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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Parkinson’s Clinical Trials: MDS-PD Criteria Implications

UK Parkinson's Society Brain Bank criteria
By Tomislav Babic, MD, PhD, Vice President Neuroscience Franchise, Worldwide Clinical Trials,

Second only to Alzheimer’s disease, Idiopathic Parkinson’s Disease (IPD) is one of the most common neurodegenerative disorders. Despite its prevalence, approximately 5 to 10% of patients with IPD are misdiagnosed, and conversely, up to 20% of patients diagnosed with IPD reveal alternative diagnoses upon autopsy, such as multiple system atrophy, progressive supranuclear palsy, corticobasal degeneration, Ad type pathology, and cerebrovascular disease. Improving Accuracy with MDS-PD It has been suggested that an accuracy of 90% is the best that can be achieved with clinical assessment and existing Parkinson’s disease diagnostic criteria, such as the UK PD Society Brain Bank criteria. In an effort to improve on this and increase diagnostic specificity, the Movement Disorders Society (MDS) recently published Clinical Diagnostic Criteria for Parkinson’s disease (MDS-PD), which reflects more recent understanding of IPD. Increasing Recognition to Non-Motor Manifestations Designed specifically for use in clinical research, but also as a general guide to clinical diagnosis of IPD consequent to Lewy body pathology1, the updated Parkinson’s disease diagnostic criteria gives increasing recognition to non-motor manifestations (motor abnormalities remain central). As with previous diagnostic criteria, the MDS-PD criteria utilize a two-step process for diagnoses. First, parkinsonism, defined as bradykinesia in combination with either rest tremor, rigidity or both, is required. However, this definition of parkinsonism fails to take into consideration a loss of postural reflexes,...

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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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