Over the last few years there have been increased discussions in the industry around a master protocol approach to clinical trials. Those discussions have really accelerated over the past year, spurred on by the FDA, which in September 2018 released draft guidelines on this topic for the industry.
Although the development of cancer drugs for children is riddled with challenges, the requirements in Section 504 of the FDA Reauthorization Act of 2017 (FDARA) represent a significant paradigm shift in pediatric oncology. Historically, legislative initiatives that support pediatric drug development have had much less impact in oncology than in other clinical areas.
Every clinical startup requires effective management of a discrete set of activities: the production of complete and compliant regulatory documents; efficient and comprehensive contract negotiation; accurate informed consent review; and timely institutional review board (IRB) submission and approval.
Through a grant from ACGT, one Cancer immunologist is offering T cell therapy to patients in desperate circumstances. The women enrolling in this trial have advanced ovarian cancer and have gone through at least two rounds of chemotherapy that haven’t worked.
Patient participation forms the backbone of clinical research. Surveys reveal that up to 80 percent of patients say they are “somewhat or very willing” to join a clinical trial, yet enrollment levels remain low. For example, only 8 percent of cancer patients ever enroll in a clinical trial, despite substantial resources and efforts being invested in clinical trial advertising, transportation support, and other recruitment and retention activities.
Technology plays a critical role in drug development and the R&D value chain by revolutionizing clinical trials and decreasing the failure rate. Though the supply of technology has been increasing and regulation of innovative methods is easing, pharmaceutical companies have been slow to use the emerging technologies, due to the ambiguity prevailing around this space and a highly fragmented supply market. This article outlines the key technologies that have a high impact across trial phases.
Currently, clinical study protocols must be conducted according to the International Council for Harmonization (ICH) guidance on good clinical practice (GCP), which, among other things, helps safeguard the rights, safety, and well-being of study participants. If conducted as designed, the associated data should be reliable and reproducible and support clear interpretation of the results, while maintaining the participants’ protection. In light of this, one might reasonably assume that deviations from this protocol could be harmful to the participant or the accuracy of the data and should therefore be avoided.
At the outset, let me state for the record that I’m a big advocate for change. My threshold for accepting “that’s the way we’ve always done things” is actually quite low. But I confess that I’m getting a bit dizzy, dismayed, and, to be frank, disappointed with all the so-called “disruptive innovation” taking place in the industry. First and foremost, I don't really think that anything taking place really qualifies as disruptive.
Patient enrollment is critical to the success of a clinical trial and yet clinical trial designs are not always conducive to the participation of cancer patients. According to a study by Dr. Joseph Unger and colleagues at Fred Hutchinson Cancer Research Center, more than half (55.6 percent) of all cancer patients do not participate in trials because no appropriate trial is available for the patient’s cancer type and stage at the center where they are being treated. Further, when a trial was available, an additional 21.5 percent were ineligible due to exclusion criteria.
With acceptance of personal electronic devices (e.g., smartphones and tablets) by the public, the use of computerized systems to collect clinical outcomes assessment (COA) data in clinical trials is commonplace and becoming the preferred and recommended method. As the regulators continue to encourage its use in clinical trials, eCOA deployment will continue to evolve. Read more about hot eCOA topics that demonstrate the trend toward patient-centricity are described here.
Can you imagine working for months to ensure your clinical supply strategy is in place for your European studies, only to have them be delayed because labeling requirements were out of compliance, and the QP or the site(s) rejected the materials you wanted to use in a trial? The purpose of this guide is to walk US-based clinical supply professionals through the labeling requirements laid out in Annex 13 of the EU GMP guidelines.
For biopharmaceutical sponsors, clinical trial data are both the greatest organizational asset and the greatest challenge. This paper discusses the principles of data governance and how they are used to build a business intelligence framework that advances data quality, acquisition, and integration to deliver actionable information for use across the drug development enterprise.
The Food and Drug Administration (FDA) has created five mechanisms to presumably speed the approval of drugs and biologics that effectively treat serious diseases, especially those that are the first of their kind or those that provide increased benefit over existing treatments. Following is an overview on how to appropriately use these five programs to maximize speed of approval depending on the product type.
As a leader in women’s health research, Health Decisions has extensive experience in recruitment of female subjects for trials in a variety of indications, including but not limited to women-specific indications. Health Decisions is pleased to share some lessons from our experience in women’s health studies to assist sponsors in increasing female participation in studies across the therapeutic spectrum.
Insight on the major issues being raised in the rare oncology space today, including patient perspectives on rare cancer research, innovative trial designs, the regulatory landscape, and pending legislation that may impact how studies are conducted.
What can organizations – both in research and in technology – do to help define that future?
By eliminating paper source documents from their daily site operations, the clinical research facility has enhanced data sharing, reduced administrative headaches, and ensured, for their clients, high-quality data that meet ALCOA and other attributes as described by regulatory authorities and GCP.
Engaging clinical supply management and forecasting adds value by evaluating different response strategies and contingency plans and can identify supply solutions that minimize or even potentially avoid supply chain disruptions.
The CRO realized that they needed to introduce new ways to keep participants engaged and interested if they were going to successfully support this trial. The CRO identified ClinCard as the ideal software that could instantly get study participants their stipends, without adding a burden on the site staff.
A client was developing a new drug for complex neurodegenerative disease in pre-clinical development. The drug may be only effective for a particular subgroup of patients. They needed to generate a hypothesis on the molecular pathway and the targeted drug activity and identify a biomarker signature defining potential response to the new drug. Read how Cytel’s analysis produced a biomarker signature that was provided to the client for in-vivo validation.
Ensuring your material is stored under appropriate conditions is only half the battle in preserving its integrity. Equally as critical is the precarious process of transporting your material to its destination, safely and in the same condition it was sent in. Maintaining the chain of custody is of utmost importance, and a large component of this is based on the vessel selected for transportation. In this article, we’ll share some key items to consider when selecting shippers to transport your high value material.
Patient recruitment and retention continue to hamper clinical trials, causing delays in start up and forcing some studies to be cancelled altogether. Approximately 50 percent of trials have delays in recruitment, costing companies an estimated $600,000 per day. In this free collection of articles, our experts from pharma discuss the actions you can and should be taking to make trials more patient centric.
More Content CollectionsPatient participation forms the backbone of clinical research. Surveys reveal that up to 80 percent of patients say they are “somewhat or very willing” to join a clinical trial, yet enrollment levels remain low. For example, only 8 percent of cancer patients ever enroll in a clinical trial, despite substantial resources and efforts being invested in clinical trial advertising, transportation support, and other recruitment and retention activities.
Patient enrollment is critical to the success of a clinical trial and yet clinical trial designs are not always conducive to the participation of cancer patients. According to a study by Dr. Joseph Unger and colleagues at Fred Hutchinson Cancer Research Center, more than half (55.6 percent) of all cancer patients do not participate in trials because no appropriate trial is available for the patient’s cancer type and stage at the center where they are being treated. Further, when a trial was available, an additional 21.5 percent were ineligible due to exclusion criteria.
While it is not a new trend, the spotlight on digital innovation has grown brighter over the last year, with executives from all sides of the clinical research industry seeking technology solutions to improve the clinical trial experience for sites and patients alike. It was a recurring theme at this year’s Society for Clinical Research Sites (SCRS) Global Site Solutions Summit, with several sessions that addressed technological advancement and attendee feedback requesting more discussion on the topic at future Summits.
