Community – Trial Integrity – Stakeholder Synergy – New Paths
The MIHRA CTSN is a community of newly emerging and long-established research sites in Myositis-related disorders. (See below to register!)
The MIHRA CTSN enables mapping of global site resources to inform feasible and efficient clinical trials design and development.
The MIHRA CTSN serves as a community-based platform for trial sites to learn from each other and to support global growth of resources for optimal clinical trial implementation.
Community:
MIHRA CTSN was incepted as an equitable community strengthening project in 2017 awaiting an infrastructure (MIHRA!) that could support a de-centralized inclusive infrastructure. CTSN provides community trial education on logistics of set-up, initiation and navigating impairments through didactics, routine forums, special event forums and community mentorship.
The CTSN is a solution-oriented community that harnesses shared experiences and collective problem-solving to address the many hurdles and challenges inherent in trial set-up, resources and implementation. The CTSN community members work together to address individual and collective concerns regarding conducting sound, equitable, and feasible clinical trials.
The MIHRA CTSN proactively highlights inclusion, cultivation and support of new trialists which is crucial to rare disease research. MIHRA CTSN is dedicated to assisting new sites in strengthening site operations, resources and capability.
All revenue generated by the MIHRA CTSN is invested back into the global myositis research community in the form of research grants for collaborative research projects, fellowships, career enhancement and MIHRA vital programming that benefits all myositis stakeholder groups.
Trial Integrity:
Rare disease trial success demands averting costly delays in set-up, initiation, and enrollment. MIHRA CTSN trial site mapping enhances clinical trial success through expeditiously matching trial designs with member site capabilities with subsequent outreach to potentially appropriate sites.
The MIHRA CTSN maintains an updated database of individual site characteristics and capacity to ensure feasibility of trial design by mapping proposed trial designs to community capacity to project an accurate picture of enrollment. In this capacity MIHRA CTSN provides assistance in revision of trial designs.
An arm of the MIHRA CTSN is dedicated to improved clinical trial readiness in IIM diseases to ensure phenotypic inclusion as well as reliable, sensitive and discriminatory outcome measures that accurately assess therapeutic responsiveness.
Stakeholder Synergy:
The myositis community of stakeholders are comprised of patients, clinical researchers at all levels, patient organizations, biotechnical researchers and industry sponsors.
An important goal of the MIHRA CTSN is to cultivate interest, confidence and competence in clinical trial participation. Therefore, MIHRA CTSN is particularly and proactively welcoming to sites newly interested.
MIHRA CTSN works to coordinate the global voices of scientific and patient experts as well as industry to comprehensively inform feasible, efficient and successful clinical trial designs with sound outcome measures.
MIHRA CTSN protects, promotes and fortifies achieving the goals of each stakeholder community thus ‘Creating a World Where We Cure Myositis Together’.
New Paths Forward in Rare Disease Research:
MIHRA and the MIHRA CTSN are dedicated to carving new paths in rare disease research. MIHRA CTSN mapping also allows for a time when less resource rich sites might have improved access to devices, equipment and staffing.
MIHRA is applying as a central IRB through SMART IRB. In this role MIHRA is committed to becoming a trusted partner working with global regulatory entities to help expedite clinical trial approvals and initiations.
MIHRA is dedicated to working with other rare disease organizations to build special time and cost-saving pathways for rare disease study set-up and implementation across nations and institutions.
Many thanks to the MIHRA CTSN leads: Drs. Antonia Valenzuela & Lesley Ann Saketkoo AND to the MIHRA CTSN Advisory: Drs. Helene Alexanderson, Karen Cheng, Marianne de Visser, Mazen Dimachkie, Kristin Highland, Pedro Machado, Chester Oddis, Julie Paik, & Victoria Werth for coordinating this effort.
MIHRA Clinical Trial Site Network – Request for Registration Form
MIHRA CTSN – FAQs
Who can register for MIHRA CTSN membership?
MIHRA CTSN registration is open to any investigator or team interested in participating in clinical trials. MIHRA CTSN is a community of seasoned trialists as well as newly established and even not yet established sites. The goals of MIRHA CTSN are to accelerate clinical trial readiness and sound clinical trial design.
All MIHRA CTSN members must first be MIHRA community members.
MIHRA CTSN investigators provide each other with insight and support – and collectively we solve challenges experienced across all levels of investigator expertise as well as across various national and institutional circumstances. In this way, investigators learn from each other and together streamline efficiency and success in myositis trial implementation.
MIHRA CTSN accepts membership from industry, as productive dialoging about trial challenges involves multiple stakeholders. However, some events will be limited to investigators and patient experts depending on the context. The industry registration option will be found on the registration intake form. MIHRA Patient Advisory Board who are comprised of patient experts and advisors as well as MIHRA Partner Organizations are members of the MIHRA CTSN. MIHRA CTSN is dedicated to inclusivity, accessibility and cultivating global expertise.
What is the cost to be a MIHRA CTSN member?
MIHRA CTSN registration is cost-free. MIHRA CTSN is dedicated to inclusivity, accessibility and cultivating global expertise.
How does our research team register for MIHRA CTSN membership?
MIHRA CTSN registration is a two-step, but very simple, process of 1. requesting the registration form (see above request form) and 2. completing the intake registration form via a unique link for your team. The reason for the two-step process is two-fold: (a) to ensure only ONE submission and designated contacts occurs for each research team and (b) by controlling who received the registration form is another layer of protection in the CTSN database.
Can I still be a member if my team is not yet doing clinical trials?
Absolutely. MIHRA CTSN promotes new clinical trial interest and supports ‘learn before you build’ as well as ‘learn as you build’ approaches. If your site is not yet doing clinical trials but interested, we encourage you to request a registration form (see above request form) and when you receive the actual intake form, select your status and be sure to let us know about your specific interests in myositis clinical trial research. Additionally, CTSN sites are anticipated to grow in capability and capacity, thus your site’s profile can be always be updated through your unique profile link or by contacting one of the MIHRA CTSN leads.
Why is the MIHRA CTSN registration a two-step process?
MIHRA CTSN registration is a two-step, but very simple, process of 1. requesting the registration form and 2. completing the registration (see above request form). The reason for this is two-fold: (a) to ensure only ONE submission and designated contacts occurs for each research team and (b) by controlling who received the registration form is another layer of protection in the CTSN database.
What makes the MIHRA CTSN unique in myositis research?
MIHRA CTSN was incepted in 2017 by the myositis community and for the myositis community. The CTSN is a MIHRA vital program, it is owned and run by the global myositis research community under MIHRA’s 501c3 non-profit status as a charitable research organization. MIHRA CTSN is thus de-centralized, supports global visibility and inclusion. MIHRA CTSN is not a self-interested or single institution promoting enterprise.
MIHRA CTSN is designed to accelerate and elevate global clinical trial readiness and to use its generated revenue to support sustainable, collaborative research and career enhancement across the global myositis community members.
What if my institution has two or more distinct research groups in myositis?
We understand this is rare but a significant issues for some institutions. This might occur for example, if the dermatology and rheumatology run myositis trials separately. In this case, each distinct research group from the same institution will submit SEPARATE requests for MIHRA CTSN registration (see below request form).
What if our site’s capacity, capability or team members change after we register?
Each research team will receive a unique link to be able to update their profile at any time; and are also welcome to to contact the MIHRA CTSN leads for assistance with this.
When our trial site signs up for CTSN membership, will all of our site’s team members receive notifications of CTSN news and special events?
Yes. In the registration form, there will be the opportunity to list each member of your site’s team(see above CTSN membership request form) members. Each member listed will receive announcements for MIHRA CTSN events. However, only the primary site contacts will receive requests to update the site’s profile.
Do we have to be MIHRA or CTSN members to attend the CTSN Rare Diseases Events?
For our general rare disease trial events which are often coordinated with other rare disease research groups, it is not necessary to become a MIHRA or CTSN member – though we always welcome membership.
Do we have to be CTSN members to attend MIHRA CTSN Myositis Specific forums?
We are still deciding on this; but for now, we are asking attendees to myositis trial specific events, such as forums, didactics and informationals, to be both MIHRA and MIHRA CTSN (see above request form) members.