Industry Trends

How the European Union is impacting current Pharmaceutical trends.

It's official. Europe is sick-and much of the sickness derives from its economic problems.

Tufts CSDD

ISR

Tufts

KMR Group

Medidata

KMR Group

Tufts CSDD

Medidata

IMS Health

KMR Group

Tufts CSDD

KMR Group

Medidata

ISR Reports

There's a rapidly growing trend towards targeted (or risk-based) site monitoring and data review. However, some organizations remain concerned about the potential impact on data quality.

TTC

Over the past year and a half we have been monitoring the trend towards adoption of risk-based monitoring across the industry, and in particular the move towards reduced source document verification (SDV).

Clinical R&D organizations across the industry have been steadily moving away from the traditional approach to site monitoring using 100% source document verification (SDV) of subject eCRFs, and into a new paradigm where a targeted sampling of the subject eCRF data is verified against source charts.

Site per visit increases have been smaller in recent years.

Asia, Latin American, and Eastern Europe are increasingly attractive geographies in which to conduct clinical research.

Throughout the entire clinical development, who has the most interaction with prospective and active subjects? Who is primarily responsible for the quality of the source data that ultimately decides the approvability of all biopharmaceutical products?

The design and completeness of the protocol and early and open communication with research center personnel are factors that most influence investigative site willingness to participate in a clinical study.

Do Sites Prefer a Sponsor Company or CRO to Run Their Clinical Trial?

On several occasions each year, Industry Standard Research (ISR) has the opportunity to speak with sponsor companies about their outsourcing practices.

Contrary to common belief, the development of follow-on drugs, often referred to as me-too drugs, does not begin after a first new drug in a therapeutic category receives market approval. The reality is that sponsors are engaged in drug development races that are intensely competitive where the first drug candidate to receive marketing approval belongs to the sponsor that got to the finish line with a satisfactory submission the fastest.

The public would be best served if both recognize their own questionable practices.

Clinical trials in developing nations-called "ascending markets"-are exploding. These regions offer large naïve subject populations, low operating costs, and increasingly stable testing infrastructures, but regulatory reform is really driving the growth. CenterWatch data show 20%?30% of clinical trials are being conducted in ascending regions.

An extended survey was conducted on the topic of clinical quality assurance (CQA) benchmarking in pharmaceutical companies to gather new data.