Sponsors often are wary of involving patient insights in trial designs, despite evidence of success from the field and encouragement from regulators. Read More
The site selection and feasibility process is really quite straightforward on paper. And yet it is astonishingly hard. Here are some numbers that prove the point:
11 percent of sites selected never enroll a single patient;
Sponsors’ original timelines end up doubling to meet the desired goals (and nearly 80 percent of clinical trials fail to meet their timelines);
Operational costs of running a trial are an estimated $37,000 per day.
Genetic testing in the context of clinical trials raises raise important ethical issues, including ones related to informed consent and disclosure of results.
In addition, myriad operational concerns exist for sponsors and sites, ranging from finding patients to test and identifying which genes and mutations to test for, to designing appropriate protocols and managing the resulting data and results.