As cancer immunotherapies continue to emerge, the need for rigorous evaluation to assess the safety and efficacy of these products in clinical trials is critical. Doing so in the early phase setting requires a foundational focus in such areas as NME selection, protocol development, patient population, and investigator and site selection.
Data on the relationship between investigator characteristics and cardiovascular clinical trial patient recruitment are extremely limited in scientific literature. An analysis of ALLHAT, the largest antihypertensive clinical study ever conducted, identifies key investigator and site characteristics that can strengthen subject enrollment.
Integrating evidence-based planning and real-world evidence has the potential to reap big gains for development productivity. Achieving this through a "Three-Pillar" approach emphasizing knowledge sharing, evidence needs, and scenario risk-building is proposed.
Pilot study evaluates the success of building quality into clinical trials using a plan-do-check-act (PDCA) approach to quality management.
The industry is experiencing a paradigm shift from pharmacovigilance rooted in case processing and compliance reporting to a safety program built around benefit-risk management.
Robert Califf addresses questions about drug pricing at the Senate hearing to weigh his appointment to be the next commissioner of FDA.
Large pharma companies have fallen “below legal and ethical standards” for making public information from the relevant clinical trials, according to a report from Bioethics International.
Clinical Trial Agreements
December 2, 2015 - December 3, 2015 | Philadelphia, PA
CBI's Clinical Data Disclosure and Transparency
January 26, 2016 - January 28, 2016 | Philadelphia, PA
Clinical Trial Budgeting and Forecasting
February 08, 2016 - February 09, 2016 | Philadelphia, PA
Expanded Access Programs 2016
February 23, 2016 - February 24, 2016 | Washington DC
SCOPE Summit for Clinical Ops Executives
February 23, 2016 - February 25, 2016| Miami, FL
We all need help sometimes. For pharmaceutical companies, this often comes in the form of a reliable and competent contract research organization.
Randomized Clinical Trials (RCTs) have constituted the foundation for new drug approvals for over fifty years.
Few topics occasion the lamentations of clinical trial professionals more than the topic of patient inclusion/exclusion criteria in clinical protocols.
Without question, advanced cellular and gene therapies require well-defined cold-chain management solutions that reduce risk and include all elements of packaging, data collection and logistics expertise to ensure high-quality, effective treatments reach the point of care, and ultimately, the patient.
By Applied Clinical Trials Editors
Executive moves abound in the CRO world this month; plus a list of the 2015 RAPS Fellows.
By Cathy White
Accruing patients depends greatly on engaged, enthusiastic PIs, as they are the gatekeepers in helping patients decide to participate in clinical trials. Building staff awareness and enthusiasm are also essential for retaining participants.
OmniComm Systems enlisted Applied Clinical Trials to conduct a survey on eSource and discovered our audience needed more tools to understand this growing technology area. Based on the results, they crafted a targeted webinar, a successful white paper and sponsored this eBook that features educational articles around eSource and links to OmniComm resources. SPONSORED
As the use of PRO expands in clinical trials, ePRO vendors have expanded beyond this constrained definition. Increasingly, the use of eCOA is being used to encompass all data collected related to the patient, which includes PRO, clinician reported (ClinRO) and observer or caregiver reported outcomes (ObsRO). This e-Book tackles the changing world of PRO collection in clinical trials.
As the push to contain clinical trial costs and make informed business decisions continues, more pharma and CROs are looking at internal and external benchmarking and metrics to evaluate their performance—both successes and challenges. This e-Book includes articles that show how analytics uncover problem areas in clinical operations, as well as metrics and databases that are used to pinpoint internal or external performance issues.