January 30, 2019
Clinical Research Professionals: Approaches to Informed Consent
The first step of any research study is the informed consent process. Every patient and their family is asked to decide whether or not to enroll in a study through a discussion with site staff and study doctors.
Even though informed consent is important, finding the right balance of enough information at the right time is difficult. Too little information, and the decision isn’t truly informed. Too much information, and the participant becomes overwhelmed. It’s even harder when your participant is a child, or speaks English as a second language, or has limited health literacy.
Researchers at the Michigan Institute for Clinical and Health Research have been working on different ways to make informed consent better. Join the Trial Innovation Network for a webinar on March 20th. You can learn more by visiting the events page.
TRiNDS offers expert clinical operations support to research studies and clinical trials around the world. Contact TRiNDS today to request a quote.
December 20, 2018
Genetic Disorders in Clinical Trials
We specialize in neuromuscular and rare disease clinical trials. The science is fascinating, but there are a lot more complexities than in other types of clinical trials. Many neuromuscular and other rare diseases have genetic causes, which makes everything even more complicated.
It’s important to design your clinical trial protocols to minimize variability in your study population up front. For many TRiNDS studies, that means confirming participants’ genotypes during study screening. Whether you’re testing an investigational product that acts at the DNA or RNA level, or if you need to exclude certain diagnostic subtypes, having expert help is critical.
We offer central diagnostic confirmation services to research projects and all phases of clinical trials. Our licensed genetic counselors combine their clinical training and research expertise to provide consistent review and analysis of test results. After informed consent, sites or central laboratories submit de – identified reports to our team for review. Our genetic counselors interpret the results and inform the site and the medical monitoring team of the participant’s eligibility for the study.
Contact us to request a quote for central diagnostic confirmation services.
December 5, 2018
Early Bird Registration for the MDA Conference Closes Soon
Even though it’s winter here in the US, spring is just around the corner. In April, clinical providers and researchers will meet for the first combined MDA Clinical and Research Conference in Orlando, Florida. This five day conference is your opportunity to learn from the key opinion leaders caring for children and adults with neuromuscular disorders. You’ll hear about the latest research findings, the best ways to implement great clinical care, and connect with your peers working in the field.
But don’t delay – early bird registration closes at the end of December. Learn more about the conference and register today.
November 14, 2018
Frequently Asked Questions: How do You Work With Clients?
TRiNDS is a specialized neuromuscular contract research organization offering expert level support for clinical trials, post marketing studies, and academic research. Our clients are biopharmaceutical companies working to develop new treatments for neuromuscular disorders around the world.
Our approach is to work in partnership with our clients to meet project goals without wasting resources. We set goals with our clients and fit our services to meet their needs. As a smaller CRO, we offer services customized to every project. We work with clients to identify existing resources, systems, and relationships that can be leveraged to support their project. We then add services from one of our five solutions – Clinical Operations, Data Management, Patient Science Liaison, Study Measurements, and Biostatistics.
Are you considering a new clinical trial in neuromuscular or rare diseases? Contact us today to request a quote for the services you need.
November 9, 2018
New Supplements: Duchenne Muscular Dystrophy Care Guidelines
The October 2018 issue of Pediatrics included a set of critical documents for the good care of children with Duchenne Muscular Dystrophy (DMD). The special supplement included a series of 12 articles outlining best practices for multidisciplinary management of DMD. These articles build on the 3-part Lancet overview articles published in January.
Everyone agrees that good DMD care requires close collaboration of different specialty providers across the lifespan. Management of different aspects of the disease require information sharing between providers and families and an adaptive approach to the different stages of the disease.
Be sure to read the new supplement and to share it with your colleagues in your clinics and hospitals. Are you getting ready to launch a research trial in DMD? Be sure that your CRO understands the clinical care your trial patients should be receiving. Contact us today and request a quote for our customized clinical trial support services.
October 31, 2018
Happy Fall from the TRiNDS Team!
Last week, TRiNDS staff travelled to beautiful Central Pennsylvania from all over the country for our annual retreat. We spent two days together to review our company progress, update our annual training, and to plan for the future. We did take some time for play – everyone enjoyed a visit at a local farm including a hay ride and a corn maze.
Everyone finished the retreat energized and recommitted to the work at hand. We are a specialized rare disease contract research organization (CRO) bringing a wide range of services to our clients and their projects. It was exciting to hear about all the projects being supported by TRiNDS – our teams are doing everything from centralized full support to more limited service as part of a team of vendors.
Are you launching a new rare disease trial? TRiNDS is welcoming new clients with exciting projects. We work with each new client to identify the right services needed for a successful, on time, and on budget trial. Contact us today to request a quote.
October 25, 2018
FDA Invites Public Comment On Adaptive Designs
The Food and Drug Administration (FDA) released an updated draft guidance to industry in early October entitled, “Adaptive Designs for Clinical Trials of Drugs and Biologics: Guidance for Industry.”
The draft guidance reviews best practices for trial design, analysis, and reporting of clinical trials using different adaptive design strategies. The public is invited to submit comments by November 30th.
Adaptive clinical trials are designed to change in response to an interim analysis. Unlike non – adaptive clinical trials, an adaptive trial might close a treatment arm, might increase or decrease the sample size, or might change the randomization allocation. Adaptive clinical trials can increase statistical efficiency, can be more appealing to patients and families, and can increase generalizability of trial results. Adaptive trials also pose risks – increased Type 1 error and possible bias.
The draft guidance recommends that sponsors engage early with the FDA about possible adaptive clinical trials. Specifying the design and decision rules in advance are critical to avoid error and bias. Restricting access to interim trial results is important to avoid changing the behavior of the sponsor, contract research organization (CRO), clinical trial sites, or study participants. Analysis plans must account for the adaptive design and should consider the use of simulations in planning.
TRiNDS offers biostatistics and data management services. Are you thinking about starting an adaptive clinical trial? Submit a request for a quote today.
October 18, 2018
Newborn Screening Update for Duchenne Muscular Dystrophy
The Duchenne muscular dystrophy (DMD) community took two big steps toward newborn screening this month. Newborn screening programs are important because they allow early diagnosis even before symptoms are observed. Newborn screening facilitates early treatment and rapid development of new therapies for infants everywhere.
When infants are born in the United States, a heel prick blood sample is taken onto a paper card. The card is tested for a set of metabolic and genetic disorders at a public health laboratory. Once a disorder has been added to the national screening panel, each state determines whether to add it to their state testing card. You can learn more about newborn screening at http://www.babysfirsttest.org/.
Two major DMD patient advocacy groups shared news about their work to support newborn screening for DMD. Parent Project Muscular Dystrophy (PPMD) and CureDuchenne are working on different ways to make newborn screening a reality for everyone.
PPMD announced the launch of their newborn screening pilot in New York State (https://www.parentprojectmd.org/ppmd-launches-duchenne-newborn-screening-pilot-in-new-york-state/). Their pilot is a collaboration between industry, New York State Department of Health, and the Centers for Disease Control. The pilot study will collect data needed to add DMD to the national and state panels. Once DMD is added to the state testing cards, then every infant will be tested for free.
CureDuchenne announced a new partnership with Baebies to develop newborn screening tests for DMD (https://www.cureduchenne.org/press-release/cureduchenne-partners-with-baebies-to-accelerate-newborn-screening-for-duchenne-muscular-dystrophy/). These tests would be ordered by a doctor and paid for by health insurance. This would provide testing for infants born before the national panel is changed, or for infants born in places that do not have DMD on the state card.
The DMD community is supported by many strong and devoted advocacy groups. Everyone is committed to supporting families, advancing research, and thinking creatively about how to help people with DMD.
October 10, 2018
World Muscle Society was a great success for TRiNDS, CINRG, and TRiNDS’ clients and collaborators. In addition to three days of presentations, researchers presented over 175 posters in a poster session. Poster presentations shared results from all different types of research and clinical trials about all different types of neuromuscular disorders. We had a great time sharing our results at the poster session and connecting with each other.
The Cooperative International Neuromuscular Research Group (CINRG) is a consortium of researchers who work together on industry sponsored and academic research projects about people with neuromuscular disorders. Everyone works hard to answer important research questions for patients and families everywhere. Congratulations CINRG researchers on your WMS presentations!
Conferences are a great opportunity for the scientific community to share results and build relationships for future projects. We always come home more energized and more committed to neuromuscular research than ever.
TRiNDS is the coordinating center for CINRG. TRiNDS serves industry and academic research clients working for neuromuscular disorders around the world.
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