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European Pharmaceutical Contractor

Global Goals

The achievement of the first patient enrolled (FPI) into a clinical trial is one of the most highly anticipated events of the drug/device development process. The pressure to realise this milestone – whether to meet a corporate target or outpace the competition as the baton passes from one trial to the next – is intense and may precipitate premature study starts, resultant delays and an overall decrease in potential revenue. The fleeting elation at the start of enrolment is quickly abandoned. Anxiety regarding the next and arguably more important milestone – last patient out – builds rapidly. In the rush to achieve FPI, thoughtful study design and reasoned start-up considerations are often neglected to the detriment of the overall development timeline. Re-prioritising study design, in addition to careful consideration of multifactorial influences associated with international studies, will facilitate study start-up and help ensure the ratelimiting, last patient out occurs within expected timeframes.

Right the First Time

Due to the intense pressure to achieve FPI, the industry does not often get protocol design right the first time, resulting in a negative impact to overall timelines and cost. 86% of clinical trials are estimated to experience delays, and 94% of clinical trials are delayed by over one month (1). The protracted timelines associated with the clinical development process directly correlate with increased costs and decreased revenues. The projected costs to bring a new drug to market are currently between $161 million and $2 billion (2). For each day a clinical trial is delayed, up to $8 million in revenue is lost. The cost to implement a substantial amendment is approximately $500,000-$1 million, comprised of internal administrative and investigator expenses, contract change orders or new contracts with service providers, additional drug supply and regulatory fees (2). Thus, careful protocol planning is key to preventing design-related delays, which impede last patient out milestones and generate unnecessary costs associated with protocol amendments.

In addition to the complexity of protocol design, studies are increasingly being conducted in multiple countries and regions in an effort to achieve the required patient numbers to address rare diseases or run large outcome trials, which can create complexities that may not have been anticipated when the protocol was originally conceived. Factoring international considerations into trial design may facilitate a more efficient development process and provide earlier access to medicines for patients (3).

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Debbie Elliott is Executive Director of clinical operations at Medpace. She has 20 years of clinical research experience, including over four in Phase 1 research and over 16 in Phase 2/3 clinical trials. She holds a PhD in biological psychology with a minor in neurobiology. Most recently, Debbie directed the global study start-up team within Medpace and currently oversees the proposal and feasibilities team.

Colleen Grawe is Senior Regulatory Submissions Manager at Medpace. She has over 18 years of clinical research experience, including 11 years as a Regulatory Submissions Manager facilitating the start-up of clinical trials as well as seven years as a Clinical Research Associate. She has an Associate of Applied Science in radiologic technology and a Bachelor of Arts in journalism.

Jacqueline Moore is Director of Regulatory Submissions at Medpace and has over 20 years of experience in clinical research, primarily in regulatory affairs, covering all phases and a wide variety of therapeutic indications and investigational products. She has a BSc and PhD in pharmacology from the University of Glasgow, UK.

Gina Steidle is Senior Director of strategic proposals and feasibilities at Medpace. She has over 20 years of experience in pharmaceutical research, including clinical trial management, clinical monitoring management and proposals and feasibilities. She has a Bachelor of Science in nursing from Indiana University School of Nursing, US.


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Debbie Elliott
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Colleen Grawe
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Jaqueline Moore
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Gina Steidle
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