Ethics / Privacy / Approvals / Regulatory Funding Satellite Centres Timelines Additional Projects / Functionality Contact Information
Frequently Asked Questions
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Ethics / Privacy / Approvals / Regulatory
Is an application to the local REB required?

Data provided for the study can have different origins, these may include: retrospective PK data taken from a patient chart, data from a PK study you are doing for clinical reasons or PK data from a study you are doing with the intent of providing data to WAPPS. Of course these scenarios are different, as different as the various REB rules and regulations. As a study coordinating centre, the only requirement we have for you is to tick a checkbox, when registering a patient, stating you appropriately managed the consent to data provision. If you decide to submit the study protocol to your Ethical Committee, we are happy to help you prepare the needed documentation.

How are confidentiality and patient privacy protected?

The WAPPS database is hosted on a secure server in a secure location. Access to data is strictly regulated by user and password over a secure connection. Physical access to the servers is controlled by a double layer of restricted access; any physical access is logged and video recorded. The database is mirrored real time, and periodical backups are stored in a fire safe place.

Who owns the database?

Each participating center enters the network by signing a Data Transfer Agreement where the center commits to data provision and to take responsibility for clinical use of the results. The PI agrees to share ownership of the database and authorship on any publication stemming from the project. The DTA is signed on McMaster's side by the WAPPS-Hemo project's principal investigator and on the center side the local PI for the participating Centre or any entitled signed authority from the local institution.

Does use of WAPPS require a medical device exemption in FDA regulated settings?

We have submitted an application to the FDA inquiring about the need to obtain an exemption from the status of medical device, and we have been found entitled to process data in the project. Centers based in the US can participate without any specific extra level of approval.

Funding
Is this funded by B-CHERP?

Yes. B-CHERP is funding the project. B-CHERP is a funding completion posted by the Canadian Hemophilia Society, with an independent peer-review process. See http://www.bcherp.ca/ for further details.

What is the business model?

The business model is to share honors and duties!! The funding we've recieved is sufficient to cover PK modelling, website development and maintenance and central administration. It does not allow us to pay centres for the patient data they will provide. For this reason, we are inviting co-investigators to participate on the basis of the following non-funded agreement: all the centres participating in Phase 1 and 2 of the study (i.e. providing patient data and testing the system) will be co-owners of the database and co-authors of all the publications originated from it. Furthermore, they will receive PK estimates for their patients based on their input data.

Satellite Centres
How many centres are invited, and how many will be allowed to participate?

Our initial expectation for the 3-year cycle of the project was to have 15 centres, contributing a minimum of 5 patients each (45 patients). This was the minimum data set needed for validation. We have happily welcomed centres in excess of the 15. We currently have 18 investigators in about 15 centres, at various stages of the registration process, and we envision to have many more over time.

Timelines
What are the project timelines?

The first phase: website development and population PK modelling, was completed by July 2014

The second phase: Testing and validation are set to be completed by October 2015.

What is the completion date of the project?

The project will be completed in three years, which is July 2016.

Additional Projects / Functionality
Is it possible to propose satellite projects within the network, or ask for additional functionality of the website?

Of course! Any proposals are welcome. We've already had a few (e.g. the proposal to study the effect of blood groups on PK, the correlation between peak and time to trough for individual patients, etc). You are also welcome to contact us. Proponents are welcome to lead the sub-study if they like.

Is it possible to build a growth curve into WAPPS so that it would estimate levels now but also in 6-months based on average weight gain?

We are working on an additional aspect of the website in which patient-specific characteristics could be charted.

Hemoglobin is requested as a data point.
  • What data and time are you looking for?
  • What if there is no hemoglobin on that date?

Hemoglobin is not mandatory. Ideally taken at baseline, but a determination in the last month is acceptable if the patient did not have surgery in the same time frame.

What time points are you looking for in the PK study?

We don’t mandate any point. We suggest having a sample around 6-12 for HA and 9-18 for HB and/or a sample around 24, but this is not mandatory. We will see with time what works best. Please consider we may use sample after different infusion, so that a 18 hours might be a patient infused at home in the afternoon before, and sampled the day after in clinic, or a patient infused at home the morning before and sampled in clinic the day after for a 24 hr sample.

When the database requests baseline factor level, is it requesting the pre dose level, or the patient’s diagnostic level (for example, if there wasn’t a complete washout prior to the PK study, a severe hemophilia A patient may have some factor (e.g. 7%) in their blood at the PK study baseline)?
Pre-dose
When the protocol states that “subsequent data points will be required if needed”, what is this referring to?

Say you provide pre dose, 0.25, 2hrs and 4hrs, and the estimation process shows unacceptable uncertainty. We will give you an estimate with attached a “high uncertainty” suggesting you, if possible, to send a sample taken, for example, 12 hrs. after a subsequent infusion. We will then add that sample to the previous, and refine the estimate. Again, nothing is mandatory, we are trying to make PK estimate possible in real world.

In what case would we use the secondary form to re-input patient data? (under - Data collection procedure)

When there is high uncertainty in the estimate.

If the subject wishes to withdraw permission for future use of his/her data, what is the procedure to be followed?

Upon request, the patient will be deleted from the system and no further data will be collected. Any anonymized data collected for previous modeling purposes will continue to be used to run prediction models.

What will happen to the research data and/or specimens at the conclusion of the study?

After the end of the 3-year phase of the study, all data will be destroyed unless the project is extended. If the project were to be extended, all satellite centres would be contacted for an opportunity to continue with the project. All regulatory (ethical) approval procedures would be initiated at that time.

What is the estimated sample size for the SMH site (i.e. # charts to be accessed & data to be sent to Dr. Iorio)?

We would require data 2-3 data points for a minimum of 5 patients/centre.

Contact Information
How can I get in touch?

You can contact us via the Contact Page or by email at wappshemo@mcmasterhkr.com