Information Provision Procedures for Recruitment of Subjects Involved in Clinical Trials
Through these past decades, we have seen a constant development in the healthcare industry including the increase in clinical trials annually. However, public awareness of this subject is still limited hence the importance of clinical trial information relay to the public. Like any other processes, there are procedural guidelines to ensure efficiency and smoothness of the process. Clinical trials are not a new concept. Since, 1999, the Ministry of Health and Welfare (now Ministry of Health, Labour and Welfare) have already received the final report of “Study Group for Smoothly Promoting Clinical Trials”. This was then taken into consideration by the Pharmaceutical Evaluation Committee of Japan Pharmaceutical Manufacturers Association and Clinical Evaluation Committee to formulate the “Information provision procedure for recruitment of subjects involved in clinical trials” in March 2000. This is further revised in 2008 based on regulatory guidelines (shown below) issued thereafter.
- 1. Information Provision Means
- 2. Information Content
- 3. Restrictions on Expression Used in Providing Information
- 4. Things to Take into Account by Information Provider
- 5. Others
- 6. Conclusion
- 7. Contact us
Information Provision Means
There are many possible ways to do this especially through media such as posters, newspapers, magazines, flyers, televisions, radios or homepages on the Internet. However, compulsion such as force handing flyers is not permitted.
Information on clinical trials can only be disclosed according to the extent indicated by the consent/ explanatory document and clinical trial protocol. Recruitment of subjects for clinical trials, on the other hand, are only provided items indicated by the Ministry of Health, Labour and Welfare, Drug Countermeasures Division. The Medical Law (2007) states that “The general name (component name) or the development code may be used for promoting information provision on clinical trials” as providing information using media such as the Internet which is operated by a public organization for the purpose of information disclosure is not considered to be an advertisement. However, under the Pharmaceutical Affairs Law, it is prohibited to advertise non-approved drugs excluding the names of the disease targeted and brand names. Therefore, it is advised to not display the name of the study drug as well as the development code. If the promotion of the medical institution and its achievement in clinical trials is to be included, it should be based on the Medical Law.
Below shows a list of points to take into consideration for appropriate information provisions:
• Terms such as ‘new drug’, ‘new treatment’, and ‘new medical care’ should not be used without explanations about it being a trial.
• Glossaries can be included for questions like “What is a clinical trial”, “What is an anti-XX drug?”, and “What is an XXX disease?” so subjects can have a better understanding of what they are participating in. It is also possible to incorporate a brief overview about the company and its aim such as “selling or developing medicines in dozens of countries around the world”.
• If there is a statement about examining effectiveness and safety of the drug in Japan from now on, it is possible to post that this investigational drug has already been released overseas as a therapeutic agent for XXX disease.
• Following that, if the same statement of examining effectiveness and safety of the drug in Japan from now onwards is stated, it is also possible to post that this investigational drug has already been marketed as a therapeutic agent for XXX disease in Japan.
|Information Provision Contents||Suitability|
|Name of study drug (including trial code)||X (see Note 1)|
|Expected efficacy or effectiveness of the investigational drug (see Note 2)||△|
|Expected use or dose of study drug||○|
|Target disease name and symptom name||○|
|Trial purpose (see Note 3)||○|
|Clinical trial content||○|
|Subject burden reduction (see Note 4)||○|
|Name of the clinical trial site (see Note 5)||○|
|Investigator name, Department name (see Note 5)||○|
|Contact (see Note 6)||○|
Figure 1: Information Provided for Subject Recruitment
Note 1: Since under the Pharmaceutical Affairs Law, advertising of unapproved drugs is prohibited, the name of the investigational drug, a general name (component name) or a development code is not advised to be provided during information provision.
Note 2: Some expressions are possible as shown below. For example, “anti-XXX disease drugs” can be used. However, we do not use expressions that imply effects such as “effective for XXX diseases” or “improve symptoms of XXX disease”.
Note 3: The purpose of the clinical trial should be concise and easily understood, such as “to confirm the efficacy and safety” or “to investigate the influence on disease progression”
Note 4: Subject burden reduction can be described as the contents of various burden reduction and the amount of burden reduction. However, expressions using the payment of money as an incentive is not accepted.
Note 5: The name of the trial site medical institution can be described if it is reviewed by the clinical trial review board of the clinical trial site medical institution, approved by the director of the medical institution, and the medical institution can respond to inquiries.
Note 6: As a contact point, indicate when, where, and in what way it is possible to inquire. For example, reception time, reception desk, telephone number, fax number, Internet home page address, E-mail address, location, etc. may be considered. When making inquiries, avoid asking for the personal information of the person making the inquiry. If personal information is obtained, action will be taken in accordance with the Act on the Protection of Personal Information.
Restrictions on Expression Used in Providing Information
In order to accurately convey the information, it is necessary to pay attention to the following:
• False or exaggerated expressions
• An expression that depreciates the research drug and product of another company
• An expression that misleads using medical or pharmaceutical experts as a guarantee or recommendation
• An expression that induces the feeling of discomfort or anxiety
• Misleading expressions that suggest quality, efficacy, safety etc.
• An expression that impairs quality
• Expressions that use the payment of money as an incentive
• Displays that impair advertisement quality, such as exaggerating the amount of money
• Expressions that would suggest participating in the trial being recognised as a source of income
Things to Take into Account by Information Provider
The informant should always consider the sensitivity of subject information. The propriety of content, as well as the method of information provision, should be discussed with the sponsor in advance. It is also important to notify the Pharmaceuticals and Medical Devices Agency 30 days prior to the start date of information provision and 2 weeks or more before the date of submission of clinical trial planning.
1) Inquiry Window
Inquiry window should be established in preparation of an inquiry. It is recommended that the inquiry office prepare a procedure document that states the procedure, method, scope etc. of the response so that appropriate response can be made towards future inquiries. In order to protect the privacy of applicants, unnecessary questions regarding privacy are not to be asked and if personal information is obtained in the process, actions will be taken in accordance with the Personal Information Protection Act.
2) Recruitment Period
Regarding the end date of the recruitment period, to prevent any confusion to the subjects, it can be presented on the information provision medium.
The list above provides a guideline to the way of information provision for the recruitment of subjects involved in clinical trials, however, it is always good for information providers to keep in mind that information provided should be useful and easy to understand for the subjects.
Please feel free to inquire using the form below. We will respond as soon as possible between 9:30 and 18:30 (Monday – Friday Japan Tokyo time).
Published November 2008, Pharmaceutical Evaluation Committee of Japan Pharmaceutical Manufacturers Association
Information provision procedure for recruiting subjects involved in clinical trials (Revised Edition)
Retrieved from http://www.jpma.or.jp/about/basis/guide/pdf/200811-information.pdf