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A Qualitative Study

Philippe Amiel, MA; Delphine Moreau, MA; Claire Vincent-Genod, MA; Corinne Alberti, MD, PhD; Régis Hankard, MD, PhD; Philippe Ravaud, MD, PhD; Serge Gottot, MD, PhD; Claude Gaultier, MD, PhD

Arch Pediatr Adolesc Med. 2007;161(5):446-450.

Objective  To identify subjective factors that lead investigators not to invite eligible individuals to participate in pediatric studies.

Design  Qualitative study with semistructured interviews.

Setting  Four pediatric teaching hospitals in Paris.

Participants  Pediatric investigators (n = 24).

Main Outcome Measure  Report by investigator that eligible patients were not invited by him or her to participate in a clinical research study.

Results  Sixty-three percent of investigators (15 of 24) reported not inviting eligible patients. The noninvitation patterns were global (ie, investigators did not invite anyone) (37.5% [9/24]) or targeted specific patient subgroups (37.5% [9/24]). Noninvitation was often described as driven by ethical concerns related to the study design or patients or by anticipated patient refusal (58.3% [14/24]). None of the investigators kept records of noninvitation rates or refusal rates. Investigators estimated refusal rates of 1% to 10%, and none remembered a study that had failed because of potential subjects' refusals (including healthy participants).

Conclusions  Noninvitation to participate in studies is not an absence of action but rather is an organized practice that reflects investigators' perceptions. Consequences are practical (eg, recruitment bias and study failure) and ethical (eg, unequal access to trials and failure to respect the autonomy of eligible patients). Our data suggest an urgent need for quantitative studies aimed at documenting and understanding noninvitation of eligible patients to participate in research studies in pediatrics and in other medical specialties.

Author Affiliations: Institut Gustave-Roussy, Villejuif, Unité de Recherche en Sciences Humaines et Sociales (Mr Amiel); Assistance Publique–Hôpitaux de Paris, Hôpital Robert-Debré, Paris, Unité d’Epidémiologie Clinique (Ms Moreau and Dr Alberti), and Service de Santé Publique (Ms Vincent-Genod and Dr Gottot); Assistance Publique–Hôpitaux de Paris, Hôpital Bichat Claude-Bernard, Paris, Département d’Epidémiologie, Biostatistique et Recherche Clinique (Dr Ravaud); Institut National de la Santé et de la Recherche Médicale (INSERM), Centre d’Investigation Clinique 9202, Hôpital Robert-Debré, Paris (Drs Hankard and Gaultier); and Centre d’Investigation Epidémiologique 5, Hôpital Robert-Debré (Dr Alberti); and Unité 14738, Hôpital Bichat Claude-Bernard, Paris (Dr Ravaud), France.

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