Clinical Guest Contributors

  1. 5 Ways To Engage Clinical Trial Sites With Technology

    Clinical research has a reputation for being notoriously slow to adopt new technologies. This should come as no surprise to those in the industry, since we operate in a highly regulated environment.

  2. Integrating The Payer Perspective Into Drug Development

    This article discusses threats to the traditional model of drug development posed by the increasing influence of payers and considers ways for industry to embrace “value-focused development” to simultaneously adapt to the evolving market and de-risk drug development.

  3. Surveying The Clinical CRO Market & Outsourcing Landscape

    The clinical CRO market is defined as the combination of Phases 1 through 4 clinical activities, excluding discovery, preclinical, central laboratory, and post-approval/commercialization services. Within the $34 billion to $39 billion CRO market, the clinical CRO market alone is valued at $25 billion as of 2017, with an expected CAGR growth rate of 7 percent until 2020 (Figure 1). Almost 80 percent of the global CRO market revenue comes from the clinical CRO market.

  4. Beyond The Standard Patient: Increasing Diversity By Prioritizing Inclusion

    The lack of diversity of age, race, and gender in clinical trials significantly impacts healthcare in several ways. Most acknowledge the importance of a diversified patient pool in accelerating medical discovery and pre-empting safety issues that may surface post-approval. A lack of diversity can foster ongoing distrust of medical institutions. And trials designed for a homogeneous group often result in avoidable hurdles to recruitment and retention.

  5. Using Social Media To Build Patient Trust

    Understanding the proper role of social media is an important challenge for pharmaceutical companies when it comes to “connecting” with potential patients and building their levels of trust. In 2017, strategies that involve traditional mass media — such as TV and print ads — are far from dead; however, social media offers clear advantages to building recognition for a drug — and awareness of its efficacy — in ways that can be targeted to very specific audiences.

  6. Trial Return On Engagement: Quantifying Benefits Of Patient-Centric Initiatives

    Return on investment (ROI) is a key metric for business performance, and well-functioning organizations typically bring their stakeholders high ROI.  The “return on” concept can also be applied in measuring how well organizations engage with their customers.

  7. Listening To Patients To Improve Clinical Trials

    There are so many challenges around designing clinical trials that it can often be difficult to decide where to focus your efforts and resources to improve the process. Based on our recent surveys of clinical trial participants, we see that early engagement with patients can change the course of a study for the better — and research shows it can directly impact the cost of conducting the trial as well.

  8. How Will The Domestic Research Enhancement Act Change Clinical Trials Outsourcing In The U.S.?

    Earlier this year, three members of the U.S. House of Representatives introduced H.R.1234, the Domestic Research Enhancement Act of 2017. The partisan legislation would amend the Internal Revenue Code of 1986, enabling CROs to claim a portion of the Research & Development Tax Credit for qualified research conducted in the United States. Currently, pharmaceutical and biotech (sponsor) companies that outsource clinical research projects only claim 65 percent of the R&D tax credit; the new bill would make CROs eligible for the other 35 percent, which is unused.

  9. Cross-Stakeholder Collaboration: Advancing Research Through Common Protocol Templates

    In 2014, TransCelerate BioPharma launched an initiative dedicated to creating a common protocol template (CPT), with a vision of addressing the increasing complexity of clinical trial protocol development and supporting the pursuit of protocol quality through a practical, harmonized and adoptable approach. Several weeks ago, the U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH) released a final version of its own common protocol template — noting that it was in alignment with TransCelerate’s CPT, specifically, the new enhanced technology-enabled edition. They, like TransCelerate, recognized that the clinical trial protocol deserved renewed attention and modernization.

  10. 3 Hacks For High CRA Retention

    According to the 2016 California Workforce Trends in the Life Science Industry, there were 16,000 statewide life science job postings during the calendar year; 2,732 of those jobs related to clinical trials. In 2015, over 85 percent of life science positions required a minimum of a bachelor’s degree. Hiring managers expect the strong demand for talent to continue until 2018.