Contents Cover story
founder and executive director of The Synergist, and Kenneth Getz, deputy director and research professor at The Tufts Center for the Study of Drug Development (CSDD), to find out why sponsors and regulators are finally putting the processes, tools and relationships in place to get patients involved across the life cycle of drug development.
Clinical supply & logistics 17 Chain of command
6 News & numbers The headlines and figures impacting the sector.
Regulatory
8 Improving diversity A growing awareness that different demographics experience disease and medication differently has prompted industry calls for clinical trials to better represent the population a drug is intended for. With its November 2020 guidance on ‘Enhancing the Diversity of Clinical Trial Populations’, the US FDA is striving to move past the conversation about why diversity is important and drive the industry to take practical steps to change it. Monica Karpinski speaks with experts across the research sector, from regulators to patient recruitment specialists, about how industry professionals can look to this guidance, alongside work already being done in the research sector, to improve diversity in clinical trials.
11 Lean medical writing: Story not storage
The most difficult task an author can face is clearly summarising a complex and data-filled clinical regulatory document and explaining
4 Clinical Trials Insight /
www.worldpharmaceuticals.net In this issue 8 Trial design
14 Come together Until relatively recently, patient engagement involved very few conversations with patients themselves. Good practice was anecdotal rather than the norm. Elly Earls talks to Nicholas Brooke,
14
the data. Barry Drees, co-founder and senior partner of Trilogy Writing & Consulting, discusses the recent concept of ‘lean medical writing’ (LMW), and how it is being implemented and used in the pharmaceutical industry.
The pandemic has disrupted much of medical life and clinical trial supply chains are no exception. In part, this is a question of necessity. With lockdowns making traditional trials impossible, organisers have had to adapt. Amid the upheavals of the past 18 months, meanwhile, pharmaceutical companies are increasingly seeing opportunities. Andrea Valentino talks to Javier Garcia Vela, a transport and logistic services team lead at Roche, to understand how clinical trial supply chains differ from the rest of the pharmaceutical profession, the pressures his team has been under in the age of Covid-19, and how new technology is making trials easier for patients and researchers alike.
20 Ensuring uninterrupted clinical supplies during a pandemic Ancillare
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45
