Dermatology

Acne

  • PRO gap analysis and competitor review in acne vulgaris
  • PRO development in acne vulgaris
  • Concept elicitation interviews in acne vulgaris to reach saturation
  • Observational psychometric validation study in acne vulgaris
  • Single item validation and user’s manual in acne vulgaris
  • Mixed method evaluation of an acne vulgaris measure – racial equivalence in non-Caucasion subjects using existing data
  • Medical writing for development and validation of a PRO in acne vulgaris
  • Clinical outcome assessments in acne scars
  • Literature research and content validation in acne scars
  • Analysis, reporting and patient interviews PRO in acne vulgaris
  • PRO instrument review in acne
  • Content validity testing of and regulatory support for use of the PRE-FACE in acne vulgaris
  • Linguistic validation and translation of the PRE-FACE

Actinic keratosis

  • Literature review and stakeholder interviews on payer decision drivers in actinic keratosis
  • Statistical analysis and data interpretation from a multinational observational study in actinic keratosis
  • Manuscripts on a treatment for actinic keratosis
  • Patient diary study and analyses in actinic keratosis
  • Reporting on a patient diary study on adherence to topical treatment in actinic keratosis
  • Update of a dossier and development of a value story slide set to support affiliate teams in the value of an actinic keratosis product
  • Update to a core value dossier and value messages on actinic keratosis
  • Communication of PRO analysis from a phase III trial in actinic keratosis
  • Communication tool and materials on treatment in actinic keratosis
  • Publication summaries on treatment for actinic keratosis
  • Reimbursement dossier for a treatment in actinic keratosis
  • Use of PROs and ClinROs to build the best evidence and optimise market access for actinic keratosis

Alopecia

  • Gap analysis of PROs for the use of a drug to grow darker and longer hair on the scalp
  • Conference poster on a gap analysis in alopecia
  • Development and validation of a photographic assessment and symptom measure in alopecia
  • Development of a symptom and impact PRO in alopecia
  • Development of a treatment satisfaction module for alopecia
  • Brief statistical analysis synthesis and interpretation (photo guide) in alopecia
  • Patient interviews for the development of alopecia-related PRO measures
  • Observational psychometric validation study in alopecia
  • Dossier on PRO measures in alopecia
  • PRO dossier for Subject Self-Assessment of Alopecia (SSAA)
  • Observational psychometric testing study in alopecia
  • Single item analysis in alopecia
  • Development of PRO and ClinRO instruments for alopecia totalis and alopecia universalis
  • Review and provide input into the development of a data analysis plan, validation study, drafts and final report of a randomized controlled trial on alopecia medicine
  • Conceptual equivalence testing of alopecia ePROs
  • Cognitive debriefing of the revised Subject Self-Assessment (SSA) and Hair Growth Questionnaire (HGQ) with patients with androgenic alopecia
  • Psychometric analyses and regulatory support in the development of PRO and ClinRO instruments for alopecia areata patchy,¬†universalis and totalis

Dermatitis

  • Mini value dossier in atopic dermatitis
  • Analysis of the impact of chronic hand dermatitis on work productivity among healthcare workers in the UK
  • COA consulting support for a numeric rating scale in pruritus
  • Preparation of qualitative data in atopic dermatitis for FDA submission
  • Translation and linguistic validation of the numerical rating scale (NRS) in pruritus and cognitive debriefing of an ePRO diary
  • Development of a symptom-based PRO instrument in atopic dermatitis
  • Development of a PRO in adult atopic dermatitis
  • Psychometric evaluation of PROs in adult atopic dermatitis
  • COA development and content validity in atopic dermatitis
  • Development of a manuscript to communicate the patient experience of atopic dermatitis
  • Regulatory support in adolescent atopic dermatitis
  • Development and cognitive debriefing of a symptom diary for use in adults and adolescents with atopic dermatitis
  • Two abstracts to communicate the development of the atopic dermatitis adult and adolescent conceptual models
  • Usability testing of electronic handheld numeric rating scale (NRS) items in atopic dermatitis
  • Linguistic validation and translation of the PRE-FACE
  • Relationship between clinical outcome assessment (COAs) and objective measures in atopic dermatitis and sleep

Eczema

  • Literature review to identify the chronic hand eczema population in the US
  • Regulatory support in chronic hand eczema
  • Development of a manuscript to communicate the patient experience of chronic hand eczema
  • Two abstracts to communicate the development of a conceptual model in chronic hand eczema

Excess sebum (oily skin)

  • Development and validation of a questionnaire to assess patient’s satisfaction with treatment for oily skin (excess sebum)
  • Validation of the Excess Sebum Treatment Satisfaction Scale and the Patient Reported Excess Sebum Co-primary efficacy endpoint
  • Focus group sessions presentation on excess sebum
  • Cognitive debriefing interviews in excess sebum
  • Consultation on a methods study to validate primary and secondary endpoint measures in excess sebum
  • Initial psychometric validation of an oily skin questionnaire
  • Face and content validation of the oily skin PRO instruments in adolescents

Eyelash/eyebrow satisfaction

  • Development of a poster and manuscript for the validation of an eyelash satisfaction questionnaire in China
  • Development of an EMA PRO dossier for an eyelash satisfaction questionnaire
  • Validation of the EEM and ESS in eyelash hypotrichosis
  • Item-level validation for a questionnaire in eyelash health and satisfaction
  • Validation of the eyelash satisfaction questionnaire in Japan
  • Development of a PRO dossier for the 9-item eyelash satisfaction questionnaire for Japan
  • Translation and validation of an eyelash questionnaire in China
  • Gap analysis of PROs for the use of a drug to grow darker and longer eyebrows
  • Content testing and adaptation of the eyelash satisfaction questionnaire (ESQ-9) for eyebrows
  • Cognitive interviews on the eyebrow satisfaction questionnaire
  • User manual and single item validation in eyebrow satisfaction
  • Qualitative interviews to evaluate the psychological impact of the brow satisfaction questionnaire and to validate in a post-chemotherapy population

Facial wrinkling

  • Development and validation of a PRO measure in facial lines
  • Validation plan and FDA regulatory support for the Facial Wrinkling Scale
  • Poster production for two PRO measures of facial wrinkling to be presented at a dermatological conference
  • Development of a manuscript to report the results of a PRO measure in facial wrinkling
  • Validation of a PRO measure of facial line satisfaction
  • Qualitative interviews to support the concept of psychological impact on the facial line outcomes questionnaire
  • Cognitive interviews in facial line satisfaction
  • Validation of the subject facial wrinkle scale in China
  • Psychometric evaluation of a PRO in facial lines
  • Support in securing advice on marketing claims not currently in the FDA-approved product label for a cosmetic treatment for facial lines
  • FDA dossier on a cosmetic treatment for facial lines
  • EMA dossier on a cosmetic treatment for facial lines
  • Content validation of the subject-rated facial wrinkle scale for forehead lines
  • Cognitive debriefing of a ClinRO in facial lines
  • Cognitive debriefing of a PRO in facial lines
  • Validation of a skin / wrinkling module
  • Validation of questionnaires for facial lines in Japan
  • Validation of questionnaires for facial lines in China
  • Consulting for ClinROs and PROs in facial lines and hyperhidrosis
  • Content validation of the facial wrinkle scale
  • Review of PRO endpoints for use of a topical botulinum toxin in trials for the treatment of crow’s feet
  • Development of a PRO briefing document to support the facial wrinkling scale in crow’s feet
  • Qualitative analysis of patient interviews to identify how subjects describe the severity of crow’s feet
  • Cognitive debriefing of a PRO in glabellar lines
  • Preparation of a payer briefing document for a treatment for glabellar facial lines
  • Abstract and poster development for a glabellar line clinical program
  • Support in the linguistic validation of glabellar facial line PROs
  • Publication strategy of PROs in glabellar lines
  • Psychometric evaluation and regulatory strategy of PROs in glabellar lines
  • Consulting agreement for trial preparation and PRO endpoints in canthal lines
  • Evaluation of psychological impact using the facial lines outcome-11 questionnaire in forehead lines, glabellar lines and upper facial lines
  • Prescription Drug Marketing Act (PMDA) PRO dossier for a cosmetic program

Hidradenitis suppurativa

  • Core value dossier to support new treatment in hidradenitis suppurativa
  • Update to a value proposition deck with adolescent data in hidradentis suppurativa
  • Core value dossier, payer value proposition and objection handler update in hidradenitis suppurativa
  • Development and validation of a PRO tool in hidradenitis suppurativa
  • Measurement of pain in hidradenitis suppurativa
  • Development of a PRO in hidradenitis suppurativa
  • Development of an investigator training manual in hidradenitis suppurativa
  • Development of FDA response on phase II hidradenitis suppurativa study protocol
  • Poster for a PRO in hidradenitis suppurativa
  • Mechanism of Action (MOA) Equivalency Testing in hidradenitis suppurativa
  • Clinical endpoint guidance and observational study in hidradenitis suppurativa
  • ClinRO inter-rater reliability study in hidradenitis suppurtiva
  • Design, placement and placement of outcomes in registry for hidradenitis suppurativa
  • HEOR strategic consulting in hidradenitis suppurativa
  • Pre- and post-surgery research study in hidradenitis suppurativa
  • Development of three measurement dossiers in hidradenitis suppurativa to support regulatory submissions
  • Psychometric testing of the Hidradenitis Suppurativa Impact Assessment (HSIA) and Hidradenitis Suppurativa Symptom Assessment (HSSA)
  • Summary report and publications for hidradenitis suppurativa pain and relevant tools
  • Evaluating the clinical meaning of defining treatment response based on the Hidradenitis Suppurativa Clinical Response (HiSCR)
  • Statistical analyses of registry data (UNITE) in hidradenitis suppurativa
  • Literature review on hidradenitis suppurativa