Addressing Cost Pressures in Late-Phase Research

is being presented by Dr. Max Horneck, Head of eClinical Services, with Wega Informatik AG and airs on Thursday, January 19th, 2012. For more details, or to register please visit our site at www.fxconferences.com

There is no question that gathering real-life data on approved drug products is of vital importance. Data collected for marketed drugs is needed to generate thorough knowledge of the safety, efficacy and effectiveness. The challenge for clinical operations arises from significant cost pressure in post-authorization studies, while attempting to maintain an adequate level of quality and achieving study targets. Experience has shown that simply mapping procedures from early to late phase does not give the desired results. Budgets tend to be overstressed while targets and quality remain in danger.

In this audio conference, our speaker draws upon almost two decades of clinical experience and provides insight on how to to effectively maintain control of the study conduct and quality of data with reduced efforts by the use of risk mitigation, regional service providers and business intelligence. This presentation enables the attendees to safely plan and conduct late phase studies at significantly reduced costs while maintaining compliance with current regulations at the desired level of quality.

Optimizing Data Displays for Safety Messaging

is being presented by Dr. Susan Sisk, Principal, SFP Consulting, LLC and airs on Thursday, August 25th, 2011. For more details or to register, please visit our site at www.fxconferences.com

Many times, tables and listings used for preparing clinical study reports, integrated summaries, and other clinical documents are designed without closely considering how these data displays will be used by the writer and review team to expedite document preparation and support messages about healthcare products. For example, does placebo come first on your tables and, if so, does that mean placebo is first in the text, or are you more interested in the test drug, mentioning placebo in context as a comparator? Or, have you ever written narratives from listings that required you to look up information in dozens of fields and then to do manual calculations to obtain “durations” required by the template, rather than the date-formatted data provided in the displays?

This audio conference presentation is designed to educate and to provoke dialog between statisticians and writers, as well as medical, regulatory, and project managers, with respect to appropriate display of clinical information to expedite document preparation and review.

Negotiating Clinical Study Agreements With Academic Medical Institutions

is being presented by Karen A. Mullin, JD, LLM and airs on Wednesday, July 20th, 2011. For more details, or to register please visit our site at www.fxconferences.com

The process of negotiating a clinical study agreement between a bio/pharmaceutical company and an academic medical institution can be difficult, in part due to the sometimes divergent goals of the two parties. This audio conference presentation reviews the expectations of both the bio/pharmaceutical company and the academic medical institution when negotiating clinical study agreements. Our speaker addresses in depth the key issues of confidentiality, publication, intellectual property rights and indemnification. The presentation also includes discussion of appropriate language to enable the parties to fulfill their different objectives and legal obligations. Finally, our speaker shares tips and insight on ways to speed up the negotiating process.

Biomarker Data Interpretation and Challenges of Biological Variation

With the emphasis on biomarkers to improve drug development, the question arises as how to interpret the data.
The traditional clinical laboratory methodology for interpreting data involves the identification of the expected values (the normal range), and from this range, defining the probability of disease or no disease (sensitivity and specificity). The challenge in drug development is in monitoring the patient over time while identifying if important changes have occurred in the biomarker values that indicate inappropriate toxicity or demonstrate appropriate efficacy.

The use of the reference interval as a means of identifying toxicity or efficacy will be challenged and an alternative approach embracing biological variation will be proposed.

Biomarker Data Interpretation and Challenges of Biological Variation was presented by Gordon F Kapke Ph.D., Sr. Director Biomarker Services, with Covance Central Laboratory Services and aired on 2009-01-28. For more details or to download this event, please visit our site at www.fxconferences.com

Leveraging Clinical Development Opportunities in India

India presents a compelling environment for global clinical trials because of its access to investigators, large patient populations with diseases of the industrialized and developing world, a cost-effective, English-speaking graduate workforce, and progressive regulatory environment. These benefits are now well recognized by the global pharmaceutical industry. Moreover, because of India's pristine FDA audits, continued streamlining of regulatory approvals and demonstrated intent to uphold international intellectual property standards, the country has become even more attractive as an important locale for clinical development.

As a result, multinational pharmaceutical companies are striving to build clinical development capabilities within their local operating companies in India, and the country's nascent CRO industry is enjoying an annual growth of about 40%. This, however, poses resourcing constraints and unresolved ethical issues about the robustness of patient consent. Hence, it is becoming increasingly important for sponsors to select investigators, sites and resources that will be able to deliver data of the quality and integrity that they seek.

This presentation draws on recent experiences and case studies related to the benefits and challenges of conducting clinical trials as well as data management in India.

Leveraging Clinical Development Opportunities in India was presented by Dr. Nermeen Varawalla, Vice President, Investigator Relations, with PRA International and aired on 2007-05-30. For more details or to download this event, please visit our site at www.fxconferences.com

Studies in Special Patient Populations: More than Just a Regulatory Requirement

In global drug development, supportive trials -- such as those in special patient populations -- are required to complement the regulatory submission package. Studies in hepatically or renally impaired patient populations are therefore often performed in parallel to Phase III trials in order to have them completed when the NDA is filed. However, in aging populations with reduced organ function, these studies can provide valuable information on interpretation of clinical data generated in Phases II and III.

In this audio conference, the speaker discusses the strategic and organizational aspects of these trials, while providing a deeper understanding of their value in special patient populations.

Studies in Special Patient Populations: More than Just a Regulatory Requirement is being presented by Dr. Christian Reh, Vice President, Clinical Affairs, Early Development Services, with PRA International and airs on Thursday, October 29, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com

Medical Device Research and Regulations in Israel

Israel represents the largest single medical device market in the Middle East, valued at roughly 885 million dollars and growing at an annual rate of almost 5%. There is an extensive medical network and high doctor-to-patient ratio, both reflected in a low infant mortality rate and high life expectancy. Distribution of medical conditions and trauma is comparable to the EU and USA.

Israeli schools provide medical professionals with Western-level training, and as a result the country operates on the frontier of medical technology development. With its experienced doctors and high-tech medical facilities, Israel offers medical device companies a regulated, accepting environment in which to conduct clinical studies of the highest quality. Study enrolment is high, as is data quality.

This audio conference provides attendees with information on the regulations governing Israeli clinical studies, and the requirements for placing your medical device on the market in Israel.

Medical Device Research and Regulations in Israel was presented by Efraim Roe Kozorovitsky, Executive Director, Medical Devices, with Premier Research Group. This conference aired on 2009-02-05 and is available at www.fxconferences.com

Clinical Investigations in Asia

Managing clinical studies in Asia can be both rewarding and challenging, as researchers face such issues as language, regulatory requirements and logistics. However, delays and frustrations can also arise if local practices -- such as standard treatments, insurance and reimbursement, indemnification of sites and investigators, and administration of study grants -- are not considered and anticipated. In addition to a well-structured feasibility study which provides meaningful information and data, the unique considerations of "locality" and corresponding solutions would be of value.

Whether or not a sponsor engages a CRO for Asian studies, it is important that they thoroughly understand the differences, the uniqueness (what and why things are done the way they are in Asia), and the latest on the local regulatory fronts, in order to assemble a solid and achievable clinical management plan.

Focused on China, Taiwan, Hong Kong, South Korea, Japan, Thailand and Singapore, this presentation draws on the benefits and challenges of managing clinical trials in Asia, based on recent experiences. The speaker also addresses critical points to ensure successful project start-up and conduct.

Clinical Investigations in Asia was presented on 2007-06-28 and is available for download at www.fxconferences.com

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Adaptive Clinical Trials: How Advanced Adaptive Methods Can Improve Your Next Study

Adaptive methods are increasingly used for statistical issues in research, but this limited use overlooks the most powerful and sustained advantages: application of the same adaptive principles to how a study is run. This approach focuses on continuous measurement and refinement of key study metrics that include rapid enrollment, reduced waste, lowering monitoring costs, and quick study conclusion and database lock. Compared to traditional approaches, adaptive methods typically enable 20% faster enrollment, 20-80% lower study query rates, 20-60% lower monitoring costs, and 50% faster database locks.

This audio conference will discuss the tools and processes essential to this approach, along with design and planning issues and net financial impact on Net Present Value and Internal Rate of Return.

Adaptive Clinical Trials: How Advanced Adaptive Methods Can Improve Your Next Study is being presented by Michael Rosenberg, M.D., Ph.D, CEO, with Health Decisions and airs on Wednesday, February 18th, 2009. For more details, or to register please visit our site www.fxconferences.com