CenterWatch Monthly April 2008 Issue

FDA Debarment Failures a Wake-Up Call for CROs, Drug Sponsors

After Congressional hearings on the antibiotic Ketek, a Congressional committee issued a scathing report on the FDA’s debarment process. The min-ority committee charged that debarment proceedings against individuals are inconsistent and haphazard. Staffers uncovered cases where individuals convicted of a felony related to the development or approval of a drug product were not debarred, while other individuals with similar circumstances or convictions were debarred. In response to Congressional concerns, sponsor companies and CROs should examine their processes and improve investigator selection and training methods to avoid potential debarment or disqualification proceedings.

CROs: The Promise of Biotech and Beyond

CROs such as Covance, ICON, Kendle, Parexel, PRA, PharmaNet, PPD, Quintiles and others have been working hard to cater to biotech clients for several years. Those efforts should continue to pay off in 2008, which looks to be a good year for biotechs. With large pharmaceutical companies emphasizing biotech products more than ever, large CROs can leverage their expertise in biologics for additional work with existing customers. They can also take advantage of their global infrastructure in emerging markets. But there are some warning signs concerning sustained growth.

Innovative Medicines Initiative Gets Underway During DIA EuroMeeting

The afternoon session on the first day, March 3, of the DIA Euro-Meeting in Barcelona called “Innovative Medicines Initiative: The EU Commission/EFPIA Public-Private Initiative—Up and Running?” answered affirmatively the question it posed in its title.

Eye On: Osteoporosis

In osteoporosis, the density and quality of bone are reduced, with loss of bone mineral density (BMD) and changes to bone structure causing bones to become more porous, brittle and highly susceptible to fracture. Bones at the hip, spine and wrist are particularly vulnerable to osteoporotic fracture. CenterWatch has identified a pipeline of 15 drugs in various stages of development for osteoporosis. Many of these are novel formulations of PTH or target hormonal pathways in other ways, whereas others capitalize on recent advances in understanding of bone metabolism.

To read the full articles for this issue or for more information on these and other breaking stories, please click here.

CenterWatch Monthly March 2008 Issue

Unanticipated Problems Reporting Adverse Events to IRBs

FDA regulations governing adverse event reporting and IRBs have become outdated. At a time when clinical research is increasingly being conducted abroad and clinical trials are growing larger and more complex, IRBs are being inundated with single adverse event reports, which they have neither the resources nor the expertise to analyze. In recognition of this growing problem, both OHRP and FDA issued guidance last year. FDA has recognized and more narrowly defined the IRB’s role in clinical research oversight and underscored the necessity for sponsors to send IRBs analyzed reports on the data, in its draft guidance. Sites are caught between IRBs’ own clear reporting guidelines and sponsors taking a conservative position and demanding that sites report all adverse events to the IRB.

Global Growth Story Remains Strong for CROs in 2008, Beyond

Contract research organizations (CROs) report strong growth across all phases of drug development as cancellation rates remain at historic lows. Public CRO shares remain a strong sector in a shaky stock market as CROs report consistent revenue and profit growth. Global CROs are in a strong position in the industry as they solidify their leadership in global clinical trials in emerging regions. CROs such as Covance, ICON, Kendle, Parexel, PRA, PharmaNet, PPD, Quintiles and a few others are well positioned with global infrastructures in place to continue handling global growth.

Addressing the Shortage of Skilled Clinical Researchers in Europe

Difficulties finding and keeping suitably qualified clinical trials personnel have intensified in Europe. Observers agree that the available workforce simply isn’t large enough to meet staffing needs. The result has been spiraling salaries, as experienced professionals—and even relatively new recruits to the industry—capitalize on the staffing shortfalls.

Eye On Prostate Cancer

Second only to skin cancer, prostate cancer is the most common cancer, according to the American Cancer Society. In the United States, it is also the second most frequent cause of cancer-related death in men (after lung cancer), with approximately 30,000 men dying each year from the disease. CenterWatch has identified a pipeline of 23 pharmacotherapeutic agents in various stages of development for prostate cancer. Many of these affect either hormonal or immunological pathways, whereas others are novel formulations of more traditional chemotherapeutic agents.ch year from the disease.

To read the full articles for this issue or for more information on these and other breaking stories, please click here.

CenterWatch Monthly February 2008 Issue

Site Training on EDC Improves

According to a new Center-Watch training survey, more than half of investigative site staff indicated that the effectiveness of training on electronic data capture (EDC) software has improved during their career. Though training has im-proved, complexities remain. Nearly half of CenterWatch training survey respondents indicated they must learn to use at least five different EDC programs.

The Ethics of Subject Payment

Offering subjects money to participate in studies is a common practice in biomedical research. Payments can enhance recruitment but they can also generate ethical controversy. The chief ethical concern with offering subjects money is that this may be an undue influence that compromises their ability to assess the benefits and risks of participation. Phase I trials offer the highest payment, with an average of nearly $500 per trial, but payments per healthy volunteer can total thousands of dollars.

Revolutionary Public-Private Partnership for Early Phase Trials Established in France

The Centre Hospitalier Universitaire (CHU) de Caen, a university teaching hospital and the largest hospital in the West of France, and Therapharm, a large, private contract research organization founded in 1980, have joined forces to form the first public-private partnership to conduct early phase clinical research in France. The clinical research center is called Centre de Recherche Clinique-Basse Normandie (CRC-BN). The center conducts phase I and II clinical trials that are industry-sponsored, investigator-initiated and government-sponsored.

Eye On: Tropical Diseases

Tropical diseases run the gamut of bacterial, viral and parasitic infections from those commonly encountered, such as travelers’ diarrhea, to those endemic in underdeveloped nations with primitive living conditions, to rare but lethal infections potentially employed as bioterror agents. CenterWatch has identified a pipeline of 19 drugs in various stages of development against tropical diseases related to bacterial, viral and parasitic infections. Some of these drugs are vaccines and prophylactic agents, whereas others address treatment of active infections.

To read the full articles for this issue or for more information on these and other breaking stories, please click here.

CenterWatch Monthly January 2008 Issue

2007 Year in Review:  A Year of CRO Consolidation and Global Expansion

There were more pharmaceutical outsourcing mergers and acquisitions than in any previous year since CenterWatch began tracking the market in the early 1990s. Consolidation was seen across nearly every sector of the clinical trials industry. 2007 saw activity intensify in regions such as Latin America, Asia and Eastern Europe. In 2006, only a handful of sponsors and CROs had toeholds in India and China. This year, a flurry of expansions took place in those areas as the entire clinical trials industry seemed to be jockeying for the potential R&D windfalls predicted.

Academic Health Centers’ Clinical Research Efforts Buoyed

The National Institutes of Health initiative to rework the clinical research process is boosting clinical research at a dozen universities receiving the NIH’s Clinical and Translational Science Award. The grants have prompted universities to rethink their approach to internal research, collaboration with other universities and industry-sponsored research.

Spain’s Timelines May Benefit from Simplified Contract Process

With a population of around 45 million, highly experienced investigators and a well-established network of public hospitals and co-operative groups, Spain benefits from the same standards and diversity of clinical trials existing across the rest of western Europe.

Eye On: Hormone Deficiencies

Disorders of hormonal regulation include testosterone deficiency (hypogonadism) in both sexes; premenstrual syndrome (PMS), premenstrual dysphoric disorder (PMDD), and menopausal symptoms including hot flashes and vaginal atrophy  in women; and erectile dysfunction (ED) in men. CenterWatch has identified a pipeline of 17 drugs in various stages of development for hypogonadism and sexual disorders, as well as for other hormonal conditions. Most of these drugs affect estrogen or androgen receptors, including new formulations that should enhance convenience of use, whereas others have novel mechanisms of action.

To read the full articles for this issue or for more information on these and other breaking stories, please click here.

CenterWatch Monthly December 2007 Issue

Asia-Pacific Countries Set for Global Clinical Project Leadership

With more than 30% of the world's population, Asia-Pacific is becoming an integral part of global drug development, and in the future will take a leadership position on some global projects. After 50% growth between 2005 and 2006 in the Asia-Pacific region's new global clinical trials initiated by pharma and biotech, intense competition for talent has resulted. As sites conduct more clinical trials, 38% or more of sites in the top four respondent countries to CenterWatch's survey of the Asia-Pacific region believed that EDC would best prevent future delays.

Avandia Warning Spurs More Drug Safety Services

In the wake of reports questioning the safety of popular diabetes drug Avandia, contract research organizations were already seeing increased demand for work involving drug safety even before the FDA revised the black box warning on the drug's label last month. In September, the FDA Amendments Act of 2007 was passed. It gives the FDA new authority to improve drug safety. The legislation marks a significant change in the FDA's authority to monitor safety concerns post-approval.

CROs Still Expanding Eastward in Europe

The clinical research market in Central and Eastern Europe (CEE) has been growing steadily in the past five years, and contract research organizations are continuing to expand their presence there. CEE is still the emerging region with the greatest number of new global trial initiations, according to CenterWatch analysis. In fact, the number more than doubled between 2002 and 2006.

Eye On: Hypertension

Hypertension, or chronic elevation in blood pressure, is defined as a systolic blood pressure (SBP) above 140 mmHg and/or a diastolic blood pressure (DBP) above 90 mmHg. For patients with diabetes and chronic renal disease, treatment goals are more rigorous, namely to reduce SBP below 130 mmHg and DBP below 80 mmHg.

To read the full articles for this issue or for more information on these and other breaking stories, please click here.

CenterWatch Monthly November 2007 Issue

Changes in Asia-Pacific Regulations Position Region for More Growth

Between 2005 and 2006, big pharma and biotech initiated 50% more global clinical trials in the Asia-Pacific region. As regulators in the region continue to improve the approval process in their respective countries, growth should continue. Spearheaded by Japan, regulators in Asia-Pacific countries are becoming more aware of, and tapping into, the region's power as a bloc. CenterWatch surveyed 156 investigative sites from more than a dozen Asia-Pacific countries in its first ever survey of the region in late 2006. Among its findings, the survey revealed the timeliness with which patients are enrolled and what factors could best prevent future delays.

Competition Challenges U.S. Site Profitability

Investigative sites continue operating under financial pressures even as contract research organizations have had a very profitable run in 2007. Competition for research sites grows as sponsors and the larger global CROs are placing more studies globally. CenterWatch data show that pharmaceutical and biotech R&D spending has risen rapidly since 2005 and will continue to rise at least through 2009. In 2005, spending totaled $95.1 billion; next year’s spending is expected to reach nearly $130 billion. If trends continue, by 2010, R&D investment will have increased 50% in five years.

EU Phase I Programs Respond to Northwick Park Incident

The first human trial of TeGenero's TG1412 catapulted volunteer studies into the headlines for all the wrong reasons in March 2006. None of the six volunteers dosed with TG1412 at the Northwick Park site died, but they were seriously injured. The long-term effect of their injection with the anti-CD28 monoclonal antibody remains unknown. The lasting impact of the Northwick Park incident on the clinical trials industry in Europe is difficult to quantify.

Eye On: Depression

Depression, which is one of the most common diseases affecting the brain, is characterized by depressed or saddened mood, loss of interest or pleasure in normally enjoyable activities, changes in weight or appetite, fatigue, and sleep disturbances. According to the World Health Organization, at least 121 million people worldwide suffer from depression. CenterWatch has identified a pipeline of 15 drugs in various stages of development for depression. Many of these affect central neurotransmitters, whereas some have novel mechanisms of action.

To read the full articles for this issue or for more information on these and other breaking stories, please click here or contact us at cw.sales@thomson.com.

CenterWatch Monthly October 2007 Issue

Pfizer Reverses Course for Big Savings with Auctions

Pfizer is using reverse auctions within its development and medical organizations to support contract research organization (CRO) sourcing decisions. Pfizer has run reverse auctions to help select providers for many services such as site monitoring, data management, clinical programming, clinical laboratory services, study management and project management. During the past three years, Pfizer has seen substantial savings as a result of its reverse auctions. Not surprisingly, CROs and other service providers are less enthusiastic about the use of reverse auctions. Some see the process as an example of how pharmaceutical companies are turning their complex business model into a commodity.

Informed Consent: The Dual Role of the Physician-Investigator

Federal regulations in the United States do not define or offer guidance on how to handle the conflicting role of physician versus investigator. In seeking informed consent, physicians should understand the possibility of therapeutic misconception. This article presents some practical approaches to this physician-investigator conflict. There are several ways that an institutional review board (IRB) can improve the informed consent process when the treating physician is also the investigator. Each involves some form of added oversight a third party seeking the informed consent, a stepped consent process, or other measures that fit the individual situation. The question that the IRB should first ask is when this extra protection may be deemed necessary.

Vienna School of Clinical Research Offers Courses in India, Africa

The Vienna School of Clinical Research (VSCR) recently gave its first workshop in New Delhi, India, a new milestone for the school. The school is also working on multiple projects in sub-Saharan African countries, and most recently offered training to future members of the Gabonese National Ethics Committee.

Eye On: Breast Cancer

In the United States in 2005, 212,000 new cases of invasive breast cancer were diagnosed, and there were approximately 40,870 deaths, making breast cancer the second leading cause of cancer death. Despite earlier diagnosis through mammographic screening, about 20%-89% of those diagnosed with early breast cancer develop metastases within five years. CenterWatch has identified a pipeline of 20 drugs in various stages of development for treatment of breast cancer. Many target specific pathways in the cancer cell cycle to interfere with tumor growth; some enhance the effects of traditional chemotherapy, and some represent new formulations of standard chemotherapeutic agents.

To read the full articles for this issue or for more information on these and other breaking stories, please click here or contact us at cw.sales@thomson.com.

CenterWatch Monthly: September 2007 Issue

Fraudulent Study Broker At-Large: Cherie Thibodeau

Cherie Thibodeau has posed as a study broker for the past six years, in between her three stints in California State Prison. Working under numerous aliases and nine Social Security numbers, she has bilked numerous investigative sites out of potentially hundreds of thousands of dollars. Cherie Thibodeau has preyed on new and experienced sites alike. Other sites that have not yet fallen victim to her study brokering scam need to learn the warning signs for a dishonest broker. Investigative sites can avoid working with Thibodeau and her ilk.

Abigail Alliance Heading to Supreme Court

Abigail Alliance for Better Access to Developmental Drugs lost its lawsuit against the FDA last month in the U.S. Court of Appeals for the D.C. Circuit. The alliance took the FDA to court to establish that terminally ill patients in this country have a Constitutional right to have access to experimental drugs after phase I. Abigail Alliance now plans to argue its case before the Supreme Court of the United States. Some industry observers believe that if the alliance wins, it will undermine the drug development process by making clinical trials in terminal ill-nesses impossible to recruit for. Although Abigail Alliance lost its latest suit, the organization has had a marked effect on the FDA's expanded access program.

Affymetrix Launches Collaborations in Cancer Research Program in Europe

Affymetrix has partnered with about 30 leading scientists from European cancer institutes, research centers and universities, from countries including Denmark, Finland, Germany, Italy, Spain, The Netherlands and UK, as part of its collaborations in Cancer Research Program. The alliance will mean that Affymetrix will partially fund select research projects.

Eye On: Diabetes

Nearly 21 million Americans have diabetes and about 41 million have pre-diabetes, according to data from the Centers for Disease Control and Prevention (CDC). About 90-95% of patients with diabetes have type 2 diabetes, with increased attendant risk of cardiovascular disease, stroke, high blood pressure, limb amputation, blindness, neuropathy damage and kidney failure. CenterWatch has identified a pipeline of 16 different drugs in various stages of development for diabetes treatment. Some of these are new insulin formulations, and others act via different mechanisms to lower blood glucose.

To read the full articles for this issue or for more information on these and other breaking stories, please click here or contact us at cw.sales@thomson.com.

CenterWatch Monthly: August 2007 Issue

Venture Philanthropy on the Rise

U.S. Disease foundations will invest about $75 million this year in biopharmaceutical companies to fund discovery and development of new drugs and therapies for their corresponding diseases. This year's figure represents a 10-fold increase since 2000, and the figure should continue to rise. This new avenue of industry funding has been dubbed venture philanthropy.The amount of money that disease foundations contribute to industry research would not pay the development costs of even one drug today. But, the strategic timing of the funding as well as the additional resources and expertise that the foundations provide serve to enable drug discovery and development that wouldn't be undertaken otherwise and perhaps to speed that development as well.

FDA's Guidance on Supervisory Responsibilities of Investigators

The FDA's new guidance document on investigators supervisory responsibilities is useful for both experienced investigators and novices who want to understand FDA's latest thoughts about how they conduct clinical research. This article explains the draft guidance and provides step-by-step insight for investigators who need to be in compliance with the FDA.

EMEA's Bold Appointment Reflects Agency's New Broader Role

There wasn't universal rejoicing when the EMEA was born in 1995. Many politicians within the then-15 member countries of the European Union were skeptical about the need for a pan-European agency, believing it could undermine the status of their own national authorities. Meanwhile, some working in the pharmaceutical industry were concerned that the new organization might add a layer of costly bureaucracy without necessarily diminishing the difficulties in getting products approved through the various national procedures.

Eye On: Melanoma

Cutaneous melanoma is a malignancy of skin cells known as melanocytes that contain pigment and color the skin. Less frequently, melanoma may also develop within the eye (intraocular or ocular melanoma). According to the American Cancer Society, there were 62,000 cases of melanoma in the United States in 2006, which caused 8,000 deaths. CenterWatch has identified a pipeline of 17 drugs in various stages of development for melanoma treatment, many of which are biological agents or vaccines.

To read the full articles for this issue or for more information on these and other breaking stories, please click here or contact us at cw.sales@thomson.com.

CenterWatch Monthly: July 2007 Issue

Radiant Research Leads Global Change in Site Management Market

Radiant Research has claimed profitability nearly every year since it was founded in 1998. The company has grown not only through a series of acquisitions, but also by expanding existing facilities and opening new centers. Radiant is embarking on a new global growth period with the backing of a private equity group, which took ownership in June. Radiant, which has trimmed itself down to 26 owned sites, plans to take its SMO model worldwide. Other SMOs, of varying models, continue to be successful, following the niche's slide when many SMOs exited the market.

Positive Volunteer Experience Holds Steady in New CenterWatch Study

More than 90% of study volunteers say their experiences were good enough in a clinical trial that they would participate again. Despite all of the bad press about the pharmaceutical industry, study volunteers remain steadfast in their support of trial participation. CenterWatch surveyed 620 study volunteers across the United States in April and May 2007 on issues such as how they learned about the study, which factors influenced their decision to participate, and how well they understood study expectations. More than half of respondents had participated in a study this year or in 2006.

German Research Down But Far From Out

Germany has been struggling in the increasingly global clinical trials industry. A report last year by the Fraunhofer Gesellschaft research institute showed that while the significance of Germany as a venue for R&D has diminished since the early 1970s, major competitors, such as the U.S., Japan, France and the UK, have taken a larger slice of the global pie.

Eye On: Respiratory Diseases

Respiratory diseases encompass a broad spectrum of pathology including chronic obstructive pulmonary disease (COPD), asthma, and other conditions characterized by airway blockage or narrowing; restrictive lung diseases such as idiopathic pulmonary fibrosis; and a host of infections acquired both in the community and in the hospital. CenterWatch has identified a pipeline of 21 drugs in different phases of development for respiratory diseases. Several target airway inflammation via immune system cells; others act as novel bronchodilators; and various antibiotics address the problems of microbial resistance and opportunistic infections.

To read the full articles for this issue or for more information on these and other breaking stories, please click here or contact us at cw.sales@thomson.com.

CenterWatch Monthly: June 2007 Issue

U.S. Sites Rate Kendle, Covance, Omnicare as Top CROs in 2007

The Thomson CenterWatch 2007 Survey of Investigative Sites in the U.S. finds that sites have rated Kendle as the top CRO to work with. It is the first time that Kendle has been rated number one. Being organized and prepared for a study was the attribute rated most important for CRO performance with more than 86% of sites listing it as of the highest importance. Three other attributes had more than four out of five sites giving them highest ratings for importance: responsiveness to inquiries, CRAs/managers being knowledgeable and maintaining open communications.

Beyond Study Brokers

During the past five years, the study broker space has changed as new companies have entered the market and a variety of business models have emerged. And many organizations that perform study brokering have added services, changed the direction of their businesses and grown. The emergence of alliances and small site networks has also been a trend. In this model, independent sites band together and hire a full-time business development person to conduct marketing and business development duties on their behalf. Some of these alliances or networks focus a particular therapeutic area, while others represent multi-specialty investigative sites.

European CRO Federation Has Ambitious Plans

The European Contract Research Organization Federation (EUCROF) was formally established 18 months ago, and it has ambitious plans that members have wasted no time embarking on.

Eye On: Obesity

Obesity, defined as body mass index (BMI) of greater than 30, is currently the leading nutritional disorder in the Western world. According to a European study by the World Health Organization, more than 70% of men and nearly 70% of women 55 to 64 years of age are clinically obese or overweight. CenterWatch has identified a pipeline of 19 drugs in various phases of development for obesity.

To read the full articles for this issue or for more information on these and other breaking stories, please click here or contact us at cw.sales@thomson.com.

CenterWatch Monthly: May 2007 Issue

U.S. Sites Rate Novo Nordisk, Novartis and Roche as Top Sponsors in 2007

Results of the Thomson CenterWatch 2007 Survey of Investigative Sites in the U.S.  have been tabulated. Sites have rated Novo Nordisk the top sponsor to work with. It is the first time the company has ever been rated in the survey. Novartis and Roche were ranked second and third, respectively. Asked in which areas sponsors have generally become better or worse in the last three years, effectiveness of communications with investigators, case report form (CRF) design, medical staff quality, and monitor quality were the top areas showing general improvement. Monitor turnover, feasibility of project timelines, and contract and budget negotiations are the three areas sites said have suffered. Electronic data capture technologies was listed by 43% of sites as most likely to prevent future delays.

Medical Imaging Creating a Special Effect

Medical imaging in clinical trials has gained momentum since the FDA began allowing imaging as part of the evidence in support of a new drug application. The FDA, in an effort to increase new drug approvals, has identified imaging as an important technology for assessing new therapeutics and accelerating drug development in the future. There has been a big increase in demand for imaging services in the past 18 months with players ranging from Parexel to GE Medical Systems ramping up their efforts.

Increasing Interest in Small Population Trials in EU

While distinct definitions exist for orphan drugs and orphan populations, small population studies are more of a gray area, as there is no exact definition of what constitutes one, either in patient numbers or study design. The new European Medicines Agency (EMEA) Guideline on Clinical Trials in Small Populations due to have become operational in February aims to deal with problems associated with limited patient numbers available for study.

Eye On Vaccines

Despite the advent of antibiotics, infectious diseases continue to plague mankind, especially those caused by viruses that do not respond to traditional antibiotics. The likelihood of prevention therefore far outweighs that of cure, mandating development of new vaccines designed to prevent infection with such deadly viral diseases as AIDS, smallpox and hepatitis. CenterWatch has identified a pipeline of 19 vaccines in various phases of development for infectious diseases and cancer, as well as for certain autoimmune conditions including allergies and multiple sclerosis.

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CenterWatch Monthly: April 2007 Issue

Healthy Pipeline of Clinical Trials in Russia

Russia's global clinical research market has grown substantially in the past five years. But, relative to Russia's population of nearly 143 million, there is enormous potential for future growth, given that only 42,000 patients were enrolled in global clinical trials in the country last year. FDA and EMEA have begun approving drugs with clinical trial data from Russian sites, a mark of quality. That, along with rapid patient enrollment, has helped Russia emerge as an attractive clinical research market. While clinical research has been conducted in the country since the 1990s, big pharma has only recently begun to regard Russia as a potential future market for their drugs.

Patient Recruitment Companies Branch Out

Drug sponsors increasingly turn to patient recruitment providers to both rescue trials that have failed to meet enrollment objectives and for strategic advice early in the drug development process. As patient recruitment companies have broadened their services, a few have expanded into CRO-type services, such as standard protocol monitoring of trials. At least one patient recruitment company, BBK Worldwide, has split off a separate company, TCN e-Systems, which is a software platform that empowers sponsor companies to take greater control of their patient recruitment processes in-house. Other patient recruitment vendors have developed proprietary software.

EFGCP Addresses Ethics Committee Variability, Calls For Changes to Directive

Any biopharmaceutical company that has conducted a multinational clinical trial in the European Union (EU) knows that the ethics committee systems there vary a great deal, creating delays and confusion.The question is: Why are there so many differences among ethics committee systems in the EU even after the Clinical Trials Directive has been implemented?

Eye On Leukemia

Leukemia is a general term for cancer of the bone marrow blood cells. It includes acute and chronic forms of myelogenous and lymphocytic leukemia, based on which type of white blood cell is involved. Acute leukemia is rapidly progressive, leading to the accumulation in the marrow and blood of cells that are primitive, meaning still not fully developed or differentiated. Chronic leukemia progresses more slowly, allowing growth of greater numbers of more mature or developed cells. In acute leukemia, the cancerous blood cells are too immature to function, whereas in chronic leukemia, white blood cells present in excessive numbers retain some of their usual function.

CenterWatch has identified a pipeline of 20 drugs in various stages of development for leukemia. Thanks to new advances in molecular biology, several of these are monoclonal antibodies or antisense molecules with leukemia-specific targets. Others are new twists on conventional chemotherapy agents acting to suppress cancer cell replication and growth.

To read the full articles for this issue or for more information on these and other breaking stories, please click here or contact us at cw.sales@thomson.com.

CenterWatch Monthly: March 2007 Issue

FDA Oversight Doesn’t Cool Device Market

Post-marketing scrutiny of medical devices by regulators has been ratcheted up following safety questions about drug-coated stents and other medical devices. Contract research organizations (CROs) that have strong experience with post-marketing work and with smaller biotech startups have an advantage in the medical device market.

Should Prisoners Be Allowed to Volunteer for Research?

The use of prisoners as research subjects is one of the most controversial areas of human subjects research, and it has a long, complex history. The Institute of Medicine of the National Academies Report, “Ethical Considerations for Research Involving Prisoners,” urges greater oversight and safeguards in human subjects research involving prisoners. It is important to understand the report’s conclusions in their proper context, not as the last word in the discussion but as the latest chapter in an ongoing ethical debate that will likely continue for some time. Given the recent resurgence of discussion on prisoners as research subjects, the time is right to give the issue a thorough review.

Volterys Offers New Patient Recruitment Model in Europe

Volterys is a volunteer recruitment web site recently launched in France and Belgium. It represents a new patient recruitment model in Western Europe, one that circumvents some of the cultural barriers in Western Europe that prohibit recruiting patients for clinical trials over the Internet.

Eye On Hepatitis C

Hepatitis C, a liver inflammation caused by the hepatitis C virus (HCV), affects nearly 170 million people worldwide, making it the most common chronic blood-borne infection in developed countries. Currently, there is no approved vaccine to prevent hepatitis C. CenterWatch has identified a pipeline of 21 drugs in various stages of development for treatment of hepatitis C. Many of these are antiviral agents or compounds related to interferon.

To read the full articles for this issue or for more information on these and other breaking stories, please click here!

CenterWatch Monthly: February 2007 Issue

Big Pharma Collaborates for Inter-Company Auditing Agreement

As part of its strategic risk management of service providers, F. Hoffman-La Roche has spearheaded an initiative that standardizes and streamlines the auditing process among six collaborating sponsor companies. These six big pharma have joined forces to share the generic results of some of the cyclical, routine audits each conduct, thereby obviating the need for the other five to conduct the same audit. All have already benefited from significant cost and time savings.

Pediatric Clinical Trial Growth Stunted

The laws mandating pediatric clinical trials are set to expire later this year. In the past 10 years, the FDA has requested 760 pediatric studies. But growth has slowed as companies quickly handled the backlog. Some pediatric trial organizations have ceased doing business.

Europe Anticipates Surge in Pediatric Drug R&D

Drug companies, contract research organizations (CROs), regulators, and patient advocates are braced for the impact of the European Commission's new pediatric regulation, which came into force last month. More than 50% of medicines given to children in Europe have never been put through pediatric clinical trials, and have not been specifically approved for pediatric use.

Eye On: Diarrhea

Diarrhea, defined as loose, watery and frequent bowel movements, is considered chronic when it persists for more than four weeks. In adults, diarrhea is usually mild and resolves quickly without complications, but in infants and children younger than age 3, diarrhea can rapidly lead to dehydration.

To read the full articles for this issue or for more information on these and other breaking stories, please click here!

CenterWatch Monthly: January 2007 Issue

Phase I Market Consolidates

After a year of consolidation, facility building, and some controversy in the phase I market, expect additional acquisition deals in 2007 and growth to hold up in the low double digits. Industry experts estimate that the percentage of phase I work outsourced to CROs has increased to at least half of the phase I market. Several phase I units have been bought by large CROs as they increase their offerings and add global service.

2006 in Review: Industry Adapts and Adopts

CenterWatch reviews a year in which significant strides were made in the clinical trials industry even as it got past some hurdles of negative press concerning patient safety issues. 2006 may be looked back on as the year when the clinical research industry really took several big leap forwards with technology adoption including electronic data capture (EDC), electronic health records (EHR), electronic patient diaries and new approaches such as adaptive clinical trials that together will change the industry for a long time.

Romania and Bulgaria Join EU

This month marks the accession of Romania and Bulgaria to the European Union (EU), which gives both countries all the rights and obligations deriving from EU membership, including the implementation of the EU Clinical Trials Directive.

Eye On: Pain

The treatment of pain is a major healthcare and research priority. There are about 85 million people in the U.S. suffering from chronic pain conditions, and about 193 million new cases of acute pain annually. Despite recent advances in understanding pain physiology, currently available classes of analgesics have not changed significantly over the past few decades, and problems of limited efficacy, adverse effects and abuse potential remain.

CenterWatch Monthly: December 2006 Issue

Increasing Minority Participation in Clinical Trials

Ensuring that clinical trial participation reflects the racial and ethnic makeup of the U.S. population and the epidemiology of the particular diseases being studied is becoming more of a priority for industry, government and academia. The barriers—while not insuperable—are numerous. Over-coming them will take a multi-pronged approach. One four-year research program undertaken last year by the Chronic Disease Prevention and Control Research Center at Baylor College of Medicine and the Intercultural Cancer Council and funded by Genentech is attempting to tackle the issue of increasing participation by underrepresented populations, including racial and ethnic minorities.

CROs Taking Tentative Steps Toward Reform

CROs have a big opportunity to help lead any changes in the drug development process in the wake of two high profile patient safety issues involving CROs in the past year. Despite the run of bad publicity, CROs seemed to have weathered the storm with strong revenues gains and share prices. But the CRO industry isn’t about to become complacent as it takes steps to carve out a leadership role in any reform efforts.

Mandatory GCP Certification in The Netherlands?

Nearly two years past the deadline, The Netherlands passed the EU Clinical Trial Directive into national law in March. Some are wasting no time in attempting to make certification in Good Clinical Practice (GCP) mandatory for clinical researchers who want to conduct a study in The Netherlands. It is a trend that could well gain traction throughout the EU.

Eye On: Skin Conditions

The skin is the largest and most exposed organ of the body, and, not surprisingly, it is prone to a variety of diseases. Hand dermatitis, or hand eczema, popularized in television commercials as “dishpan hands,” is one of the most common work-related diseases, affecting 5% to 10% of the population. It is characterized by hand rash, redness, dryness, cracking and inflammation.

CenterWatch Monthly: October 2006 Issue

CenterWatch Monthly: September 2006 Issue

CenterWatch Monthly: August 2006 Issue