​ARCS Summit Round Up - Stream 'C'

Innovations in clinical trials: Beyond COVID-19

C1. Road map to innovation – opportunities for realigning research ethics and governance

COVID has presented the Australian research ethics and governance landscape with a trans-formative opportunity to realign processes.

KEY POINTS:

The 7 principles to guide realignment of ethics and governance include:
  • Non-parochialism

  • Pragmatism, flexibility, creativity

  • Proportionality

  • A focus on the needs of users and ‘downstream stakeholders’

  • Consultation, engagement and coordination

  • Strong, thorough and continuous workforce and user training

  • Continuous review and a commitment to process improvement


COVID has been the catalyst

for driving tele-trials and guidance documents and national SOPs are being prepared.

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COVID has facilitated the acceptance

of electronic signatures (for clinical trial agreements) and e-consent; and there’s been an increase in remote monitoring (however sites are at different stages of digitisation).

HRECs and research governance offices

are adopting innovative processes to ensure rapid re-views in the COVID era, which will improve efficiencies and outcomes post-COVID.


CONNECT WITH YOUR SPEAKERS:
Melissa Hagan
Suzanne Hasthorpe
James Cokayne
Jeremy Kenner
Bernadette Swart
Sonia Hancock



C2. Road map to innovation – opportunities for realigning research ethics and governance


COVID has resulted in improved ethics and governance processes. Session C2 is the “Road map to innovation – opportunities for realigning research ethics and governance”.

KEY POINTS:


COVID has accelerated

initiatives already being proposed in the areas of workflow; communication; streamlining processes; virtual HREC meetings; streamlining meeting procedures; hold-ing extraordinary HREC meetings for COVID studies; electronic signatures; e-consent; electronic submissions and approvals; and central repositories of all requested documentation.


One of the Ethics challenges in COVID

has been the lack of regulatory/institution guidance regarding the requirements of safety/background data required for early phase COVID treatment or vaccination trials.


Changes to how Ethics applications are processed

have included a focus on decreasing the du-plication of reviews (eg by combining both ethics and governance responsibilities); streamlining communication; increased frequency of Ethics Committees and expedited reviews for COVID studies.


CONNECT WITH THE SPEAKERS:
Liz Wilson
Sianna Panagiotopoulos
Katrina Brosnan
Jan-Louise Durand
Tam Nguyen




C3. The ‘E of everything’ – A panel discussion covering what is new, what has changed and what the future holds in the eClinical research area


The ‘E of everything’ is Session C3 at Wednesday’s ARCS Summit:

KEY POINTS COVERED INCLUDE:


E-consent and E-signatures are becoming the new norm.

GCP allows for e-consent ie it doesn’t have to be a ‘wet ink signature’.

The benefits of executing Clinical Trial Research Agreements (CTRAs)

using electronic signatures include: reduced delays; reduced costs; enhanced security; and is aligned with Government-derived requirements and Safe Work principles (health risks).


eConsent is a major advance for ‘informed’ consent.

“Information about research

should be presented to participants in ways to support them to make good decisions about their participation, and support them in that participation”. In this regard E-documents (using an entire suite of technology) provide advantages over written documents.


eConsent allows under-represented populations to be reached.

The uptake in E Consent

will be the catalyst for enhanced Digital Patient Engagement.


CONNECT WITH THE SPEAKERS:
Aaron Davis
Leanne Weekes
Karla MacKenzie
Nik Zeps
Roberta Lusa



C4. Clinical trial innovation in times of change


COVID has been the catalyst for tremendous innovation. Session C4 of the ARCS Summit dis-cussed these key points:


There’s been an increase in COVID related research in the Sydney LHD in mental health

(predictors of psychological distress and psycho-social impact of isolation), immunology (maintaining immunological memory to mild and moderate COVID disease) and screening (serological evidence of COVID infection in household contacts and healthcare workers).


FDA has provided guidance

on how to manage trials impacted by COVID including the management of underpowered studies because of poor patient recruitment.


Queensland initiatives include:
  • The New Normal Project team

  • A Mobile Task Force

  • The Queensland Clinical Trials Portal (www.clinicaltrialsqld.com)


The TGAs GCP Inspection pilot program

was discussed, and is being extended for remote inspections of COVID vaccine trials


Further industry innovations discussed included:
  • Remote monitoring

  • E-signing

  • More risk-based monitoring

  • A new way of working

  • The Shared Investigator Platform


CONNECT WITH THE SPEAKERS:
Teresa Anderson
Maureen Davis
Luke Edington
Katherine Clark
Roberta Lusa
Bernadette Morris-Smith



C5. Clinical trials landscape 2021 and beyond

“COVID has forced Clinical Research to become more innovative and these innovations are here to stay” is the main theme of Friday’s C5 Session: Clinical trials landscape 2021 and beyond.

KEY POINTS:


COVID has accelerated

the need for the virtualisation of clinical trial monitoring.


Innovations have included

remote monitoring strategies with central statistical monitoring, central data monitoring and remote source review.


The technologies ensure

oversight of patient workflows, communications, study finances, data quality, monitoring, and regulatory compliance from any geographic location.


Synergistic technology tools

provide transparency, increase collaboration, help improve clinical trial data outcomes and maintain patient centricity.


Next-generation analytical tools and algorithms

are being leveraged to support remote monitoring and maintain oversight.


Tools can automate reminders

provide alerts and enable real-time oversight to ensure compliance with regulatory guidelines.



CONNECT TO THE SPEAKERS
Brian Barnes
Candida Barlow MSN, CTN, RN
Jon Carrano