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Originally published as JCO Early Release 10.1200/JCO.2008.21.3967 on March 16 2009 © 2009 American Society of Clinical Oncology.
Study of Newspaper Reports Regarding Clinical Trials in JapanDivision of Social Communication System for Advanced Clinical Research, The Institute of Medical Science, The University of Tokyo, Tokyo, Japan
Division of Social Communication System for Advanced Clinical Research, The Institute of Medical Science, The University of Tokyo; Division of the Strategic Outcome Research Program for Cancer Control, Ministry of Health, Labour and Welfare Commission, Japan Cancer Society, Tokyo, Japan
Division of Social Communication System for Advanced Clinical Research, The Institute of Medical Science, The University of Tokyo, Tokyo, Japan
Ministry of Health, Labour and Welfare, Aide of the Minister, Health Sector Reform Office, Tokyo, Japan
Division of Social Communication System for Advanced Clinical Research, The Institute of Medical Science, The University of Tokyo, Tokyo, Japan To the Editor: Clinical trials are necessary for the development of new drugs and treatment methods. To conduct clinical trials smoothly, it is essential to improve public awareness of clinical trials. Accordingly, information regarding clinical trials must be disclosed and provided to the public in an understandable form. However, in Japan, 50% of patients in general and 70% of all participants in clinical trials have stated that the amount of information regarding clinical trials is scarce,1 and people perceive the information services related to clinical trials to be deficient. The mass media, including newspapers and television broadcasts, are effective means of providing information to the public. In Japan, 8.3% of the television audience is equivalent to approximately 3 million people,2 and the circulation of major newspapers ranges from 2.2 million to 10 million per day. Therefore, the use of mass media facilitates the provision of information to a large number of people at once. On the other hand, cooperation from mass media is necessary to improve public awareness of medical care.3–5 However, many physicians appear to be dissatisfied with the media reports regarding medical care.2 Therefore, it cannot be said that the relationship between these two parties is favorable. To conduct clinical trials effectively, cooperation from mass media is essential. However, there have not been any studies that have systematically investigated mass media reports regarding clinical trials, so the situation thereof is unknown. We used the most up-to-date newspaper database to examine the situation of reports on clinical trials in the major Japanese newspapers. Our study was directed at the five major newspapers in Japan (ie, Asahi, Mainichi, Yomiuri, Sankei, and Nihon Keizai). The total number of subscribers to these newspapers is 27 million per day. The largest newspaper database in Japan, Nikkei Telecom, was used to obtain article information. This database incorporates articles from almost all newspapers that are issued in Japan, including every article in the five major newspapers since 1992. First, using a thesaurus search of Igaku Chuo Zasshi (Japan Medical Abstracts), we extracted words related to clinical trials to define the following words as keywords: investigational agent, preclinical study, drug screening, nonclinical test, clinical trial, sponsored study, clinical protocol, prospective study, comparative test, blind study, phase I study, phase II study, phase III study, phase IV study, postmarketing surveillance, randomized clinical trial, Good Clinical Practice, Good Laboratory Practice, clinical research coordinator, institutional review board, and clinical investigator. To investigate the number of articles related to clinical trials and the reported content, the articles published by the five major Japanese newspapers from 1992 to 2007 were then examined for the number of articles that contained these keywords, annual change, and content. Figure 1A shows the annual change in the total number of articles in the five major newspapers. Although the total number of articles had been increasing from the early 1990s, there was almost no change after 2000. After 2000, the total number of articles in the Yomiuri, Asahi, and Mainichi newspapers was approximately three times that in Nihon Keizai and Sankei. Figure 1B shows the change in the number of clinical trial–related articles in the five major newspapers. The proportion of the number of clinical trial–related articles among the total number for all five major newspapers temporarily increased to 0.167% in 1996 (Fig 2). The number of such articles in Nihon Keizai increased after 2000. The number of such articles in Sankei reached a slight peak in 2002. Most of the articles in Nihon Keizai were related to the performance of pharmaceutical companies, such as the development of new drugs. For the four other papers, the proportion of the number of articles in the other periods remained constant at about 0.07%. Figure 3 shows the peak year for the appearance of each keyword. The major keywords appeared most frequently in 1994 and 1996. The peak year for the appearance of words related to the methodology of clinical trials, such as phase and protocol, was 1994. The peak year for the appearance of words such as the Ministry of Health, Labour and Welfare; lawsuit; Pharmaceutical Affairs Law; clinical trial; ethics; and others was 1996.
Our study revealed that in the newspapers, clinical trial–related articles occupied a certain space but accounted for a small proportion of total articles. In the five major newspapers, the percentage of clinical trial–related articles among all articles was approximately 0.07%, which means that two or three articles were disseminated per day. As the aging of Japanese society progresses, public awareness of medical care has been increasing. Many clinicians seem to think that this has resulted in an increasing number of clinical trial–related reports in the major newspapers. However, despite these anticipations, the proportion of such articles remained substantially unchanged in the four newspapers other than Nihon Keizai, except for a temporary peak in 1996. That is, despite the efforts of the medical community, the number of clinical trial–related articles did not increase in the general readership newspapers. Considering the fact that many people obtain medical information from newspapers, it would be difficult to believe that there have been recent improvements in public awareness of clinical trials. Significant differences were observed in the percentage of clinical trial–related articles by newspaper company. In particular, it is interesting that Nihon Keizai recently showed an increasing percentage of clinical trial–related articles. From 2002 to 2007, the percentage of clinical trial–related articles became more than double the percentage in the 1990s. Nihon Keizai is an economic paper, so it regards pharmaceutical companies as a growing field in Japan, and thus reports on clinical trials from the perspective of investment and pharmaceutical industry performance. Health care professionals rarely view clinical trials from the perspective of investment and economic growth. Therefore, there may be some discrepancies between their perspective and that of the public. The number of clinical trial–related articles increased sharply in 1996. This was because in the same year, HIV-tainted blood scandals6 and cases of drug-induced Jacob's disease7 became social problems. Furthermore, in 1994, misconduct in a clinical trial for sorivudine8 led to a social problem, resulting in an increased number of related articles. These facts conform to the tendency of mass media to prefer to deal with incidents and new events. In 1994 and 1996, there was an increased appearance of words related to the methodology of clinical trials such as phase II and phase III as well as keywords such as the Ministry of Health, Labour and Welfare; lawsuit; Pharmaceutical Affairs Law; clinical trial; and ethics. Therefore, it is believed that people were exposed to information regarding the methodology of clinical trials and the administrative role of pharmaceutical affairs via news reports on medication scandals and misconduct in clinical trials. It is undeniable that the reports of major newspapers on clinical trials in relation to medication scandals and misconduct could possibly have an influence on the formation of negative public impressions regarding clinical trials. On the other hand, in Japan, the system of clinical trials has developed greatly since 2000, and the Pharmaceutical Affairs Law was amended considerably in 2002.9,10 Our study found that the appearance of certain keywords reached a peak during that time: coordinator in 2002, and doctor-led model clinical trials in 2005. During this period, there were no major medication scandals or incidents of misconduct. These keywords were used in articles regarding amendments of the system of clinical trials. It should be noted here that the number of reports with these keywords (coordinator and doctor-led model clinical trials) was approximately 10% that of reports on medication scandals in 1996. This fact means that the administration of pharmaceutical affairs and discussions regarding the system of clinical trials may be reported in the newspapers, but only with a small amount of text. Therefore, in comparison with the topics of medication scandals and misconduct, it may be difficult to promote public understanding regarding the systemic reform of clinical trials. Taking these facts into consideration, to enhance public understanding regarding clinical trials, it may be important to utilize means of providing information other than newspapers, which often emphasize medication scandals and misconduct. Our study shows that clinical trials are topics that the major newspapers report. However, many of the newspaper reports emphasize the performance of pharmaceutical companies and incidents of misconduct, such as medication scandals, while providing insufficient information regarding the system of clinical trials. It is recommended that health care professionals fully understand these characteristics of the major newspapers. AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST The author(s) indicated no potential conflicts of interest. REFERENCES 1. Saito K, Kodama Y, Ono S, et al: Current status of quality in Japanese clinical trials. Contemp Clin Trials 26:503–509, 2005.[CrossRef][Medline] 2. Matsumura T, Yuji K, Nakamura T, et al: Possible impact of the NHK special questioning cancer treatment in Japan on clinicians' prescriptions of oxaliplatin. Jpn J Clin Oncol 38:78–83, 2008. 3. Grilli R, Ramsay C, Minozzi S: Mass media interventions: Effects on health services utilisation. Cochrane Database Syst Rev 1:CD000389; 2002.[Medline] 4. Tian Y, Robinson JD: Media use and health information seeking: An empirical test of complementarity theory. Health Commun 23:184–190, 2008.[CrossRef][Medline] 5. Bala M, Strzeszynski L, Cahill K: Mass media interventions for smoking cessation in adults. Cochrane Database Syst Rev 1:CD004704; 2008.[Medline] 6. Swinbanks D: Documents confirm delays in Japanese HIV blood scandal. Nature 379:760; 1996.[Medline] 7. Dillner L: BSE linked to new variant of CJD in humans. BMJ 312:795; 1996. 8. Swinbanks D: Deaths bring clinical trials under scrutiny in Japan. Nature 369:697; 1994.[Medline] 9. Saito K, Kodama Y, Ono S, et al: Quality of Japanese clinical trials estimated from good clinical practice audit findings. Am J Ther 13:127–133, 2006.[CrossRef][Medline] 10. Saito K, Kodama Y, Ono S, et al: Reliability of Japanese clinical trials estimated from GCP audit findings. Int J Clin Pharmacol Ther 46:415–420, 2008.[Medline]
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Copyright © 2009 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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