As clinical trials create large amounts of data, and researchers seize the opportunity to use de-identified data as a means to develop and discovery, managing the information has become more and more complex.
The FDA is addressing increasingly complex eligibility criteria in an effort to expand patient participation in cancer clinical trials, a move which will help shorten study recruitment timelines, among several other benefits to both researchers and patients,...
Bridging the gap between clinical care and research means creating two-way collaboration, improving the way in which data is collected, organized, shared – and engaging EHR vendors, says conference panelist.
Regeneron and UK Biobank announce human sequencing data resource for global research and to accelerate improved patient care through outcome algorithms.
TrialAssure releases anonymizing SaaS to enable sponsors to share clinical trial data, as the industry shifts towards utilizing big data while maintaining patient privacy.
Novartis Pharma AG partners with Target PharmaSolutions to support its global longitudinal observational study designed to generate real-world clinical data.
Houston Methodist Hospital joins the TriNetX global health research network to provide RWD for study feasibility and academic collaboration in industry-sponsored clinical trials.
Integrated research organizations aim to bridge the gap between clinical research and clinical health care with the use of RWD, yet, the data may not be ready for research, according to Elligo Data Scientist.
Getting patients into possibly life-saving trials has long been a complex process, however, with the age of electronic health records and cloud-based data, there are opportunities for simplification.
Clinical trial sites often cannot keep up with patient referrals from marketing campaigns – with research suggesting that one-third of referrals are never processed, says patient recruitment firm.
Large clinical trials can be particularly useful in the early treatment and prevention of neurodegenerative diseases because of the amount of data collected, though patient recruitment and retention are challenging, says biostatistician.
By Barbara Lopez Kunz, global chief executive, DIA
The practice of incorporating the voice of the patient into clinical development has gained significant traction over the past decade, and rightfully so.
Genetic discoveries have taken place in narrow population groups, say researchers, who for the first time, reveal that such studies are concentrated in a handful of countries – and conducted by a ‘tight-knit group of researchers.’
The industry’s pledge to improving the patient experience drove significant change in 2018 and will continue to do so this year, with so-called “convenience” services to become standard, says Greenphire CCO, who outlines several other trends to watch.
For research in areas such as Parkinson’s disease, digital endpoints may soon be used as primary endpoints, allowing for in-home clinical trials to be conducted over longer periods of time, says CRO.
By Jim Kremidas, executive director, Association of Clinical Research Professionals
This time next year, I hope I can write a column with the headline “2019: The year of cooperation and communication in the clinical trial industry.” We’ve made some exciting progress toward that end in 2018. Now it’s time to take it to the next level.
Clinical trials suggest that long-acting injectable antipsychotics should be expanded into a broader range of clinical settings and patient populations, says Premier Research executive.
The digital patient recruitment and engagement company has released its new digital solutions to build long-term relationships with clients, sponsors, and CROs.
In the era of big data, the industry is working to address the ethical concerns of integrating patient information into the health care landscape – though a key challenge will be reaching a consensus on what constitutes reliable evidence.
The FDA recently released open source code and technical documents for its new mobile app – MyStudies – which is designed to collect information about medication use, health system touchpoints, and patient-reported outcomes.
Litmus Health’s profile of the wearables market names the top 15 devices today available to researchers incorporating real-life data into studies and trials – with a focus on data quality and transparency.
The industry must be “relentless” in driving the adoption of new advances in technology, says Janssen, which has shifted from doing things for patients and investigators, to doing things with them.
Iqvia describes the new platform as the marriage of eConsent with an authoring system – giving the clinical trial a framework for transparency and transformational change.
The pharmaceutical industry has increasingly been adopting artificial intelligence – which has demonstrated the ability to predict instances of schizophrenia with 74% accuracy.
The health care social network Inspire is expanding its research solutions to help life science stakeholders integrate the patient voice and experience into research.
Data Cubed’s new CCO David Kiger – who has held roles at Bioclinica and Parexel – says the company is primed to be the go-to provider as the industry continues to shift to virtual clinical trials.
Advanced Clinical is partnering with Cognitive Clinical Trials to overcome recruitment road blocks in Alzheimer’s clinical trials and expedite research through patient centric model.
A consumer rights watchdog is calling on regulators to suspend research at a Minnesota-based medical facility in response to concerns surrounding informed consent for a study involving Ketamine.
The online resource organizes and maps myriad sources of research on clinical trial recruitment to help users identify promising interventions, say report authors.
Hu-manity.co is taking on the human data marketplace with its mission to establish a 31st Human Right: Legal ownership of human data as property – a shift that could help improve clinical research and increase transparency, to begin.
Genetic testing could potentially transform the way clinical trials are conducted – but for the patient, the role of the genetic counselor is a key component of this process.
The EMA has revealed that it is having to cope with “significant staff losses” due to Brexit, which means that it will have to temporarily cut certain activities.
It has been nearly 20 years since a currently available drug was tested and approved specifically for the newborn population, say industry experts who are calling for education and policy changes to address the needs of this special patient population.
Bayer AG and Elsevier studied more than 1.6m adverse events to show how big data can be used to reduce animal testing and design trials "altered to potential risks," says researcher.
President Trump says he will sign the “big legislation” after the US House of Representatives passed the Right to Try Act – opponents of which warn lacks key patient protections.
Glenmark Pharmaceuticals has suspended a Phase II clinical trial at a site in India following media reports that villagers were allegedly “deceived” into participating.