不再有瑞士漏洞：填补临床试验披露的空白

No More Swiss Holes:Filling the Gaps in ClinicalTrial Disclosure Use Case| No More Swiss Holes: Filling the Gapsin Clinical Trial Disclosure The challenge A pharmaceutical sponsor is preparing to conduct a Phase I interventional drug trial inSwitzerland. While the company has extensive experience running clinical trials in majormarkets like the US and the EU, this will be its first study in Switzerland. The disclosure team is uncertain about regulatory requirements specific to Switzerland.It needs to understand whether trial registration is required, what information must bedisclosed, when disclosures must be made, and which registry or platform should be usedfor submissions. The solution The team turns to TrialScope Intelligence — a centralized, interactive repository of globalclinical trial disclosure regulations and insights — to navigate these unfamiliar requirements.TrialScope Intelligence’s library contains over 1,000 authoritative regulatory texts globally,providing source documents in their original language along with English translations. TrialScope Intelligence maintains 59 registry records globally, each providing detailedtechnical specifications across more than 86 data fields, including submission workflows,data formats, contact details, and registry-specific processes. Use Case| No More Swiss Holes: Filling the Gapsin Clinical Trial Disclosure STEP 1: Starting with the country profile1 In the TrialScope Intelligence platform, the user begins with the country profile forSwitzerland, one of 193 country records available globally. This profile includes: •the governing regulatory bodies and competent authorities responsible forclinical trial oversight•the general application processes for conducting trials in this jurisdiction•key disclosure obligations For Switzerland, the user learns that the Swiss Agency for Therapeutic Products(Swissmedic) and the Federal Office of Public Health (FOPH) serve as the primaryregulatory authorities, operating under frameworks such as the Federal Act onResearch involving Human Beings (HRA) and the Ordinance on Clinical Trials inHuman Research (ClinO). The profile indicates that clinical trial registration ismandatory and legally required, and that specific disclosure obligations exist forcertain study types. Use Case| No More Swiss Holes: Filling the Gapsin Clinical Trial Disclosure STEP 2: Applying filters to refine results2 To refine the information displayed, the user applies filters using the study andtrial parameters available in TrialScope Intelligence. These parameters allowcustomization based on: •Study/Trial Type:Interventional, observational/non-interventional, orexpanded access/compassionate use•Intervention Type:drug, biological, or vaccine•Phase:bioequivalence/bioavailability studies through Phase I, II, III, IV For this particular trial, the user selects“interventional”as the study type,“drug”as the intervention type, and“Phase I.”With these parameters applied, thecountry profile displays only the disclosure requirements specifically applicable tothese criteria. Figure 1.Countries requiring protocol registration providing a visual overview of wheremandatory clinical trial registration obligations exist worldwide Use Case| No More Swiss Holes: Filling the Gapsin Clinical Trial Disclosure STEP 3: Examining the Requirement Record3 Having established that disclosure obligations exist for their study type, the usernavigates from theCountry Profileto the relevantRequirement Record. TrialScopeIntelligence maintains over 75 Requirement Records globally, each organizedinto10comprehensive sections containing over 211 data fields. These recordsconvert complex regulatory requirements into actionable, comparable information,enabling precise tracking of requirements across various disclosure components. The Requirement Record for Switzerland protocol registration indicates thatregistration is mandatoryrather than voluntary. Sponsors must register the trialbefore it starts and within six months after approval has been granted. For Phase Iclinical trials where the medicinal product is administered exclusively to adults,certain data elements may initially be excluded from registration but must beentered and published within 30 months after completion or early termination. Therecord also specifies ongoing obligations. Figure 2.Protocol registration timing requirements by country, showing whether registrationmust occur before study submission, during approval, after approval, relative to enrollment,or with no defined timing Use Case| No More Swiss Holes: Filling the Gapsin Clinical Trial Disclosure STEP 4: Identifying permissible registries The requirement record identifies the permissible registries for Switzerland.Switzerland requires dual registration:Sponsors must register in both a WHOPrimary Registry (such as ClinicalTrials.gov or another WHO-recognized registry)and in the local Swiss registry, Human Research Switzerland (HumRes). Althou