Applied Clinical Trials-06-01-2013

KMR Group

S

Women should be represented more in studies and greater attention paid to their general health issues.

Industry news focusing on the people and organizations who work in the clinical trials profession.

Risk-based monitoring was in Trans-Celerate BioPharma's sights since the pharmaceutical company collaborative was announced in September 2012.

Food and Drug Administration officials are busy implementing its provisions that offer new approaches to clinical trial design and application review.

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

Treatment networks and network meta-analysis of randomized trials can boost understanding of how much evidence is available for each treatment and treatment comparison.

Making clinical research data more widely available creates both opportunities and risks.

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

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

Industry Standard Research

We are now being encouraged by regulators worldwide to re-think our approach to monitoring and apply risk-based monitoring strategies rather than continue with our more traditional approaches.

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

Trial Design: Cystic Fibrosis Clinical Trials Patient Retention Strategies PRO in Analgesia Trials Subject Recruitment: Community-Based Recruitment Also in this issue: Female Trial Subjects Data Transparency Mitigating Risk