Patient Data Reporting Featured Articles

  1. Shared Decision Making & Its Impact On Clinical Trial Consideration 12/3/2019

    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.

  2. Protocol Deviation Reporting: Cutting Through The Ambiguity 11/26/2019

    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.

  3. Driving Innovation: Blockchain Adoption For Clinical Trials Optimization 10/31/2019

    Pharmaceutical companies and research institutions are feeling the pressure to reduce the time, financial, and other resource costs associated with conducting clinical trials. With the influx of emerging applications for technologies such as machine learning, robotics and automation, and blockchain and other distributed ledger technologies (DLTs), many see a new path to more efficient and effective processes that can address the challenges faced today.

  4. 5 Narrative Elements That Will Reveal The Masterpiece In Your TMF 10/15/2019

    In response to the increasing opacity of the trial master file (TMF), clinical trial decision makers have embraced quantitative metrics as a way of characterizing and understanding the health of a TMF. Quantitative metrics are easily generated through the reporting functionality of a modern electronic TMF (eTMF) and appear to add value by leveraging the data passively generated through modern clinical applications. Although helpful to address specific concerns, especially those related to completeness, these metrics are often unintuitive and do not readily describe the aspects of a clinical trial most instrumental for TMF health.

  5. New Technology Implementations: What You Need To Know 9/19/2019

    In the first article of this new technology series, we discussed the challenges inherent in undertaking a clinical technology purchase and getting the selection process underway.  In this article Larry Florin, president of LBF Biopharma Consulting, finishes discussing the finer points of the product selection process leading to the product implementation phase of the project.

  6. Overcome The Challenges Of Selecting A New Clinical Technology 9/17/2019

    Despite the best intentions, most companies will struggle to execute new technology selection and implementation. This fate may be more pronounced in the biopharma clinical development arena where the highly regulated, conservative, and somewhat luddite nature of our industry makes us averse to adopting and implementing new technologies.

  7. The Journey To Global eConsent Adoption: Where Do We Currently Stand? 9/10/2019

    Technological innovation is ongoing and is impacting all aspects of clinical studies, from study start-up through close out. While the shift to digital technologies is pervasive, the informed consent process remains paper based in many clinical trials around the world. Given its inherent inefficiencies and the increasing complexity of clinical studies, the current approach can raise challenges with respect to quality, compliance, and participant understanding. Considering this, sponsors must find new ways to ensure that potential study participants are fully informed, despite the complicated information provided.

  8. What I Learned At AbbVie's Development Design Center 8/28/2019

    In July 2019 I had the opportunity to visit the AbbVie campus in North Chicago. My purpose for being there was to tour the company’s Development Design Center (DDC), which provided a detailed look into what AbbVie sees as the future of clinical trials.

  9. What Do Sponsors And CROs Think About Technology Use In Trials? 8/26/2019

    Each year, The Avoca Group surveys industry professionals to understand trends in clinical development. For one of its most recent surveys, Avoca examined what sponsors and CROs think about innovation and the use of technology in clinical trials.

  10. The Keys To A Successful Training, Change Management, & Support Program 8/19/2019

    Implementing a new technology presents many challenges for companies. There is the implementation itself, the training of users, managing the change, and finally providing support to users. A panel discussion at the 2019 Oracle Health Sciences Connect conference tackled these challenges, providing advice on how to manage all facets of a new technology implementation.