Pain Relief for Irritable Bowel Syndrome
TLS is collaborating with NV Rose to develop a non-opioid analgesic to alleviate pain episodes associated with IBS. All IBS sub-types will be considered for this study; IBS-D, IBS-C and IBS-M/A. We are focusing on pain episodes – whatever the type and duration. This trial study will evaluate the analgesic efficacy of ROSE-010 compared to placebo and will evaluate pain response to treatment.
We are seeking feedback in key areas of the trial, including:
- Primary and Secondary Endpoints
- Inclusion/Exclusion Criteria
- Nature and Severity of Symptoms
- Study Population and Enrollment Criteria
- Duration of Trial
- Mode of Drug Delivery
- Trial Design
- Safety/Regulatory Concerns
- Use of Wearable Devices and Video Visits
An Opportunity for Publication
All participants will be able to review and comment on drafts of the protocol as they are produced. Participating in this crowdsourcing project also enters you into a friendly competition among the research community. When we identify the researchers who have provided the best input for a certain section of the survey, we will name up to three winners of the section.Protocol Builder Results
Our goal is to assess patient expectations for remote measurement techniques in clinical trials for IBS, and we'd also like to evaluate patient willingness and levels of trust in this new type of clinical trial.
We're seeking input from researchers about various aspects of the trial in order to ensure optimized results and patient experience.
We are asking patients to share information about their backgrounds with IBS, which will be aggregated so that we can make the trial as comprehensive as possible.
We are asking for researcher input regarding demographic criteria in order to ensure the patient population is properly suited to the trial.
We are interested in patient willingness to take medication through various methods.
We are seeking researcher feedback on the dosing schedule as it relates to the overall trial design.
We want to hear about patient experience with various telemedicine devices, as well as their level of comfort using such devices in a medical context.
We are seeking researcher feedback regarding the efficacy of using telemedicine devices in a clinical trial in terms of patient convenience and safety.
We want to make sure that we address patients’ concerns about safety and comfortability with this new type of trial design.
We ask researchers to provide insight into trial safety, especially in the context of telemedicine.
We want patients to share any ethical concerns they might have about this trial, especially those related to telemedicine devices and data privacy/security.
We are looking for researcher insight that will allow us to best optimize our regulatory strategy for this trial.