“The participation in clinical trials is essential if we want to move the field forward and bring new and better MS therapies into clinical practice. Therefore it is essential for MSers to be an integral part of the research process and for them to be actively engaged with the clinical trial process. Part of the function of this blog is to inform you about new and upcoming trials and the results of MS trials when they become available.”
Epub: Maida et al. Overcoming recruitment challenges in patients with multiple sclerosis: Results from an Italian survey. Clin Trials. 2014.
BACKGROUND: Recruiting MSers for randomized clinical trials is still extremely difficult. While there has been much research in oncology patients, no previous studies have consistently addressed specific factors affecting the willingness to enroll in multiple sclerosis trials from the MSer’s perspective. To this end, we conducted an exploratory study to assess the related factors and to find ways to improve recruitment.
METHODS: This is a single-center, observational study involving 352 consecutive outpatients followed at one site in Italy. MSers completed the Enrollment Problems Questionnaire and Beck Depression Inventory.
RESULTS: Over 50% of the MSers would consider participating in a randomized trial. Willing patients are frequently older, with no children, have a diagnosis of secondary progressive multiple sclerosis, and have already participated in clinical trials. MSers’ choices were positively influenced by expectations of having (a) a greater chance of cure, (b) an unavailable drug, (c) a specialist’s care, and (d) the chance to contribute to medical research. Willingness was significantly increased by the use of optimistic language and practical/psychological assistance during the decision-making process.
CONCLUSION: MSers’ willingness to participate in a randomized trial is mainly related to both altruistic and individual considerations, as well as to a greater chance of specialist/improved care. More effective information flow and an effective, long-standing patient-physician relationship may improve recruitment overall.