Michael Sydes

Clinical Design Considerations and Monitoring 

Recognizing each design type-A must for CRA’s

	Clinical trial design leans heavily upon whether the study is based upon a device, an observation, or a drug. Random Clinical Trials are still hailed as the gold standard. The job of CRA is to set up and monitor each study. A certain intimacy with each type of design is needed to effectively monitor the trial as is detailed reporting and collection of data. CRA’s often find the biggest challenges with data management and participant retention. A few of the biggest assets CRA’s can do is know the design type, cluster variations, and trial objectives.

	o Assisting to offset possible problems during the design recruitment stage.

	o Monitoring physician-patient interaction to ensure there aren’t any missing gaps.

	o Preventing patient drop-out and managing missing gaps in collection of data.

What each CRA needs to know about regulatory documents and NDA filings

	As a standard of quality assurance; there must also be a plan to ensure regulatory adherence for both pre and post clinical trial considerations. Investigators and field monitors must assess each protocol uniquely. For example: IND filings are typically a dedicated responsibility as are adverse drug reporting. Each elemental component of the planning phase should merge into the regulatory benchmarks that need to be met without error. 

	GCP Objectives Should Address 2 Main Essential Questions:

	o What is the driving motivation for the trial?

	o The validity and efficacy of predicted performance?

Numbers Matter - Statistics and Methodology 

How CRAs can effectively collect and configure data

	Clinical research has utilized statistical methods in an effort to provide formal accounting for sources of variability in patients’ responses to treatment. The use of statistics allows clinical researchers to draw reasonable and accurate inferences from collected information and to make sound decisions in the presence of uncertainty. Mastery of statistical concepts can prevent numerous errors and biases in medical research.

	What Statistical Guidelines Are in Line With GCP’s?

	o Data management collection protocols must be acceptable for form of study.

	o Analytical abilities should be targeted to each individual type of study as opposed to a blanketed methodology.

	o Clear and concise collection methods must be in place.

	o Cloud based monitoring software should be routinely updated for accuracy.

	o Statistical based technology should be regularly updated.

Assessing the Challenges in Eligibility and Retention

Effective trial management tools for CRA’s.

Arguably one of the biggest concerns in clinical trial design is bias. Strategizing the design principles to cloud out bias and pre-interpretative data can prove to be a major obstacle. Technological advances have assisted greatly in this regard, however, there are hurdles in every trial design to overcome. Identification of potential bias plays an integral role in design principality. The concept of clinical equipoise is a heavily debated topic especially as it relates to RCT’s. Despite debate, it is agreed that meeting objectivity and potential bias head-on can be easily managed by strict discernment of patient selection. 

	Mastery of These Three Areas Can Assist CRA’s with GCP’ with Bias:

	o Managing Overestimation in Treatment Effects

	The job function of the CRA is multi-faceted. With heavy travel, integrated job functions not often listed in their roles, much credit is given to those CRA’s who make maintaining GCP’s effortless. Many CRA’s report their success as a team effort among all those involved on the CR teams-the investigators, statisticians, researchers, personal physicians, and also the patients. The ultimate goal is always improved patient outcomes.

 Rai K. Integrated monitoring: Setting new standards for the next decade of clinical trial practice. Perspectives in Clinical Research. 2011;2(1):28-33. doi:10.4103/2229-3485.76287.

 Chan S, Jönsson A, Bhandari M. Planning a clinical research study. Indian Journal of Orthopaedics. 2007;41(1):16-22. doi:10.4103/0019-5413.30520.

 Fries JF, Krishnan E. Equipoise, design bias, and randomized controlled trials: the elusive ethics of new drug development. Arthritis Research & Therapy. 2004;6(3):R250-R255. doi:10.1186/ar1170.

 is Marketing Communications Manager at George Clinical

Articles

Michael Sydes outlines some strategies that CRA's can use to maintain good clinical practices. 

Author | Michael Sydes