Opinion of SÚKL's Department of Clinical Trials on Medicinal Products on Ongoing Clinical Trials and To-Be-Commenced Clinical Trials in Light of the COVID-19 Epidemiological Situation

With reference to numerous repeatedly asked questions regarding the conduct of ongoing clinical trials or to-be-commenced clinical trials in view of the current coronavirus epidemiological situation, SÚKL hereby provides its general recommendations for those cases when the sponsors propose and plan measures aimed at patient/trial subject safety:

1) A change of a physical follow-up visit of a trial subject in order to ensure the subject’s safety or due to closed healthcare facilities to a telephone visit does not have to be notified to SÚKL or the ethics committee, but it has to be documented with a rationale referring to the current situation. Thereafter, the sponsor shall mention this change in the annual progress report for the clinical trial. In case a follow-up visit is completely omitted, it has to be documented and thereafter evaluated in terms of its impact upon the validity and quality of data from the clinical trial.

2) SÚKL’s approval must be sought in case the trial subject has to be supplied with more study medication without a visit to the trial site. The sponsor must propose how the provision of the investigational medicinal product would be safeguarded for all patients, providing all the necessary details – who would deliver the medicinal product to the trial subject, what product is concerned and what transport conditions it requires (such as temperature monitoring), how records will be kept, whether the trial subject’s visit would be conducted by phone, etc. Each clinical trial is specific – patients with various degrees of risk, various products (tablets, thermolabile products, parenterally administered products, etc.), necessity to collect control samples prior to continued therapy, etc.

3) Changes to the monitoring plan involving a change of a site visit to remote monitoring or change of dates of monitoring do not have to be reported to SÚKL or to the ethics committee by the sponsor, yet everything has to be documented and justified in the clinical trial dossier. SÚKL does not provide its opinion on the organisation of monitoring when authorising clinical trials, either, and it does not have to be included in the annual progress report for the clinical trial.

4) With regard to safeguarding trial subject safety, SÚKL recommends not to:

• Commence new clinical trials or enrol new patients/trial subjects in ongoing clinical trials wherever practicable;
• Conduct clinical trials involving healthy volunteers or “healthy patients”, i.e. such clinical trials that do not provide therapeutic benefit to the enrolled trial subjects, such as bioequivalence or pharmacokinetic studies;
• Commence clinical trials involving, in particular, therapies that affect/influence the immune system.

5) In case it is necessary to inform trial subjects, SÚKL recommends to avail of options other than “face-to-face contact”, e.g. provision of information by phone and its documentation in the CRF; e-mail communication of the information and its documentation in the CRF.

6) If the sponsor requires evidence that SÚKL has been notified, it is possible to send a letter with the respective information to SÚKL with a request for confirmation of the document receipt.

Due to the variability of clinical trials, it is not practicable to cover all of the possible situations. Trial subject safety in ensuring data validity, and hence the quality of the clinical trial conduct, is the responsibility of the sponsor.

Should you have any further questions, please contact MUDr. Alice Němcová, Director of Department of Clinical Trials on Medicinal Products (272 185 817, alice.nemcova@sukl.gov.cz ) or MUDr. Ondřej Palán, Head of Clinical Trials on Pharmaceuticals Unit (272 185 327, ondrej.palan@sukl.gov.cz).

 

Department of Clinical Trials on Medicinal Products

Date: 13 March 2020