Q: Why is CADTH initiating a Scientific Advice Program?
CADTH is initiating a Scientific Advice Program in response to requests from pharmaceutical companies. Since 2008, CADTH has received numerous requests from pharmaceutical companies to consider implementing a Scientific Advice Program.
Read about the purpose and benefits of the Scientific Advice Program for pharmaceutical companies and for CADTH.
Q: Why do we need a CADTH Scientific Advice Program when there are already established programs that exist internationally?
In Canada, we have heard from companies that there is significant value in understanding similarities and differences in health technology assessment (HTA) perspectives around the world in order to optimize drug development strategies. In addition, understanding the Canadian perspective through CADTH can have specific strategic value.
Q: What are some specific outcomes of Scientific Advice for pharmaceutical companies?
Some specific outcomes of Scientific Advice for pharmaceutical companies include:
- Earlier affirmation of development plans or earlier termination of development
- Redesign of studies to better meet stakeholder requirements
- Reduced cost via elimination of unnecessary studies
- Enhanced alignment within companies regarding HTA requirements.
Q: How will the exchange of documents be handled for the CADTH Scientific Advice Program?
CADTH plans to exchange all documents electronically using secure email and secure web-based systems.
Read more about the security of information for the Scientific Advice Program.
Q: How and when does CADTH intend to evaluate the success of the Scientific Advice Program?
CADTH plans to solicit feedback from all parties involved in the Scientific Advice Program at the close of each application through an online feedback survey. As we move forward initially, we expect to be making ongoing changes to optimize the quality and efficiency of the Program based on the feedback we receive, as well as based on our own experiences at CADTH.
Once we have gained more experience with the Program, we plan to undertake a larger survey of past participants. In addition to assessing satisfaction with the Program and the Scientific Advice provided, we will also attempt to assess the impact by asking how companies have used the Scientific Advice provided. Timing for this evaluation has not yet been determined but will likely occur after six (6) to 10 Scientific Advice applications have been completed.
CADTH is committed to continuously improving the quality of the Scientific Advice Program. We would also be happy to receive feedback from any involved party at any point in time.
Q: Where is Scientific Advice housed at CADTH? Is it part of the CADTH Common Drug Review?
The Scientific Advice Program and the CDR Program are housed in different Directorates within CADTH. Individual members of the CADTH executive team have oversight for each of these Directorates. This was done purposefully in order to preserve the independence of both programs and to avoid any perceived conflict of interest between the two programs.
Q: Who can I contact if I have additional questions about the CADTH Scientific Advice Program?
If you have additional questions, you may email email@example.com. A member of the CADTH Scientific Advice team will get back to you.
Q: What products are eligible for CADTH Scientific Advice?
Drug products, are eligible for CADTH Scientific Advice. This includes new drug products, existing drug products with new indications, drugs for rare diseases, and subsequent entry biologics. To be eligible for the Scientific Advice Program, a drug product must be in early-stage development at a point where clinical trials may be modified based on the Scientific Advice provided (i.e., before phase 3 trials have begun).
Q: What products are not eligible for CADTH Scientific Advice?
CADTH does not offer Scientific Advice on vaccines, non-drug technologies (medical devices, procedures, or diagnostic tests), or generic drugs.
Q: At what point in drug development should applicants seek CADTH Scientific Advice?
CADTH Scientific Advice is provided at a point before the initiation of phase 3 trials. The ideal time to seek Scientific Advice is during the planning stage for phase 3 trials. Application to Scientific Advice may occur before phase 2 trials have been completed. The inclusion of phase 2 trial results in the application form and the Briefing Book is at the applicant’s discretion. CADTH does not require phase 2 results in order to provide Scientific Advice. Note that for CADTH to provide useful Scientific Advice, applicants must be far enough along in development to raise specific issues and to have detailed rationales for CADTH to comment on.
Q: Does the CADTH Scientific Advice Program offer Scientific Advice at the post-phase 3 trial stage?
The CADTH Scientific Advice Program does not offer Scientific Advice once a phase 3 trial has begun. CADTH provides early Scientific Advice on prospective drug development plans at a stage where the feedback provided can still be incorporated into development plans. CADTH does not offer advice on the analysis of existing data.
Q: Does the CADTH Scientific Advice Program offer Scientific Advice on proposed economic evaluations, as well as on proposed clinical development plans?
Yes. Read more about the type of advice offered through the Scientific Advice Program.
Q: How do prospective applicants apply for CADTH Scientific Advice?
Q: What do I do if my preferred time period for the Scientific Advice meeting is already taken?
We encourage you to book early to increase the chances of securing your preferred meeting time period. If your preferred time period is not available, you may indicate your desire to be added to a waiting list on the application form. Read more about application to the CADTH Scientific Advice Program.
Q. What is a Briefing Book and what information should be included in the Briefing Book?
A Briefing Book is a document that applicants submit to CADTH as part of the Scientific Advice process. The Briefing Book contains background information about the drug and the indication for which advice is being sought. The Briefing Book also contains the list of questions or issues for which the applicant wishes to obtain advice. Each question or issue is followed by a proposed approach (or proposed options), with justification. Please review the Guidance on the Briefing Book for Scientific Advice and use the Briefing Book Template in preparation of your Briefing Book. These documents have been designed to assist applicants in providing information that will be most useful to CADTH for developing relevant Scientific Advice.
Q: How much time do applicants have to prepare the Briefing Book?
CADTH requires that applicants apply for Scientific Advice at least 24 weeks before the desired Scientific Advice meeting date. In this scenario, companies have 10 weeks to prepare the Briefing Book, as the Briefing Book is due 14 weeks before the Scientific Advice meeting. However, companies may apply for CADTH Scientific Advice more than 24 weeks in advance if they would like more time for Briefing Book preparation. For example, if a company applies for CADTH Scientific Advice 36 weeks in advance of the Scientific Advice meeting date, they would have 22 weeks to prepare the Briefing Book.
Q: How many questions or issues can an applicant submit for CADTH Scientific Advice?
CADTH Scientific Advice is provided verbally at a three-hour face-to-face meeting with a written Record of Scientific Advice produced after the meeting. Applicants should consider the amount of information that can be discussed in a three-hour meeting when determining the final number of questions or issues to submit. As a general rule, ten (10) questions is usually the maximum that can be discussed at the meeting; however, this is dependent on the complexity of the questions. More or fewer questions may also be reasonable. CADTH may provide feedback on the number of questions if there are concerns.
Q: Will there be penalties if the applicant is unable to meet the ten (10)-day deadline for clarifications?
There will be no financial penalties if an applicant is unable to meet the ten (10)-day deadline for clarifications. However, it may mean that work on Scientific Advice needs to move ahead without the requested information. This may compromise the usefulness of the Scientific Advice provided.
Q: How will the Scientific Advice team use the information regarding past or anticipated Scientific Advice from a regulatory agency, or another HTA agency, that is requested as part of the Briefing Book?
This information will allow us to determine when applicants seek Scientific Advice from CADTH in relation to when they seek advice from other existing programs. Having this information will help determine the best way forward for the program if there is demand for parallel HTA and regulatory Scientific Advice or demand for multi-HTA Scientific Advice in the future.
If minutes from regulatory Scientific Advice are provided (this is optional), CADTH will consider the regulatory Scientific Advice already provided in developing the CADTH Scientific Advice. This may assist in avoiding conflicting Scientific Advice in some cases or in the suggestion of ways to address the needs of HTA while still addressing regulatory needs, if possible. Having this information will also help determine the priority level for greater collaboration with regulators in the provision of CADTH Scientific Advice as we move forward.
Q: What is the purpose of the Scientific Advice meeting and what should applicants expect from this meeting?
The purpose of the Scientific Advice meeting is for CADTH to provide advice verbally to the applicant based on the questions or issues submitted in the Briefing Book. This meeting also provides an opportunity for open dialogue and discussion between CADTH and the applicant.
CADTH representatives at the meeting include the Director, Scientific Advice; one to two Scientific Advice staff members; one to three external experts; and additional CADTH staff, as required. Applicants are permitted up to ten (10) representatives. Applicants and CADTH will exchange the names and titles of the representatives attending the meeting approximately three (3) weeks before the meeting. The role of each representative should be clearly indicated. The meeting is chaired by CADTH. Applicants have an opportunity to make a brief presentation on their drug at the beginning of the meeting. The remainder of the meeting time is used to provide CADTH Scientific Advice and to discuss the issues.
Q: Does CADTH provide a written Record of Advice?
Yes, CADTH provides a written Record of Scientific Advice. CADTH provides advice verbally at the Scientific Advice face-to-face meeting. Twenty (20) business days following the meeting, CADTH provides a written Record of Scientific Advice, which summarizes the Scientific Advice communicated at the meeting. The Record of Scientific Advice template is used for this purpose. Applicants have one opportunity to submit clarification questions (these must be directly related to the Record of Scientific Advice, as new questions cannot be addressed at this point) and to participate in a clarification teleconference, if desired, before the final Record of Scientific Advice is issued.
Q: What is the difference between a Scientific Advice meeting and a CADTH Common Drug Review pre-submission meeting?
Scientific Advice Meeting
To assist in drug development planning by providing feedback on evidence requirements from an HTA/payer perspective
To facilitate efficient submission preparation/filing; manufacturers can introduce drugs and clarify submission requirements
Very early in drug development process (5 to 7 years before Health Canada approval, before phase 3 trials have been initiated)
Late in drug development process (within 6 months of submitting to the CADTH Common Drug Review)
Includes communication with pharmaceutical company, consultation with experts, and preparation by CADTH; results in the creation of a CADTH product (Record of Scientific Advice)
Meeting with pharmaceutical company; no CADTH product
HTA = health technology assessment.
Q: Is patient input part of the CADTH Scientific Advice Program? If so, what is the process?
Yes. Patient input is part of the CADTH Scientific Advice process for all applications.
Read about patient involvement in the CADTH Scientific Advice Program.
Q: Why is CADTH requesting information about patient engagement activities in the Briefing Book and how will the information be used in the context of providing Scientific Advice on the design of phase 3 studies?
Patient engagement in clinical trial design is being discussed in various forums internationally. If applicants have sought input from patients in their product development plans related to the design of phase 3 clinical trials, CADTH requires this information so it can be taken into account in preparing the Scientific Advice. If applicants have not sought this type of input from patients, it should simply be indicated in section 4.5 of the Briefing Book (Summary of Patient Engagement, If Available).
Q: Should the information provided on patient engagement in the Briefing Book be focused only on Canadian patients?
All information related to consultations with patients on clinical trial design should be included; however, the country where the consultations were carried out should also be indicated.
Q: At what stage in the overall process are patients engaged and how are they recruited? Is there a call put out, similar to what is done for the CADTH Common Drug Review?
Patient engagement occurs early in the Scientific Advice process before the Briefing Book is submitted by the applicant. In order to protect the identity of the applicant and the applicant’s information, no public call for patient input is done. Instead, patient representatives are solicited directly by CADTH though patient organizations.
Read more about patient involvement in the CADTH Scientific Advice Program.
Q: Do patient representatives attend the Scientific Advice meeting?
No. Patient representatives do not attend the Scientific Advice meeting according to the CADTH Scientific Advice process at this time.
Q: Will CADTH provide the Briefing Book to patient representatives?
CADTH will share the Briefing Book with patient representatives only if the applicant has indicated permission to do so in the online application form and only if the patient representatives would like to review it.
CADTH will speak with the patient representatives before the applicant submits the Briefing Book. As background information for the patient representatives, applicants are asked to complete and submit a Patient Drug Information Form. This form requests information about the drug and the related phase 3 clinical trials to allow for a relevant conversation about the application. Completion of the form is optional for applicants and the form may be completed in whole or in part (i.e., all fields are optional except the drug name and the applicant name, as these are needed for identification).
Q: Does the applicant have the ability to suggest whether or not patient involvement is required in an application for CADTH Scientific Advice?
No. Patient involvement is part of the CADTH Scientific Advice process for all applications. However, applicants have the opportunity to determine what, if any, information submitted by them or produced by CADTH as part of the Scientific Advice Program is shared with patient representatives. Applicants indicate permission to share information as part of the online application form for the CADTH Scientific Advice Program. Applicants also have the option of completing a Patient Drug Information Form, which will be shared with patient representatives in order to provide background information on the drug to enable a relevant conversation with CADTH staff.
Read more about patient involvement in the CADTH Scientific Advice Program.
Q: Does CADTH have secure systems for exchanging documents electronically?
Yes. CADTH has in place secure email and secure web-based systems for the exchange of documents.
Read more about security of information for the CADTH Scientific Advice Program.
Q: Can applicants share the Record of Scientific Advice with other companies or with other HTA agencies?
According to the Confidentiality Guidelines for Scientific Advice, all documents submitted by applicants and produced by CADTH as a part of the Scientific Advice Program are to be kept confidential between the applicant and CADTH (including authorized recipients and patient representatives, as applicable) except as agreed by expressed, advance, or written permission from both CADTH and the applicant, or as required by law or by order of a legally qualified court or tribunal.
Q: Will members of the Canadian Drug Expert Committee (CDEC) have access to the Record of Scientific Advice, if available, as background information for their deliberations on a CADTH Common Drug Review submission?
No. Members of CDEC will not have access to the Record of Scientific Advice. CADTH will not disclose to the committee whether or not the drug under review has previously received CADTH Scientific Advice.
Q: Who has access to Scientific Advice files within CADTH?
Access to Scientific Advice files is restricted to the staff involved in the Scientific Advice Program and files are kept in a secure location. However, CADTH Scientific Advice staff members are permitted to share information across the organization, as deemed appropriate by CADTH. As an example, CADTH Scientific Advice staff members may share information about a new methodology that they were made aware of through the Scientific Advice Program with other CADTH staff. In this case, the information would be shared for the purposes of training and the information would be shared without specific reference to drug name or applicant name. Note that all CADTH staff privy to Scientific Advice information must comply with the Confidentiality Guidelines for Scientific Advice and the CADTH Conflict of Interest Policy for Employees.
Q: What is the fee for CADTH Scientific Advice? Is there a fee schedule?
Q: What are the consequences for applicants if they must change the Scientific Advice meeting date or if they must cancel the meeting?
Changes in meeting dates, particularly at the last minute, are challenging for CADTH. CADTH requires as much advance notice as possible in order to manage date changes. CADTH will make every attempt to accommodate date changes if required for good reason; however, accommodation cannot be guaranteed. In the case of a meeting date change, CADTH will retain the fees already paid but will shift the remaining payment schedule to align with the new meeting date.
If an applicant withdraws from the CADTH Scientific Advice Program, CADTH will not refund fees already paid. Depending on the point of withdrawal, an additional partial charge may apply based on costs incurred to date and work completed. The applicant will be provided with an invoice for any additional fees within 30 days of their withdrawal.
Please refer to the Fee Schedule for Scientific Advice for information on payment of fees.
Q: Does CADTH engage experts and how will they participate in the process?
CADTH aims to engage two (2) clinical experts and one (1) economic expert (if relevant) for each Scientific Advice application. All experts must complete a conflict of interest declaration. Conflict of Interest declarations are assessed before experts are accepted as Scientific Advice team members for a particular application. Experts will be involved in the preparation of the Scientific Advice with CADTH staff prior to the face-to-face meeting. Experts will also attend and participate in the face-to-face Scientific Advice meeting and will be engaged in the preparation of the written Record of Scientific Advice.
Q: How does CADTH choose experts to participate in the CADTH Scientific Advice Program?
Experts are chosen based on their relevant clinical, economic, and/or methodological expertise. The assessment of conflicts of interest is also part of the process.
Q: Are representatives from publicly funded drug plans involved as experts for the CADTH Scientific Advice Program?
The CADTH Scientific Advice Program includes clinical, economic, and/or methodological experts as part of the process. A representative from publicly funded drug plans is not routinely included as one of the experts for a Scientific Advice application.
Q: Are members of the Canadian Drug Expert Committee (CDEC) involved as experts for the CADTH Scientific Advice Program?
Current members of CDEC will not be involved as experts for CADTH Scientific Advice. However, past CDEC members could be engaged as experts, if appropriate.
Q: Will CADTH consult the applicant in the selection of experts and/or will the external experts selected be mutually agreed upon by CADTH and the applicant?
No. The applicant will not have input in selecting the experts who assist in developing CADTH Scientific Advice. However, we will be interested in feedback from applicants on the quality of discussion and input provided by the experts we select. We will use this input to help us select appropriate and effective experts as we go forward.
Q: Will applicants be able to highlight the Scientific Advice received through the Scientific Advice Program within a subsequent submission to the CADTH Common Drug Review (CDR)?
According to the Disclaimer for Scientific Advice, the Scientific Advice provided to the applicant is not considered to be relevant and is not to be taken into account in any future CADTH assessments or recommendations. Therefore, the Scientific Advice provided is not permitted to be included as part of a submission to CDR.
Q: Will CADTH staff members, experts, patient representatives, and members of the Canadian Drug Expert Committee (CDEC) who were previously involved in the Scientific Advice Program for a particular drug be allowed to later participate in the CADTH Common Drug Review (CDR) process concerning the same drug?
Current members of the Canadian Drug Expert Committee (CDEC) will not participate in the Scientific Advice Program; however, past members of CDEC may participate, if appropriate. A current member of CDEC, who has participated in providing Scientific Advice for a drug prior to appointment on the committee, will not participate in discussions, deliberations, and recommendations for the same drug if it is later submitted to CADTH through CDR. Experts, patient representatives, or CADTH staff members who have knowledge of the content of the Record of Scientific Advice for a drug, or who have attended the Scientific Advice meeting for a drug, will not participate in the review for the same drug when submitted to CADTH through CDR.
Read more about conflicts of interest for the CADTH Scientific Advice Program.