White Papers

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. Establishing Risk-Based Monitoring Within A Quality-Based System As “Best Practice” For Clinical Studies 12/20/2019

   This report based on a survey of ACRO members reveals that Risk-Based Monitoring (RBM) makes clinical trial quality review more efficient and effective. It found that when a company reviews data through a centralized system using the RBM model, CROs and technology companies are better able to detect quality issues earlier and make rapid corrections at the site level. This type of approach is now central to ensuring the safety of patients in clinical trials, and is expected to continue to grow in importance as clinical trials becomes more numerous and complex.

10. Unlocking The Full Potential Of Precision Medicine In Oncology 12/20/2019

    Precision oncology promises a new standard of care where therapies are tailored to the molecular profile of a specific tumor. For the full potential of precision medicine to be realized, regulatory, technical, clinical, and economic frameworks will need to evolve to the nuances of these novel treatments.