The Association of Clinical Research Professionals (ACRP) is developing competence standards for principal investigators (PIs) as part of its goal to reduce variability in performance across various clinical research roles.
The lawsuit cites more than 150 alleged clinical trial-related deaths since 2014 with plaintiffs calling on the FDA to update current informed consent regulations.
Sponsors are encouraged to use a master protocol approach to accelerate clinical development programs, though experts say the advantages and challenges should be carefully weighed.
Clinical trial transparency efforts are falling short, with half of trials left unreported, according to a recent UK parliamentary committee report, which calls on the government to take action.
New guidances from the FDA update language and provide clarity for innovative approaches to the design and execution of clinical trials, say industry executives.
The FDA is calling on the digital health industry to innovate and proposing a new Center of Excellence for Digital Health – the timing of which is critical, as the industry is receiving more funding and opportunities than ever before, says industry exec.
Oracle is adding goBalto’s clinical trial site selection and activation solutions to the Oracle Health Sciences Cloud – in an aim to deliver ‘the best end-to-end clinical trial experience.’
Novotech has acquired a CRO to further support its customers’ clinical research programs across different phases and countries in Asia-Pacific – an area in which it has 10 partnership agreements providing access to more than 1.4bn people.
eTheRNA announced it will be opening a cGMP compliant mRNA manufacturing facility in Belgium, to increase production of its three mRNA encoding proteins.
Premier Research is expanding its presence in the Asia-Pacific region to include South Korea, Singapore, and Taiwan – with greater health care spending and patient access to new drugs driving demand.
Specialized capsules and encapsulation techniques can streamline early phase clinical studies – and help researchers meet drug program timelines, says CDMO.
LabKey and Linguamatics have designed an integrated NLP data management solution to help accelerate clinical data abstraction and curation of unstructured notes and reports for clinical research.
The price of running a clinical trial to obtain FDA approval is a fraction of the total drug development cost – challenging traditionally held beliefs about the amount of money required to study prescription drugs, according to new research.
As aging populations grow and treatment paradigms shift, the industry must prepare for greater challenges in the rare disease clinical trial space, says CRO executive.
In this first part of a two-part investigation, we look at how NDMA receptor antagonists, such as ketamine, could be poised to make a breakthrough in the treatment of depression – an area where the pharma industry has struggled to identify new targets...
Iqvia is expanding its alliance with Salesforce through which the companies will release SaaS and technology-enabled services to automate clinical trial processes and reduce patient burden.
Patient centricity quite plainly means to put the patient at the “front and center,” explained Rhonda Henry, vice president, site collaborations and patient centricity, PPD – though many remain confused on how to be “patient centric.”
Integrating clinical research into the health care ecosystem improves patient engagement and quality of care while reducing costs, though only 1% of the general population participates in clinical trials.
Undisclosed pharmaceutical industry payments to authors of oncology clinical trials published in scientific journals raise concern around credibility and trustworthiness, according to a recent report.
Virtrial’s vision is to replace up to half of the standard clinical trial visits with virtual ones, using a hybrid approach incorporating telemedicine.
The contract services provider is now collecting and using peripheral blood mononuclear cells (PBMCs) for early phase clinical trials at its Antwerp, Belgium-based Clinical Pharmacology Unit (CPU).
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.
Cryoport is supporting a record number of clinical trials driven by rapid growth in regenerative medicine – a space that will continue to grow and outpace the pharmaceutical industry, says CCO.
In an update on the implementation of the new Clinical Trials Regulation, the MHRA expresses increased confidence that the UK will exit the EU with a deal – and reaffirms its commitment to align with parts of the legislation “within the UK’s control.”
Outsourcing-Pharma recently conducted a second ‘state of the industry’ survey to gauge views about the current state of the global pharmaceutical outsourcing market and the evolving relationships of those involved.
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.
WCG’s acquisition of KMR Group and MCC addresses sponsor and CRO need to establish a common set of metrics to understand and manage clinical trial performance, says CEO.
The industry needs “to strike a balance” between science and feasible execution as increasingly complex clinical trial protocols are impeding efficiency and driving up costs, says industry expert.
Ignoring pediatric considerations is no longer an option for the development of new medicines – though clinical trials in children are still not widely accepted by society, explains industry executive.
“Arbitrary upper age limits for trial entry are almost never justified,” says FDA, which has renewed its efforts to include older adults in clinical trials and tackle some of the key enrollment challenges.
While senior citizens consume roughly one third of all medications – and make up only 13% of the population – factors that complicate geriatric clinical trials leave gaps in knowledge and developments.
Patient-centric programs for clinical trials, such as travel assistance, are major deciding factors for patients considering participation – and should be standard for all studies, says BBK.
Innovations in drug development positively affect clinical trial timelines, market launch likelihood, and patient access – though adoption remains low, says report.
There is an increased need for transparency to improve the conduct of pediatric clinical trials and enhance the site investigator experience, says Syneos executive.
Iqvia has launched a new suite of virtual study options to challenge the traditional clinical research mindset with a patient-centric approach, says company executive.
CTTI has completed more than 25 projects on issues affecting clinical trials over the past decade, since which time the industry has changed greatly, says executive director.
An update to guidance on patient payments in clinical trials has been released by the US FDA, urging institutional review boards and investigators be wary of undue influence impacting subject consent.
Apple has updated its Health app to give users access to their medical records – a new feature that could fundamentally change the way research is conducted, says Medidata.
DNAnexus has secured $58m financing, including a strategic investment from Microsoft, in order to further develop its translational medicine solutions.
Drug firms that want to trial or sell vaccines in India, or import them into the country, will need to seek CDSCO permission via an online portal from now on.
