Merus N.V.’s Post

And the results are in!

Learn more about the latest data presentation from the clinical trial of SYNC-T SV-102 in this article, published by the @ASCOPost. The article covers details of trial design, interim results, and the focus of our late-breaking presentation at this year’s annual AACR meeting. https://lnkd.in/ebXimJJH

In a companion piece Jake asks: what are the simple things we can do RIGHT NOW to improve the clinical trial processs, and why aren’t we? No day like today. https://lnkd.in/e_ND6hf4

Jake, Thank you for sharing your journey.  I am so deeply sorry for all you have been through.  I am also so very grateful to you for sharing your experience; the frustrations, the incomprehensible barriers, the blindness to options, the indifference to stray from protocol at times.  It is not a clean, linear and well marked road.  We all owe you a debt of gratitude for sharing your journey with us. I have spent a decade in the arena of clinical trials and I concur that we must change our mantra to “there is no tomorrow” when it comes to clinical trials.  Anything other than this view will paralyze us in a state of inadequacy and limitations.  The truth is that there are many things that can be done now. There is an entire ecosystem of actors that participate in the clinical trial realm.  Hospitals and hospital networks, physicians, care coordinators, tumor boards, trial primary investigators, insurers, pharma, CROs, Just-In-Time trial networks, public trial registries, advocacy groups, patients and more… The list is long. To those actors, I have a question for you:  “Are you a good citizen within the ecosystem?  Are you vested in improving the process?”  As of today, in my opinion, the answer is largely “No”.  This is not to say that there aren’t individuals and organizations fully engaged in the pursuit of elevating the accessibility and enrollment in clinical trials.  My view is at a macro level, where I see fiefdoms that are siloed, walled off and protected.  I see liability concerns, reimbursement concerns and an ownership of patients and/or data that paralyzes adoption.  I see a lack of awareness of institutionally hosted trials and even further, private networks of trials that one cannot even find in the public domain. I will provide a second post with some areas we can focus on right now that would have profound implications on the awareness and acceptance of clinical trials as a treatment option.....

Bess and Jake, thank you both for sharing this story. It’s a must read for anyone involved in oncology care or the clinical trial space. We’ve been working nearly ten years at MolecularMatch to improve the searchability of clinical trials and to position clinical trials as a primary care option rather than as a last resort chance at survival. Although we’ve made significant progress in the search experience to find clinical trials, many systemic challenges remain across the clinical trial space to improve patient access to trials. We share the frustration Bess and Jake experienced, and sadly, theirs is one of countless stories on how defeating the entire process is for patients and their families. Although some of the challenges facing these patients are difficult to solve, there are others that can be remedied now. So, what can we do now? 1. Integration between EHR systems, clinical trial coordinators and clinical trial surveillance to improve physician awareness and consideration of clinical trial options throughout a patient’s treatment journey, beginning as soon as a patient is established at an institution. 2. Develop better clinical trial management tools for institutions to locally track, update, improve and enrich the data for both the public and private trials they host so that it’s in one place and easily searchable. 3. Stop waiting for patients to find clinical trials and instead bring best fit trials to the patient through the expansion and exposure of just-in-time trial availability that allows the patient to receive care near their home. Just as we continue to explore new ways to advance care through clinical trials, we hope Jake’s story will motivate everyone involved in patient care to streamline an already arduous journey these patients face.

part 2: what can we do now? Build a decoupled, nimble layer on top of government run public registries to mitigate staleness, incompleteness and imprecision and to enrich the ‘schema’ of the trial to make it more actionable and interactive. Furnish institutions with the ability to incorporate private trials that are not available in public registries Furnish institutions with the ability to claim public registry locations and liberate reliance on the public registry.  This would accelerate and improve the freshness and quality of contact information, recruitment status, enrollment statistics, etc. Establish concreteness of medical facilities and investigators with widely adopted identifiers.  A trial site should correspond to a google place id, and a trial investigator could link to a google scholar id or orcid identifier.  This would disambiguate these essential links. Furnish the ability to more precisely specify inclusion and exclusion criteria.  There are widely accepted terminology compendiums (i.e. Entrez gene, SNOMED, rxNorm) that can add consistency and concreteness to essential matching criteria. Institution-defined enrichment of trials to include pre-eligibility questionnaires and to allow for prerequisites of eligibility consideration (i.e. a diagnostic test or NGS panel) Longitudinal Patient Care   Starting when the patient first presents, identify trials that may intersect with their disease progression and be careful not to disqualify them early in their journey. A mechanism aimed at keeping the physician up to date on clinical trial treatments over the course of the patient journey.   Hold physicians accountable to trial consideration for pertinent institutional trials. Integrate just-in-time trial network offerings to the public domain so that these highly valuable trial offerings can be considered.  If you have a rare disease or a rare mutation, this model identifies the patient first and then is designed to spin up a local trial for you very quickly.  This is a game changer. Leverage and engage with a clinical trials search engine that delivers results and builds trust and confidence. A search engine that coalesces all of the aforementioned to include public registry trials with the veneer of institutional private trials or in-network just-in-time trials containing claimed trial site enhancements. A search engine that eliminates the challenge of terminology synonyms and ontological concepts and provides meaningful feedback of how a trial result matches the search criteria (as well as what it’s not matching on).  A technology that builds trust and confidence. MolecularMatch has been dedicated to improving clinical trial access and awareness through its innovative search engine.  We continue to explore ways to improve the perception and accessibility to clinical trials.

I adore Clinical Trials Day! Let's pave the way for innovation in clinical research together. 🌟From improving feasibility to building trust, there's much we can do to accelerate progress. What steps do YOU think we should prioritize? #clinicalresearch #ClinicalTrialsDay #collaboration

Why do so many clinical trials fail? This customer story showcases how integrating patient and provider insights from the start can drastically improve outcomes. Discover our approach to designing flexible and robust clinical trial protocols: https://hubs.la/Q02rQ4d00

Here's some news! The Center for Drug Evaluation and Research (CDER) at the FDA has established a new CDER Quantitative Medicine (QM) Center of Excellence (CoE). QM involves the development and application of exposure-based, biological, and quantitative modeling and simulation approaches derived from nonclinical, clinical, and real-world sources to inform drug development, regulatory decision-making, and patient care. These approaches contribute to the totality of understanding of a drug's benefits and risks, helping to advance therapeutic medical product development and inform regulatory decision-making. Check out the posting below for more details!

Science 37 joins Citeline Connect’s growing network of 100-plus vetted organizations that help study sponsors find, educate, engage, and enroll clinical trial participants. Science 37 enables expanded access to a new, more diverse patient population that may not currently be reached by traditional sites. Through this partnership, Science 37's existing engagement with more than 800,000 diverse patients in the clinical trial space will help match those patients to more trial opportunities.🧑🔬 See what David J. Laky, General Manager, Clinical & Regulatory at Citeline had to say regarding our new partnership with Science 37. https://ow.ly/uch150QiVPI Want to learn more about Science 37? Check out their website: https://ow.ly/HH5Y50QiVN4 Tap into Citeline's 100 partners, reaching over 100,000,000 patients globally through one platform: https://ow.ly/sYsS50QiVN3 #CitelineConnect #Science37 #ClinicalTrials