Your browser doesn't support javascript.
Oncology clinical trials' management in Italy during the covid-19 emergency: Challenges and improving opportunity
Tumori ; 106(2 SUPPL):97, 2020.
Article in English | EMBASE | ID: covidwho-1109837
ABSTRACT

Background:

The global COVID-19 pandemic has adversely affected all aspects of clinical care and it has not spared even clinical trials on cancer. Indeed the need to adopt precautionary measures for the containment of COVID-19 infection have affected the access of cancer patients in clinical trials. The devastating effects of this global crisis have also negatively impacted the work of our Oncology Unit which has so far conducted more than 120 phase I-III studies.

Method:

We faced numerous challenges with conducting clinical trials due to COVID-19. In order to contain infection all the actor involved had to apply several precautions. Pharmaceutical companies, no-profit Sponsors, CROs and either our organization have applied or extended smartworking in order to continue their activities related to clinical trials but monitoring visit on site were suspended. When possible remote monitoring visits have been performed. Start initiation visit for new trial, for which it is essential the presence on site, were strongly postponed. Ethics Committee evaluation of clinical trials or substantial amendments have suffered inevitable strong delays nearly to 3 months because they had to adapt their activities also with organize their meetings by web-conferences. Only access to compassionate use was ever granted.

Results:

At site particular attention was needed in the enrollment of new patients in the trials evaluating the risk/ benefits ratio. For each patient the possible postponement of access to receive treatment has been assessed on the basis of the relationship between the risks, for the patient and the community related to access to the site, and the expected benefits of the treatment itself. The closure of several Hospital Units due to spread of contagion and limited availability of ancillary services caused the interruption of enrollment in clinical trials.

Conclusions:

Our clinical research activity during the pandemic has suffered negative repercussions but we think that what happened could be an useful opportunity to improve and transform clinical trial conduction system for example by simplifying the study design, optimizing the number of on-site monitoring visits and reducing patient's access to the hospital.

Full text: Available Collection: Databases of international organizations Database: EMBASE Type of study: Prognostic study Language: English Journal: Tumori Year: 2020 Document Type: Article

Similar

MEDLINE

...
LILACS

LIS


Full text: Available Collection: Databases of international organizations Database: EMBASE Type of study: Prognostic study Language: English Journal: Tumori Year: 2020 Document Type: Article