Change of Clinical Trial Sponsor

Introduction

When the Sponsor of a Clinical Trial changes, the task of Informing Regulatory Agencies and Ethics Committees initially appears to be a straightforward administrative task.

In many cases, it actually is. However, when this task needs to be co-ordinated for multi‑national clinical trials, the differences in requirements between countries and regions requires some research and planning.

It is always most useful if the submission can be managed by a local office in the relevant country. Guidance documents are not always very specific, and experience may be needed to understand the nuances of implementation.

Type of Application?

The type of application to register a Change in Sponsor can vary from a straightforward notification, following which the sponsor change can be implemented immediately, to a substantial modification/amendment (or equivalent) requiring full review and approval with corresponding timelines.

Therefore, if the sponsor change is taking place on, or close to, a certain date, the timelines for completion of the application procedure require consideration.

The Sponsors – former and new

Most applications require the inclusion of signed and dated statements from the former and new sponsors to:

• Relinquish and transfer the clinical trial sponsorship (former)

• Undertake the responsibilities of the clinical trial sponsorship (new)

The majority of countries require further documentation to be submitted with the application, and, in some cases, documents must be agreed and signed by both the former and new sponsor. So, it is very helpful to establish an early contact between sponsors; you can then work together to complete the application – most applications are submitted by the former sponsor but sometimes they are submitted by the new sponsor and sometimes by both.

How to submit?

Some Agencies, such as the National Pharmaceutical Regulatory Agency of Malaysia, require the application to be submitted in hard copy, but many Agencies now have dedicated portals for the submission of different types of applications. Initial registration of the new sponsor on these portals may, therefore, be required before the application can be submitted and this needs to be factored in.

If a local representative is required to submit the application, a valid entity will need to be established beforehand, and any necessary documentation or registration completed for the sponsor change submission to be enabled.

Generally, no other procedures can be ongoing when a Change of Sponsor application is made. Usually, a Change in Sponsor application has to be submitted in isolation and cannot be combined with other amendments.

Notification of the sponsor change to Ethics Committees is good practice, even if not stipulated and it should be noted that the sponsor change will have implications for other trial documents such as the protocol and ICF, which will subsequently need updating. In some countries, Ethics Committee notification and/or approval precedes the submission to the Regulatory Agency.

Guidance

Some Agencies have excellent published guidance available, including step-by-step screenshots on how to make the submission on the respective portals.

Guidance from other Agencies may not be as explicit and, if so, it is recommended that if clarification is required, the Agency is contacted directly, especially when the application process is more complex. Risking an incorrect interpretation may lead to invalidation of an application.

The time of response to such a query does vary between Agencies, but many will reply within 24 hours and are extremely helpful – such contact does also raise awareness that additional published guidance may be necessary.

In the UK, the Health Research Authority recommends that contact is made prior to submitting an amendment via the IRAS portal, so that the applicant can receive instructions specific to its particular trial.

Harmonising

Ideally, for an international trial, if the change of sponsor applies to all participating countries, the date of the change should be the same in each country. Usually, this date can be specified within the application in a document such as the Cover Letter, or the statements from the former and new sponsor. However, in some portals, such as the CTIS and IRAS portals, this cannot be facilitated and the date of change of sponsor is the date that full approval is issued.