Use of medical imaging in clinical trials expanding
Outsourcing-Pharma (OSP) recently connected with Kevin Jacob (KJ)—head of imaging for Illingworth Research Group, a Syneos Health company—about how utilization of medical imaging has expanded in recent years, and how it can elevate accuracy and efficiency.
OSP: Could you please talk about how medical imaging has evolved as a tool limited to mostly dermatology, to uses beyond that field?
KJ: Twenty years ago, medical photography was deemed an extravagance by many clients, who viewed it as introducing another layer of cost and complexity when site investigators could score dermatological efficacy during each site visit. Several factors have eroded this viewpoint from different angles, in order of significance:
- The transition from film to digital (gradually) has made quality imaging accessible to all, whether safety images captured via a mobile device or calibrated true color Digital SLR images. Consequently, imaging applications are no longer limited through dermatological necessity. Wherever any visual record is required and can be captured—whether oncology injection site reactions, achondroplasia physiological documentation, or myriad other clinical scenarios--digital imaging can easily record the event or timepoint, not just efficacy endpoint data.
- Investigator assessment variability can be offset by employing one (or a panel) of specialist central assessors. Any variability can be accurately quantified and reported through repeat or standardized image scoring. In addition, the use of blinded central assessments reduces site investigator time because trained study coordinators can capture and upload images centrally. Ultimately, this increases both efficiency and accuracy of image-derived data.
- Hybrid studies had been gaining traction for many years prior to COVID and the pandemic has further increased adoption. Home visits allow photography, videography and audio to record changes in severity, the extent of movement, or neurological understanding, respectively. Secure systems for such file transfer have led to medical imaging becoming ubiquitous in its application.
OSP: Could you please share some detail about how medical imaging is useful in early phases — how does it help save time, increase efficacy, etc.?
KJ: The ability to document the correct IMP or dressing application, an adverse event, or the extent of known side effects, in addition to efficacy endpoint imaging, means regulatory submissions which include medical images are able to provide a holistic data set. By capturing imaging data from the outset, safety review and dose escalation panels – even potential investors, subject to appropriate imaging consent – instantly have all the information required to make informed judgments. This real-time visibility is especially crucial for maintaining patient safety, correct study direction and overall momentum for early phase development.
OSP: How can medical imaging benefit (via boosted workflow, efficiency, etc.) in late-stage studies?
KJ: Irrespective of study design, larger and late-stage studies still require accurate images but efficient capture, transfer, monitoring, assessment and reporting becomes more important. The life cycle of a study image and its derived data is a balance of efficiency for the client and accuracy for the study images, and these core values must be prioritised at every step.
Ideally, the international imaging vendor would produce remote training videos in local languages, ship locked-down equipment prior to training, validate every site user, and monitor all study images centrally within 24 hours, then escalate any repeat issues thereby promoting image importance to sites from the outset.
OSP: You mention there are some specific challenges with implementation of medical imaging. Could you please explain the challenges, and how you recommend sites and sponsors work to clear these up?
KJ: Three of the biggest challenges we see with implementation are lack of familiarity with study imaging, confusion with various competing systems on the market, and inexperience in implementing imaging endpoints.
Site staff who are new to study imaging may be cautious initially, especially those with more hands-on than technical experience. As with inexperienced sponsors, such individuals require practical demonstrations and remote training sessions (following equipment receipt) to familiarize themselves and gain the confidence required to capture accurate images during busy clinics.
For any given study there may be several potential dedicated capture systems or consumer cameras which could be configured to meet the study requirements. As mentioned earlier, it is critical to consider every aspect of the image journey, from site set-up to efficacy data, prior to selecting a capture system or camera.
Each vendor and supplier will advocate their system and each PI or competitor will have used a particular configuration on a similar study. Without completing due diligence, either directly or through an independent imaging vendor, sponsor may be putting their studies at risk. At best, the wrong system may produce inferior images/data or be more costly and, at worst, such system may be impractical for the final protocol, resulting in unusable images and necessitating a rescue package – all of which we have experienced.
Other issues we have seen from some sponsors who do not have much or any experience with implementing imaging endpoints include:
- After seeing the costs involved in access-controlled systems, putting forth the suggestion to simply take images on phones and email them. In this scenario, we educate sponsors on the potential data privacy and IT security issues associated with handling personal study data outside of controlled systems.
- Assuming that a CRA monitoring study images is the same as a qualified medical photographer completing real-time quality control and feedback on image content and capture technic – or that batch QC at the end of the study just prior to analysis is an acceptable efficiency.
- Assuming that images captured within the patient’s home can be used for direct comparison with the clinic-based images for that study without having to engage differing systems. Employing portable calibrated devices, practical training, user validation and prompt image QC/feedback for every visit ensures that both site and remote images are indistinguishable.
OSP: Are there any therapeutic areas that especially lend themselves to medical imaging use? Similarly, are there areas that would not?
KJ: Beyond the dermatological therapeutic areas, consider if an image, video or even an audio recording of the study participant could capture that moment in the study visit where a record would provide insight to others not present. This could be a still image, a demonstration of their movement, or any combination of images along with the tone of their response to an endpoint questionnaire.
If such audio-visual data could be captured, would it be beneficial for that participant or clinician to reference back to, or a central reviewer to deride efficacy data? In short, it is the intended outcome of a treatment which determines whether medical imaging is applicable, rather than the therapeutic area.
OSP: What recommendations would you offer to clinical trial pros looking to make better use of medical imaging in their operations — what equipment, training, and other resources might they need?
KJ: When investigating possible vendors, ask who is responsible for image quality and the derived data. If the vendor indicates that responsibility lies with the investigative site, then exercise caution. The imaging vendor can only achieve optimum image quality and efficient working if everyone from the site photographers through to central assessors (or analysis technicians) fully appreciates how to accurately complete their step of the image cycle.
It is the imaging vendors’ responsibility to determine what the optimum route is and proactively work with all parties to ensure it can be achieved. Demonstrating that the most efficient route for each user is in compliance helps focus their attention.