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Facilitating Clinical Trials in Europe

March 14th, 2012 - (EU Commision) -Healthcare Regulatory update


The Commission is preparing a proposal for the revision of the Clinical Trials Directive for later this year. Clinical trials are crucial to many people! They provide hope for patients and relatives; essential testing for researchers and industry to develop new medicines and treatments; are key for the creation of growth and jobs in the public health sector and; play a major role in R&D accounting for investments of over €20 billion per year in the EU.


Authorisation for approximately 4400 new clinical trials is given each year and, at any point in time, some 12 000 clinical trials are ongoing in Europe. But, worryingly, there has been almost a 15% decline in trials in the EU in recent years. Costs - resources and bureaucracy - have doubled and delays have increased by 90%. It is immensely important that we facilitate multinational clinical trials in Europe - 25% of EU trials take place in more than one Member State - not only to keep this innovative research in Europe but to guarantee state of the art cures.


There are several factors contributing to the decline of clinical trials in the EU, such as the commitment of industry to R&D, the relationship between industry and academic research, availability of investment or return on that investment. However, the bureaucracy of the process is clearly also one important factor.


The Commission wants to improve the regulatory framework and address concerns that have been voiced:

  • Creating a simpler single portal for submission of clinical trials applications;
  • Developing a faster, lighter system for assessments while maintaining patients' rights and safety and;
  • Increasing cooperation between Member States.
Physicians fear sunshine regulations could harm their careers

March 13th, 2012 - (Medscape) -Healthcare Regulatory update


The public, including medical societies and drug and device makers, had until February 17 to tell CMS what it thought about the proposed sunshine rules. The American Medical Association (AMA) and 92 other medical societies urged CMS to ensure that published reports on physician–industry financial relationships are accurate. "The proposed rule," they stated, "opens the door to the real possibility that a large number of physicians could become the victims of false, inaccurate, or misleading reporting and suffer significant damages including investigation by government and private entities, potential disciplinary actions, public censure, ridicule, and destruction of professional reputation and livelihood."

Payers : Gatekeepers or translational bridge to personalized medicine

March 11th, 2012 - (William J Canestaro; Lori A Martell; E Robert Wassman; Rick Schatzberg) -Personalized Medicine


Healthcare payers represent stakeholders who can act as either a bridge or a gate to the translation of personalized medicine into routine clinical practice. To date, the slow realization of the promise of personalized medicine has been partly attributable to the lack of clear evidence supporting the clinical utility of genetic and genomic tests and the lag in development of clinical guidelines for the use and interpretation of tests.


Success for personalized medicine depends on how quickly health insurance plans will develop appropriate coverage guidelines along with a fair reimbursement policy. As physicians strive to deliver treatments and tests that inform clinical decisions and improved outcomes for their patients, payers must learn about new laboratory tests and create policies to reimburse for tests with clinical value.


The design of alternative strategies for collaborative evidence-generation, clinical decision support and educational initiatives for healthcare providers, patients and the payers themselves are critical needs to achieve the full benefit of personalized medicine in day-to-day healthcare settings.

New Insurer-Hospital ACO claims early success

March 8th, 2012 - (KHN) -Quality and efficiency in Healthcare


Illinois’ largest hospital system and biggest health insurer agreed in late 2010 to form an Accountable Care Organization, a network in which the organizations would cooperate to boost quality and restrain cost increases, sharing in any savings.


With six months of operating data in hand, Advocate and partner Blue Cross Blue Shield of Illinois claim spending reductions that are greater than those for patients outside the network.


Key to the results were the hiring of 60 “care managers,” many embedded in physician practices, to manage high-risk cases and post-acute care, said Lois Elia, vice president at AdvocateCare.


Six months of data do not guarantee success of the three-year experiment. “This is good but too early to draw conclusions,” Elia said.

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