A Medical Device Daily
Ask any sponsor whether it helps its PMA application to be required to include data from study subjects who opt to drop out of the study, and chances are good they'll say it does not. All the same, FDA has updated its guidance on data retention for study subjects who withdraw from clinical trials, and it is clear that the agency is offering no leeway on the subject.
The guidance notes that the agency has "a long-standing policy that already-accrued data relating to individuals who cease participating in a study are to be maintained as part of the study." As for exceptions, even study subjects will get no leniency from the agency. The guidance states that in the event that a subject sues to have their data pulled, FDA's view would still be that "if a subject were able to control the use of his or her data, and particularly if the clinical investigation was not blinded, the bias potential would be immense." This would apply even in an instance in which "subjects, due to life-threatening conditions, are unable to provide informed consent."
The notice states that the concern about the reliability of a study is amplified "when subjects withdraw their data in a non-random way because they are unhappy with their experience," whether because of lack of efficacy or because of adverse events. The agency notes that the omission of such data could remove important safety signals from data sets and opens the door to "unscrupulous parties [who would] improve study results by selectively encouraging certain subjects to withdraw."
A study subject may agree to provide their post-study data after withdrawing from the study, but such inclusion of data would have to be preceded by informed consent. On the other hand, a clinical investigator may beef up the data set left behind and "consult public records, such as those establishing survival status," to round out data sets from disenrolling subjects who do not consent to provide their post-study data.
NIH snags state-of-the-art Aquilion
Scientists working on the federal dime rarely have to worry about whether they'll have access to the latest and greatest in imaging equipment, and a recent announcement posted at the web site for Toshiba America Medical Systems (Tustin, California) shows that the agency's appetite for imaging equipment is still healthy.
According to Toshiba's Dec. 8 statement, NIH "has installed the most advanced, lowest radiation CT (computerized tomography) system available," the Toshiba Aquilion, which the firm describes as "the world's first dynamic volume CT system." Toshiba indicates that the interest at NIH is in "improv[ing] patient outcomes with a study focusing on low-dose cardiac exams." Toshiba also states that future studies may "include examining coronary artery disease and myocardial perfusion."
Doug Ryan, senior director of Toshiba's CT business, says in the statement, "we designed the Aquilion One to not only show whole organ anatomy but also the changes in the entire organ over time resulting in a better, faster and more complete diagnosis."
He also said the unit "has the potential to replace multiple existing tests, reduce overall exam time for patients and physicians, and decrease the amount of radiation and contrast dose." NIH "will be one of our key sites validating its potential," Ryan said.
Toshiba's statement says that the Aquilion, which was introduced in November 2007, "scans an entire organ in a single pass and produces 4-D videos that show an organ's structure, its movement and blood flow." The company claims that even a 256-slice unit "can only capture a portion of an organ in a single pass, requiring physicians to stitch together' multiple scans of an organ to get a full image." The new unit will "reduce multiple exposures to radiation and exam time."
Terumo issues recall for cannulae
Terumo Cardiovascular (Ann Arbor, Michigan) recently reported an urgent recall of its Tenderflow pediatric arterial cannulae for 21 lot codes after receiving five reports of "difficulty retracting the introducer from the cannula," according to the Dec. 1 FDA announcement. Under these circumstances, the cannula must be removed and replaced, which can lead to damage to the aorta, blood loss and/or death. However, the FDA notice states that "there have been no reports of patient injury or death associated with the product."
The Tenderflow is described as a disposable set used to perfuse the ascending aorta during cardiac bypass operations. Terumo is said to have notified all 68 of the hospitals to which the firm distributed the device in an Oct. 16 voluntary recall letter. The company and FDA recommend that surgeons not use the product "unless medically necessary."