Welcome to our fifth ACTA STInG Newsletter, and our first newsletter of 2020. While we realise that this is not an easy time for you all, and for research in general, we hope you and your families are all well, and that you are managing to keep your projects progressing. In some ways it is an exciting time for research, with many new and important trials on COVID-19, which are presenting different challenges and promoting global opportunities for collaboration.
The Executive Committee of ACTA STInG continues to move forward with developing our ‘Find an expert’ statistician page and expanding the resources on Data Safety Monitoring Boards (DSMBs) - see below or the ACTA STInG website for details. If you have any comments or suggestions on current initiatives or ideas on future initiatives, please drop us an email at sting@clinicaltrialsalliance.org.au.
We are keen to continue our outreach and support for statisticians working on clinical trials across the country, so if you know of any colleagues who might be interested in connecting with other statisticians please encourage them to join STInG here. Multidisciplinary networks can inform, educate, enlighten and challenge us, so we would also like to encourage STInG Members to consider becoming members of ACTA. You can find Membership details here https://clinicaltrialsalliance.org.au/membership/
We hope you enjoyed attending our events earlier in the year but, to comply with social distancing measures that are keeping our communities safe, future events will be web-based. We are planning a lively program of webinars with discussion for the membership. We look forward to seeing you online.
Kind regards,
The ACTA STInG Executive Committee
Initiatives/news
Find an expert / DSMB mentoring plan
Last year we invited you to participate in a survey to support the development of a ‘find-a-statistical-expert’ consisting of a list of statisticians willing to be contacted by other statisticians within ACTA STInG for advice or guidance about trial statistical issues, a list of statisticians who would be willing to serve on a Data and Safety Monitoring Board (DSMB), and a DSMB statistician mentoring scheme. Thank you to all who completed the survey. Out of 128 STInG members, we received a total of 46 (35%) responses. We are currently working with ACTA to create a searchable restricted access webpage for the two lists and we are developing plans for the mentoring scheme. Stay tuned for the launch of all of these things later this year.
Upcoming STInG Award
Nominations are still open for the ACTA Trial of the Year, ACTA STInG Excellence in Trial Statistics Award and the ACTA Consumer Involvement Award. The nominations have been extended until COB 20 May 2020, that's International Clinical Trials Day. The ACTA Clinical Trials National Tribute and Awards Ceremony will take place later this year. Guidelines and nomination forms can be found here here.
Past events
Workshop - Pragmatic randomised trial designs for evaluating health policy and practice change interventions (November 2019)
Hosted by VicBiostat in partnership with Melbourne Academic Health Centre (MACH), Monash Partners and ACTA, this workshop was developed to assist policy-makers, clinician researchers, early career researchers and biostatisticians to understand the options and merits of various pragmatic randomised designs to evaluate the impact of health policy and practice change interventions.
The workshop emphasised the stepped wedge design, which combines rigorous scientific evaluation of the effect of an intervention with policy or practice implementation at scale.
Speakers included two international presenters - Prof Karla Hemming (UK) and A/Prof Monica Taljaard (Canada) - along with local experts in the field - Prof Andrew Forbes, Dr Jessica Kasza and A/Prof Joanne McKenzie.
The three-day workshop was well received, and the audience appreciated the technical as well as non-technical aspects of the workshop.
Workshops – Bayesian adaptive trials (December 2019)
The workshop was developed by Telethon Kids Institute in partnership with ACTA and sponsored by Telethon Perth Children’s Hospital Foundation. The aims of the workshops were to help researchers and statisticians gain knowledge and practical skills to design simple (Day 1) and more complex (Day 2) Bayesian adaptive trials using a combination of lectures, trial simulator tutorials in R and small group exercises to illustrate response-adaptive randomization and defining trial decision rules.
The workshops were run in Perth by Bayesian clinical trial experts Ben Saville, PhD, Anna McGlothlin, PhD from Berry Consultants (Texas, USA) and Mark Jones and Julie Marsh, PhD, from Adaptive Health Intelligence, Telethon Kids Institute (Perth, AUS).
They were attended by 40 participants, who appreciated the opportunity to learn from the leading experts in Bayesian adaptive trial design and network with like-minded trialists from across the country.
Workshops - Bayesian adaptive randomised clinical trials workshops - Melbourne and Sydney (February, March 2020)
Hosted by ACTA, VicBiostat and AusTrim, the two days workshops focused on methods for the design and analysis of adaptive clinical trials with a particular emphasis on complex clinical trials for personalised medicine. The workshop illustrated methods for designing innovative trials that improve the efficiency of the current experimental architecture for testing novel treatments. Statistical methods for platform studies were presented and real examples were used to illustrate how Bayesian adaptive designs work.
International experts in Bayesian adaptive trials, Dr Lorenzo Trippa and Dr Steffen Ventz conducted the workshops, which were held in Melbourne and Sydney.
The workshops were attended by 55 attendees and the audiences appreciated the international experts’ knowledge and experience as well as the workshop program.
More details can be found here
Webinar - DSMBs for Adaptive Trials (April 2020)
ACTA hosted a webinar on the considerations of a DSMB for adaptive trials, in conjunction with Dr Scott Berry and Dr Michelle Detry from Berry Consultants, who are world-leaders in the design, conduct, analysis and reporting of investigator-initiated as well as commercially sponsored adaptive trials.
The webinar outlined issues associated with composition, role and processes for the DSMB as well as issues related to pre-specifications in the trial protocol, the DSMB charter, the statistical analysis team and the trial management team. It was aimed at clinical researchers, clinical trialists and statisticians.
The webinar wrapped up with a lively Q and A session, providing the audience an opportunity to interact with Scott and Michelle.
Further details, including the presentation and a recording of the webinar can be found here
Future events
Registry Randomised Trials Key Methodology Workshop
On Tuesday 19 and Wednesday 20 May, ACTA’s Innovative Outcome Data reference group is hosting a virtual workshop across two half-days for key stakeholders to address barriers to uptake of registry randomised trials.
This event will provide a forum for trialists, registry scientists, statisticians, healthcare managers, healthcare policymakers and consumers to exchange experiences, best practices and ideas related to current and emerging issues associated with registry randomised trials.
If you have questions about this workshop please contact anitha.b@clinicaltrialsalliance.org.auFind out more and register here
ACTA STInG Meetings
There are currently no plans for a face-to-face meeting of ACTA STInG due to the current COVID-19 health emergency, but we will plan a meeting as soon as things get back to normal – please keep an eye on the website for information.
Other news
The European Commission, European Medicines Agency (EMA) released guidance for sponsors that may need to adjust their clinical trials during the COVID-19 pandemic. The guidance can be found here.
The US Food and Drug Administration (FDA) issued guidance to help sponsors assure the safety of trial participants, maintain compliance with good clinical practice (GCP) and minimize the risks to trial integrity during the COVID-19 pandemic. The guidance can be found here.
The World Health Organization (WHO) has issued a novel Coronavirus COVID-19 Therapeutic Trial Synopsis. The document can be found here.
ACTA is tracking any key information or guidance updates relevant to clinical trials and distributing them via their newsletter list. They are also collating them on the ACTA website.
Other events
Beyond COVID-19: A solution-focussed forum
As an extension of the COVID-19 updates ACTA has been providing for the clinical trial sector, we have created a COVID-19 forum with collaborators PRAXIS, ARCS and CT:IQ.
The forum is designed to be a place where researchers can readily seek and share information related to clinical trials and the impact of COVID-19.
We will be launching Beyond COVID-19: A solution-focussed forum on International Clinical Trials Day, Wednesday 20 May with a special online event from 1.30pm to 2.30pm AEST, but we welcome members of ACTA STInG prior to the official launch.
We invite you to join the forum, ask questions and contribute to the discussion with other experts across the sector - simply register to post.
The forum is a little hidden away until we officially launch it, but you can find it at https://clinicaltrialsalliance.org.au/forums/
Social media and membership
To know more about ACTA and ACTA STInG, please follow us on Twitter here, Linkedin here
To become an ACTA Member, please visit https://clinicaltrialsalliance.org.au/membership/
Or subscribe to the ACTA newsletter at https://clinicaltrialsalliance.org.au/about-acta/