Study Start-Up Support

Study Start-Up Support

Set up your trial for success with the selection of the right endpoints and enhanced feasibility support in assessing rater qualifications and past performance and scale and language availability.

 

ProPhase offers comprehensive study start-up services, which include:

Endpoint and Outcome Selection
Rater and Site Feasibility
Scale Availability
Scale Licensing, Translation, eDaptation
Scale Development and Validation

Endpoint and Outcome Selection

New targets require a deep understanding of the clinical signal in order to separate it from the inevitable noise of global clinical trials. Utilizing our extensive clinical, scientific, and research experience in global clinical trials, we evaluate research design and strategies, key endpoints, relevance, and the potential impact of your research programs to deliver a set of prioritized recommendations that maximize scientific value and operational success. Identifying and selecting the appropriate measures for inclusion and endpoints is critical to the success of any research program.


Rater and Site Feasibility

Signal detection in clinical trials is significantly impacted by site rater performance. Site rater performance is in turn dependent on a number of factors, including protocol complexity, competitive landscape, and current competitive environment for patients, site resources, staff turnover, etc. While standard feasibility processes capture some of this information, they do not capture the quality of the data produced by sites nor are these processes designed to capture some of the finer nuances that will impact performance of raters at a given site whether individually, or as a whole. In the studies where outcome measures have an element of subjectivity and therefore rely on competent raters to produce quality data, it is crucial that the risks associated with site rater performance are identified and addressed before the sponsor embarks on the complex and costly relationship that ensues with a site under contract. At ProPhase, we use a set of empirical indicators from raters on current and completed studies that in aggregated form can serve as performance metrics for ranking countries and sites.


Scale Availability

All outcomes, whether they are Clinician Reported (ClinROs), Patient Reported (PROs), or Observer Rated (ObservRos) in multinational clinical trials require some level of translation or local adaptation. In studies where the Investigators are bilingual, CRF materials and rater training may be in English, with translated versions provided as an aid to understanding. Patient-Reported Outcomes (PROs) however, must always be presented to the patient in their native language and additionally require Linguistic Validation to be performed to ensure the concepts that the scale is intended to measure are valid in that specific language and culture. The Linguistic Validation process can take anywhere from 8-12 weeks, and we can improve on this timeline by giving you advance information on scale availability by language before a study even starts.


Scale Licensing, Translation, e-Daptation

Featured Service: E-daptation
As clinical trials are increasingly integrating more technology and moving towards fully electronic trial records, our study management team has been leading the effort to encourage license holders to embrace this development and participate in the next phase of digitization of clinical research. In addition to facilitating licenses for electronic use, we have developed a rigorous empirical methodology for ensuring that rating scales are implemented in electronic devices (eCOA) in a user-friendly but psychometrically valid way. Our methodology is centered on a systematic, publisher-endorsed approach to ensure that electronically delivered scales are implemented in accordance with legal and scientific requirements.

Scale Licensing
We work with license holders to ensure the integrity of each scale, from licensing to design and final compilation of materials. Each component of the scale management process undergoes clinical review by our training team to ensure that the finished product meets the exact requirements for use in the study. We pass on to our clients the benefit of Master Licensing Agreements and other preferential arrangements with license holders, to expedite the start-up timelines and minimize cost.

Management of Translation and Linguistic Validation
We partner with translation industry leaders to provide translation and linguistic validation of study scales. We are able to provide quality translations at competitive costs where a validated translation does not already exist, as well as arrange licensing and procure all necessary documentation for regulatory submissions. Every translation is internally reviewed to ensure the linguistic integrity of your study materials.

Material Production and Global Distribution to Sites
We have provided materials to virtually all countries where clinical trials are conducted. Our team provides assistance in any logistical issues, such as expedited shipments, customs clearing issues, and resupply of sites as needed.


Scale Development and Validation

Over the past decade, we have collaborated with Key Opinion Leaders in academia and industry to proactively identify and address areas of unmet need in applied measurement science for clinical trials. The ProPhase-developed outcome measures have been used in studies ranging from early phase or investigator-initiated studies to global pivotal trials.

Test of Psychological Symptoms for Placebo Response (TOPS-PR)
TOPS-PR is designed to enhance patient selection in clinical trials by identifying individuals who may be unsuitable for trial participation. This test identifies individuals who hold misconceptions about the purposes of research and who are highly suggestible, have a tendency toward symptom exaggeration, or unusual symptom presentations. Items on the TOPS were created using principles from forensic psychology and were modeled after validity indicators used in current assessment tools.

New York Assessment of Adverse Cognitive Effects of Neuropsychiatric Treatment (NY-AACENT)
NY-AACENT is used to detect changes in cognitive function subsequent to pharmacological or similar treatments for neurological or psychiatric problems. It is specifically designed to be used in pediatric populations (ages 12-17), but can be utilized with other age groups as appropriate. It has been used in two pivotal (Phase 3) global pediatric programs to date.

Qualitative Assessment of Biopsychosocial Conditions (Qual-ABC)
Qual-ABC is a brief open-ended assessment with an optional checklist designed to enhance patient selection efforts, as well as caregiver and informant suitability. It incorporates elements that are critical in illnesses where impaired insight is a hallmark of the disease, such as schizophrenia. By collecting and reviewing Qual-ABC responses along with other case data, the rater can identify in a structured way patients with environmental instability, complex comorbidities, past evidence of primary or secondary treatment resistance, or other confounds that make them a poor fit for the study. This scale has been used several pivotal (Phase 3) programs of schizophrenia to date.

Dynamic Social Cognition Scale (DSCB)
The DSCB is a group of tests designed to assess the construct of social cognition in patients with psychiatric disorders. It is a self-administered multi-media assessment, using video clips of standardized social interactions with both verbal and non-verbal cues. The DSCB presents a series of tests to assess three components of social cognition: emotion identification (verbal and non-verbal), theory of mind and attributional style.

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