As an academic researcher, I am familiar with the confusion and “finding your way” feeling that can be associated with developing, delivering and reporting on a clinical trial.
While the research questions and ideas can be novel and ambitious, some of the more challenging questions can often be found in teasing out the methodological issues that surround a clinical trial. These trial methodology issues heavily influence the success, or otherwise, of a trial.
The new Health Research Board-Trials Methodology Research Network initiative
In Ireland, a new initiative has been established recently, which hopes to address these critical issues in clinical trials. The Health Research Board-Trials Methodology Research Network (HRB-TMRN) is funded by the Health Research Board in Ireland and is a collaborative partnership between six higher level academic institutes; National University of Ireland (NUI) Galway, University College Cork, University College Dublin, Trinity College Dublin, Queens University Belfast, and now the University of Limerick.
Under the direction of Professor Declan Devane, NUI Galway, our network aims to address the methodological issues around clinical trials; from deciding the research question, to exploring the best options for conducting a trial, and synthesizing trial evidence in a bid to directly improve healthcare in Ireland.
Our network works in close partnership with the five university-based Clinical Research Centers / Facilities and with Clinical Research Coordination Ireland (CRC-Ireland). The HRB-TMRN has also expanded its collaborative links outside of Ireland and we are proud to have working links with the Medical Research Council-Hubs for Trials Methodology Research (MRC-HTMR), TrialForge, the Cochrane Collaboration, and the COMET initiative in the UK.
As with most collaborative efforts, “the whole is greater than the sum of its parts”, a phrase which aptly captures the synergy and support our network has experienced since we started in late 2014.
To date, we have welcomed over 500 trialists, and those interested in improving clinical trial methodology, to educational events taking place across Ireland.
What can the HRB-TMRN offer?
While the research questions and ideas can be novel and ambitious, some of the more challenging questions can often be found in teasing out the methodological issues that surround a clinical trial.
Dr Sandra Galvin
Coordinator for the Health Research Board-Trials Methodology Research Network (HRB-TMRN)
In September, we are really excited to host Ireland’s first (and fully subscribed) Clinical Trial Methodology Symposium in Dublin, which includes a keynote address by Sir Iain Chalmers. This event is one of many scheduled low cost training events to take place over the next number of years.
Other training events include: introduction to the conduct of clinical trials, methodology in medical device trials, health economic evaluation in clinical trials, systematic reviews, behavior change strategies to improve trial success, and our latest is a course on reporting guidelines for grant applications. Our educational activities are delivered with the participant in mind, with many held as online live webinars, and presentation recordings available for download.
Our network relies on the collaborative engagement of researchers, clinicians, patients and trialists coming together to share expertise and relevant knowledge.
The HRB-TMRN offers researchers a range of online supports, including direct access to methodological experts through our Trial Methodology and Reporting Advisory Service. This service is the first of its kind available in Ireland, and provides a central support for trialists who may be spread across a variety of settings.
The simple online application form can be used to submit a methodological request to the network. The focus of this service is to address the non-standard methodological questions encountered in clinical trials.
We also provide access to Ireland’s first searchable clinical trial expertise database (C-TED). This database provides details of individuals that have specific expertise or training. This includes both methodological expertise, but also clinical area specific expertise such as cardiology or nursing. This database allows people to connect easily and identify people to collaborate on grant applications, or informally engage to receive advice.
The scientist is not a person who gives the right answers, he’s the one who asks the right questions.
Le Cru et le cuit, 1964
Involvement in clinical trial methodological research
Our network is also actively engaging with primary methodological research through several paths.
Firstly, the network is delighted to have four funded PhD students based in NUI Galway, University College Cork, Trinity College Dublin and University College Dublin, each involved in a program of research answering fundamental methodological questions related to clinical trials.
Secondly, the network has the capacity to address novel methodological questions in currently active clinical trials by offering funding to conduct studies within a trial (SWAT); for example, the SWAT -1 study that was recently published in Trials, which looked at the effectiveness of a ‘site visit’ intervention on recruitment rates in a multi-center randomized trial.
Thirdly, the network will increase awareness and knowledge in the importance of appropriate methodology among future trialists through the provision of 13 funded summer studentships available in 2016.
So, for those involved in designing, conducting or reporting on a clinical trial in Ireland at any level or in any capacity, there may still be the feeling of “finding-your-way”; however there is now a network that supports this journey and wants to know more about the questions you want to ask, after all:
“The scientist is not a person who gives the right answers, he’s the one who asks the right questions”. – Claude Lévi-Strauss, Le Cru et le cuit, 1964