Device Consortium Pushes for Stronger Patient Voice in Trials
Despite all the hoopla about patient engagement, the fact is that the industry is still not really engaged. Recent surveys show more than 80 percent of industry respondents never seek patient input as part of protocol development and almost one-third estimated they sought such input less than 25 percent of the time.
In a 45-page report released last week, the Medical Device Innovation Consortium (MDIC), a partnership of the FDA, NIH and several pharma heavyweights, presented a roadmap of tactics trials can use to increase patient involvement.
MDIC suggested that when researchers engage patients about participating in a trial that they include a discussion about the applicability of exclusion criteria, on the grounds that some criteria may be unnecessarily preventing patients who are otherwise willing to participate.
Patients and advocacy groups should be adequately compensated for their participation in a trial, and a transparent communication plan between them and researchers is essential, MDIC said. It added that clinical trial participants or advisers could continue to play a positive role in supporting interpretation of a study’s findings, and reminded researchers that the process of patient engagement doesn’t end once the patient’s insights have been recorded and evaluated — it may be necessary, for example, for researchers to reconcile patient input with input from other stakeholders, especially if the feedback from both groups are not aligned or are in conflict with each other.
MDIC has 64 members, including Johnson & Johnson, Medtronic, Siemens, Philips, Danaher and Becton Dickinson.
Read the MDIC report here: https://bit.ly/3mtLoIX.