Are Electronic Data Capture and Early Phase Clinical Research Still an Unlikely Pair?

Electronic Data Capture (EDC) in clinical research
By Dr. George Atiee, Vice President and Medical Director at Worldwide Clinical Trials Early Phase Services Unit,

  At a time when technology is well and truly embedded within people’s everyday lives, the adoption of modern technology within clinical research has been an obvious step forward for the industry. Fifteen years ago, Electronic Data Capture (EDC) in clinical research was still a relatively rare entity. However, fast forward to today’s clinical trials and electronic data capture solutions have a proven track record of supporting studies of all sizes and complexities.

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Phase I Clinical Trials: The Role of Pharmacy in an Early Phase Clinical Research Unit – Part 1

Early Phase, protocol review and drug accountability
By Sherilyn Adcock, Ph.D., Executive Vice President, Worldwide Clinical Trials Early Phase Services,

Phase I clinical trials form an important foundation for drug development and eventual approval of life-saving therapies. This two-part blog will review the role of the pharmacy in a state-of-the-art Phase I clinical research unit (CRU) and discuss best practices. Part 1 will consider the importance of pharmacy staff, the novel role of protocol review and drug accountability, with the next installment discussing manufacturing and compounding, investigational drug blinding and dispending and dosing.

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Phase I Clinical Trials for LDX: How Do We Treat ADHD?

attention deficit hyperactivity disorder; Lisdexamfetamine dimesylate
By Kenneth Williams, M.D.,

  One of the most common behavioral disorders in childhood, attention deficit hyperactivity disorder (ADHD) affects an estimated 8-12% of children worldwide and follows an estimated 10-70% of patients into adolescence and adulthood. The most common treatment for ADHD is stimulants—but concerns about the association between ADHD and substance use disorder, tampering, and other forms of misuse have prompted research into new, nonabusable treatments for ADHD. One potential solution lies in prodrugs—compounds that are pharmacologically inactive until metabolized in the body. By undergoing biotransformation before exhibiting its therapeutic effect, a prodrug can be administered once-daily, providing prolonged delivery, more consistent clinical effects, and less abuse potential. Today, there is only one prodrug stimulant: Lisdexamfetamine dimesylate (LDX, marketed as Vyvanse™ by Shire U.S. Inc.), which is indicated for the treatment of ADHD in children aged 6 to 12 years. Therapeutically inactive before ingestion, LDX is converted into naturally-occurring l-lysine and active d-amphetamine after ingestion. Studying the Efficacy of LDX After an in-vitro study, a Phase 1 clinical study determined the pharmacokinetic profile of the LDX formulation. With three 1-week study periods, with a 7-day washout between doses, eighteen healthy volunteers—9 men and 9 women, aged 18 to 55 years old—received a single 70 mg LDX dose under three dose conditions: Fasting, with capsule only; a solution containing the capsule contents; and...

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