Partnering with the New e-Patient for Recruitment Success

The Internet has changed the way people approach their own health care, creating a new breed of engaged, empowered consumer known as the ‘e-patient’. They are taking charge of finding information about their diagnoses and treatment options, and they aren’t shy about interacting online with other patients to exchange experiences and learn more. The most active searchers, according to a groundbreaking white paper by Dr. Tom Ferguson and the e-Patients Scholars Working Group, are acute (newly diagnosed) and chronic patients – arguably, the optimal candidates for clinical trial participation.

This conference profiles the new e-patient, offers strategies for getting his/her attention, and assesses the benefits and challenges of partnering with this population to optimize clinical trial participation.

Partnering with the New e-Patient for Recruitment Success is being presented by Rob Laurens & Matt Stumm, with BBK Worldwide and airs on Thursday, April 23rd, 2008. For more details please visit our site 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

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

Leveraging Technology for Conducting More Efficient Trials in India

Compelling fundamentals are driving the growth factor of the clinical development sector in India. There is potential for innovation and sector transformation if technologies, processes and workflow can be leveraged to select quality sites that have the subject populations to meet enrollment goals and efficiently manage your clinical trial projects while enhancing the quality, regulatory and ethics training of clinical site research personnel. Are your clinical trial management processes well-suited for this clinical trials landscape? Increasing efficiency with costing and timelines is crucial to a successful trial, and there are an array of technologies available to help you achieve your clinical trial goals.

This audio conference will provide insights on technology, process and procedures to effectively manage clinical trials in India. You will be armed with the most efficient technology-based solutions mapped with workflow processes for continued success in the Indian pharmaceutical marketplace.

Leveraging Technology for Conducting More Efficient Trials in India is being presented on Wednesday, March 18th, 2009. For more details, please visit our site www.fxconferences.com

Meeting the Challenges of Global Oncology Trials

Successful global oncology trials require careful planning, starting with looking at the strategic elements that span people, process and technology. Challenges in clinical research in oncology today include multiple new agents for multiple new targets combined with an increase in the number of patients needed to demonstrate that a therapy provides a significant benefit for patients. There is also a need to minimize the time it takes to go from basic science discoveries into clinical studies. The risk posed by delays in study start-up and patient recruitment can be mitigated by proactively planning for the study.

Planning needs to reflect the traditional and nontraditional considerations of feasibility and study design and incorporate trends and best practices. Patient recruitment is a key strategic consideration, along with epidemiological and genetic factors. Facilities, expertise and other resources along with technology play a key role in global trial planning.

Area-specific regulatory requirements vary in terms of standards of care, and differences among healthcare systems influence trial planning, as do local and cultural considerations.

This presentation focuses on the central challenges in global oncology trials today and make recommendations about how they might be addressed to mitigate risks in terms of timelines and costs.

Meeting the Challenges of Global Oncology Trials was presented by Dr. Ute Berger, Senior Director of Therapeutic Expertise Oncology & Hematology, with PRA International and is available for download at www.fxconferences.com

Regulation vs. Communication: Finding the Balance

It's no wonder pharmaceutical companies are hyper-focused on regulatory compliance. For the first time ever, a physician was indicted for off-label promotion (Xyrem, Gleason; case pending). Over the past two years, off-label promotion fines increased from $3 to $5 billion. Even company executives have been personally fined (Purdue Frederick, guilty plea, $38M).

At the same time, the need to reduce the morbidity and mortality associated with chronic disease has driven investment in consumer and patient education about illness and drug treatment. Spending on DTC advertising increased by 330% from 1996 to 2005 (NEJM). Spending on eMarketing/promotion will reach over $480m by 2011 (Visiongain).

It's a double-edged sword. Companies cannot afford to pay the price for noncompliance (e.g. legal fees, criminal prosecution, corporate integrity agreements, and negative media attention). Yet, to maximize health outcomes, marketing communications must ensure that the messages break through at a time and place where patients can hear them. Prime example: social networking, which has opened the door for more participation and spontaneous emotion. How does the industry stay compliant and be creative at the same time? In the end, we owe it to ourselves, our associates and our organizations to deliver on this goal within an ever more restricted regulatory environment.

Regulation vs. Communication: Finding the Balance was presented by Ilyssa Levins, President, with HCIL Consulting and aired on 2008-01-10. For more details or to purchase a download of this event, please visit our site www.fxconferences.com