The Future of Clinical Trial Site and Patient Recruitment Is Here

is being presented by Kent Tholke, Senior Vice President, Scientific and Medical Affairs, with PRA International and airs on Thursday, July 22nd, 2010. For more details or to register, please visit our site at www.fxconferences.com

The key to successful site and patient recruitment is having the ability to mine electronic health records as well as pharmacy, claims, laboratory and historical CRO recruitment data using proprietary search algorithms. Current research indicates that more than 25% of clinical trial sites are unproductive. Relying on a data-driven decision making process will lead to far fewer non-productive clinical trial sites, shorter development timelines, greater patient recruitment and ultimately lower drug development costs.

With more clinical trials being conducted — and with the majority of them operating under delayed timelines — patient access has become the critical piece to solving what has become a very inefficient and costly puzzle known as drug development. While the process of drug development over the last few decades has been heavily driven by scientific methodology, the process by which clinical trials are conducted has consistently lacked the same rigor. Achieving successful patient access and meeting clinical trial timelines will require CROs to use more accurate processes for site selection and targeted patient enrollment.

Although having access to relevant data is important to enhancing site selection and patient recruitment, sponsors and CROs must also mine this data with algorithms that have been established to match planned patient populations and inclusion/exclusion criteria. When sponsors and CROs apply detailed search algorithms across multiple patient data platforms, they are able to find and target sites with the appropriate patient populations and confirm that the planned trial design matches customary care practices. This confirmation is the first step to both determining a trial’s feasibility and mining patient data. In addition, sponsor companies can use data-mining algorithms to determine if medical professionals are treating the target patient population as expected and to locate the patients by physician practice.

This audio conference explores the power of mining EHR/EMR, lab, pharmacy, claims and historical CRO recruitment data. It will also review how using data-driven decision making to validate trial designs and patient and site selection is a key to successful drug development.

Recent Perspectives on Trial Design - Minimizing Patients for Oncology Trials

is being presented by Dr. John Constant, Vice President Scientific Affairs, with PRA International and airs on Wednesday, May 26th, 2010. For more details or to register, please visit our site at www.fxconferences.com

Oncology trials have long been at the forefront of novel design thinking, due in part to the extreme needs and historically toxic or complex therapies for cancer. With the regulatory Critical Path Initiatives and the general urgent need for more efficient clinical development adaptive and other patient – efficient designs are continuing to receive increasing attention and FDA has recently published their long-awaited Guidance on adaptive designs. This session will overview recent developments in oncology design thinking and issues related to adaptive, single arm and Phase I/II designs as used in practice in oncology trials.

Periodic Safety Update Reports: Be Compliant and Cost Effective

is being presented by Dr. Hemendra Misra & Mark Nelson Tyrrell, with PRA International and airs on Tuesday, March 23, 2010. For more details or to register, please visit our site at www.fxconferences.com

Periodic Safety Update Reports (PSURs) are a regulatory requirement in the European Union, Japan, and in an increasing number of ICH and non-ICH countries. The US FDA, in conjunction with the goal to harmonize reporting globally, also accepts a PSUR in place of the Periodic Adverse Drug Event Report (PADER).

Planning and writing of PSURs involve significant effort and costs. In times of peak workload, pressing timelines or competing priorities, maintaining compliance becomes a challenge. Lessons learned from the industry were employed to develop customized strategies to keep up with the associated regulatory, scientific and public health demands.

Establishing Value for Diagnostics & Biomarkers in a Real-Life Setting

While considered a relatively novel term in research, biomarkers and diagnostics have been extensively used in the pre-clinical and clinical research and diagnosis arena for many years. Their magnitude in positively influencing the medical community’s ability to accurately diagnose and treat human conditions, although still undefined, seems limitless. Currently, a renewed focus is being placed on healthcare outcomes, and the containment of medical cost, diagnostics, biomarkers and personalized medicine are fostering better outcomes and savings.

In this Webinar, our speakers discuss how the need for more clinical applications for diagnostic biomarker testing is expected to have an explosive growth among several disease categories in the five years. They also explain how the operational execution of biomarker and diagnostic research varies greatly from traditional clinical research, while looking at the unique requirements and challenges.

Establishing Value for Diagnostics & Biomarkers in a Real-Life Setting is being presented by Dr. Jerome Wilson & Kathleen Kushner, Sr. Scientific Affairs Director & Scientific Affairs Director, Late Phase Services, with PRA International and airs on Tuesday, February 23, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com

Adaptive/Novel Designs in Oncology: Overview & Issues

Oncology trials have long been at the forefront of novel design thinking, due in part to the extreme needs and historically toxic or complex therapies for cancer. With FDA's Critical Path Initiative and the general urgent need for more efficient clinical development adaptive designs, these trials are receiving increased attention. There is a call to modernize drug development and utilize bioinformation to evaluate safety and effectiveness.

Adaptive designs have become popular tools in oncology research, helping to achieve more effective and affordable trials. This conference gives an overview of adaptive design thinking and issues, and explores their place in oncology trial design.

Adaptive/Novel Designs in Oncology: Overview & Issues was presented by Dr. John Constant, Vice President Scientific Affairs, Statistical Consulting, Oncology/Hematology, with PRA International and aired on 2009-05-19. For more details or to download this event, please visit our site at www.fxconferences.com

Clinical Trials: Why is India Irresistible?

In recent years, India has proven itself as a solid-performing region for conducting clinical trials. As it has evolved and emerged, it has caught the attention of global pharmaceutical and biotech companies. The reason for the growth in this region is simple: India, with a population of over 1.15 billion people, has one of the largest patient populations in the world. In addition to its large patient population, India has nearly 700,000 specialty hospital beds, 290-plus medical colleges, and skilled English-speaking medical professionals.

In this session we examine the factors that have made India one of the hottest places in the world to conduct clinical trials. Attendees come away with proven strategies to overcome challenges and maximize the “India advantage.”

Clinical Trials: Why is India Irresistible? is being presented by Dr. Pramod Kabra, Director of Clinical Operations, with PRA International and airs on Thursday, January 28, 2010. For more details or to register, 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

Design and Regulatory Considerations in Anti-Infective Drug Development

The current regulatory environment in anti-infective drug development is changing due to updates in submission requirements as well as the potential for risk mitigation strategies post-launch. Conversely, the need to develop drugs with acceptable risk/benefit profiles for emerging and re-emerging infectious diseases is certainly present considering the rising concerns of disease due to drug-resistant pathogens, biothreat agents and novel influenza strains.

In this conference our speakers review some of the basic principles surrounding anti-infective drug development in the framework of regulatory submissions. They also provide an update on some of the most important changes in recent years related to specific anti-infective indications.

Design and Regulatory Considerations in Anti-Infective Drug Development is being presented by Dr. John Powers, George Washington University School of Medicine & Dr. Carl Kraus, PRA International and airs on Wednesday, December 16, 2009. For more details or to register, please visit our site 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 by Edward C. Ian, Director of Operations in Asia, with PRA International and is previously recorded. For more details or to download this event, please visit our site at www.fxconferences.com

ForeignExchange Translations provides specialized Korean, Japanese, and Chinese translation services to medical device and pharmaceutical companies.

Clinical Trial Success in Latin America

Latin America has proved to be a solidly performing region for clinical trials, catching the interest of global pharmaceutical and biotech companies. GCP (Good Clinical Practice) has been adopted as local regulatory requirement in most Latin American countries over the last decade. Since then, industry-funded clinical research has grown rapidly, and Latin America is routinely considered for global drug development programs. The reasons for this growth are simple: a large patient population, solid investigators with experience in clinical research, well-equipped qualified study institutions, strengthened clinical research infrastructure (laboratories, drug depot services and logistics), and internationally recognized standard treatments.

This audio conference reviews the major factors that have made Latin America a successful region for global clinical research studies. Drawing on recent experiences, the speaker outlines the benefits and challenges to managing Latin American clinical trials, while sharing practical advice on critical points to take into account when conducting trials in Latin America.

Clinical Trial Success in Latin America is being presented by Dr. Frederico Lerner, Senior Director of Operations, with PRA International and airs on Friday, November 13, 2009. For more details or to register, 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

Optimizing Country Selection for Clinical Research

A number of elements can influence decision-making when developing a global footprint within the clinical research environment. These elements include: knowledge of the regulatory framework and timelines, suitability of the healthcare setting, compatibility of standard of care, interest within the physician community, internal resource availability to train sites and monitor high quality data, and the competitive landscape.

In this presentation, Dr. Stansfield discusses these elements, with a primary focus on the ways that patient access can influence the successful outcome of clinical research for a new product. She also highlights the pros and cons of different approaches.

Optimizing Country Selection for Clinical Research was presented by Susan Stansfield, PhD, Executive Vice President Product Registration Europe, Africa & Asia Pacific, with PRA International and aired on 2008-02-14. For more details, or to download this conference please visit our site at www.fxconferences.com

Current Trends in Clinical Neuroscience: A Focus on Multiple Sclerosis

Recent advances in the treatment of multiple sclerosis represent the most significant therapeutic success in neurology since the introduction of L-dopa for Parkinsonism 40 years ago. Traditional clinical trials in MS have required large numbers of subjects for a period of six months or longer. However, due to the intense competition for MS subjects, as well as technological advances and understanding of imaging techniques, MS clinical trial design is evolving. Efficient and focused subject recruitment approaches, combined with state-of-the-art trial design, are required to assess the large number of potential therapeutics in the clinical development pipeline.

In this audio conference, Dr. Peroutka discusses recent successes in MS treatment and provides attendees with practical knowledge concerning CNS clinical research, the competitive MS landscape and the analytic approach to MS subject recruitment. He also shares his insights on the conduct of MS studies, including how to leverage global experience locally.

Current Trends in Clinical Neuroscience: A Focus on Multiple Sclerosis is being presented by Dr. Stephen Peroutka, Vice President, Neurosciences, Scientific Affairs, with PRA International and airs on Thursday, October 1, 2009. For more details or to register, please visit our site at www.fxconferences.com

From Emerging to Emerged: Clinical Development in Asia Pacific

Although in the past Asia Pacific was deemed an emerging region for clinical research, it has now evolved and emerged, catching the interest of global pharmaceutical and biotech companies. Good Clinical Practice (GCP) was adopted as a local regulatory requirement in most of these counties in the late 1990s. Since then, industry-funded clinical research has grown rapidly in the eleven countries that are routinely considered for global IND studies.

The reasons for this growth are simple: Asia Pacific provides sponsors with several advantages, including streamlined regulatory and IRB processes, highly educated investigators and study personnel, well-equipped qualified study institutions, strengthened clinical research infrastructure, and internationally recognized standard treatments.

This presentation reviews the major factors that have made Asia Pacific such an attractive region for global clinical research studies. Drawing on recent experiences, the speaker outlines the benefits and challenges to managing clinical trials in the Asia Pacific region. Attendees also receive practical advice on critical points to take into account when conducting trials in Asia Pacific.

From Emerging to Emerged: Clinical Development in Asia Pacific is being presented by Edward C. Ian, Senior Director of Clinical Operations, Asia Pacific, with PRA International and airs on Wednesday, September 2, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com

To learn more about Korean translations, please visit ForeignExchange Translations website at www.fxtrans.com

Oncology Trials in 2009: Challenges & Innovative Approaches

One of the greatest risks for oncology trials today is the delay in clinical development timelines. The main reason for the timeline delay is patient recruitment. Due to the increase in the number of ongoing clinical trials in recent years, and subsequently decreased enrollment in the developed countries, innovative approaches are necessary to mitigate the risk of delay.

To meet clinical development timelines, proactive planning and comprehensive data analysis are necessary to mitigate the risk. Detailed planning and appropriate site and country selection are the most critical factors in meeting target patient accrual goals. This audio conference provides practical guidelines and innovative ideas which are useful when conducting oncology trials in the current environment.

Oncology Trials in 2009: Challenges & Innovative Approaches is being presented by Dr. Ute Berger, Vice President & Head of Medical Affairs - Europe, Africa & Asia-Pacific, with PRA International and airs on Tuesday, July 28, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com

Meeting the Requirements: Blending REMS Science & Operational Execution

We invite you to listen to the PRA Risk Management, Epidemiology and Late Phase Operational experts who are currently consulting, designing and conducting REMS activities under the new FDAAA regulations. These experts give insight into current issues concerning REMS, such as risk management activities, observational safety-surveillance studies and performance-linked access programs. They also discuss the potential payoff from the new REMS requirements, as well as which REMS requirements have been proposed for incorporating adaptive designs.

In this audio conference the speakers present various REMS strategies based on a “tiered” approach, as well as some recent case studies. In addition, the presenters cover lessons learned and program components to consider, based on current FDA thinking and requirements for a REMS.

Meeting the Requirements: Blending REMS Science & Operational Execution is being presented by Mark Nelson Tyrrell, Kathleen Kushner & Jerome Wilson, Director, Safety and Risk Management, Scientific Affairs Director & Senior Scientific Affairs Director, with PRA International and airs on Tuesday, June 16, 2009. For more details, please visit our site at www.fxconferences.com

Adaptive/Novel Designs in Oncology: Overview & Issues

Oncology trials have long been at the forefront of novel design thinking, due in part to the extreme needs and historically toxic or complex therapies for cancer. With FDA's Critical Path Initiative and the general urgent need for more efficient clinical development adaptive designs, these trials are receiving increased attention. There is a call to modernize drug development and utilize bioinformation to evaluate safety and effectiveness.

Adaptive designs have become popular tools in oncology research, helping to achieve more effective and affordable trials. This conference gives an overview of adaptive design thinking and issues, and explores their place in oncology trial design.

Adaptive/Novel Designs in Oncology: Overview & Issues is being presented by Dr. John Constant, Vice President Scientific Affairs, Statistical Consulting, Oncology/Hematology, with PRA International and airs on Tuesday, May 19, 2009. For more details please visit our site at www.fxconferences.com

Determining Feasibility in Global Clinical Trials

The single greatest challenge to drug development today is successful patient accrual. The sheer volume of actively recruiting trials advertised by the NIH -- nearly 16,000 in 2006 -- illustrates the extensive competition for patients to participate in clinical trials in the United States. In an effort to access more patient populations to address these issues, it has become necessary to include a global mix of countries.

The key to including sites outside the United States is understanding exactly where the selected patient populations are located. Detailed feasibility is a critical step to planning and conducting successful global clinical trials. Understanding the medical standards of care, local healthcare systems, national health insurance and reimbursement, drug importation and tax implications, local regulatory requirements and treatment paradigms are all essential to determining where globally to place a specific clinical trial.

This presentation focuses on how to perform global feasibility to aid in the planning and conduct of clinical trials to economize your development times and clinical trial costs and explores the benefits of including regions such as Eastern Europe, Latin America, Asia and India.

Determining Feasibility in Global Clinical Trials was presented by Kent Thoelke, Sr. Vice President, with PRA International and aired on 2007-08-02. This conference is available for download at www.fxconferences.com

Phase I Studies with Hepatitis C Compounds in Healthy Volunteers and Patients - Views from Inside

New Chemical Entities (NCEs) that increase the percentage of sustained viral response with current standard treatment for hepatitis C have great marketing potential. Protease inhibitors, polymerase inhibitors, interferons, enzyme inhibitors, viral entry blockers, TLR agonists and oligonucleotides all seek to be included in the future armamentarium. Whether these different classes of compounds can fit together and lead to a successful combination treatment is still unknown. Registration of these NCEs is a long and arduous path, with no guarantee of success.

Drawing on his expertise and 19 years of experience, in this audio conference Dr. van Vliet provides an inside look at opportunities and obstacles when developing a hepatitis C compound, and discusses the critical steps necessary to optimize the chances of the NCE -- condensed Phase I development programs, subsequent proof of concept studies to verify efficacy, and competition for patients versus Phase III trials.

Phase I Studies with Hepatitis C Compounds in Healthy Volunteers and Patients - Views from Inside is being presented by Dr. Andre van Vliet, Vice President of Medical Affairs, Early Development Services, with PRA International and airs on Tuesday, April 14, 2009. For more details or to register, please visit our site at www.fxconferences.com

Beyond Global Feasibility: An Evidence-Based Approach to Creating Realistic Development Timelines

One of the greatest risks to successful drug development today is delayed clinical development timelines. Detailed planning and appropriate site and country selection is the most critical factor in meeting target patient accrual goals within the planned timeline. Historically, site and country selections have been made primarily utilizing survey-based prospective feasibility. Unfortunately, survey-based feasibility alone is no longer sufficient to provide the detail necessary to select countries and sites to maximize patient accrual and minimize development timelines. An evidence-based methodology approach coupled with survey-based feasibility provides the most accurate forecast for patient accrual and the selection of sites and countries with the highest likelihood of being productive.

In this audio conference we will discuss the key items of an evidence-based approach to feasibility and ultimately, site and country selection.

Beyond Global Feasibility: An Evidence-Based Approach to Creating Realistic Development Timelines is being presented by Kent Thoelke, Sr. Vice President of Therapeutic Expertise, Scientific & Medical Affairs, with PRA International and airs on Wednesday, March 25, 2009. For more details or to register, please visit our site www.fxconferences.com