Newsletter | August 7, 2019

08.07.19 -- Trial Navigators: The Key To Increased Patient Participation In Clinical Trials

Featured Editorial
Trial Navigators: The Key To Increased Patient Participation In Clinical Trials
By Erika Brown, president, CEO, and cofounder, Paltown Development Foundation

The appallingly low rates of patient participation in cancer clinical trials, especially in the community setting, is no secret. The fact is that 98 percent of our patient population isn’t aware of available trials, doesn’t know how to apply, or is under too much financial and emotional strain, etc. to even consider joining a trial. The blame for this rightfully falls on the proverbial shoulders of the main stakeholders: the biopharmaceutical industry, healthcare institutions, government, and — yes — patient support groups. 

Improving Study Efficiencies With Protocol Templates For Nonclinical Studies
By Todd Page, director of toxicology, Eli Lilly & Company

Clinical research organizations (CROs) are often required to adhere to a variety of sponsor-specific protocol and/or reporting templates, often presenting the same information in various places or in different ways, depending on sponsor-specific requests. Maintaining multiple templates requires a significant amount of time and resources.

Industry Insights
The Importance Of Inventory Management: Do You Know Where Your Samples Are?
Article | By Bruce C. Simpson, Thermo Fisher Scientific

With the exciting advances in research and drug development, the importance of sample management has never been higher. If you have ever experienced sample management mishaps, we ask: Do you know where your samples are? In this article, we’ll explore some of the common causes of inventory mismanagement and best practices to guard against sample loss and near misses.

Business And Cultural Considerations When Managing Clinical Supplies For Asia-Pacific Studies
Article | By Michele Stokes, Catalent

In addition to careful adherence with all applicable regulatory and customs requirements, sponsors should understand and be sensitive to the cultural and business norms of each country included in their study.

Moving Clinical Trials To The Patient’s Turf: eClinical Technologies Make it Possible
Article | By Shawn Blackburn, YPrime

Wearables and mobile devices are the tools behind a new kind of clinical trial. Read how, when they are paired with complementary technology such as eCOA, IRT, and other eClinical systems, it can drive patient-centric studies that also benefit sponsors and investigator sites.

Capturing The Attention Of Investors: Create A Compelling Value Story
White Paper | IQVIA Biotech

While demonstrating the value of a product is important for any organization, the pressure is more acute for small and emerging biotech companies. It’s critical to convey to investors that your drug candidate has the potential to meet the unmet needs of patients today and tomorrow. Explore three key components to creating a compelling value story.

Expert Project Management And An Effective Comparator Sourcing Strategy Streamline Sponsor’s Complex Global Trial
Case Study | Almac Group

Some clinical trials face numerous and critical complexities that increase pressure and risk for the success of the trial. This case study highlights the complexities faced by one sponsor that were compounded by rigid timeframes, comparator sourcing availability, sensitized drug product, and intricate kit design. By partnering with Almac, the sponsor was able to harness Almac’s expertise in project management and comparator sourcing to deliver multiple shipments to sites and depots on time and within specified conditions.

Data Standardization For Late-Stage Development And Periapproval Studies
Case Study | United BioSource LLC (UBC)

Now, more than ever, especially in rare disease populations, and as manufacturers look to add many different types of data from a variety of sources, challenges exist when data with differing data elements from a number of sources (EDC, registries, claims, HCPs, pharmacy, lab, etc.) converge. Therefore, standardization of the data is paramount in generating evidence to benefit patients, especially rare disease patients, where population sizes are limited.




ISR Reports is a full-service market research company and sister company of Clinical Leader. Operating exclusively in the pharmaceutical and pharmaceutical services industry, their syndicated and custom market research capabilities enable their customers to make smarter, more informed business decisions.


Topics include: patient recruitment, enrollment, and retention barriers, study protocol design, investigator and site selection, clinical study feasibility strategies and best practices, use of CROs and specialty providers, and recruitment strategies.


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