What's the answer to issues with incomplete clinical trial data?
As Sanofi Clinical Study Director, Maarten Boomsma understands the importance of maintaining the integrity of Clinical Trials very well indeed, and his Case Study on the subject today was an object lesson. Poor practice or misconduct can devalue months or even years of hard work and ingenuity. At what point must we draw a line and say incomplete data is too big an issue to bypass?
At Conversis it’s our pleasure and privilege to work with clinicians who play by the rules, but even when we do exactly that, issues with incomplete data persist.
What happens when the distribution of observed data delivers notably different results from distribution of complete data? We can address these problems at source by doing everything possible to keep patients engaged and drastically cut dropout rate, and first we must understand the key reasons why patients drop out of trials. The individuals concerned may have medical issues that stop them participating. Or they may be dependent on a spouse for transportation, and if that person develops problems of their own the knock-on effect will be swift. By far the biggest issue, though, is trial protocols that simply aren’t patient-friendly. Maarten Boorsma’s thoughts on how to sidestep this problem were well-received:
Is your clinical trial providing an active drug at a certain time for all patients?
Are you focusing on a primary end point at the earliest possible date?
How well are you choosing your outcomes? Are you avoiding invasive procedures? Are you focusing on a small number of outcomes to avoid stretching the patient’s goodwill and confidence?
Are you allowing for dose reduction to give patients suffering adverse effects a period of recovery?
Are you considering temporary discontinuation with a view to resumption in due course?
The more flexible we’re prepared to be at the outset, the more likely we are to achieve meaningful results at the end. When Sanofi announced positive results from their Soliqua diabetes trial this summer it was the result of hard work and good choices at every stage of the research, development and trial process. Clinicians considering Soliqua as part of a personalised treatment plan for diabetic patients have solid, verifiable data to inform them. That’s all we can ask for. Yes, prevention of excess data loss and patient dropout is both essential and achievable. And with prevention comes the possibility of cure. Thank you to Maarten Boomsma for sharing that positive message today.
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