Study finds that despite the use of new approaches to streamline and accelerate study start and improve site selection and activation, the impact on start-up cycle times has been limited. The reasons why are explored.
The largest antihypertensive trial ever conducted throughout North America, ALLHAT, was organized using a coordinating center model for oversight. Regional coordinators played a key role in carrying this trial out.
With a unique business model, pharmaceutical companies and their subcontractors need to find every way possible to shorten drug development times consistent with patient safety. The challenges facing commercially oriented organizations developing prescription drugs are substantial.
According to the FDA, the most common compliance deficiencies during inspections include inadequate investigator oversight, protocol deviations, poor record keeping, insufficient investigational product accountability, and issues with subject protection and consenting. Any deviations during an inspection can lead to a Form 483, leading to a lengthy process to address the problem.
These articles can help you prevent receiving a 483 by creating best practices.
This Best Practice in Patient Recruitment report displays what percentages of patients are recruited from and where.
This recent report explores key factors behind customer satisfaction and other dynamics within the Late Phase market.
Report shines light on the current state of the Phase II/III clinical trial market and its anticipated direction into 2020.
Cellular therapies offer potential to improve medicine and fill the needs of patients with few treatment options, though these products must be stored at cryogenic temperatures. Incorporating cold chain logistics into your clinical trial can prove beneficial in making these products available to patients.
By Ashok Ghone
Investigational sites’ readiness to support new monitoring initiatives such as risk-based monitoring and centralized monitoring will dictate their success. Here are key aspects that sponsors and CROs should establish with investigational sites while implementing these new initiatives.
Eosinophilic esophagitis (EoE) is a rare esophageal condition that currently has no FDA-approved medications resulting in major gaps in treatment. Therefore, the need for better options and opportunities for drug development is apparent.
Studies in Hepatic and Renal Impaired special populations have almost always required drugs with systematic absorption resulting in unclear conclusions. A solution for this would be a study design based on pharmokinetic properties that incorporates principles of Hepatic and Renal Impaired pathologies.
The Cancer Moonshot 2020 Initiative has been a long time coming for the team working to develop the program’s infrastructure and logistics. Following years of planning the result has been an increased response in the belief that a vaccine-based immunotherapy to battle cancer will be available by 2020.
TransCelerate’s Site Qualification and Training Initiative has launched a special project aimed at improving Electronic Data Capture system efficiencies between sponsors and sites. Adam Colley of Merck explains the improvements that this initiative will provide for training providers and sites.
Oncology remains the therapeutic area with the most drug failures, the lowest numbers of patients enrolled and the highest with the number of drugs in clinical trials. Many trends in oncology clinical trials seek to address these challenges and include the use of biomarkers, immunotherapies, and adaptive designs.
This special report offers an article regarding current FDA thinking and future direction with these assessments. ERT--a cloud platform solutions provider that captures quality efficacy and safety endpoints in centralized Cardiac Safety, Respiratory, Suicide Risk Assessment, and Clinical Outcome Assessments—offers expert view on this regulatory change.
Clinical trials have increased in number and complexity for numerous reasons—global trials, outsourcing, protocol requirements, and multiple regulatory issues. Factor this with the increased need to bring efficiencies and lower prices to the clinical trial process, and the need to stay on top of trials only becomes more crucial. This eBook will include articles on logistics of clinical trials supplies, negotiating with investigative sites, use of e-signatures and more.