Trial Design

Regulatory authorities routinely inspect clinical trials, sites, sponsors, investigators, and other relevant parties to ensure compliance with good clinical practice guidelines.

Conducting Large Simple Trials to answer questions about "real-world" medical interventions is not a recent concept.

Objective internal monitoring can help clinical trial sponsors transform a regulatory mandate into a valuable quality improvement tool.

PCORI underscored existing trends toward increasingly individualized and personalized medical care...

The clinical trials world is starting to adapt computer-aided design.

Companies that don?t collect pharmacokinetic data during Phase II and Phase III clinical trials are missing major dividends.

Study results using a quality-by-design method, risk-based monitoring, and real-time direct data entry.

Science exhibit will give children and young adults a rare look inside clinical trial patient experience.

It should go without saying that the success of oncology clinical trials depends greatly on enrolling adequate numbers of eligible patients.

Examining a region's comparator reimbursement climate to better inform trial expansion decisions.

Half of all drugs in clinical testing are interrupted by in-licensing, co-development, joint venture and M&A arrangements – and they are taking significantly more time to develop.

How molecular profiling is impacting today's cancer medicine.

The Pediatric Working Group of the European CRO Federation conducted a follow-up survey on the status of pediatric clinical trials in Europe.

A survey on the perception of European pediatricians and industry/CROs

A discussion of summary findings from the CISCRP 2013 Perceptions & Insights Study

Incorporating CDISC-based libraries to store study components for study design and building eCRF pages.

Clinical research processes need to be simplified before new technology can be properly utilized.

In a phase III trial in vascular disease, over 4,500 patients were randomized across 160 sites.

Physician participation in and patient access to cancer treatment clinical trials (CCTs) are key measures for delivery of quality cancer care.

Planning for ethnic sensitivity from a scientific and regulatory perspective.

Bring Your Own Device (BYOD) makes sense economically and socially and is the future of clinical trials.

Adaptive trial designs have the potential to transform success rates, but require new operating strategies and practices.

Multinational pharmaceutical companies are under intense financial and competitive pressures to make the drug development process more effective and efficient, and to expand into a greater number of international markets.

The 505(b)(2) new drug application (NDA) provides a potentially streamlined path for sponsors who have developed improvements to drug products that have previously received FDA approval.

Despite the growing need for pediatric-approved medications, clinical trial enrollment for pediatrics remains challenging.

Expect the FDA to be looking at a new metric in the drug approval process: driving safety.

Central labs promote scientifically objective results, through independence of action on a contractual basis with the sponsor.

Transfer of knowledge between pre-clinical and clinical research is necessary to deliver effective medicines to patients.

Work is needed if true efficiencies are to be gained in clinical trial performance.

Central statistical monitoring can improve RBM solutions by efficiently detecting errors, sloppiness, tampering, and fraud.