged with many new technology companies addressing RBM in the last couple of years.

Recent trends indicate that sponsors are comfortable outsourcing source data verification and monitoring visits to CROs but they prefer to insource Clin Ops and data management so they can have more real-time control over the study, and mitigate any fallouts as they happen.

The FDA recently developed a risk-based site selection tool which collects NDAs by clinical investigator sites and allows the agency to use the stratified data in order to select site for GCP inspections.

Experts point out that as more companies are executing RBM, clinical trial teams should differentiate between the critical endpoints of study protocol and monitoring setup, and the clinical data that will reflect the critical safety and efficacy endpoint. The value of RBM would not be leveraged if all data would otherwise be treated equally instead of being classified.

Another useful piece of advice is to pay attention to data trails and the changes made, having 100% QC of any modifications. The recent trend in higher RBM adoption has adapted the monitoring role to keep track of any changes the study team and sites are making. Experts say that is the way for people, processes and technology to complement each other when using RBM in a clinical trial.

 

econsent eConsent Adoption

The FDA defines electronic consent as “using electronic systems and processes that may employ multiple electronic media (e.g., text, graphics, audio, video, podcasts and interactive web sites, biological recognition devices, and card readers) to convey 30 information related to the study and to obtain and document informed consent”.

There are several eSignature and eConsent systems currently available on the market. In addition, companies such as Apple are also entering the medical research market with apps and wearable technology. For example, Apple’s ResearchKit has a module for building electronic consent forms.

A recent survey of the top 50 pharma companies shows that about 66% of them are either using eConsent or planning to in the near future. The percentile is even higher among the top 25 companies on the list- 88% of them have implemented eConsent. 100% of the top ten companies have also put eConsent initiatives in place.

 

 

ePRO ePRO to Replace Paper Soon

Technology is also placing the patient at the epicenter of clinical research. Fast-developing ePRO technologies allow patients to report clinical data themselves. The modern ePRO systems are designed to maximize the ease in which patients report their observations. Additionally, they better integrate with eClinical systems to capture and spread relevant clinical data faster to clinical teams. For example, ePRO systems integrate with electronic data capture (EDC) systems to automatically and securely import clinical data from the ePRO directly into the EDC system. This allows a quicker response time in the case of adverse events for example.

In a recent survey, examining 22 sponsors and CROs, 18 reported having adopted ePRO which resulted in increased data quality, patient compliance and efficient data collection. 61% of the surveyed companies indicated they implemented ePRO in the last five years, 28% in the last 10 years, and 11% over 10 years ago. Experts say the increased emphasis placed on patient reported outcomes and the push for technology adoption in clinical trials has resulted in significant increase in ePRO use. The Tufts survey also points out there’s been an overwhelming increase in ePRO usage in the oncology field. The main drawback has been the cost of using ePRO compared to paper.

However, the higher ePRO adoption trend is likely to continue as more companies see its value for post-marketing trials, as well as its benefits and capabilities expanding as more vendors enter the space each year.

 

integration1eClinical Integration

With increased regulatory requirements and the trend towards personalized medicine, sponsor companies and CROs need to access more specific solutions to meet their need, making systems integration an increasing necessity for a successful clinical trial. In addition, risk management of the product’s life cycle includes investigators, regulators and patients. This is where systems integration comes in; ensuring data is more accurate and consistent.

Leveraging technology to optimize speed, quality and cost of clinical trials is a big hurdle for pharma and their CRO partners. Bringing drugs and medical devices to market faster is most important for business success. CROs are quickly realizing that in order to remain competitive, they need the IT infrastructure to accommodate an influx of clinical data that would be well-organized and easily accessible from a central data warehouse.

This warehouse should handle the integration, reporting, management, visualization and analysis of all clinical data. For example, an integrated system, comprised of custom CTMS, Pharmacovigilance, EDC and a CDISC-compliant data warehouse enables the timely analysis of clinical data. Traditional integration between electronic data capture (EDC), clinical trial management systems (CTMS), clinical data repositories (CDR), clinical data management systems (CDMS) and statistical analysis systems (SAS) may require a lot of manual data sharing. While many sponsors can afford to transcribe data in the right format before sending it to their CROs, smaller companies still struggle to prepare their data for FDA submission.

That is why integration is crucial for both clinical trial sponsors and CROs to exchange data during all trial phases. Big pharma reportedly spends close to $200 million annually for data transfer. But new trends are emerging to combat the old ways of not transferring data until all collection is done. More and more trials are now conducted with the data moving in the early phases. This method allows managers to spot and ferret out potential problems, thus saving money and time. Another trend which saves time and money is following the CDISC’s (Clinical Data Interchange Standards Consortium) CDASH (Clinical Data Acquisition Standards Harmonization) data submission fields. This saves companies from not having to restructure their data in the drug-approval process. CROs must also follow data aggregation formats such as STDM (Standard Data tabulation Model).

Whether you choose EDC & CTMS, eTMF & Safety, or EMR integration, there is no one-stop-shop solution. For example, CTMS solutions such as Advanced Clinical Software’s Study Manager have been installed at over 2,000 sites but there are still no defined metadata and communication standards that allow CTMS and EDC solutions to share data. A common issue with EDC-CTMS integration occurs when there are complex investigative site business practices. Most EDC systems only capture clinical trial data through eCRFs that lack CTMS information. Another issue is that some EDCs may lack timeline planning features such as reaching target subject recruitment milestones, for instance. As for eTMF & Safety integration, common issue here is the lack of real-time inspection and ICH/GCP compliance.

One way for improving this process is to focus on data analysis, not just warehousing it. Most companies only focus on front-end integration without considering the need to generate reports for regulators later. If data were integrated from the start, it would be easily accessible at any point. However, this is easier said than done, as implementing systems integration is estimated to cost about $500K and take as much as 3-6 months, which can come up to nearly 10% of the research budget.

Collaboration and consolidation among front-end and back-end systems, as well as the emergence of advanced eClinical systems or modules, shows that the value of integrating will only continue to grow as users see the efficiency in storing and viewing their data on a single interface.

 

cdisc_titles2 CDISC Standards Mandate Affecting U.S. and Japanese Submissions

Last December the FDA published a landmark package of Guidances, specifications and other documents governing electronic submissions. These have the force of law, which in effect made the use of CDISC standards mandatory in the United States and Japan by December, 2016.

The FDA Guidances establish the framework for the requirement of standardized study data in submissions, and cover most aspects of submission data and documentation.

The new mandate adds on pressure for CROs and sponsors to conform. In addition, the FDA is also considering updating the CDASH standards, which would also have a significant impact on current clinical trial processes.

 

Medicine doctor hands holding capsule medicineClinical Trial Paradigm Shift

A paradigm shift is taking place in the oncology clinical trial space, partially as a result of the Obama Administration launching its “Precision Medicine Initiative” earlier this year. Precision medicine is an innovative approach that takes into account individual differences in people’s genes, environments, and lifestyles.

According to a White House release, a $215 million investment in the President’s 2016 Budget will be allocated to the Precision Medicine Initiative to pioneer this patient-powered research and provide clinicians with new tools, knowledge and therapies to select the treatments that work best for their patients.

The funding will be spread out between the National Institutes of Health (NIH), the Food and Drug Administration (FDA) and the Office of the National Coordinator for Health Information Technology (ONC) [15].

According to the White House, the objective for the National Cancer Institute is to accelerate the design and testing of tailored treatments for cancer by expanding genetically based clinical cancer trials. In June of this year, the NCI announced the launch of its nationwide clinical trial, utilizing DNA sequencing. In other words, subjects are grouped based on similarity in their genetic mutations, not the location of their cancer. The grouping is also known as “basket trials”. In the study, a few thousand patients at 2,400 sites throughout the United States will be sorted out into over a dozen treatments based on their tumor’s mutation.

The American Society of Clinical Oncology also recently announced the launch of a project that will provide patients with drugs targeting similar molecular abnormalities, and collect the data from their oncologists in order to monitor the effectiveness of the treatments.

The National Institutes of Health (NIH), in collaboration with other agencies and stakeholders, will launch a national, patient-powered research cohort of over a million Americans who volunteer to participate in research.

The trial subjects will be involved in the design of the Initiative and will have the opportunity to contribute various data—including medical records; profiles of the patient’s genes, metabolites (chemical makeup), and microorganisms in and on the body; environmental and lifestyle data; patient-generated information; and personal device and sensor data.

The Initiative will include reviewing the current regulatory landscape to determine whether changes are needed to support the development of this new research and care model, including its critical privacy and participant protection framework.  As part of this effort, the FDA will develop a new approach for evaluating Next Generation Sequencing technologies — tests that rapidly sequence large segments of a person’s DNA, or even their entire genome.

 

 

 

 

 

 

 

20
Dec

3 Methods to Remove Data from the HDFS VAPUBLIC Directory

When working with HDFS, you are often loading data to the various directories to upload into SAS Visual Analytics. However, sometimes you want to remove that data. Here’s three different ways to remove the data. Method 1: Use the SAS VA Administrator Tools If you have access to the Manage Environment area, you can use the Explore HDFS tab to interact with the data in the HDFS. You ... This post appeared first on BI Notes for SAS Software Users. Go to the site to subscribe or view more content.

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11
Dec

EDC Adoption on the Rise

smart doctor The move to conduct clinical trials from paper to Electronic Data Capture (EDC) has accelerated over the past 10 years in an overall effort to increase data quality, regulatory compliance and to reduce cost. This trend has grown because of the need to share real-time data and facilitate strategic decisions to be made during the study based on its progress.

According to a newly released report, the healthcare cloud computing market is expected to grow from $3.73 billion in 2015 to $9.48 billion in 2020. The eClinical solutions market, including cloud-based solutions, is projected to grow 14% by 2020, reaching an estimated $6.52 billion, up from $3 billion in 2014.

Different sources of data present many data management challenges, which is why cloud solutions are quickly gaining popularity. Cloud-based technology brings efficiency and cost-effectiveness in managing clinical data, and works for both pharma companies and their CROs. Utilizing cloud infrastructure scales and streamlines data, improving its quality and allowing for a simple, seamless experience.

According to a recent report by the Industry Standard Research (ISR), in 2013 two providers accounted for more than 50% of EDC service. This year, five EDC providers accounted for over 50% of the market share, which shows that the market for these services is growing. The same report also shows that EDC has become standard practice with approximately 88% of Phase 3 clinical trials initiating use of the technology.

Clinovo’s ClinCapture EDC was featured in this report along with 21 other vendors, selected out of a list of 651 EDC providers.

Try ClinCapture Free EDC

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2
Dec

DNA sequencing is changing the oncology clinical trial space

dna A paradigm shift is taking place in the oncology clinical trial space, partially as a result of the Obama Administration launching its “Precision Medicine Initiative” earlier this year. Precision medicine is an innovative approach that takes into account individual differences in people’s genes, environments, and lifestyles.

According to a White House release, a $215 million investment in the President’s 2016 Budget will be allocated to the Precision Medicine Initiative to pioneer this research and provide clinicians with new tools, knowledge and therapies to select the treatments that work best for their patients. The funding will be spread out between the National Institutes of Health (NIH), the Food and Drug Administration (FDA) and the Office of the National Coordinator for Health Information Technology (ONC).

The objective for the National Cancer Institute is to accelerate the design and testing of tailored treatments for cancer by expanding genetically based clinical cancer trials. In June of this year, the NCI announced the launch of its nationwide clinical trial, utilizing DNA sequencing. In other words, subjects are grouped based on similarity in their genetic mutations, not the location of their cancer. The grouping is also known as “basket trials”. In the study, a few thousand patients at 2,400 sites throughout the United States will be sorted out into over a dozen treatments based on their tumor’s mutation.

The American Society of Clinical Oncology also recently announced the launch of a project that will provide patients with drugs targeting similar molecular abnormalities, and collect the data from their oncologists in order to monitor the effectiveness of the treatments.

The National Institutes of Health (NIH), in collaboration with other agencies and stakeholders, will launch a national, patient-powered research cohort of over a million Americans who volunteer to participate in research. The trial subjects will be involved in the design of the Initiative and will have the opportunity to contribute various data—including medical records; profiles of the patient’s genes, metabolites (chemical makeup), and microorganisms in and on the body; environmental and lifestyle data; patient-generated information; and personal device and sensor data.

The Initiative will include reviewing the current regulatory landscape to determine whether changes are needed to support the development of this new research and care model, including its privacy protection framework. As part of this effort, the FDA will develop a new approach for evaluating Next Generation Sequencing technologies — tests that rapidly sequence large segments of a person’s DNA, or even their entire genome.

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