Conducting clinical studies during COVID-19 pandemic

In the current situation, may patients continue to be included and treated in clinical studies? Here you will find relevant information, regulations and answers to frequently asked questions.

On Friday, 20 March 2020, the Federal Council decreed more stringent measures to contain the COVID-19 pandemic. The Rectorate of the University of Basel has subsequently tightened its regulations in the area of research and is switching research to emergency operation until further notice.

Guideline of the DKF tast force COVID-19, 25 March 2020

This guideline replaces the statements of the DKF directors of 19 and 24 March 2020.
It is binding for the University Hospital Basel and was recommended for adoption by the University Children's Hospital Basel, the University Psychiatric Clinics Basel, the Cantonal Hospitals Baselland and Aarau as well as the Felix Platter Hospital, St. Clara Hospital, the University General Practitioners' Centre and the University Dental Clinic.

Based on the information provided by the rectorate of the University of Basel on 22.3.2020 regarding the conversion of research to emergency operation, the following regulations apply to clinical research activities at the USB with immediate effect and initially until 19 April 2020. The aim of this directive is to protect patients, healthy volunteers, study and hospital personnel from infection with SARS-CoV-2 and not to place an additional burden on the hospital infrastructure.

Research activities in the clinical research groups

1. Phase I trials have to be stopped. The Outpatient Study Center at the University Hospital Basel will remain closed for the treatment of patients with immediate effect and until further notice. Maintenance work will continue to be carried out by DKF staff.

2. Observational studies with physical patient contact may be continued with already included patients, taking into account the conditions mentioned in paragraph 4. The inclusion of new patients has to be stopped.

3. Patients already enrolled in therapeutic intervention studies may also continue treatment, taking into account the conditions mentioned in paragraph 4. The inclusion of new patients is also possible under strict risk-benefit considerations. Paragraph 4 applies analogously.

4. Conditions for the continuation of studies according to paragraphs 2 and 3:

  • Study visits may only be carried out by our own study staff, without any additional burden on hospital staff
  • Follow-up visits for outpatients must be possible by telephone or home visits
  • The current hospital instructions and hygiene guidelines for handling COVID-19 must be applied by all study staff
  • The hospital infrastructure/resources must not be put under additional burden by study activities

The study must be reported to and approved by the DKF Task Force COVID-19 with the following information provided to

  • Study title
  • Study Synopsis
  • Principle Investigator and Sponsor at the study site
  • Number of patients affected
  • Duration of the visit
  • Brief justification why the study should be continued
  • Short description of what is done to protect the patients / test persons (e.g. home visits, telephone interviews etc)

5. Studies on COVID-19

All clinical studies on the prevention, course or treatment of COVID-19 diseases must also be reported with the following information provided to

  • Study title
  • Study Sponsor
  • Principle Investigator at the study site
  • Study type: Intervention/observation
  • Status: running/planned

6. Studies without patient contact and without the presence of study personnel in the clinical facilities of the University Hospital (e.g. retrospective master's theses) may be continued without approval from the DKF, provided they comply with the additional instructions of the University of Basel.