Hospital Approvals of Clinical Trials-

(towards harmonised approval of multi-

centre clinical trials)

Susan Lennon

Clinical Research Manager 26th January

2012

Understanding the landscape How do hospitals approve multi-centre trials ?

– Annual workload per hospital

– What information is required to achieve hospital

approval ?

– What currently works?

– What are the key challenges?

– Conclusions and areas for further discussion/action

Hospital Approval in the Clinical Trial

Continuum

Process for gathering/assessing

information on hospital approval

• Who is responsible for review and sign off in the

hospitals?

• Interview with 6/9 teaching hospitals prioritised

– so far

• Categorisation of the information received

• Review of the categorised information

High Level Results

Key (High Level Preliminary Results)

Volume

0

10

20

30

40

50

60

70

80

90

100

A B C D E F

Nu

mb

er

of

an

nu

al a

pp

rova

ls

Hospital

Estimated applications/annum/hospital

Key (High Level Preliminary Results)

Types of studies

Number of Hospitals

Pharma/Med Device Sponsored

Investigator led studies 100% 100%

Key (High Level Preliminary Results) Has Hospital/Institution acted as a Sponsor?

0

0.5

1

1.5

2

2.5

3

3.5

4

Yes No

Nu

mb

er

of

Ho

sp

ita

ls

Sponsorship

Key (High Level Preliminary Results)

Average timelines for sign off

0

1

2

3

4

5

6

A B C D E F

We

ek

s

Hospital

Average time to approval

Key (High Level Preliminary Results)

Department responsible for review

– Legal

– Risk Management

– Finance

– Ethics Department

– Special committees

Key (High Level Preliminary Results)

Hospital Specific Forms required?

Hospital Specific Forms Required

Yes

No

50% 50%

Key (High Level Preliminary Results)

Data Reviewed

– IMB approval (if required)- 100%

– REC Approval- 100%

– Protocol- procedures- 50%

– Indemnity/Insurance-

– Consistently look for advice – 33%

– Sometime seek advice – 16.5%

– Rarely seek advice- 33%

– Don’t know – 16.5%

– Clinical Trial Agreement- 100%

– Data Protection – 50%

– Finances – 50%

Key (High Level Preliminary Results) Routinely check for use of hospital

Resources

0

0.5

1

1.5

2

2.5

3

Yes No

Nu

mb

er

of

Ho

sp

ita

ls

Key (High Level Preliminary Results) Main objective of review process

• Protect hospital – 1

• Protect PI and hospital – 1

• Protect hospital and patients – 1

• Protect hospital, patients, PI - 3

Key (High Level Preliminary Results)

Communication

50% 50%

Routine Communication with personnel in other hospitals with this responsibility ?

Yes

No

Key (High Level Preliminary Results)

What works well?

• HSE Indemnity form

Key (High Level Preliminary Results)

Main challenges

– Differing Clinical Trial Agreements

– Indemnity/Insurance

– Uncertainty

– lack of shared understanding

– Differing support documentation

DOHC Guidelines 2007

2.2 Site Specific Assessment The EU Directive and the Clinical Trials Regulations, 2004- only one ethical review per state

The site specific assessment (SSA) form (Form 3) must also be completed and submitted

with the standard application form and supporting documentation in order for an application

to be valid.

In the case of a single-centre clinical trial, SSA form completed and the “Declaration of the

Chief Investigator/Investigator” should be signed by the Investigator at that site.

In the case of a multi-centre clinical trial, the SSA form should be completed and signed by

the Investigator at each site in Ireland, (i.e. one for each site).

The Investigator at each site must forward the SSA form to the Chief Investigator of the clinical

trial. The Chief Investigator should submit all of the SSA forms, together with all other

supporting documentation.

An application for an ethical review will not be valid unless the SSA form for each of the

proposed sites has been submitted.

DOHC Guidelines 2007

2.3 Seeking Permission from the Site to conduct a

clinical trial The Investigator at each site responsible for obtaining permission for the clinical

trial to be conducted at his or her specific site from the site CEO or person acting on

his or her behalf.

It is the view of the Supervisory Body that the SSA form contains all the

necessary information required by the CEO or person acting on his/her behalf

to decide whether to give permission for the clinical trial to be conducted at

the site.

The CEO or person acting on his/her behalf is only being asked to decide

whether the site has sufficient facilities, personnel and resources to conduct

the particular clinical trial at the site.

Where aspects of the clinical trial conflict with the particular ethos of the site, the

CEO or person acting on his/her behalf cannot request any changes be made to the

clinical trial. He or she can only grant or refuse permission for the clinical trial to

take place at that site.

DOHC Guidelines 2.3- continued

If the CEO or person acting on his/her behalf is satisfied that the site is in a

position to conduct the clinical trial then he or she should sign the

Declaration of CEO or person acting on behalf of CEO” and return it to the

site Investigator (Chief Investigator in the case of a single-centre clinical

trial). In the case of a multi-centre clinical trial, each site Investigator must

forward the SSA form signed by the CEO or a person acting on his/her

behalf to the Chief Investigator who must then forward them to the REC for

its file.

A clinical trial cannot commence at a site until the CEO or a

responsible person acting on his/her behalf at that site, signs the

“Declaration of CEO/ person acting on behalf of CEO” at the end of the

SSA form. This is the case irrespective of whether the REC gives a

favourable opinion on the trial for that site.

DOHC Guidelines 2.3- continued

The timelines set out in the Clinical Trial Regulations do not extend to the

CEO or to the person acting on his/her behalf and the REC does not need

the SSA Form (Form 3) with the box entitled “Declaration of CEO/ person

acting on behalf of CEO” completed, in order for an application for ethical

review to be validated.

However, in keeping with the spirit of the Directive and the Regulations,

CEOs and persons acting on their behalf, are strongly urged to make a

decision and to complete the SSA form as early as possible.

Potential areas for further

discussion/action – Agreed defined Checklist and process for

SSA/Hospital Approval

– Are any supporting documents required ? – if so

– Definition of the requirements of each support document

– Fit for Purpose

– Not a regulatory/ethics review

– Harmonised Clinical Trial Agreement Template?

– Elements e.g. Indemnity

– Forum for support and sharing of “best practice”

Thank you for your attention

www.MolecularMedicineIreland.ie

MMI – Enabling Clinical & Translational Research