Trial Design

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.

The reality of risk-based monitoring: history and successful implementation for late phase research.

The eClinical Forum Risk Based Monitoring Taskforce offers some best practices for ensuring clinical data quality.

The use of RBM may be the only way forward as long as the development of medicines relies on clinical testing.

Risk-based monitoring ushers in the move from the traditional experimental design.

Addressing patient dropout with an arsenal of tools that leverages both technology and communication.

Community-based recruitment engages multiple stakeholders in a collaborative approach.

PRO measures enrich the evaluation of treatment effectiveness and help sponsors differentiate products.

Changing demographics and evolving standards of care bring additional challenges when creating protocol designs.

A useful tool for clinical research professionals to estimate potential recruitment duration.

Only eight percent of CNS drugs will reach approval, in part because of the high adverse effects standards.

How partnering can speed companion diagnostic development.

Sponsor-driven, CRO/recruitment provider collaborations propel cost-efficient study completion.

Partnership agreements for CROs and eClinical technology providers can be as beneficial as sponsor/CRO partnerships.

How Covance has achieved successful outsourcing relationships with pharmaceutical sponsors.

Current commercial forces are working to accelerate the adoption of adaptive monitoring designs.

Survey results show that the recruitment of Latino subjects requires specialized tactics.

Stay in the know with this list of up-to-date, commonly spoken, shortened words that are used often among clinical researchers.