White Papers

1. Regulatory Perspective: Digital Health Technology Tools 1/24/2020

   Digital health technology tools (DHTTs) can help capture patient experiences in real world settings. In addition to providing richer and more comprehensive information on how patients are functioning and feeling, DHTTs can help minimize barriers to obtaining patient experience data during clinical investigations. Read how these novel approaches and tools can support regulatory decision-making.

2. Actigraphy For Pain And Activity 1/22/2020

   Pain is a complex medical condition that involves many physiological functions. Assessment of a patient’s sleep and activity can be critically important for understanding the full dimensions of their pain and the effect of therapies.

3. What Level Of Review Does Your Study Need? 1/21/2020

   The level of IRB review required for research involving human subjects depends on the study’s specific design and the risks involved. Some research must be reviewed by the fully convened IRB, while others may be reviewed by a designated IRB member. Some projects may not even require IRB review. By applying the same four-step evaluation process used by IRB members, research professionals can better plan for a study’s necessary level of review and save time in study startup.

4. Informed Consent: 6 Approaches To Increase Clinical Trials Participant Comprehension 1/21/2020

   Ensuring participants have appropriate knowledge of a study is a crucial goal of the informed consent process. This paper describes six research-based approaches for improving informed consent and supporting participants’ understanding of the studies they are asked to join.

5. 10 Tips For Writing Compliant Clinical Trial Participant Materials 1/21/2020

   Recruitment materials are a potential participant’s first introduction to the study, and post-consent materials can influence an individual’s decision about continued participation. It is important to adhere to the principles of participant protection, allowing participants to make informed decisions about what is in their own best interest, with the materials that appear at the earliest stages of recruitment as well as through the life of the study. Well-informed prospective and current participants lead to improved recruitment and retention rates.

6. Clinical Trial Transparency Policy Reference Guide 1/14/2020

   A transparency policy can go a long way toward building trust and enhancing a company’s brand reputation. Discover six commitments related to disclosure and data sharing that a solid transparency policy should include.

7. Local Lab Normalization 1/10/2020

   Local laboratory data normalization is a routine process in clinical trial data management. However, even with standardized collection and transport procedures across the laboratories there is often variability to account for. This paper highlights the modern need for access to local laboratory data in near real time.

8. A Guide To Evaluating eRegulatory Software For Clinical Research Sites 1/8/2020

   Researching eRegulatory management software for your investigative site? Start with this easy-to-follow buyer's handbook on the most important features to consider.

9. Expert Screen Review Instead Of Mode Equivalence Testing: Who Are These Experts? 1/7/2020

   Electronic data collection is fast becoming the preferred method (versus paper) for capturing patient-reported outcome data in clinical trials. This transition necessitated expensive and time-consuming mode equivalence testing. But now, the process of “expert screen review” is being considered as a more efficient and less expensive alternative.

10. A View From The Clinical Floor 1/2/2020

    Adaptive designs allow more flexibility and control over the trial and, hopefully, will lead to defining the optimal strategy for the given therapy. Bayesian statistics is likely to dominate the future standard of trial design but does involve change in how clinicians interpret the results.