INC Research Acquires PRC; Expands Late Stage Capabilities

Posted by: Stephen DeSantis

INC Research, a Raleigh, N.C.-based contract research organization (CRO),has acquired Pharmaceutical Research Corporation (PRC), a late stage–focused CRO based in Hatboro, Penn. INC was actively searching for an opportunity to grow in the area of late stage trials. The acquisition allows INC to expand its phase IIIb/IV capabilities. About 90% of INC’s business is in the phase I to III market, while 70% of the trials that PRC services are in phase IIIb/IV. “PRC has a strong reputation in that area, and so they were an obvious choice for us to talk to. It was also culturally similar with some great goals for growth,” John Potthoff, president and chief operating officer, INC Research told CWWeekly.

Top Stories for the Week of Sept. 25th 2006

Terrifying Budget Numbers

Posted by: Steve Zisson
 
For all that consumers expect from the U.S. Food and Drug Administration, it is completely irresponsible of the federal government to fund it with less than $2 billion a year. By comparison, that’s exactly the same dollars the federal government is spending each week on the war in Iraq.

Now some in Washington would argue that spending $2 billion a week on the war in Iraq is central to fighting the war on terror. But the FDA is also on the front lines of protecting the American people from terrorist threats against our food and drug supply. With the latest E. coli scare in the news, it became clear that the FDA does not have the resources for that particular fight to protect our citizens.

Medical Device CROs Setting Up Shop in Emerging Markets

Posted by: Stephen DeSantis

Alquest, a medical device focused contract research organization (CRO) based in Minneapolis, Minn., has launched services in India. The company claims to be the first such CRO to expand medical device offerings into the emerging India trials market. Medical device companies are particularly afflicted by challenging patient recruitment rates, and Alquest feels many companies will head to India to shave costs.

Alquest was started by Linda Alexander in 1993, as a consulting company to the device industry. In addition to the company’s Minneapolis headquarters, Alquest holds an office in the San Francisco Bay Area. Earlier this month, Alquest announced the promotions of Ann Quinlan-Smith to president and Elizabeth Kempen to chief operating officer. It employees a staff of about 50 employees.

Stephen DeSantis, Senior Associate Editor, Thomson CenterWatch.

Top Stories for the Week of Sept. 18th 2006

Fighting The Logjam In LatAm Drug Trials

Posted by: Sara Gamrbill

Clinical research in Latin America has grown significantly over the past 10 years but obstacles to continued growth still exist. In our first-ever survey of investigative sites in Latin America, we at Thomson CenterWatch found that bottlenecks at the site level continue to hinder growth of clinical research in the region as researchers strive to improve the system.

In the survey, 86% of respondents said that regulatory delays and bureaucracy were the biggest challenge to conducting clinical trials. Two of the largest markets, Brazil and Mexico, have the lengthiest and sometimes slowest moving regulatory approval systems. Both countries have said, though, that they are committed to streamlining their processes.

The six major markets—Argentina, Brazil, Chile, Colombia, Mexico and Peru—account for 425 million people, or 80% of the region’s population, equal to the population of the entire European Union but less than half the size of India or China.

CenterWatch Monthly: September 2006 Issue

FDA Offers Guidance on Informed Consent Exemptions

Posted by: Stephen DeSantis

Helping to quell a storm of a controversy, the FDA has issued new guidelines describing the circumstances when informed consent can be waived for clinical trials in emergency or ambulatory settings. It's a big issue. Informed consent is a 'sacred cow' in today's clinical trial industry, and rightly so.

The 30-page document entitled “Guidance for Institutional Review Boards, Clinical Investigators and Sponsors: Exception from Informed Consent Requirements for Emergency Research", lays down the criteria where such consent is not explicitly required.

For instance, the drug or device being studied cannot be for a disease or injury where there is an approved or more appropriate treatment option available. The document also requires such trials to have a direct benefit to patients, have no other recruitment recourse (i.e. similar patients who can provide consent) and go through some attempts to determine -- or in some cases infer -- whether a patient would or would not consent (i.e. familiarity with patients their beliefs).

Top Stories for the Week of Sept. 11th 2006

Former Head of German CRO IMFORM Sentenced for Fraud, Corruption

Posted by: Sara Gamrbill

Peter U. Witte, former president and chief executive officer of IMFORM, a contract research organization (CRO) based in Darmstadt, Germany, was sentenced in August to four years in jail in Munich District Court for fraud, corruption, and aiding and abetting the betrayal of confidence. CW Weekly has been investigating what led up to Witte’s sentencing for several months. Witte confessed that for years he had defrauded his principal client, Japan-based pharmaceutical company Sankyo, with bills for several million euros for services supposedly performed during a drug study, according to a published report in Süddeutsche Zeitung.

Sara Gambrill, Senior Editor at Thomson Centerwatch.

The full article appeared in our August 21st issue of CW Weekly. To read the full articles for this issue or for more information on these and other breaking stories, please click here!

How Much is Enough? The High Cost of Source Document Review (SDR)

Posted by: Karen E. Woodin, PhD

Source document review, sometimes called source document verification, involves checking the data recorded in the case report forms against data found in available source documents, including the patient chart, laboratory reports and other supporting documents. (A source document is any document where the data are first recorded.)

The purpose of source documentation is twofold: first, to verify that the subjects exist and, second, to verify that data in the CRF are consistent with the information found in the source documents, which verifies the integrity of the data.

For example, one would expect to see basic demographic information in an office chart for a patient, including name, address, phone number, insurance information and a social security number.  The usual office chart will also contain lab reports or reports of other tests. This information is indicative that the person entered in the trial actually exists.

Disapproving Look

Posted by: Steve Zisson

Well, it’s about time the FDA took a hard look at the compounding of drugs at some pharmacies. Until now, the FDA sort of looked the other way at pharmacists who custom-blended drugs from bulk ingredients. Particularly popular have been custom hormone replacement therapies or drugs that remove an ingredient that may be an allergen.

Wyeth has been wanting the FDA to step up to the plate with tighter regulations. Of course, Wyeth has a drug that competes with some of these special blends of hormones. On the other side, pharmacists in Texas have argued that the FDA shouldn’t treat custom blends as unapproved new drugs, even if the pharmacists have been touting their blends as safer than the approved drugs.
If they want to make those kinds of claims about the safety of the drugs they are blending, then they better think about conducting some expensive clinical trials to prove it.

Steve Zisson, managing editor of Thomson CenterWatch.