| ObjectiveIn order to understand the ethical overview of Alzheimer' s disease(AD),vulnerable groups,regional ethical committee(REC),and technically regulatory guidelines for clinical trials of Chinese medicine(CM),we conduct a literature research.Based on above literature analyses and expert investigation,this study attempted to develop standardized pracitces involving rights protection of vulnerable groups in clinical trials of CM medicine for AD.We hope these considerations could provide references to the management of ethics review and drug trial regulation.MethodsThe study used a.combined strategy of evidence-based literature analyses and expert consensus.Previous literature researches mainly focus on assessing the fulfillment of ethics disclosures and ethical status for AD anti-drug trials in China.Chinese databases of WanFang,China National Knowledge Infrastructure,VIP and Sinomed were extensively searched in China in the years of 2014,2009 and 2003,respectively.Two researchers independently performed the literature review and data extraction.The frequencies of reporting involving REC approval,informed consent from participants(ICP),study registration for protocol(RFP),reference to Declaration of Helsinki(DOH),and conflict of interest(COI)statement,et al.were evaluated,respectively.SPSS v21 software was used for the statistical analyses.Based on broad access to domestic and foreign documents and monographs of medical ethics,drug clinical trials,and related core principles,standardized pracitces involving rights protection of vulnerable group in clinical trials of CM medicine for AD were initially fomulated.Then,by setting up drafting group,expert group,consultation and advisory committee,etc.,we attempted to seek advices and comments from the industry experts,thus forming the draft of"Rights protection of vulnerable groups in clinical trials of CM medicine for AD",further consultating and analyzing the experts' suggestion.Through standardized the process of drug trials involving ethics consideration,feasibility and practicability of quality control would be explored.Results1.A total of 1900 articles were taken into consideration in this review,with 1035 published in 2014,576 in 2009,and 289 in 2003.The objects of study involved AD patients in clinical drug trials.The randomized controlled trials(RCTs)were found 1242 in total,with 289 in 2014,348 in 2009,and 75 in 2003.The different journal included 217 categories in 2014,238 in 2009,and 162 in 2003.Among above studies,79.13%(819/1035),60.42%(348/576),and 25.95%(75/289)were RCTs,with statistically differences found between the 3 groups respectively(P<0.001).Among those RCTs,4.99%(62/1242)of the studies reported the statements of REC approval,with 6.84%(56/819)in 2014,1.15%(4/348)in 2009,and 2.67%(2/75)in 2003.Statistically significant differences were observed among three groups that stated that REC approval had been acquired(Chi square=17.571,P<0.0001).Further comparison between two groups,statistically significantly more reports seen in 2014 mentioning REC approval while in comparison with that in 2009(P<0.0001).There were no statistical differences between the two groups for the rest.For the reporting of ICP consent,14.17%(176/1242)of the eligible articles described this item,with 17.34%(142/819)in 2014,7.76%(27/348)in 2009,and 9.33%(7/75)in 2003.Statistically significant differences were seen among three groups that described ICP consent(Chi square=19.963,P<0.0001).Further comparison between two groups,statistically significantly more reports found in 2014 mentioned REC approval while compared to that in 2008(P<0.0001).Results for other comparisons between two groups were not significantly different.For the reporting of reference to DOH,a total of 5.56%(69/1242)of studies included stated this domain,with 7.45%(61/819)in 2014,1.44%(5/348)in 2009,and 4.00%(3/75)in 2003.Statistically significant differences were observed among three groups that stated reference to DOH(Chi square=17.188,P<0.0001).Further comparison between two groups,statistically significantly more reports found in 2014 stating reference to DOH while compared to that in 2008(P<0.0001).There was no statistical difference between the other pairs of groups.For the reporting of study registration,7.01%(87/1242)of the included trials mentioned this domain,with 9.28%(76/819)in 2014,2.59%(9/348)in 2009,and 2.67%(2/75)in 2003.These reporting proportions were significantly different between the 3 groups(Chi square=19.103,P<0.0001).Further comparison between two groups,it indicated that significantly more reports noted in 2014 for study registration while in comparison with 2009(P<0.0001).No significantly differences were observed between the two groups for the results.In view of the information of COI statement lack of or could not get any reply although we contacted the potential author by E-mails,the conditions of COI statement could not perform further analyses.More high-quality evidences are required for better support.The main results of literature research section indicate that in comparision to 2003 and 2009,the ethics reporting conditions for ICP,REC approval,reference to DOH,and study registration of protocol for AD anti-drug trials in China were improved in 2014 in the key medical journals.However,more than ninety percent of the domestic biomedical articles lacking specific statements of ethics protection still could be found,and this continues to seemingly publish in Chinese journals.To some extent,the recent overall consciousness and ethics consideration for vulnerable group in clinical trials still call for strengthening,and taking measures for better improvement.2.Based on the comments of drafting group,expert group,consultation and advisory committee,etc.,the domains of "Rights protection of vulnerable groups in clinical trials of CM medicine for AD" were drafted.Using small range of investigation and discussing repeatedly,we modified the above texts as the exposure draft.Based on the process of experts' consultation by letter or telephone,online consultation,and conference consultation,suggestions and comments were obtained.Till March 25th 2017,168 copies of exposure draft have been sent to the potential experts,and 68 ones return(including 40 one noted with expetrts' suggestions).80 pieces pf comments has been taken into consideration and adopted finally.Based no the advices above,the exposure text has been further revised as draft standard for examination.The domains above including three phases i.e.before the trial beginning,during the trial,and after the end of trial,ranging from the process of informed consent,special handling with AD psychiatric subjects,control drugs and the follow-up therapy choice after finishing the course,parties and corresponding responsibilities.ConclusionThis study performed a literature research focusing on assessing the fulfillment of ethics disclosures and ethical status for AD anti-drug trials in China.To improve the ethical compliance of clinical trials,we attempted to put forward three approaches:to perfect local governmental regulations,to conduct preventive measures in the education of ethics issues for medical researchers,and to carry out the security mechanism of publishing reinforcement by journal editors.Furthermore,our group developed a detailed text i.e."the standardized pracitces involving rights protection of vulnerable group in clinical trials of CM medicine for AD".This exposure text included three phases i.e.before the trial beginning,during the trial,and after the end of trial,ranging from the process of informed consent,special handling with AD psychiatric subjects,control drugs and the follow-up therapy choice after finishing the course,parties and corresponding responsibilities.All these could provid references to ethical review for AD vulnerable group. |
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