Internship - Qualitative, Patient Centered Outcomes

Internship - Qualitative, Patient Centered Outcomes

Office based in Lyon, France

3 month opportunity

INTITULE DU THEME STAGE / TITLE OF THE INTERNSHIP

Presenting longitudinal data from qualitative research embedded in clinical trials

¨ DOMAINE(S) COUVERT(S) PAR LE STAGE/FIELD COVERED BY THE INTERNSHIP

Specific Aims:

• To explore the best methods and the feasibility to analyse qualitative data collected from longitudinal patient interviews embedded in clinical trials
  • To capture change over time (i.e. how to assess and document if specific concepts are improving/ worsening/ ceasing/ appearing/ not changing)
  • To categorise patients as responders or non-responders or as mild/moderate/severe (i.e. explore the feasibility to put patient into clinically-relevant groups based on the content of their interviews)
  • To link the qualitative data to quantitative data collected in the trial (e.g. clinical data, patient-reported outcomes (PRO) data)
• To identify tools to present visually such qualitative findings

Background:

• The US Food and Drug Agency (FDA) is currently developing a series of guidelines to support the integration of the patient voice in the drug development process. While this has been commonly addressed until now by using patient-reported outcomes (PRO) questionnaires, there is a growing demand to also make use of patient interviews. The objective of patient interviews within a clinical trial is to collect more information on patient experience over time, from trial entry to trial exit, to better understand how the treatment benefit and overall experience with the treatment translate into the actual patients' lives. Besides few practical challenges, there are analytical challenges to determine the best method to analyse such data and the best approach to present the findings to a wide audience including medical teams, physicians, payers, qualitative researchers.

Significance:

• The importance of this research is twofold:
  • First, for ICON, in light of the increasing demand to run interviews within clinical trials, it will allow a more systematic and robust approach across projects and will ensure ICON is innovating and leading in this new emerging field. This expertise will not only generate specific business for the Patient-Centered Science department, it will also differentiate ICON clinical research from competitors for large clinical trials projects.
  • Second, for the trainee, it will allow them to best position themselves in an expanding field, which is becoming an integrated part of clinical drug development. ICON is a leader both in clinical research and in Patient-Centered Outcomes Research. An experience in this group is highly valued in Pharma industry and specialised CROs.

Approach:

• Study design and approaches

We propose to use an existing set of transcripts and review the coding process used to identify any gaps or improvement in the coding to appropriately capture a change. Based on the gap analysis, all information should be used to support the development of a qualitative analysis plan specific to longitudinal analysis to allow a systematic and rigorous approach to be followed by the team. The next challenge is to identify appropriate graphical presentation to communicate the findings in a powerful and succinct manner.

• Study population and sample size (if applicable)

The precise study populations and sample sizes will vary according to studies chosen for inclusion in the analysis based on sponsor approval. Currently the ICON plc team has access to over 30 sets of transcripts relating to projects in the following areas: Rare diseases, Allergies, Cardio-vascular diseases, Dermatology, Endocrinology, Gastroenterology, Hematology, Infectious Diseases, Musculoskeletal disorders, Nephrology, Neurology, Metabolic disorders, Obstetrics, Oncology, Ophthalmology, Otorhinolaryngology, Pain, Respiratory, Urology.

Résultats attendus : / Expected results

• A report discussing the methods used and the results for the tasks described above.
• A qualitative analysis plan for longitudinal analysis
• Publication on methods/findings upon sponsor approval

Connaissances et aptitudes recherchées chez le stagiaire :/Knowledge and abilities required for the trainee

• Knowledge : qualitative research
• Abilities : creative approach to problem solving, flexibility