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22 posts from September 2012

September 28, 2012

Joint Commission Issues New Criteria for Medical Education and Clinical Research

Joint Commission Criteria
Joint Commission-accredited academic medical centers (AMCs) will see new criteria for medical education and clinical research incorporated into the evaluation process.  The new standards for AMCs were issued on July 1, 2012 and will be effective for all eligible organizations on January 1, 2013.  

An independent, not-for-profit organization, The Joint Commission accredits and certifies more than 19,000 health care organizations and programs in the United States. Joint Commission accreditation and certification is recognized nationwide as a symbol of quality that reflects an organization’s commitment to meeting certain performance standards. 

“These standards were also developed to present a framework for including medical education and human subject research into the quality and patient safety activities of academic medical center hospitals,” Paul vanOstenberg, JCI's vice president of International Accreditation, Standards and Measurement, said today in a statement.   “These standards were also developed to present a framework for including medical education and human subject research into the quality and patient safety activities of academic medical center hospitals.  Unless deliberately included in the quality framework, education and research activities often are the unnoticed partners in patient care quality monitoring and improvement.” 

To meet the eligibility criteria, hospitals must be organizationally or administratively integrated with a medical school, serve as the principal site for the education of both medical students and medical specialty residents from the integrated medical school, and conduct academic and/or commercial human subject research involving patients of the hospital. 

Meanwhile, those considered AMCs must make sure to carefully explore mergers, acquisitions and affiliations to survive in the consolidating healthcare environment, advised Healthcare Strategies & Solutions, noted Becker's Hospital Review

To achieve clinical growth and fulfill their academic mission, academic medical centers need to take a proactive approach to finding the most suitable partner.  A March report from consulting firm PricewaterhouseCoopers (PwC) recommended academic medical centers team up with high-quality, low-cost providers like community hospitals. 

The new standards applicable to academic medical centers are divided into two chapters – Medical Professional Education (MPE) and Human Subject Research Programs (HRP) – as medical education and clinical research are most frequently organized and administered separately within academic medical centers. For all hospitals meeting the eligibility criteria, these two chapters will be a required addition to the Joint Commission International Accreditation Standards for Hospitals, 4th Edition.  

These new standards will be integrated into the evaluation process for the accreditation of hospitals. For example, when the on-site evaluators are reviewing patient care in a clinical unit, they will also evaluate the contribution of medical trainees to care processes in that unit, and the integration of clinical research protocols into the care provided on the unit and the quality monitoring processes. 

Not every hospital with students or conducting research is considered an academic medical center hospital under these new standards, according to vanOstenberg. JCI will evaluate hospitals under the academic medical center hospitals requirements when the hospital:  

  • Is organizationally or administratively integrated with a medical school;
  • Is the principal site for the education of both medical students and medical specialty residents from the medical school noted in the previous criterion; and
  • Conducts academic and/or commercial human subject research involving patients of the hospital.

September 27, 2012

Ten BioPharmaceutical Companies Launch TransCelerate BioPharm, Inc. to Accelerate Product Development

Ten leading biopharmaceutical companies announced that they had formed a non-profit organization to accelerate the development of new medicines. Abbott, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Johnson & Johnson, Pfizer, Genentech a member of the Roche Group, and Sanofi launched TransCelerate BioPharma Inc. ("TransCelerate") , the largest ever initiative of its kind, to identify and solve common drug development challenges with the end goals of improving the quality of clinical studies and bringing new medicines to patients faster. 

Each of these company’s should be applauded for their efforts to solve these very real problems.  As we noted last year, the “valley of death” for most companies developing drugs can be brutal.   

Through participation in TransCelerate , each of the ten founding companies will combine financial and other resources, including personnel, to solve industry-wide challenges in a collaborative environment.  Together, member companies have agreed to specific outcome-oriented objectives and established guidelines for sharing meaningful information and expertise to advance collaboration. 

“There is widespread alignment among the heads of R&D at major pharmaceutical companies that there is a critical need to substantially increase the number of innovative new medicines, while eliminating inefficiencies that drive up R&D costs,” said newly appointed acting CEO of TransCelerate BioPharma , Garry Neil, MD, Partner at Apple Tree Partners and formerly Corporate Vice President, Science & Technology, Johnson & Johnson. “Our mission at TransCelerate BioPharma is to work together across the global research and development community and share research and solutions that will simplify and accelerate the delivery of exciting new medicines for patients.” 

Other companies, including smaller ones, will be able to join, Mr. Neil said.  The companies will contribute money and personnel to work on the various projects.  While TransCelerate will have a headquarters in Philadelphia, the employees from different companies will not all work together at that location, instead meeting as necessary, Mr. Neil said. 

Members of TransCelerate have identified clinical study execution as the initiative's initial area of focus.  Five projects have been selected by the group for funding and development, including:  

  1. Development of a shared user interface for investigator site portals,
  2. Mutual recognition of study site qualification and training,
  3. Development of risk-based site monitoring approach and standards,
  4. Development of clinical data standards, and
  5. Establishment of a comparator drug supply model. 

Forbes expanded on this list:

  1. Creating clinical data standards, as with the case of notation of gender, so that all clinical trials note things like gender, changes in blood pressure, and such in the same way.
  2. Standardizing the way that risk to patients is measured in studies, so that side effects are always handled in the same way.
  3. Building a common Web site for doctors enrolling patients in clinical trials to use, so that each company isn’t running its own portal with a different look and feel.
  4. Standardizing the process of training doctors and qualifying clinical trial sites, so that a physician doesn’t need to go through separate but similar training programs in order to work in clinical trials run by two companies.
  5. Standardizing the process by which companies strike deals to do clinical trials that compare an experimental drug to a standard regimen made by another company. 

As shared solutions in clinical research and other areas are developed, TransCelerate will involve industry alliances including Clinical Data Interchange Standards Consortium (CDISC), Critical-Path Institute (C-Path), Clinical Trials Transformation Initiative (CTTI), Innovative Medicines Initiative (IMI), regulatory bodies including the US Food and Drug Administration (FDA) and European Medicines Agency (EMA), and Contract Research Organizations (CROs). 

Janet Woodcock, MD, director of FDA's Center for Drug Evaluation and Research, said, “We applaud the companies in TransCelerate BioPharma for joining forces to address a series of longstanding challenges in new drug development. This collaborative approach in the pre-competitive arena, utilizing the collective experience and resources of 10 leading drug companies and others to follow, has the promise to lead to new paradigms and cost savings in drug development, all of which would strengthen the industry and its ability to develop innovative and much-needed therapies for patients.” 

“These leading pharmaceutical companies are in a position to significantly influence changes in the way that clinical trials are done, so that better answers about the benefits and risks of drugs and other therapies are provided in a more efficient manner,” said Robert Califf, MD, Co-Chair of CTTI and Director of the Duke Translational Medicine Institute.  “This initiative is complementary to efforts of CTTI, and we look forward to working with TransCelerate BioPharma to improve the conduct of clinical trials.” 

TransCelerate BioPharma evolved from relationships fostered via the Hever Group, a forum for executive R&D leadership to discuss relevant issues facing the industry and solutions for addressing common challenges. TransCelerate was incorporated in early August 2012 and will file for non-profit status this fall. The Board of Directors includes R&D heads of ten member companies. Membership in TransCelerate is open to all pharmaceutical and biotechnology companies who can contribute to and benefit from these shared solutions. TransCelerate 's headquarters will be located in Philadelphia, PA.

Glen Giovannetti, Ernst & Young Global Biotechnology, Leader says today’s announcement encouraging because it is unique.  “We haven’t seen one quite like this before where 10 pharmaceutical companies paired up of sort of their own volition in a way,” he says. “They join other consortia. This seems to be more of a real commitment of their resources and their effort. I think it’s great. They’re going to concentrate on getting some standardization around the clinical trial process. Perhaps more important in the long term, how data is gathered and assembled it really could move toward greater standardization of data so that trial results downstream could be more easily pooled and shared and investigated for insights.”


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