Vesical imaging reporting and data system (VI-RADS), a new modality in bladder cancer treatment

Abstract

Clinical trials prior to licensing of COVID-19 vaccines collected key information on effectiveness and safety in general population. During rollout of COVID 19 vaccines, larger and diverse populations is vaccinated. Certain groups, e.g. immunocompromised patients or pregnant women, have not been included in pivotal clinical trials or number of patients included was small. Only approximately 4 percent of the patients enrolled in the phase III trial of Pfizer COVID-19 vaccine had a malignancy of any type, and these patients were not analyzed separately to assess vaccine efficacy;patients with cancer were not enrolled on the Moderna COVID-19 vaccine trial. In the Janssen COVID-19 vaccine phase III trial, only 0.5 percent of patients had cancer. Licensure of a vaccine that is rolled out to a large population in a short time requires not only regular spontaneous reporting but also cohort event monitoring to obtain more in-depth information on the safety of the vaccines. A large-scale cohort event monitoring system is very useful for newly introduced vaccines or for new target groups, in addition to existing spontaneous reporting systems and healthcare database studies (i.e. secondary data), as it is complementary to these systems in several ways. It generates more comprehensive safety data, e.g. on disease course and impact of the adverse events. Moreover, in contrast to spontaneously reported data, the denominator of the studied cohort is known (in real time) so that adverse drug reactions frequencies can be calculated. Therefore, European medicines agency stared study Cohort event monitoring to assess safety of COVID-19 vaccines using patient reported event in several European countries including Croatia to collect more data especially in immunocompromised patient, pregnant woman and patients with allergy in medical history. In Croatia all vaccinated adults can be included up to 6 days after the first or the third dose (more info: http://www.halmed.hr). Clinical Guidances suggest that all individuals with active or prior cancer who are eligible for vaccination according to local allocation priorities be fully vaccinated to prevent SARS-CoV-2 infection. Immunocompromised patients may have attenuated immunogenicity to the COVID vaccines, but vaccination is still recommended in immunocompromised populations. For individuals undergoing hematopoietic cell transplantation (HCT) or cellular therapies such as chimeric antigen receptor (CAR)-T-cell therapy, clinical guidances usually suggest waiting at least three months for vaccination, if possible. Given the potential for a blunted immune response to vaccination, it is important to counsel immunocompromised patients on maintaining personal protective measures despite vaccination.