Choosing between placing a sizable bet on metrics to predict successful investigative site performance versus on implementing practices to support site performance success, most sponsors and CROs would choose the former. Ideally, both approaches play an important role. But most sponsors and CROs are investing in the former approach without much to show for it. Perhaps it's time that more sponsors and CROs focused attention on the latter?

The ethical aspects of biobank research have become a source of intense discussion after Swedish authors claimed that having to obtain informed consent for the use of left-over human tissue samples could be hampering essential studies. Biobank research has a valuable role to play in R&D, but handling the consent process is rarely straightforward.( Source: Biotec Services International )

In June 2011, Pfizer announced the REMOTE trial, the first "virtual" randomized clinical trial under an IND to assess the safety and efficacy of Pfizer's Detrol LA, a treatment for overactive bladder.

As pharmaceutical, biotechnology, and medical device manufacturers of every kind are discovering in the wake of March 2010's Patient Protection and Affordable Care Act (PPACA), big legislation can mean big change in the world of drug development and clinical trials.

Wayne R. Kubick

Jill Wechsler

Eighty-five to 90% of clinical trials have a stipend or travel reimbursement to compensate subjects for their participation. While reimbursement amounts may not be large from the perspective of industry professionals, the payments can still make a difference to a volunteer. Greenphire CEO Sam Whitaker says, "Many studies typically deliver reimbursements on a monthly or even quarterly basis.

What is a cluster? A cluster is a way of organizing a group of competing companies in geographic proximity to one another. Perhaps the most well known clusters in the drug development world are the biotechnology clusters in Cambridge, Massachusetts and San Diego, California. There are further clusters in Scandinavia and throughout Europe, and new clusters are appearing in the Asia Pacific region.

Consent is not just the static form; it's a dynamic process by which the subject and investigator embark on a collaborative relationship optimized via conscientious consent planning, consistent implementation, and complete verification. The ethical principles are already set in the Declaration of Helsinki and ICH-GCP, and it suffers chronic deficiencies, however informed consent remains central to the protection of human subjects. It is a process; it does not mean that the pediatric trialist just briefly explains the clinical trial and then the parents (or of-age child) signs the documents.

September is back-to-school time in many places around the world--and certainly in Europe. So this month's column offers a quick reminder of where the European Union's engagement in clinical trials fits into the larger picture of the EU's broader health policy. Some sense of this context may be helpful in grasping how the debate evolves in the upcoming revision of Europe's clinical trials rules.

The European Medicines Agency has confirmed its long-term commitment to remain in London by signing a 25-year lease agreement for office space in a new 20-story building on the Canary Wharf estate. The Agency plans to move in 2014, when the leases on its current premises expire. A computer-generated image of the EMA's new home, located in the Canary Wharf Estate.