Trial design
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, 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 fi nd out why sponsors and regulators are fi nally putting the processes, tools and relationships in place to get patients involved across the life cycle of drug development.
ompared with the meticulous processes and state-of-the-art technology that goes into much of the drug development process, talking to patients is hardly rocket science. One might be forgiven for assuming that it is, however, given the scant focus that engaging the very people for whom drugs are being developed for has received, until very recent years.
C
The argument for patient involvement in clinical trials is simple. If sponsors understand what the people who are living with the burden of a particular disease need, clinical trials will run more smoothly, have better outcomes and the treatments that are ultimately developed will be more relevant and meaningful to patients’ lives. Historically, though, sponsors have engaged with clinicians to determine
14
what protocols would be most suitable for clinical trials, rather than getting the information straight from the horse’s mouth. It’s hardly surprising then that around one in five trials is terminated because of under- recruitment, an average of 30% of participants drop out before the end of their trial and, even when they do see the process through to the end, only 46% of patients would encourage their peers to do the same, according to a whitepaper by Clinical Leader. “What we see in practice is that every single time patients are involved – I’m talking about the right set of patients – I have yet to come across someone who is not happy about it,” says Nicholas Brooke, founder and executive director of The Synergist, an incubator that brings public and private players together to build programmes that solve societal
Clinical Trials Insight /
www.worldpharmaceuticals.net
Iconic Bestiary/
Shutterstock.com
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
