Lay summaries and writing for patients
Lisa Chamberlain James of Trilogy Writing & Consulting and Trishna Bharadia, patient
engagement consultant, examine the trend for increasing and more transparent patient
information, and ask how close we have come in the past few years to producing useful and
meaningful information for patients.
All on file
Given the new EMA guidelines put in place to assist sponsors and investigators with clinical trial master ﬁle (TMF) requirements, it’s more important than ever to work closely with vendors and CROs to ensure compliance. Isabel Ellis talks to Francis Crawley, executive director of the GCP Alliance, about the role of oversight in maintaining data integrity.
No clear path
Driven by ethical considerations and the aim to gain an edge within drug approval, comparator use is growing steadily in clinical trials. However, implementation is by no means straightforward. Will Moffitt speaks to Niklas Mattsson, head of comparator planning at Merck, about the potential pitfalls and how the Falsified Medicines Directive (FMD) adds an extra layer of complexity.
Central to success
There is increasing emphasis on the importance of patient-centricity within clinical trials, including encouragement from the FDA to incorporate the patient voice through the drug development process. Diana Villalobos, vice-president, clinical, at Dermavant Sciences, speaks to Emma Green about how to implement this approach to maximise recruitment and retention.
The mind leading the blind
Interactive response technology (IRT) systems are crucial to the efficient management of clinical trials. The medium has evolved from a telephone-based interface to one based almost entirely on computers, and issues concerning training, interoperability and safety remain. Greg Noone talks to consultant and former Pfizer executive director Michael Moorman about the contribution made by these programs, and the pitfalls when a trial relies on a poorly designed variant.