Dr. rer. nat. Karin Köhler-Hansner, MSc’s Post

Interesting article on the decline of clinical trials in Europe. My take aways: maybe we should learn from Spain and China and reduce the administrative burden to start clinical trials (it is painful to witness….) Thanks Karin for sharing!

In a new STAT op-ed I co-authored with Rob Metcalf, we underscore the importance of modernizing FDA’s regulatory framework governing clinical research. Updated regulations are necessary to ensure that we expand patient access to clinical trials by eliminating barriers to participation. Community-based (decentralized) trials have the potential to drastically increase participation and diversity in clinical research. Through robust collaboration among all clinical trial stakeholders, we believe that by the end of this decade, community-based trials will become the norm, not the outlier. Please read the full piece here:

Excellent article on the need to update regulatory frameworks to enable modernized clinical trial approaches and make clinical trials more accessible. Community-based clinical trials and digital health technologies need to be considered as standard approaches to consider in clinical development plans rather than innovative exceptions. Hopefully, the forthcoming ICH GCP revision advances global acceptance and convergence.

A great piece here Jeffrey Francer & Rob Metcalf. In the aspiration to bridge the divides and disparities in care access it is imperative that innovation and development of the requisite tools put into context the same needs in clinical care. Unfortunately, this has not been the trend with consistent drawbacks especially on the clinical trials front where centralization of clinical research disenfranchise specific communities & regions where the need is even higher. Drawing from an #African experience I believe the pointers highlighted are as resoundingly true and compounded further by infrastructural inadequacies. From a regulatory perspective there were improvements on the backdrop of COVID-19 with flexibilities but these are not being sustained or structurally mainstreamed into the regulatory best practices. On use of digital technologies - lack of clarity and harmonized standards for clinical end-points serves as a drawback with regulatory agencies and ethics review & scientific committees not embracing use of digital tools. Another key piece that I believe will be worth considering and mainstreaming is on the adoption and use of #RealWorldEvidence as part of clinical research data with specific end-points to inform regulatory decisions - both in registration, line extension, new indications, benefit-risk recalibration or even reimbursement on #HTAs. This will be critical especially where communities most socially vulnerable and disadvantaged don't participate in trials but end up using these tools later. It's important that their clinical experiences find a way to be mainstreamed into the clinical evidence for future clinical, regulatory and financing decisions for care. #ClinicalResearch #RegulatoryPolicy #DecentralizedStudies #ClinicalTrials African Pharmaceutical Network (APN)

Clinical trials are essential to allow patients access to the latest innovative treatment options, up to 5-10 years before launch! That is one of the key findings of a new study by @IQVIA for @Efpia.    In the report they conclude that while the number of clinical trials is increasing globally, the share of trials performed in #Europe is falling considerably. In actual numbers, this translates to 60,000 fewer patients today accessing a trial involving a country within the European Economic Area, compared to a decade ago.   If #patients in Europe are to have the same opportunities to access medical breakthroughs as patients elsewhere in the world, we need to urgently address this downward trend. This will only be possible if the EU works to harmonize and simplify its #clinicaltrials landscape across the region, making it easier to carry out multi-country trials.    To read more on the findings and recommendations: https://lnkd.in/dpam-2BQ   #healthforall #hungerfornone @Bayer @BayerPharmaceuticals

What do DMCs have to do with FDA's recent draft guidance on multiregional clinical trials? My close colleague, and Advarra's Executive Director of Biostatistical Services Barbara Schneider, Ph.D., MBA explains in this article:

Data shows a negative trend in the number of clinical trials for European patients, which limits their access to novel therapies, delaying treatment and reducing their chances to a positive outcome and improved quality of life. It is time for policymakers to take urgent action to address the regulatory barriers and facilitate multi-country clinical trials!

🚨 New report from the The Assistant Secretary for Planning and Evaluation (ASPE) on COVID-19 and clinical trials references IQVIA Institute’s report, Lesson Learned from COVID-19 Vaccine Trials: A CRO perspective on accelerating clinical development. The report explores the impact of the pandemic on clinical trials and highlights key lessons learned. Download it here: https://bit.ly/4dIZ2lD #COVID19 #ClinicalTrials #GlobalHealth

'Pazdur made clear that the FDA wants sponsors to “have the studies ongoing.” And that means the actual confirmatory studies are ongoing, not just the dose-finding stage. But in other occasions, including as part of the OCE’s relatively new Project Confirm, Pazdur and the agency “strongly recommend” that the confirmatory trials be “well underway if not fully enrolled” at the time of accelerated approval.' I think we have a bit of a problem with the requirement the studies to have fully enrolled patients. If you have a rare disease it may not be so easy to have full enrolment in a short period. In some cases it may take years to enrol the patients. I know they say the decision is made on case by case basis but it is not so simple for the companies to say if their 'case' will be accepted. Also how FDA will handle potential bias which could affect the competition between different companies? My personal view is that the have to have clear transparent criteria on what is required. #clinicaltrials

This statement is thought-provoking. They identified several fields in the FDA1572 which seem to be obstructing clinical trial decentralization. I think more discussion and consensus by various stakeholders, especially on risk-based approach, will be crucial to overcome such challenges. "It identified FDA's Statement of Investigator Form (Form 1572) as a key barrier, with ambiguities and inconsistencies in usage of Form 1572 compromising local access to trials (ie, follow-up care and testing closer to a patient's home and/or at home). This ASCO Board–approved research statement includes consensus-driven findings and solution-oriented recommendations that necessitate multistakeholder engagement to address research-related regulatory and administrative requirements that are burdensome and critical barriers to improving access to and decentralizing clinical trials. " https://lnkd.in/g34WB8mn