OPTIMAL DESIGN FOR THE RECRUITMENT OF PARTICIPANTS AS A FACTOR FOR THE EFFECTIVE IMPLEMENTATION OF A CLINICAL TRIAL

OPTIMAL DESIGN FOR THE RECRUITMENT OF PARTICIPANTS AS A FACTOR FOR THE EFFECTIVE IMPLEMENTATION OF A

CLINICAL TRIAL

Experiences of the TRIGR trial

B. Aschemeier BHC

, C. Bittner

, K. Lüpke

, O. Kordonouri

, T. Danne

1

Diabetes - Zentrum für Kinder und Jugendliche, Kinderkrankenhaus auf der Bult, kk Hannover,

Charite Kinderklinik, Humboldt Universität Berlin, Berlin, Germany

Introduction: In May 2002 the multinational TRIGR-Study (Trial to Reduce IDDM in the Genetically at Risk) was started in 14 countries all over the world².

The probands of this study are newborns with high genetic risk to develop type 1diabetes. This very large primary prevention study will determine whether delayed exposure to intact food proteins will reduce the chances of developing type 1 diabetes later in life. The trial will also be able to analyze whether exclusive breastfeeding can reduce the risk to children of developing type 1 diabetes. Approximately one year after the official launch the recruitment rates varied from 0% to 90% (median 12%) of the rate predicted before the initiation of the study.

Aim: The objective of the present study was to analyse the characteristics of the centre and the information which were associated with a better recruitment rate.

Methods. After one year time of recruitment 48 centres participating countries received a semi-standardised questionnaire (22 items) regarding the local structure of the centre, their information strategies and detailed procedures of recruitment. A representative sample 58% (n=28) responded.

Results: The majority of centres (82%, n=23) were familiar with the organisation of trials. Although 52% (n=12) took part in more than 2 trials per year, only 44% (n=10) had experience with newborns as probands. A fourth (n=7) collaborated with other specialised institutions to raise the awareness of the trial. Approaching professional caregivers through a targeted professional journal was used only in half of the centres. The internet (39%) was more frequently utilized than TV (21%). Almost all centres (96%) used meetings for public relation (PR) work. A majority of the centres (57%) had a recruitment rate of less than 50 probands per year. Only 9 centres were able to adhere to the planned schedule for the start of the recruitment. The centre with the best

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recruitment rate had started with their PR efforts well before the initiation of recruitment and used primarily targeted information in conventional lay press.

Conclusions: The recruitment rate is influenced by factors related to the structure of the study centre, timing of the PR efforts with respect to the study initiation, using various media for raising awareness about the trial and identifying proper target groups. Using strategies that focus on the targeted patient groups, especially supplying information through the patient related conventional lay press are particularly successful. This approach achieved the best recruitment rate for a large scale multicentre primary prevention trial in newborns at increased diabetes risk.

References

1 Steiner, M., Pelster, D. (2002): Defizite und Auswege. Die Situation der Klinischen Forschung in Deutschland im internationalen Vergleich. DZKM, 11/12, S. 22 2 Akerblom, H.K.,Vaarala, O., Hyöty,H., Ilonen, J., Knip, M. (2002): Evironmental factors in the Etiology of Type 1 Diabetes. Am. Journ. of Med.Genetics (Semin.Med.

Genet.) 115: 18-29