Welisch Eva, Altamirano-Diaz Luis A
Department of Pediatric Cardiology, Western University, LHSC, 800 Commissioners Rd. E, London, ON, N6A 5W9, Canada,
Paediatr Drugs. 2015 Feb;17(1):55-9. doi: 10.1007/s40272-014-0114-0.
Pharmacological research in the adolescent population is not meeting adolescents' needs. Medication is still frequently prescribed off label, and studies especially in sensitive areas of adolescent health care are underrepresented. Adolescents did not benefit from the new knowledge gained in cancer research, and their outcome has essentially not improved during the last two decades in comparison to younger children and adults. There are many obstacles that make it challenging to enroll adolescents in pharmacological research. Access can be difficult. Confidentiality plays an essential role for minors and may be a hindrance, notably to studying sexual and mental health matters. Pharmaceutical companies may exclude the adolescent patient because of a lack of profit and in fear of a complex study design. Research concepts should be explained to the adolescent in a comprehensive manner, and assent and consent forms should be clear and understandable. New laws and incentives have been developed to encourage pharmaceutical companies to engage adolescents in their research projects. Centralization and collaboration of all parties involved may make the whole approach to adolescent research more efficient and uniform. The mature minor doctrine has facilitated the enrollment process. Parental consent may be waived for low-risk medical trials to promote recruitment. Ethics committees therefore play a major role in protecting the adolescent from harm from participating in research. In conclusion, pharmacological research in adolescents has to be encouraged. This will increase the safety of current medical treatment regimens and will allow this population to benefit from therapeutic advancements.
针对青少年群体的药理学研究未能满足青少年的需求。药物治疗仍经常超说明书用药，尤其是在青少年医疗保健敏感领域的研究较少。青少年并未从癌症研究中获得的新知识中受益，与年幼儿童和成年人相比，他们在过去二十年中的治疗结果基本没有改善。有许多障碍使得招募青少年参与药理学研究具有挑战性。获取渠道可能困难。保密对未成年人至关重要，但可能成为障碍，尤其是在研究性健康和心理健康问题时。制药公司可能因缺乏利润以及担心研究设计复杂而将青少年患者排除在外。研究概念应以全面的方式向青少年解释，同意书和知情同意书应清晰易懂。已制定新的法律和激励措施，以鼓励制药公司让青少年参与其研究项目。所有相关方的集中化和协作可能会使青少年研究的整体方法更高效、更统一。成熟未成年人原则促进了招募过程。对于低风险医学试验，可以免除家长同意以促进招募。因此，伦理委员会在保护青少年免受参与研究的伤害方面发挥着重要作用。总之，必须鼓励针对青少年的药理学研究。这将提高当前医疗治疗方案的安全性，并使该群体能够从治疗进展中受益。
