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8 Essential Imaging Strategies to Revolutionize Your Clinical Study

Imaging is utilized in clinical trials across most therapeutic areas and is leveraged to monitor safety, assess efficacy, and provide primary, secondary or exploratory endpoints. The challenge imaging has faced ever since it's been incorporated into clinical trials is that it has succumbed to being "the forgotten one". Many times the preparation and conduct of imaging is an afterthought in clinical trials and for whatever reason is thought to be an easy part of the study design, implementation and execution. Nothing could be further from the truth. It's essential to prepare for imaging needs and have the necessary processes in place early.

So, what can we do? Here are eight essential strategies that will have a successful impact on the execution of imaging acquisitions and assessments for your clinical trial.

  1. Engage the imaging experts during protocol development

    Early involvement of imaging physicians and scientific experts is a key starting point in trial protocol development. They can provide the background and clinical feedback that is critical to choosing the appropriate imaging modality for a study. Many times there are choices in modalities and depending on the size of the trial, availability of the modality, variability of the acquisition, availability and cost, the engagement of experts will help to sift through these variables and provide a smooth course to proper implementation.

  1. Define endpoints

    Imaging endpoints you choose and define have a direct impact on the most appropriate imaging modality to deploy for a clinical trial. Again, experts in the field can help provide the scientific background early on in the trial development process to allow companies to incorporate the proper imaging endpoints in a study and give it the best opportunity for a successful outcome.

  1. Utilize experienced sites

    When the appropriate modality and endpoints have been determined, it's a good time to find the experienced sites suitable for the study. Selecting sites with imaging experience and clinical trial experience plus the personnel to support the study are important to a cost effective and efficient start-up. There are many strategies for selecting experienced sites and all generally provide similar information through tools such as pre-trial questionnaires and assessments.

  1. Capabilities assessment of vendors

    Central imaging services are typically recommended for a study with imaging endpoints or safety and efficacy assessments. Therefore, selecting a vendor early will allow for proper set-up of study needs, qualification of sites and training of study teams, imaging centers and central imaging readers. There are many imaging vendors to choose from and it’s important that there is careful review of their strengths and weaknesses as it pertains to the modality utilized in the study. Finally, cost of services should not be the sole reason for vendor selection. Too many times the least expensive option can often lead to higher costs because of delayed study timelines due to the vendor's lack of resources and/or expertise and the client then is placed in a situation of selecting a second imaging services vendor to "rescue" the study.

  1. Apply imaging standards and guidelines

    Imaging data has been part of clinical and research applications for many years. From this wealth of data, the use of developed imaging acquisition procedures and guidelines in addition to defined endpoints and assessments is recommended for clinical trials. Applying imaging standards and guidelines to clinical trial protocols provides the opportunity of quality imaging and the consistency and reproducibility of data collected and reported across trials.

  1. Training

    Prior to the first subject being screened, a comprehensive training program is critical to facilitate communication of imaging terminology and processes to the study team, protocol specific imaging needs to the enrolling sites and read rules and procedures to the central services readers. Such a program will support a smooth start-up and provide consistent communication across all study teams.

  1. Efficient and effective imaging processes

    When the imaging components of a trial protocol are considered, designed and deployed early in the trial set-up process, it allows for efficient and effective processes leading to proactive as opposed to reactive strategies and will aid in enrollment efforts and save time and save on costs.

  1. System testing

    Over the years the collection and processing of clinical trial records has evolved from paper based to mostly digital and cloud based. The same is true for processing imaging exams submitted in clinical trials today. Much of the imaging is submitted electronically and requires the development, set-up and testing of the systems providing this solution. An early understanding of the modalities being leveraged, the imaging systems collecting exams, the file types to be submitted and the subject data to be collected with the imaging data, will ensure quality imaging and collection from first patient/first visit to last patient/last visit.

These eight strategies hopefully E.D.U.C.A.T.E.S. you to be ready for your next study that includes imaging acquisition, collection and analysis. Bioclinica Medical Imaging Services has successfully supported many studies implementing these strategies. For inquires on how we may support your study, contact us today.



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