There were numerous articles in 2018 that covered a wide range of topical issues. Here are ten of the best stories you might have missed… (click the headline to finish reading the story)
The persistent lack of diversity among clinical trial participants, and the resulting lack of data on multi-ethnic patient bases, requires us to consider the implications of this situation before we can address possible solutions.
It may seem obvious, but it is worth stating: when segments of the population are not included in clinical trials at levels that do not meet statistical significance, it is impossible to determine if the therapy in question will work equally, better, or worse as for the population in which it is studied.
Most companies engaged in clinical research and development utilize Interactive Response Technology, or IRT systems to help manage clinical trials and more specifically, the Investigational Product (IP). In this article, we will explore how to select the right IRT vendor for your specific needs, how to design the IRT to maximize usefulness, how to navigate User Acceptance Testing (UAT), and how to integrate your IRT with Electronic Data Capture (EDC) systems.
Since May 2017, a new Medical Device Regulation (MDR) came in force with a transition period of three years. Medical Device manufacturers have until the end of 2019 to comply with it. The scope of this regulation has increased as even some non-medical products as cosmetic contact lenses and esthetic surgical implants are included (Annex 16). For manufacturers of such devices, this new regulation can be critical as they are not used to such requirements.
Over the past eight years, I’ve seen some trends with investigator brochures (IBs), which I view as very positive. They appear to be getting shorter, more clinically oriented, and increasingly similar to future package inserts. As one of the key tools to informing a clinical investigator about your product, I believe a clear and concise IB is essential to trial conduct. The IB is also essential to pharmacovigilance and is set in law as the go-to document for determining whether adverse events (AEs) are expected. Having a well-made IB helps sponsors comply with GCP guidelines and legal obligations in all regions.
The consumer mobile health technology revolution has dramatically altered the way we view health care. Personal health tracking apps and wearables provide real-time and continuous data to the user, allowing them to understand, track, and trend everything from heart rate to blood pressure, from cognitive function to memory, and everything in between. Caregivers can even be notified in the event troubling data is received.
The revolution doesn’t just stop there, though. Sensors don’t just provide data on users; they are also embedded in everything from cars to consumer packaging, giving real-time data on surroundings, informing on viability of product, or any of a host of other data points. Finally, tools like telemedicine can provide on-demand knowledge of a medical professional with the convenience of at-home care.
The announced acquisition of Parexel in May 2017 by private equity firm Pamplona Capital Management represents a denouement for the top four market-leading contract clinical research organizations (CROs). Quintiles, Covance, Parexel and PPD have each now experienced a change of ownership.
The owners are strategic partners, well-positioned within the broader health care and life sciences arena, and private equity investors with considerable capital and broad life sciences portfolios. In all cases, the acquiring companies are not clinical research insiders.
There are new regulations and data repository platforms (e.g. EU Portal) on the horizon that will affect the data management landscape and how we operate in the future. The newly revised ICH E6 (R2) GCP Addendum and other proposed regulatory changes will significantly impact clinical trial decision making, planning, conduct and monitoring.
As data managers, we will need to maximize the use of this new technology by expanding our knowledge and awareness of how these changes will affect building the systems and collaborative relationships needed across organizations.
Back in May 2017, my colleague and I wrote an article, Data Integrity Control Strategies – A Matter of Gaining Control. It outlined: a) the importance of Data Integrity as one of the hottest topics in GMP compliance, and b) How a Data Integrity Control Strategy is a valuable tool to document tangibly the controls in place for your GMP systems.
The focus of this article is to reiterate that data integrity is not just a temporary focus by regulatory bodies. Furthermore, I will share personal experiences related to the challenges of identifying the right level of compliance and how that was managed – through understanding the importance of a risk-based approach.
We all love trends; fashion trends, music trends, twitter trends, you name it. In clinical trials it is no different – we love our trends. Be it patient centricity, risk-based monitoring, digitization, adaptive trials or analytics.
However, we sometimes fail to see and plan for the impact these trends can have on the way we outsource our work. Below we will look at five of the current biggest clinical trial trends and see how each may impact clinical outsourcing decisions, and potentially create trends of their own.
It must be said that clinical development and clinical trials don’t always operate like clockwork. Clinical data management (CDM) organizations need to evolve continuously to properly respond to an environment that changes rapidly and constantly. Data management departments are facing two forces of change, both internal and external.
The internal changes are originally generated because of the company’s strategies, reorganizations, and differing outsourcing models. The external forces for the change come mainly from market, regulatory and health authorities, from rapid clinical technological development, as well as the associated cost of clinical trial services.