Presentations

MAPI Group Presentations

Sohéla EL KEBIR, Yann BOURHIS, Xavier FOURNIE. "Challenges to obtain real-life data in observational studies: What are the solutions when the patient is the main data provider?" Poster, November 2011, ISPOR.
 Poster: Challenges_to_obtain_real-life_data_in_observational_studies.pdf

Sohéla EL KEBIR, Yann BOURHIS, Rahaf HUSSEIN R., Remi GAUCHOUX. "What are the factors influencing parental apprehension about consenting children to participate in pediatric observational studies? A survey conducted in France with In fine PHARMA®, a pharmacist network" Poster, November 2011, ISPOR.
 Poster: Factors_influencing_parental_apprehension.pdf

deMoor, Carl. "Appropriate Collection of Safety Data within an EAP - Organize Data without Overburdening Sites" Session, CBI 4th Expanded Access Programs, October 2011.

Webb, Stephen. "Respond to Increased Payer Requirements for Evidence of Value to Support Reimbursement Decisions" Panel Moderator, September 2011, CBI 14th Registries and Post-Approval Studies Congress.

Webb, S, deMoor, C. "Optimize Post-Marketing Requirements (PMRs) and Risk Evaluation and Mitigation Strategies (REMS) to Benefit Sponsor and Regulatory Authorities" Session, September 2011, CBI 14th Registries and Post-Approval Studies Congress.

Fournie, Xavier. "Direct to Patient Contact Management" Session, September 2011, CBI 14th Registries and Post-Approval Studies Congress.

deMoor, C, Maier, W. "Design and Leverage Epidemiology Studies to Support Safety Studies" Session, September 2011, CBI 14th Registries and Post-Approval Studies Congress.

Sohela El Kebir, Sami Boussett, Karine Bloch, Florence Susini-Poulet, Benoit Soubeyrand, Xavier Fournie, Remi Gauchoux, Marlène Seux, Barbara Bougain, Yann Bourhis. "Direct to Patient Contact: An Added Value to Follow up Patients in Observational, Longitudinal Studies" Poster, ISPE 27th International Conference, August 2011.

Mechin, Hubert. "Using Direct-to-Patient Strategies for Optimal Study Performance" Session, February 2011, CBI Late Phase Conference.

Maier, William. "Gain a Competitive Advantage by Executing Comparative Effectiveness Studies in a Post-Approval Setting" Workshop, February 2011, CBI Late Phase Conference.

Gonzalez-Bermejo, J., Aguilaniu, B., Mueser, M. et al. “ADL study. Validation of the "COPD and daily activities" questionnaire , a short questionnaire evaluating handicap of patients with COPD.” Etude ADL. 14th Congress of Pneumeology of the French Language. 2010.

Hao, Y., Lasch, K. “Employing patient-reported outcomes in support of oncology product labeling claims: Regulatory context and major challenges”. 2010. ISPOR.

Christensen, R. “Role of Rare Disease Registries in Clinical Research, Advancing Rare Disease Research: The Intersection of Patient Registries, Biospecimen Repositories, and Clinical Data” NIH Office of Rare Disease Research (ORDR) Workshop, January 11, 2010, Bethesda, Maryland. Workshop.

Christensen, R. “Chair of Breakout Session, Clinical Research, Patient Registries, Patient Care and Disease Management, Advancing Rare Disease Research: The Intersection of Patient Registries, Biospecimen Repositories, and Clinical Data”, NIH Office of Rare Disease Research (ORDR) Workshop, January 12, 2010, Bethesda, Maryland.

Scott, J. “Content Validity: Issues in the Development of Endpoint Assessments for Labeling Claims”. Drug Information Association (DIA) 22nd Annual EuroMeeting, Monaco, 08-10 March 2010.

Oyee, J., Thomson, A., Sendersky, V., Asmussen, M.B., Philips, Z. “The budget impact of intranasal fentanyl spray (Instanyl®) in the treatment of breakthrough pain (BTP) in patients with cancer in the UK”. 8th Palliative Care Congress, Bournemouth, UK. 10 March 2010.

Anfray, C., Giroudet, C., Berne, C., Acquadro, C. “The importance of guidelines for ClinROs: the ADAS-Cog, a case study”. Value in Health, May 2010; 13 (3), pA145:PND40. Presented at ISPOR 15th International Meeting, Atlanta – USA, May 2010.

Caron, M., Emery, M.P. “PRO labeling claims in antineoplastic agents”. Value in Health, May 2010; 13 (3), pA45:PCN111. Presented at ISPOR 15th International Meeting, Atlanta – USA, May 2010.

Caron, M., Emery, M.P. “Comparison of the PRO endpoints found in labeling claims of products for the treatment of psoriasis with those recommended by the corresponding EMEA guidance”. Value in Health, May 2010; 13 (3), pA148:PSS15. Presented at ISPOR 15th International Meeting, Atlanta – USA, May 2010.

Hergibo, P., Plowright, R., Bradley, C., Weatherley, B., Gekkieva, M., Unemori, E., Conway, K. “The impact of a host country’s culture on immigrant language”. Value in Health, May 2010; 13 (3), pA18:PMC22. Presented at ISPOR 15th International Meeting, Atlanta – USA, May 2010.

Neewoor, S., Varni, J.W. “Age-specific originals: using the Pediatric Quality of Life Inventory™ (PedsQL™) diabetes module to study similarities and differences in target languages”. Value in Health, May 2010; 13 (3), pA63:PDB49. Presented at ISPOR 15th International Meeting, Atlanta – USA, May 2010.

Vo, P., Chambers, J., Evans, C., Nothaft, W., Marx, S. “Systematic literature review on the burden of illness in painful diabetic peripheral neuropathy”. American Pain Society (APS), 6-8 May 2010.

Vo, P., Evans, C., Dennee-Sommers, B., Wolfram, N., Marx, S. “Systematic literature review on the burden of illness in painful diabetic peripheral neuropathy”. 2010. American Pain Society (APS), Baltimore, MD, 6-8 May 2010.

De Jong, F., Viala, M., van Herwaarden, R. et al. “Psychometric validation of a patient questionnaire evaluating satisfaction with a darbepoetin alpha pre-filled device for self-injection (Aranesp® Sureclick tm device) and a home-service (2care® service) in chemotherapy-induced anaemic cancer patients”. 17-5-2010. ISPOR 15th Annual International Meeting, May 15-19, 2010, Atlanta, GA, USA.

Lee, S., Oh, D., Kim, S. et al. “Evaluation of the willingness to pay for anticancer treatment among Korean patients with metastatic breast cancer: A multicenter, cross-sectional study”. 20 May 2010. ASCO.

Arbuckle, R., Abetz, L., Picchietti, D. et al. “Development of the Pediatric Restless Legs Syndrome Severity Scale (P-RLS-SS): A Patient Reported Outcome Measure of Pediatric RLS Symptoms and Impact”. 5-6-

2010. 33rd Sleep Conference, San Antonio, USA, 5-9 June 2010.

Picchietti, D., Arbuckle, R., Abetz, L. et al. “Pediatric Restless Legs Syndrome: Qualitative Analysis of Symptom Descriptions and Drawings”. 5-6-2010. 33rd Sleep Conference, San Antonio, USA, 5-9 June 2010.

Lasch, K., Stokes, J., Liepa, A., Meldahl, M., Arnett, L., Basch, E. “Drivers of Treatment Decision Following First-Line Therapy in Advanced Non-Small Cell Lung Cancer”. 24 June 2010.

Regnault, A., Siliman, G., Dubois, D., Kerstens, R., Marant, C. “Development of symptom indices using formative structural equation models: Application to the PAC-SYM questionnaire”. 30 August 2010. ISCB 2010, Montpellier, France.

Viala-Danten, M., Regnault, A., Berdeaux, G. “The interpretation of patient-reported outcome data: a challenge for statisticians?”. 30 August 2010. ISCB 2010, Montpellier, France.

Bettiol, E., Marant, C., Burlina, A., et al. “International development of disease-specific questionnaires to assess the impact of phenylketonuria and its treatment on daily life: qualitative steps”. 31-8-2010. SSIEM Annual symposium, 31 August-3 September 2010, Istanbul, Turkey.

Regnault, A., Gilet, H., Meerding, W.J., Arnould, B. “Methodological challenges for the evaluation of patient-reported screening tools: Example of a neuropathic pain screening tool”. 31st Annual Conference of the International Society for Clinical Biostatistics (ISCB), Montpellier, France, 29 August - 2 September 2010.

Rofail, D., Myers, L. “Treatment Satisfaction in Patients with Chronic Low Back Pain: Results of a Qualitative and Quantitative UK Study”. 13th World Congress on Pain, Montreal, Canada, 29 August - 2 September 2010.

Vo, P., Chambers, J., Evans, C., Nothaft, W., Duan, R., Marx, S. “Systematic literature review on the burden of illness in Osteoarthritis”. Osteoarthritis Research Society International (OARSI) Meeting, Brussels, Belgium, 23-26 September 2010.

Abetz, L., Chalmers, R., Begley, C., et al. “The Impact of Dry Eye on Everyday Life (IDEEL) Questionnaire: Saturation, Reliability, Validity and Discriminative Ability Compared to Generic Measures”. The 6th International Conference on the Tear Film & Ocular Surface (TFOS): Basic Science and Clinical Relevance, Florence, Italy, 22-25 September 2010.

Rofail, D., Kitchen, H., Heron, L., Sacco, P. “Cognitive impairment associated with schizophrenia: the humanistic and economic burden”. American Neurological Association 135th Annual Meeting, San Francisco, USA, 12-15 September 2010.

Anfray, C., Eremenco, S., Patrick, D., Conway, K., Acquadro, C. “Copyright of translations of PRO measures: rules and applications”. Quality of Life Research, October 2010; 19 (supp.1), p37:1669. Presented at ISOQOL 17th Annual Conference, London – United Kingdom, October 2010

Anfray, C., Giroudet, C., Berne, C., Acquadro, C. “The importance of guidelines for ClinROs: the ADAS-Cog, a case study”. Quality of Life Research, October 2010; 19 (supp.1), p56:35/1425. Presented at ISOQOL 17th Annual Conference, London – United Kingdom, October 2010.

Caire, P., Plowright, R., Conway, K., Bradley, C. “Is it necessary to adapt the UK English original of the Diabetes Treatment Satisfaction Questionnaire (DTSQs) for use in other countries?”. Quality of Life Research, October 2010; 19 (supp.1), p63:56/1214. Presented at ISOQOL 17th Annual Conference, London – United Kingdom, October 2010.

Conway , K., Méar, I., Irvine, J. “Conceptual definition of PRO measures: a case study with the Quality of Life in Inflammatory Bowel Disease Questionnaire (IBDQ)”. Quality of Life Research, October 2010; 19 (supp.1), p114:218/1604. Presented at ISOQOL 17th Annual Conference,London – United Kingdom, October 2010.