RECRUITMENT ISSUES Recruitment in pediatric clinical trials is a major issue that investigators and sponsors have to tackle. There are several reasons for difficulties faced in recruitment:[20,38] Fear of harming or hurting children, objections to using children as ??guinea selleck screening library pigs??, misconceptions regarding the need for placebos and the increasing complexities of information sheets, contribute to parents?? reluctance. Parents seem to be reluctant to enroll children in research studies that do not offer perceivable immediate benefit. The childhood population is smaller and healthier than the adult population and generally, diseases in children are less commonly associated with adverse outcomes.
There are complex ethical issues associated with pediatric research studies The regulatory oversight is significantly more restrictive The additional requirement of obtaining parental permission as well as participants?? assent The consequences of poor recruitment could be disastrous. Many trials are abandoned due to poor recruitment. Thus, several important research questions remain unanswered, efforts and resources get wasted and more importantly, risks and inconveniences suffered by participating children go in vain. These issues need to be tackled with multi-pronged approach. Public confidence in clinical research is integral to improving participation in research. The people need to be assured that studies have been carried out only when necessary, adequate steps are being taken to minimize risks involved, the regulatory oversight is ensuring that studies are being conducted in a scientific and ethical manner and the results would be available in the public domain so that other children would benefit.
 There is also a need to improve research infrastructure, including funding systems, for pediatric studies. More pediatricians should undergo GCP training and efforts should be taken to maintain the trial sites. A posse of trained pediatric pharmacologists should be created, too. Recruitment can be improved through advertisements. However, these should be used judiciously. These should give introductory factual information requesting interested parents to contact the investigator for more details. In no case should benefits be exaggerated or risks downplayed. Their content should be reviewed and approved by the Ethics Committees.
The practice of paying healthcare workers in the hospital a direct financial incentive for enrolling research participants (finder’s fee) should, however, be shunned; as it has the potential of coercion or undue influence. Networking and getting into newer geographical Cilengitide areas are two ways of increasing the accessible selleck inhibitor population. Pediatric clinical research networks (PCRNs) have been existence for over five decades with pediatric oncology community establishing the first networks in the 1950s.