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International Clinical Trials
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| The centralised independent reviewing process improves the skills and knowledge of the reviewers – providing important benefits for the healthcare community, the pharmaceutical industry and patients, explains Oliver Bohnsack and Manuela Lesch of Perceptive Informatics, a PAREXEL International company
Advanced medical imaging technologies play a vital role in many pivotal clinical trials today, providing primary and surrogate endpoints to support the safety and efficacy of a wide variety of biopharmaceutical products. With the dramatic improvements in these technologies in recent years, clinical study sponsors increasingly rely on imaging modalities such as magnetic resonance imaging (MRI), computed tomography (CT), ultrasound, and positron emission tomography (PET) to validate novel therapies and decrease the time and cost of clinical development.
An essential adjunct to the growing importance of medical imaging technology in clinical trials is the need for independent reviews of the study images. The initial reviews of medical imaging are performed by site-based radiologists who are directly involved in the study, therefore regulatory agencies such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) require additional reviews by independent radiologists to validate the results. |
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Oliver Bohnsack is a Medical Director based in the Berlin office of Perceptive Informatics,
the technology business of PAREXEL. In this role, he has led the imaging component of multiple
studies, from both a medical and a scientific approach. Oliver is a Board Certified Radiologist and
has broad clinical radiology experience in Germany and the US, as well as at various companies
in the biopharmaceutical industry. He holds a PhD in Radiology from the University of Munich and
a Masters in Business Administration in Health Care Management from the University of California,
Irvine. Oliver has presented at several international conferences on the topic of medical imaging
in clinical trials, and particularly regarding the utilisation of standardised review criteria.
Manuela Lesch is a Medical Research Scientist based in the Berlin office of Perceptive Informatics.
Manuela develops study-specific documents and guidelines, and assists in reviewer management.
She supports companies with charter development, including presenting at investigator meetings
and conferences. Manuela also has expertise in overseeing imaging operations of a range of
therapeutic studies, including central nervous system (CNS) studies. A Radiologic Technologist
by training, Manuela has several years of experience in multiple imaging modalities, including
conventional radiology, CT, MRI, nuclear medicine and radiation therapy, and has also specialised
in neuroradiology imaging. |
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Industry Events |
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4th Annual Patient Recruitment and Retention in Clinical Trials
13-15 October 2008, Amsterdam
Patient recruitment
is now consuming thirty percent of clinical trial time - more time than any
other clinical trial activity - and almost half of all trial delays result from
patient recruitment problems.
As the
recruiting culture becomes more sophisticated and the forces affecting patient
enrollment grow more numerous and complex, pharmaceutical companies are
striving to discover new strategies to facilitate enrollment in clinical
trials.
With
increasing industry pressure to develop, test and market greater numbers of new
drugs faster, pharmaceutical companies need to perform clinical trials as
quickly as possible. Inefficient patient recruitment processes is a formidable
barrier to pharmaceutical companies' success in launching new products.
Improving the patient recruitment process is imperative to avoid wasted
investments and eliminate costly delays in bringing new drugs to market --
today and even more so in the not-so-distant future. Improved patient
recruitment presents one of the largest opportunities for pharmaceutical
companies to eliminate delays in clinical trials, thereby making it possible to
reduce time to market. With patent time limits and large overheads
meaning that any delays in the development timeline can be disastrous, a good
understanding of how to successfully recruit patients for trials is vital for
any company looking to succeed.
More info >> |
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