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European Pharmaceutical Contractor

Paediatric Developmental Disabilities – Getting Research Right

Targeted education can facilitate interest in clinical research participation – Kathleen Drennan and Beth Koch of Iris Global Clinical Trials Solutions give a new insight into the advantages of qualitative market research in ASD

Recent experience has shown that targeted education directed towards parents/caregivers can facilitate interest and participation in autism spectrum disorder (ASD) research. The opportunity to speak with this audience about their children’s ASD elicited valuable feelings regarding the condition and available treatments, and can be an important part of central planning in ASD research.

ASD has recently gained considerable attention at local, national and global levels. Diagnoses of ASD are increasing and though the reason for the increase may be unclear, even controversial, research on the condition, as well as possible treatment options, have become a growing interest for the medical and research communities.

ASD is a group of developmental disabilities caused by abnormalities in the brain, which based on prevalence statistics from the National Institutes of Health (2004) and the Centers for Disease Control and Prevention (2001), affects one in every 166 births (1). Children with ASD exhibit problems along a spectrum of symptoms, including social interaction, verbal and non-verbal communication, and repetitive behaviours or interests (2), which begin in early childhood and last throughout their lives (3). No two people with ASD have the exact same symptoms and their ability levels vary from mentally gifted to mentally challenged (3). ASD occurs in all racial, ethnic and socio-economic groups (3) and is five times more likely to occur in boys than girls (4).

The cause of ASD is still unknown and there is no cure, only treatment. Treatments include support and facilitation, behaviour modification, educational therapy and pharmaceuticals; usually neurologics, already marketed for other indications. New medications for treatment of these behavioural disorders are currently being evaluated.


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Drawing from 25 years’ experience in pharmaceutical research and clinical trial development, Kathleen Drennan has implemented a system of integrated services and tools that offers significant opportunities in trial acceleration, pre-and post-marketing, and brand optimisation. Her expertise in patient recruitment, retention and site-related services are long recognised in the industry. Currently Senior Vice President and Managing Director of Iris Global Clinical Trial Solutions, a division of Corbett Accel Healthcare Group, she is a founding member of the Society for Women’s Health Research and resides on the Board of Directors. Kathleen also presides as Editor-in-Chief for Elsevier’s journal, Contemporary Clinical Trials.

Beth Koch is a Project Manager for Iris Global Clinical Trial Solutions, where she runs projects that focus primarily on patient recruitment and retention, and site support. She also serves as Managing Editor for Contemporary Clinical Trials. Beth gained a BA in Interpersonal Communications from Bowling Green State University, where she later obtained a masters in Scientific and Technical Communication.

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Kathleen Drennan
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Beth Koch
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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.
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