Clinical research organizations (CROs) and pharma sponsors believe finding the right principal investigators is the hardest part of patient recruitment, says an Industry Standard Reports (ISR) survey.  But principal investigators disagree, stating that limited patient awareness is currently the most challenging obstacle. Regarding the outsourcing of clinical trials 75 percent of sponsor companies indicated a willingness to allow CROs complete control over site selection and patient recruitment in exchange for a guarantee of trial success… The Pharmaceutical Research and Manufacturers of America (PhRMA) issued voluntary clinical trial guidelines on October 1st. The guidelines ban ghostwriting of medical journal articles, urge companies to post "summary results" of all clinical trials of drugs that have been approved for sale - and drugs that didn't make it - and ban doctors who have an ownership stake in a drug from being a clinical investigator in a trial of that drug… The Association for the Accreditation of Human Research Protection Programs (AAHRPP) has issued the final version of the first major revision of its standards in its eight-year history. AAHRPP streamlined the number of standards and increased flexibility in how to interpret them, even as it added or strengthened standards on global research, conflict of interest, community-based research, and data and safety monitoring.

 

 

The African Network for Drug and Diagnostics Innovation is planning "the first African-owned and -managed innovation fund to finance drugs and diagnostics research," the Independent Online reports. The plan calls "for a R4.4 billion [$590 million] endowment fund in Africa that would generate a sustainable income of up to $30 million (about R230m) a year to support African drug and diagnostic innovation." Discussions are already under way with the African Development Bank to host the fund… A new report by EuropaBio and Venture Valuation examines the biotech industry across the 12 newest European Union (EU) member states, as well as candidate countries Turkey and Croatia. While some new EU member states have established a flourishing biotech sector - Hungary, Poland, the Czech Republic, and Estonia - the report finds an "overall lack of awareness and information on available resources both at EU and national levels" and, in some cases, a lack of funding opportunities… MDS Pharma Services' early clinical research and clinical pharmacology operations in Northern Ireland, and its clinical pharmacology and bioanalytical services operation in Nebraska, have been certified by the Brazilian Sanitary Surveillance Agency (Agencia Nacional de Vigilancia Sanitaria – ANVISA). ANVISA provides regulatory approval for drugs and other products seeking to enter the Brazilian market. “MDS Pharma Services is the only contract research organization in the U.K. and one of only two in the U.S. to offer clients the benefits of ANVISA certification,” said MDS Pharma Services President David Spaight.

 

 

"If the FDA (Food and Drug Administration) label were required to indicate what is and is not known about a product's superiority to other treatments, then clinicians, patients, and payers would be less willing to pay more for a new treatment without proof that it improved health outcomes," says a recent New England Journal of Medicine editorial. They suggest several strategies to accomplish more comparative effectiveness research (CER), including greater use of statistical tools, and large private and governmental payers conducting CER clinical trials… Is a drug innovative enough that it will be paid for? Increasingly, drug developers and their partners are asking this question as they map out the future of a drug. For example, where therapeutic alternatives exist, biotech company Genzyme does financial modeling to determine what an appropriate reimbursement would be and how the drug would be used, essentially trying to duplicate the analysis done by the United Kingdom's National Institute for Health and Clinical Evidence (NICE)… "CER provides a wake-up call that draws attention to the potential pitfalls of bias in research more generally, and highlights the need for openness in the design and reporting of all types of research," argue the editors at PLoS Medicine. "The importance of valid negative results, and of their immediate and open availability, is of particular pertinence in the movement to undertake comparative effectiveness research (CER)."

 

 

New regulatory initiatives in the U.S. and Europe aimed at improving drug safety and effectiveness are having their impact on drug companies, according to an IMS Health survey. Additional resources are needed, say the survey respondents, especially in regulatory departments in the next six months, and for medical and commercial in the next year. Growing demand by regulators for real-world data will see increasing investment in patient registries or observational trials, they predict… There are "lots of inefficiencies in the clinical trial process and improvements need to be made," explains Adam Chasse, global head of Prime Sites at Quintiles. The clinical research organization (CRO) has taken a proactive approach to managing trial sites with their Prime Sites program, helping sites with administrative processes, in particular assessing study feasibility and regulatory delays, and recruitment efforts… Clinical trials conducted by CROs are completed around 30 per cent faster than those carried out in-house by pharmaceutical firms according to a new Business Insights (BI) report. Although there has been significant consolidation among CROs of late, says the report, over 1,100 CROs now exist, with five companies holding about 55 percent of the market. The authors argue that this dominance is based on the breadth of services offered by the top five CROs, suggesting that sponsors prefer to select a single partner capable of taking a drug from preclinical to phase IV, rather than splitting the work between several collaborators.

 

 

"Biotech in China is blooming, but we have not seen any global product coming out of China," says Frank Jiang, Sanofi-Aventis' head of research and development in China. According to Jiang, several challenges exist: the best science remains in the universities and academic institutions, the lengthy timeline for clinical trial approval to begin Phase I-III studies, and the Chinese culture itself, which can be risk-averse… Despite significant increases in funding for drug development between 1995 and 2005, the number of approvals by the FDA has fallen, says a PLoS One research paper. The researchers propose several remedies including decreasing the cost of clinical trials, modifying economic incentives to favor "high impact, high cost" conditions, disseminating negative results openly and reorganizing research operations… Three-quarters of  British pharmaceutical companies polled do not see the United Kingdom (UK) as an attractive place to do business, reports a survey conducted by ComRes. The business climate is seen as especially difficult "when viewed in a global context, and policy and regulations are seen as inappropriate for the modern pharmaceutical industry." The two most important steps the government could take to improve the environment? "Reducing the time it takes for patients to gain access to modern medicines" and "rewarding innovation."

 

 

One aspect of healthcare reform in the U.S. centers on efforts to fund research into the "comparative effectiveness" of different treatments. The stimulus bill allocated $1.1 billion for such research, and also created a council to coordinate the efforts. The Gannett news service examined the issue over the weekend.  Health care bills moving through Congress contain provisions promoting the concept, but the research is controversial. Insurers, medical groups, and consumer organizations favor such research, arguing it would help doctors provide better care. The pharmaceutical industry and some congressmen fear it could lead to healthcare rationing. ... The German Research Federation has created five more research groups. The goal, as is the case with existing Clinical Research Units, is to tightly link the fields of clinical, applied and basic research in Germany, while also training the next generation of researchers. ... Where is most clinical research conducted? The online publication Outsourcing Pharma recently mapped data it drew from the National Institutes of Health's clinicaltrials.gov database, which lists trials currently underway in 172 countries. The largest numbers of trials are still being conducted in North America and Western Europe, but the numbers are growing elsewhere in the world.

 

 

"Evidence-based medicine can only be effective if all the results from clinical trials are published promptly in medical journals," argue the authors of a study examining the publication rates among completed trials registered on ClinicalTrials.gov. The study tracked the reporting of registration information among a cross-section of trials over six-and-a-half year period. They found that "critical trial information" was not included in the ClinicalTrials.gov registry and that registration in ClinicalTrials.gov "does not guarantee that trial results will appear in a timely manner in the scientific literature…"  Is there consistency in the primary outcomes specified in trial registries with those reported in published articles? A study published in the Journal of the American Medical Association (JAMA) found that among articles with trials adequately registered, 31 percent showed evidence of discrepancies between the outcomes registered and the outcomes published. The authors also found that "selective outcome reporting is prevalent…"  "Rather than penalizing patients for the use of innovative medicines through higher co-pays, health care systems should adopt outcome-based approaches that maintain the incentive to invest in developing high-value innovative medicines," says David Brennan, AstraZeneca's chief executive officer. "I believe that any healthcare system, whether public, private or a combination thereof, can improve health and productivity while helping to relieve the pressure on healthcare budgets by focusing on preventing chronic disease and recognizing the important contribution that innovative medicines can make."

 

 

Clinical research organizations (CROs) in China devoted to late-stage research will grow at an 18 percent annual rate, predicts Ranjith Gopinathan, senior research analyst at Frost & Sullivan. An increasing number of CROs in China, local and foreign-based, are moving into more lucrative stages of the drug development chain, including preclinical studies, as well as human trials… The clinical trial outsourced market in India will grow at a CAGR (compound annual growth rate) of over 30 percent during 2010-2012, reports industry research firm RNCOS. "All the major pharmaceutical/biotech players as well as major CROs are making India their base for conducting global clinical trials," the RNCOS' study found. And although India is attractive for many reasons, "steps need to be taken by the Indian government to ensure an easy approval system for promoting foreign investments..." Clinical trial service provider Synexus is acquiring clinical trial sites in Poland and is hoping to expand in India soon. While most clinical trial sites recruit through general practitioners (GP) patient lists or patient organizations, Synexus also uses advertising and marketing initiatives, greatly increasing patient recruitment numbers, says Michael Fort, chief executive of Synexus.

 

 

Although research spending in the U.S. has dropped overall, many pharmaceutical and biotech companies are increasing R&D expenditures, reports BusinessWeek. Some are mining the industry for licensing deals, while others are simply spending more on clinical trials as products in their pipeline advance to later stages...  A re-analysis of data from a 2006 study contradicts the claim that U.S. drug firms overtook European companies in pharmaceutical innovation. Author Donald Light found that U.S. research productivity has been "low and flat in proportion to the large company investments in R&D, while the number of major new drugs credited to Europe is high and increasing in proportion to company investments..." goBalto, an online drug development partnering site, is adding to its database over 950 Latin American-based investigator sites and hospitals that are part of the Chilean clinical research organization Clinical Trials Support (CTS).  The deal will help users "to more quickly and easily evaluate the leading investigator sites" in Latin America, said goBalto CEO Jae Chung.

 

 

"Why are inert pills suddenly overwhelming promising new drugs and established medicines alike?" asks Steve Silberman, referring to the rise of the "placebo effect" in clinical trials. The National Institutes of Health (NIH) is directing the Placebo Response Drug Trials Survey, a data-gathering effort intended to determine which variables may be responsible. Half of all drugs that fail in late-stage trials drop out of the pipeline due to their inability to beat sugar pills… "It is just enormously frustrating to me that many interests, including quite a few physicians, do not recognize CER (comparative effectiveness research) as a companion project to NIH's basic research," declares Gail Wilensky, Ph.D., an economist with Project HOPE and former Republican White House health policy advisor. "I believe that providing information about what works when, and allowing that information to be used as part of a reimbursement decision, is reasonable and sensible…"  "Observational studies, including patient registries … (can) serve as a guide for helping to determine which products will be reimbursed by insurance companies based on the relative safety and efficacy of each treatment option," writes Nancy Dreyer, Ph.D. and Sarah Garner, Ph.D., in a Journal of the American Medical Association commentary. Exploring the growing need for patient registries and how their data is used to support decision-making by physicians, regulatory authorities, and payers, the authors call for greater clarity on how to evaluate the quality of registry studies.