Shanna Allen, MPH, CCRA
To conduct clinical trials efficiently and effectively from start to finish,
there are a number of factors to consider. Critical steps in a trial can have
huge impacts on outcomes and can affect whether or not your trial stays
on track from start-up to close-out. While there seems to be agreement
within the clinical research community that such factors should be taken
under consideration, there is no clear consensus regarding what factors
should be considered and the best practices to address these factors.
This may in part be due to the diverse nature of clinical trials, which often
requires a level of uniqueness in the conduct and management of each
clinical trial. Nonetheless, the clinical research community as a whole
can still benefit from sharing best practices. The following are a few best
practices from a clinical operations perspective you may consider when
conducting your next trial.
Parastoo Azadi
As defined by the US Food and Drug Administration (FDA) “a biosimilar
product is a biological product that is approved based on showing
that it is highly similar to an FDA-approved biological product, known
as a reference product, and has no meaningful differences in terms of
safety, purity and effectiveness from the reference product.”1 In Europe
a legal framework for approving biosimilars was established in 2003.
The growth hormone Omnitrope (somatropin) was the first biosimilar
drug approved by the European Medicines Agency (EMA) in 2006.
Twenty-one biosimilar products are currently on the market in Europe.
In the U.S, the passage of the Affordable Care Act (ACA) in 2010 created
an abbreviated licensure pathway for biological products classified
as "biosimilars”.
David Ulrich, Rafik H. Bishara, Ph.D., Colleen S. Hutter, Richard P. Poska, Desmond G. Hunt, Riekert Bruinink, Arminda Montero, Michael E. English
Twenty years ago, the risk to drug substance/product quality due to
temperature excursions during shipping was not generally appreciated.
A series of studies led to several papers in USP PF which documented
some of the risks1-4. In response, increasing regulatory requirements
related to supply chain temperature controls have led to inconsistent
approaches to what types of data are required and, once data is
developed, which sections within the filing (eCTD) to submit these types
of data.
Dr. Istvan Udvaro
Oncology drug discovery is thriving, but with so many potential cancer treatments in development, recruiting patients for clinical trials represents a significant challenge.
Nigel Walker
Given that over $60 billion of biopharmaceutical sales will lose patent protection by 2020, it is not surprising that most major biologics manufacturers have established biosimilar development programs.
Behzad Mahdavi, Dr. Eytan Abraham, Dr. Uwe Gottschalks
In general, cell-based therapies involve the delivery of living cells to a patient to replace a missing cell type, the introduction of modified cells with altered function, or the provision of necessary factors to treat a disease by addressing the underlying cause.
At Capsugel, we engage each customer initiative with an alliance
mindset. The spirit behind this approach is that we view ourselves
as seamless extensions of our customers’ project teams. Our goal is
to collaborate and communicate with our customers throughout
the product development cycle.
Chris Dailey
Patient engagement, which has alternatively been known by many
names, including patient centricity and patient activation, refers to the
process of involving and empowering patients to improve their health
care. By improving patient engagement, it is thought that overall health
can be improved, and health care costs can be reduced.
Jan Gunnar Gustafsson
To develop a biosimilar you are basically copying an existing product to
make your own product. Is this an easy way to have a new product on
the market, in a short time frame? Are there any problems? A biosimilar
is a biological medicinal product that contains a version of the active
substance of an already authorized original biological medicine product,
the reference product, in the European Economic Area (EEA) and/or
an FDA-licensed biological product.
Derek Hennecke
It was a single tweet last September, aimed squarely at an HIV drug
producer which had raised prices 5,000 percent on an HIV drug, overnight.
Sonal Pathak, MS, Harshada Sant, MS, Hemant N. Joshi, Ph.D., MBA
This column summarizes New Drug Applications (NDAs) for March and
April 2015. In these two months, FDA approved 25 NDAs.
Nicole Yingst
As the use of third party vendors continues to increase, the necessity
of a strong communication network is apparent. A 2015 article by
Cutting Edge Information stated that The Association for Clinical
Research Organizations estimates sponsor use of third party vendors
to support studies has increased by 44% from 2007 to 2011. Whether
a third party vendor is engaged to support a portion of a project or
a full project, it is imperative to establish a routine communication
plan that fosters transparency and clear goals. This communication
channel should also follow company standard operating procedures
and contain escalation pathway, to ensure any delays or issues are
managed proactively. A NAVEX Global survey of over 300 business
professionals responsible for ethics and compliance activities revealed
that 71 percent admitted they do not track information on some or all
of their third party relationships. This sets a company up for several
issues, including holes in metrics, missed deadlines and, most critical,
high risk for ethics and compliance issues.
Christina D. Mack, PhD, MSPH, Emma Brinkley, MS, Louise Parmenter, PhD, Nancy A. Dreyer, PhD, MPH
Enriched real-world data studies combine primary data collected directly from physicians and patients with existing (secondary) data such as electronic medical records (EMRs), insurance claims or established registries.