The International Clinical Trials Methodology Conference (ICTMC) was held on the 6th - 9th October 2019 and gives people who work in Clinical Trials the opportunity to network and discuss the current issues within trials and trials methodology. Many members of the SITU Team attended this brilliant training opportunity and have collated moments from the conference.
ICTMC – Data Perspective (Heidi Fletcher)
The conference gave me a great insight into what other people working in Clinical Trials are doing, and it turns out we are all doing similar things! A lot of the talks were about quantifying what works best. I came away with some good ideas. Here are some of my favourite talks:
- Using systematic data categorisation to quantify types of data collected in clinical trials. They looked at several trials and categorised the data e.g. primary, secondary, protocol compliance and discovered that the primary outcome accounts for the smallest number of data items and secondary is often the largest. No big surprise, but it does highlight that often as data managers we are spending a lot of our time on data that is not the primary outcome.
- The use of regular text messaging over one year to collect primary outcome data in a randomised controlled trial. For this trial they were asking a single question collected weekly. They found that the majority of participants indicated a preference to respond via text message, rather than phone calls and the response rate was better using SMS.
- The importance of communication and teamwork in achieving high quality data in clinical trials. This was about communicating with sites during the query process. They found that often sites didn’t understand the priority of responding to data queries in time for a DMC meeting, and so they produced an infographic to show the data query workflow and to explain the importance of the DMC.
ICTMC - Trial Management perspective (Molly Glaze)
Pilot and Feasibility Studies - Pilot and feasibility studies are needed to answer whether a trial can be performed successfully. The conference was a great opportunity to learn more about this important area in clinical trial methodology.
A couple of highlights for me were:
- Internal pilot progression criteria. One of the talks discussed the importance of clearly defined progression criteria from which to measure the success of pilots within trials. These clear targets make it easier to determine how the trial design is working in practice and form a stronger evidence base for changes in study design.
- Consent in feasibility studies. One talk highlighted that patients often consent to studies so that a treatment comparison will be made, and potentially cause a change to NHS care. This isn’t the case for pilot and feasibility studies, we are only answering whether a comparison can be made. Those who have informed consent discussions with patients in pilot and feasibility studies need to make this difference clear in order to ensure participants are truly giving informed consent.
One speaker quoted a Ghanaian proverb: You never test the depth of a river with both feet. The talks and posters on pilot and feasibility studies (including ours!) were a helpful reminder that this advice is being followed in clinical trials, and is leading to a strong, evidence-based methodology.
Some snippets from The International Clinical Trials Methodology Conference #ICTMC2019 - @SITU_Oxford
"What the team do whilst at a seaside conference." Trip to the beach!
Dr Janet Dancey opening with the first of many exciting presentations about data.
A truly inspiring, personable and powerful Doug Altman Memorial Keynote Lecture by Marion K Campbell. She argues the strengths and limitations of RCTs VS Real World Evidence, and proposes strategies for moving towards this. Many looked up to Altman who was described as a 'stats super-hero', 'true opinion leader', and 'generous friend' leaving the audience, including SITU members, feeling moved.
An interesting talk from Ines Rombach about how well binary outcomes are analysed and the findings reported.
Professor David Beard, Director of SITU, gave the final keynote speech at ICTMC 2019.