As the number of biotech trials continues to rise, sites should not underestimate the complexities such trials pose for site staff and sponsors, experts say. Read More
Sites that take steps to minimize the impact of the placebo effect on trial data not only improve the overall quality of their data, they make themselves more attractive to potential sponsors. Pretrial training of both site staff and trial participants allows sites to control placebo bias from the beginning, saving sponsors time, money and the risk of skewed data. Read More
The FDA published draft guidance for trial investigators and sponsors in late June recommending that patients with incurable cancers be considered for oncology trials regardless of whether they have received existing alternative treatment options. Read More
The FDA released a new draft guidance near the end of June aimed at helping sponsors comply with expedited safety reporting requirements for drugs and biologics. Read More
The Biden administration released its first unified agenda of proposed regulatory actions, a set of goals that include rules to synchronize FDA regulations with requirements of the Common Rule. Read More
