Now just emerging from a year of legal and financial blows and bad publicity, SFBC has decided to change its name to PharmaNet Development Group, pending shareholder approval later this month. The company’s late stage division will continue to be called PharmaNet, and its early stage divisions will operate under the names Anapharm and Taylor Technology.

SFBC’s second quarter shows how this difficult year has affected the company’s balance sheet. Showing signs that the worst may be behind them, the company reported strong growth ahead with a total backlog of anticipated direct revenue of $353.5 million.

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India has come a long way as a center for clinical drug trials, but is the country ready for Phase I studies? I think the short answer - and others would agree - is “no”. Take, for instance, recent comments by Ashwini Kumar, the Drug Controller General of India (DCGI), who spoke recently at the Drug Information Association’s (DIA) Annual Meeting in Philadelphia. Kumar, head of the Central Drug Standard Control Organization (CDSCO), India’s regulatory agency, said that India needed to create an environment for the best quality assurance before embarking on phase I studies...

As a first step, the country upgraded regulations governing clinical research - Schedule Y - last year to harmonize them with U.S. and international standards. It also eliminated “phase lag,” which mandated that India not begin a phase of a global trial program until that phase had been completed elsewhere.

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Changing Investigator Meeting Formats

Investigators and coordinators who have sat through many investigator meetings agree that changing formats can only make the time-worn meetings more useful. Despite that feeling, investigators and other site personnel enjoy attending investigator meetings in person and overall they rate meetings well. When asked about key aspects of investigator meetings in the Thomson CenterWatch 2005 Investigator Meeting Survey, 78% found the meetings’ overall usefulness to be “Good” or “Excellent.”

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It’s ironic that at a time when several high-profile marketed drugs have been given a black box warning or withdrawn from the market that the Abigail Alliance has gathered steam.

The Abigail Alliance is a patient advocacy group that is suing the U.S. Food and Drug Administration for the patients’ “right” to take an experimental drug after it has been through only one phase of drug development. Two members of the three-judge panel of the U.S. Court of Appeals for the D.C. Circuit found that patients with a life-threatening and otherwise untreatable disease have a constitutional right to seek experimental treatments, even if researchers have not determined efficacy. In addition, the court said that the government should be removed from the equation unless it has a “compelling interest.”

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Top News

ACRP Acquires DIA Certification Programs

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The issue of clinical trial result transparency continues to evolve at a rapid pace. During the past few years, almost every stakeholder has taken action in some form.  This should be a positive development because there is a lot attention being focused on a very important issue. But at the end of the day, have we made a difference? Has the noise that this caused just confused the issue more for patients and physicians, or made finding trial information easier and more useful?

The fact is patients today have to navigate a world of disparate databases with listings written in difficult medical terminology and formatted in different ways in order to find trial information. The creation of some clinical trial search engines might help the patient find trials faster, but the search results simply link you to the different registries so the same problem remains. The industry has spent nearly $100 million during the past 24 months to respond to the outcry from advocacy groups, government agencies and professional associations to be more transparent with information about their active and completed clinical trials. But, are we any better off as a result?

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Posted by: American Medical Writers Association’s (AMWA) Jim Cozzarin, MaryAnn Foote, Adam Jacobs, Mary Royer, and Barbara Snyder.

Medical writing has been the subject of numerous editorials.  Recently, two journals decided that they will no longer accept manuscripts prepared with the help of a medical writer.  This decision is both startling and drastic, and may have untoward consequences.  At least 1 journal, however, has endorsed the use of medical writers...

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Symbios Clinical, a new contract research organization (CRO) based in Minnesota, has recently begun formal operations. The CRO focuses on the medical device industry. The company began with $500,000 in start-up financing. Co-founders Ethan Rooney and Ryan Wilson began the company after careers in the medical device sector, both working for large companies. During an interview conducted by CenterWatch, Ethan Rooney elaborated on the need for such a CRO in the medical device industry:

"We see a need out there for a specialized CRO that speaks to the device industry and understands the nuances that go along with it. When working with CROs that are not familiar with medical devices, there is a language barrier there, and that spills over into their ability to work effectively with the clients. So in many cases the technology is different, and there is a major learning curve regarding how the product will work with a patient’s anatomy and physiology," said Rooney.

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Top News

Now Public, ClinPhone Raises $100 Million

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The Association of the British Pharmaceutical Industry (ABPI) and the BioIndustry Association (BIA) taskforce has established recommended guidelines to enhance patient safety in phase I studies with novel agents. The taskforce was created to address safety concerns following the events during the TeGenero trials with the immune stimulate TGN1412...

Specific recommendations included the use of an alternative dose assessment for certain novel agents, the administration of drug to only one subject on the first day, and the use of staggered dosing regimes. The taskforce also recommended better manufacturing controls to ensure quality, and the possibility of having some trials conducted in a hospital setting with access to intensive care facilities. The recommendations were submitted to Professor Gordon Duff, chair of the scientific expert group.

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A proposal in Congress to boost funding for the FDA makes a lot of sense. But don’t stop there, Congress - a super-sized FDA would help solve many of the issues around drug safety. Make sure it’s truly independent, though, and free from pressures from the pharmaceutical industry, brought upon it by a lack of resources. Drug research reformists often suggest creating an independent clinical trials agency to perform trials for the industry, but that’s a far-fetched and unworkable solution.

AHAA lot of those calls come from academics who occasionally have as many conflicts of interest as other stakeholders in drug research. A fully funded FDA would create more checks and balances in the industry, and help it to ensure that quality data was being produced in clinical trials, to a much greater extent than it can now.

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The San Diego, Calif.-based company IT&E International, a regulatory compliance and validation services provider has agreed to merge with Averion, a contract research organization based in Framingham, Mass., for roughly $25 million, including $20 million of stock and notes and $5 million in cash. The new company will retain the Averion name, and allow Averion to become a publicly traded company.

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Wyeth plans to make bold changes to its phase II program, cutting the number of sites participating and using more sites in China, India, Latin America and Central and Eastern Europe. Wyeth also plans to use more sites in emerging regions for its entire clinical program.

Wyeth has a robust pipeline of compounds entering phase II. While phase II clinical trials study a relatively small population of no more than a few hundred subjects, Wyeth uses 50 to 100 sites, 30% of which enroll zero to two patients for phase II trials. This practice is common among most large international pharmaceutical companies. Wyeth plans to reduce the number of sites in a typical phase II program to about 10-20 worldwide...

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It’s great to see the FDA making a move this week to develop guidelines for adaptive clinical trials. Their time has come, given recent advances in scientific tools, such as toxicogenomic assays.

Of course, purists will argue that changing a trial midway through a study somehow benefits pharmaceutical companies by potentially allowing them to manipulate results. Some worry that bias is more likely when results are known during the trial, compared with keeping trials blind...

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Posted by:  Dr. Chandrashekhar Potkar

-Clinical Trials Today’s guest author, Dr. Chandrashekhar (Shekhar) Potkar, is the Director of Clinical Research & Regulatory Affairs at Pfizer LTD in Mumbai, India. Over the coming weeks, Dr. Potkar will explore India’s rapid expansion into the clinical trials arena through a series of posts highlighting on one of the hottest topics in the industry today.

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India’s participation in global clinical trials has nearly quintupled between 2001 and 2005, as investment in the country by large international and domestic pharmaceutical companies, small and medium-sized Western biotechs and the National Institutes of Health (NIH) has grown as well. The clinical research outsourcing market in India grew to $70.5 million last year and will continue to climb.

India’s business and regulatory climates have undergone dramatic change in the past 18 months through passage of a patent bill, regulations updated to harmonize with U.S. and international standards, and plans for a more FDA-like regulatory body. In CenterWatch’s July issue of The CenterWatch Monthly, we explore these issues, challenges and trends within India’s burgeoning clincical trials market landscape.

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AstraZeneca is investing $100 million more in China over the next three years to build the AstraZeneca Innovation Centre China, an R&D facility to study the benefits of new drugs to Chinese patients. Already one of the most heavily invested in China among big pharma companies, AstraZeneca is further distinguishing itself as the leader there with this new commitment.

The Innovation Centre, expected to open by the end of 2009, will focus on translational science by building knowledge of Chinese patients, biomarkers and genetics. Initially, research there will target cancer, a major cause of death in China. AstraZeneca’s lung cancer drug, Iressa, has proved more effective in Asian patients than it has in Caucasians, and China is becoming an important market for sales...

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During DIA 2006, CenterWatch got the inside scoop on ICON's new The Oncology Solution service model during an interview with imaging CRO Beacon Bioscience’s David LaPoint, Vice President of Business Development. Beacon Biosciences was acquired by ICON Clinical in July 2004. According to LaPoint, the solution will allow ICON to bring together their full range of clinical service offerings, including imaging, central laboratory, IVRS and CRF data services.

Here are a few excerpts from that interview:

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This year’s Drug Information Association (DIA) 42nd annual industry conference, held in Philadelphia, Penn attracted nearly 10,000 attendees from across every sector in the drug development industry. Presenting at the show were over 400 U.S. and close to 200 international companies, from both developed markets and emerging regions around the globe. Nearly 1,000 delegates from 50 countries were scheduled to attend.

While attending last week’s conference, CenterWatch gathered an abundance of exciting news, conference highlights and emerging trends from across the industry. Here is a quick summary of just a few of the many notable events during the show:

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When it comes to efficient drug development, pharmaceutical companies have a lot to learn. Recent research we conducted at CenterWatch suggests, however, that they might just be getting t he message, at least when it comes to clinical trials In a recent survey, we polled users of electronic data capture (EDC) software – the folks on the front line of research who conduct their clinical trials using this software – for their views on the factors most likely to prevent future drug development delays.

Their top answer: EDC software. When we conducted the same survey in 2003, EDC software came in fourth.That’s not to say that the industry has embraced the technology yet – only about 10% of clinical trials are currently done electronically. But the results of our survey certainly show a readiness to embrace an electronic trials process, unsurprising given the immense pressures on pharma companies from the courts, regulators, investors and the public at large. Paper trials, it seems, must end.Two recent quarterly reports from small EDC companies support the idea that biopharma is getting serious about efficient drug development...

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A recent Boston Globe article reported on a National Institute of Health (NIH) senior scientist selling human tissue to drug giant Pfizer, for Alzheimer’s disease research.

The news was released by the House Energy and Commerce Committee, along with details of a nearly $300,000 collaboration involving the NIH’s National Institute for Mental Health and Pfizer, spanning several years.

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Recently, the well known industry chemist and blogger Derek Lowe, PhD discussed an important issue plaguing the drug development industry; a general lack of public knowledge with regard to how drugs are brought to market. Given the need for direct patient involvement in clinical trials, the issue is especially of great concern for our industry. The challenges and complexities of drug development are not easy tasks to relay to the layperson, but a greater attempt to bring public clarity to this process, would only benefit our shared goals: finding new therapies to treat disease...

Check out his post here.

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In the wake of Vioxx and the recent events during the German biotech TeGenero AG’s trial, involving a severe immune reaction in six British subjects given an investigative monoclonal antibody, the industry has made a major effort to review trial safety precautions. Among other areas under scrutiny, the work of independent review boards (IRBs) has received much attention. Recently, the roles and challenges of Data Safety Monitoring Boards (DSMBs) have also been discussed in preventing further safety issues during clinical trials AND after market approval...

Hoping to shed some light on the subject, National Public Radio (NPR) recently conducted an interview with David DeMets, the chairman of the Department of Biostatistics and Medical Informatics at the University of Wisconsin. DeMets has also authored of several books on trial monitoring, and co-edited the book “Data Monitoring in Clinical Trials: A Case Studies Approach” with Dr. Curt Furberg Professor at the Department of Public Health Sciences at Wake Forest University and Dr. Lawrence Friedman is a former Director of the Division of Epidemiology and Clinical Applications at the National Heart, Lung, and Blood Institute.

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The CenterWatch 2006 European Investigative Site Survey marks the fifth time CenterWatch has surveyed investigative sites—those front-line researchers conducting clinical trials in Europe. MDS Pharma earned the top score for contract research organizations, improving from third place in the 2004 survey.

The factors rated most important by sites concerning CRO performance include being organized and prepared for a study, knowledge level of CRAs/monitors, quality of protocol design, timeliness of availability of the study drug, and simplicity of the case report form—critical aspects of study success.

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A story in the Chicago Tribune today reports on a new National Cancer Institute (NCI) study planning to enroll over 10,000 women with breast cancer, in order to better understand when the use of chemotherapy is warranted in preventing their tumors from returning after surgery. The study, called TAILORx (Trial Assigning IndividuaLized Options for Treatment Rx) is design to determine whether an individual gene, thought to be associated with the risk of relapse for women with early-stage breast cancer, can be used to aid doctors in choosing treatments with the greatest likelihood of success. The study is sponsored by the National Cancer Institute (NCI), and coordinated by the Eastern Cooperative Oncology Group (ECOG)...

Trial Assigning IndividuaLized Options for Treatment (Rx), or TAILORx, was launched today to examine whether genes that are frequently associated with risk of recurrence for women with early-stage breast cancer can be used to assign patients to the most appropriate and effective treatment. TAILORx is sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health (NIH), and is coordinated by the Eastern Cooperative Oncology Group (ECOG).

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