EFFECTS has established the trial management, IT systems to manage web-based randomisation, drug allocation, stock control, follow-up, data collection, verification, and an electronic follow-up system (eCRF). In total, the Chief Investigator and Trial Manager, have met almost 500 possible investigators from the whole country. One major obstacle has been the lack of Good Clinical Practice (GCP) training. Hence, we have been forced to arrange ten separate half day training sessions in GCP. In total, we have certified almost 150 investigators in GCP. Further, we have completed five investigator meeting, the latest in October 2017 with 53 participants from the whole of Sweden. We now know important aspects of recruitment, medication adherence, questionnaire completion and follow-up rates. All systems are fine-tuned and running smoothly. We have also registered two PhD students for the EFFECTS study.
Organisation, randomisation, clinical data management system and website
- Established a Clinical Trial Unit that consists of a Chief Investigator (Erik Lundström), Trial Manager (Eva Isaksson) and Trial Manager Assistant (Nina Greilert).
- Established a Trial Steering Committee and Data Monitoring Committee.
- Established a randomisation system with a minimisation algorithm.
- Established an electronic clinical data management system that captures all our variables throughout the study.
- Set up a website.
Prof Katharina Stibrand-Sunnerhagen (chair), Prof Bo Norrving, Prof Per Wester, Prof Håkan Wallén, docent/psychiatrist Björn Mårtensson, statistician Per Näsman, Chief Investigator Erik Lundström and Trial Manager Eva Isaksson.
Data Monitoring Committee
Prof Kjell Asplund (chair), Anders Ljungström (statistician), Docent Kerstin Hulter-Åsberg.
Progress of the study
We are currently recruiting subjects from 33 centres in Sweden, see Table 1. We have closed Högsbo and Visby due to a lack of principal investigators. The average recruitment has been 30 pat/months between Jan – Sep, and 37 patients/months between Oct – Dec.
High quality of data
We have high data quality. At our primary outcome, we have a response rate of over 98%. Our monitor reports also show good quality of source data.
Publication and legal aspects of the study
- Published the study protocol in Trials
- Published a Statistical Analysis Plan in Trials
- Monitor plan included monitors from Karolinska Trial Alliance
- Ethical approval (Dnr: 2013/1265-31/2. Date 2013-09-30)
- Amendment 1 (Datum: 2015-04-15)
- Amendment 2 (Dnr: 2015/991-32. Date 2015-06-10)
- Amendment 3 (Dnr: 2015/2056-32). Date 2015-11-30)
- Amendment 4 (Dnr: 2016/1191-32). Date 2016-06-14)
- Amendment 5 (Dnr: 2016/2531-32). Date 2017-01-04)
- Amendment 6 (Dnr: 2017/638-32). Date 2017-03-28)
- Approval from the Swedish Medical Products Agency: Dnr: 5.1-2014-43006, Date 2014-08-08
- EudraCT number: 2011-006130-16
- Clinicaltrials.gov NCT02683213
- Two accepted PhD students at Karolinska Institutet
EFFECTS has received substantial economic support, totalling 35 874 000 SEK. The Swedish Research Council (Vetenskapsrådet, VR) has granted us 31 114 000 SEK, the largest ever grant from VR for a clinical study in Sweden. We currently have tenancies of VR funds up to the end of 2018, but we are hopeful that we will get an extension of this until the end of 2019, meaning that EFFECTS has stable finances.