Question 1

How many arms are there on the trial?

Accepted Answer

Currently there are 4 arms being recruited to; 002 – Bencentinib, 003 – MEDI3506, 004 – Acalabrutinib and 006 – Zilucoplan.
Arm 005 has had some start-up work completed by sites but is not being pursued at this time and there is a committee that reviews other drugs that may be of interest to the ACCORD platform.

Question 2

Do sites only have the option to take part in one arm?

Accepted Answer

No, sites can open two arms at the moment. IQVIA colleagues have worked hard with new and existing sites to open arm 003 and arm 006 at as many hospitals as possible due to a re-focus on enrolment for the study.

Question 3

Who is running the study?

Accepted Answer

The study is being run in a new hybrid for non-commercial research as there are many stakeholders. 
Funding is provided by UK Research and Innovation (UKRI) who are a national funding agency, the study is sponsored by University Hospitals Southampton, where the CI Tom Wilkinson is based.  IQVIA are supporting many of the operational site tasks including site set-up, monitoring and data management.

Question 4

We don’t have the patient population at the moment, will we be penalised?"

Accepted Answer

Absolutely not. The ACCORD platform team are well aware that numbers on incidence are falling everywhere in the UK and the NIHR have scrapped metrics for the time being  which sites have found a help in lifting some of the usual pressures.  We hope to have sites open and prepped in case on local incidence and also any surges that may occur.

Question 5

Our patient is unsure about taking part in research, what can I do?"

Accepted Answer

The NIHR website have some fantastic videos about COVID -19 research (https://bepartofresearch.nihr.ac.uk/COVID-19-Research/Public-Resources/#Barts%20-%20interventional%20video%20COVID-19)and consent that you could share to explain things further.

Question 6

What if my patient doesn’t read or understand English well enough?

Accepted Answer

We are presently having all the patient information sheet’s translated into 12 different languages.  Advice on the languages required for translations was taken from sites but if you feel we have missed an important one for your area please let your CRA know.

Question 7

What can we do to consent a patient if we have poor connection on wards?

Accepted Answer

Paper Patient Information Sheet (PIS) is the only other option at this time but the recent amendment to study documents has now made this a much shorter document and so hopefully more patient friendly.

Question 8

My patient is put off by the amount of blood needed to be taken, what can I do?"

Accepted Answer

The CI’s on the sub-protocols have stated that only the safety blood work is absolutely necessary.  The research blood work is a “nice to have” and if a patient is put off by the amount of blood they are being asked to give then the research samples need not be taken.

Question 9

Which other studies can we co-enrol to?

Accepted Answer

Presently Recovery-RS and 2 arms of REMAP-CAP have agreements for co-enrolment.  Should other options be agreed in the future the information will be cascaded to each site.

For site staff