My perspective on trials developed after serving as a subject in three clinical trials and as a patient advocate on an NCI review committee, as well as on a data safety and monitoring board (DSMB) for a trial that lasted years.
The DSMB meetings involved a multdisciplinary team. At the table for the sponsoring biotech company were the CEO, the VP Medical Affairs and consultants in biomedical product development. Members with no connection to the biotech company included two oncologists (one a Director of a Cancer Center and the other a transplanter), one biostatistician and one patient advocate (me).
Over the years of the study, money was spent on travel (flights, food, lodging) for out-of-town members. Before each meeting, thousands of pages of data were mailed to each member for review.
At each participating site, the trial required the services of physicians and nurses who identified eligible patients for the trial and educated them, ordered the appropriate tests, sent scans for independent review, submitted data to the committee in proper form -- a task that demanded additional paperwork beyond that required in the usual care of cancer patients -- and responded to questions posed by the DSMB. Each of these steps required the time and effort of many professionals.
Next, I'll provide an overview of the players in the approval drama.
[P.S. Thank you to everyone who offered support regarding the transition in my personal life. My mother is adjusting well to her new home in a retirement complex near me. I recently returned to my own home, where I can resume my writing and blogging. An ongoing process, this transition demands I take one day at a time.]