{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,3]],"date-time":"2026-02-03T17:29:52Z","timestamp":1770139792667,"version":"3.49.0"},"reference-count":53,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2023,6,20]],"date-time":"2023-06-20T00:00:00Z","timestamp":1687219200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Med."],"abstract":"<jats:sec><jats:title>Objective<\/jats:title><jats:p>Including qualitative research in clinical trial design is an innovative approach to understanding patients\u2019 perspective and incorporate the patient\u2019s voice in all stages of drug development and evaluation. This review aims to explore current practices, lessons learned from the literature, as well as how qualitative interviews are considered by health authorities for marketing authorization and reimbursement.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>A targeted literature review of Medline and Embase databases was conducted in February 2022 to identify publications on qualitative methods embedded in clinical trial of pharmaceutical products. An additional search of guidelines and labeling claims of approved products regarding qualitative research was performed in various sources of grey literature.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>From the 24 publications and nine documents reviewed, we identified the research questions addressed with qualitative methods during clinical trials (e.g., change in quality of life, symptoms assessment, treatment benefit), preferred data collection methods (e.g., interviews), and data collection points (e.g., baseline and exit interviews). Moreover, the data from labels and HTAs demonstrate that qualitative data can play an important role in approval processes.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The use of in-trial interviews is still emerging and is not yet common practice. Although the industry, scientific community, regulatory agencies and HTAs are showing an increasing interest in the use of evidence generated via in-trial interviews, guidance from regulators and HTAs would be helpful. Developing new methods and technologies to address the common challenges for such interviews is key to progress.<\/jats:p><\/jats:sec>","DOI":"10.3389\/fmed.2023.1197529","type":"journal-article","created":{"date-parts":[[2023,6,20]],"date-time":"2023-06-20T10:59:46Z","timestamp":1687258786000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":6,"title":["Integrating qualitative interviews in drug development and the use of qualitative evidence in product labelling and health technology assessments: a review"],"prefix":"10.3389","volume":"10","author":[{"given":"Anne-Sophie","family":"Michel","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Paul","family":"Kamudoni","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alexia","family":"Marrel","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rocco","family":"Adiutori","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"C\u00e9line","family":"Desvignes-Gleizes","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sally","family":"Lanar","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter","family":"Schache","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Erica","family":"Spies","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Josephine","family":"Park","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1965","published-online":{"date-parts":[[2023,6,20]]},"reference":[{"key":"ref1","doi-asserted-by":"publisher","first-page":"397","DOI":"10.1056\/NEJMp1114649","article-title":"Toward patient-centered drug development in oncology","volume":"369","author":"Basch","year":"2013","journal-title":"N Engl J Med"},{"key":"ref2","volume-title":"Patient-focused drug development: methods to identify what is important to patients","year":"2022"},{"key":"ref3","unstructured":"Patient-reported outcome measures: use in medical product development to support labeling claimsMaryland, USFood and Drug Administration2009"},{"key":"ref4","doi-asserted-by":"publisher","first-page":"967","DOI":"10.1016\/j.jval.2011.06.014","article-title":"Content validity--establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: part 1--eliciting concepts for a new PRO instrument","volume":"14","author":"Patrick","year":"2011","journal-title":"Value Health"},{"key":"ref5","doi-asserted-by":"publisher","first-page":"978","DOI":"10.1016\/j.jval.2011.06.013","article-title":"Content validity--establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: part 2--assessing respondent understanding","volume":"14","author":"Patrick","year":"2011","journal-title":"Value Health"},{"key":"ref6","author":"Alladin","year":"2022"},{"key":"ref7","doi-asserted-by":"publisher","first-page":"811855","DOI":"10.3389\/fmed.2021.811855","article-title":"The added value of patient engagement in early dialogue at EMA: scientific advice as a case study","volume":"8","author":"Murphy","year":"2021","journal-title":"Front Med (Lausanne)"},{"key":"ref8","doi-asserted-by":"publisher","first-page":"579","DOI":"10.1186\/s12913-014-0579-0","article-title":"PICO, PICOS and SPIDER: a comparison study of specificity and sensitivity in three search tools for qualitative systematic reviews","volume":"14","author":"Methley","year":"2014","journal-title":"BMC Health Serv Res"},{"key":"ref9","doi-asserted-by":"publisher","first-page":"1995","DOI":"10.1016\/j.jval.2022.06.004","article-title":"Natural language processing for automated classification of qualitative data from interviews of patients with Cancer","volume":"25","author":"Fang","year":"2022","journal-title":"Value Health"},{"key":"ref10","year":""},{"key":"ref11","year":""},{"key":"ref12","doi-asserted-by":"publisher","first-page":"743","DOI":"10.1007\/s10461-014-0859-z","article-title":"Accuracy of self-report and pill-count measures of adherence in the FEM-PrEP clinical trial: implications for future HIV-prevention trials","volume":"19","author":"Agot","year":"2015","journal-title":"AIDS Behav"},{"key":"ref13","doi-asserted-by":"publisher","first-page":"1361","DOI":"10.1007\/s10461-016-1458-y","article-title":"Experiences with HPTN 067\/ADAPT study-provided open-label PrEP among women in Cape Town: facilitators and barriers within a mutuality framework","volume":"21","author":"Amico","year":"2017","journal-title":"AIDS Behav"},{"key":"ref14","doi-asserted-by":"publisher","first-page":"e0202990","DOI":"10.1371\/journal.pone.0202990","article-title":"Hurdles on the path to 90-90-90 and beyond: qualitative analysis of barriers to engagement in HIV care among individuals in rural East Africa in the context of test-and-treat","volume":"13","author":"Ayieko","year":"2018","journal-title":"PLoS One"},{"key":"ref15","doi-asserted-by":"publisher","first-page":"e89118","DOI":"10.1371\/journal.pone.0089118","article-title":"Women's experiences with oral and vaginal pre-exposure prophylaxis: the VOICE-C qualitative study in Johannesburg, South Africa","volume":"9","author":"Van der Straten","year":"2014","journal-title":"PLoS One"},{"key":"ref16","doi-asserted-by":"publisher","first-page":"113376","DOI":"10.1016\/j.psychres.2020.113376","article-title":"Self-reported review of the value of esketamine in patients with treatment-resistant depression: understanding the patient experience in the STRIVE study","volume":"293","author":"Starr","year":"2020","journal-title":"Psychiatry Res"},{"key":"ref17","doi-asserted-by":"publisher","first-page":"201","DOI":"10.1186\/s12872-021-02008-3","article-title":"Health-related quality of life in patients with recurrent pericarditis: results from a phase 2 study of rilonacept","volume":"21","author":"Lin","year":"2021","journal-title":"BMC Cardiovasc Disord"},{"key":"ref18","doi-asserted-by":"publisher","first-page":"228","DOI":"10.1186\/1745-6215-13-228","article-title":"The patient deficit model overturned: a qualitative study of patients' perceptions of invitation to participate in a randomized controlled trial comparing selective bladder preservation against surgery in muscle invasive bladder cancer (SPARE, CRUK\/07\/011)","volume":"13","author":"Moynihan","year":"2012","journal-title":"Trials"},{"key":"ref19","author":"Nelson","year":"2012"},{"key":"ref20","doi-asserted-by":"publisher","first-page":"325","DOI":"10.1186\/1745-6215-14-325","article-title":"QUALZICE: a QUALitative exploration of the experiences of the participants from the ZICE clinical trial (metastatic breast cancer) receiving intravenous or oral bisphosphonates","volume":"14","author":"Nelson","year":"2013","journal-title":"Trials"},{"key":"ref21","doi-asserted-by":"publisher","first-page":"215","DOI":"10.1186\/s13063-020-4129-2","article-title":"What influenced people with chronic or refractory breathlessness and advanced disease to take part and remain in a drug trial? A qualitative study","volume":"21","author":"Lovell","year":"2020","journal-title":"Trials"},{"key":"ref22","doi-asserted-by":"publisher","first-page":"e039191","DOI":"10.1136\/bmjopen-2020-039191","article-title":"The lived experience of participants in an African RandomiseD trial (LEOPARD): protocol for an in-depth qualitative study within a multisite randomised controlled trial for HIV-associated cryptococcal meningitis","volume":"11","author":"Lawrence","year":"2021","journal-title":"BMJ Open"},{"key":"ref23","doi-asserted-by":"publisher","first-page":"bmjspcare-2021-002994","DOI":"10.1136\/bmjspcare-2021-002994","article-title":"Advanced prostate cancer experimental radioactive treatment-clinical trial decision making: patient experiences","author":"Viljoen","year":"2021","journal-title":"BMJ Support Palliat Care"},{"key":"ref24","doi-asserted-by":"publisher","first-page":"955","DOI":"10.21873\/anticanres.15555","article-title":"Hope as a lifeline: Imatinib discontinuation in patients with Oligometastatic gastrointestinal stromal Tumours","volume":"42","author":"Fauske","year":"2022","journal-title":"Anticancer Res"},{"key":"ref25","doi-asserted-by":"publisher","first-page":"404","DOI":"10.1186\/s13023-021-02027-5","article-title":"Self-regulation in Barth syndrome: a qualitative perspective of adolescents, adults and parents in the U.K","volume":"16","author":"Searle","year":"2021","journal-title":"Orphanet J Rare Dis"},{"key":"ref26","doi-asserted-by":"publisher","first-page":"e25173","DOI":"10.1002\/jia2.25173","article-title":"Qualitative research on community experiences in large HIV research trials: what have we learned?","author":"Camlin","year":"2018","journal-title":"J Int AIDS Soc"},{"key":"ref27","doi-asserted-by":"publisher","first-page":"759","DOI":"10.1016\/j.clinthera.2016.03.002","article-title":"Patient-reported symptom experiences in patients with carcinoid syndrome after participation in a study of Telotristat Etiprate: a qualitative interview approach","volume":"38","author":"Gelhorn","year":"2016","journal-title":"Clin Ther"},{"key":"ref28","doi-asserted-by":"publisher","first-page":"4721505","DOI":"10.1155\/2018\/4721505","article-title":"What are the Participants' perspectives of taking melatonin for the treatment of Nocturia in multiple sclerosis? A qualitative study embedded within a double-blind RCT","volume":"2018","author":"Khan","year":"2018","journal-title":"Mult Scler Int"},{"key":"ref29","doi-asserted-by":"publisher","first-page":"2680","DOI":"10.1007\/s12325-017-0632-6","article-title":"Exploring the diabetic Gastroparesis patient experience: patient exit interviews","volume":"34","author":"Ervin","year":"2017","journal-title":"Adv Ther"},{"key":"ref30","doi-asserted-by":"publisher","first-page":"A731","DOI":"10.1016\/j.jval.2017.08.1991","article-title":"PRM6 - using convergent mixed methods to evaluate treatment risks and benefits in rare disease: an example from a phase ii registration trial in metastatic Merkel cell carcinoma","volume":"20","author":"Bharmal","year":"2017","journal-title":"Value Health"},{"key":"ref31","doi-asserted-by":"publisher","first-page":"100914","DOI":"10.1016\/j.gore.2021.100914","article-title":"Patient experiences of conservative treatment for early stage endometrial cancer and endometrial hyperplasia with atypia using levonorgestrel intrauterine device: a qualitative study","volume":"39","author":"O'Hara","year":"2022","journal-title":"Gynecol Oncol Rep"},{"key":"ref32","doi-asserted-by":"publisher","first-page":"e049495","DOI":"10.1136\/bmjopen-2021-049495","article-title":"Acceptability of intravitreal injections in geographic atrophy: protocol for a mixed-methods pilot study","volume":"11","author":"Enoch","year":"2021","journal-title":"BMJ Open"},{"key":"ref33","doi-asserted-by":"publisher","first-page":"491","DOI":"10.1186\/1475-2875-13-491","article-title":"\"every drug goes to treat its own disease\u2026\" - a qualitative study of perceptions and experiences of taking anti-retrovirals concomitantly with anti-malarials among those affected by HIV and malaria in Tanzania","volume":"13","author":"Mangesho","year":"2014","journal-title":"Malar J"},{"key":"ref34","doi-asserted-by":"publisher","first-page":"e048537","DOI":"10.1136\/bmjopen-2020-048537","article-title":"Perspectives of mild asthma patients on maintenance versus as-needed preventer treatment regimens: a qualitative study","volume":"12","author":"Foster","year":"2022","journal-title":"BMJ Open"},{"key":"ref35","doi-asserted-by":"publisher","first-page":"106154","DOI":"10.1016\/j.rmed.2020.106154","article-title":"Patient experiences of as-needed budesonide-formoterol by Turbuhaler\u00ae for treatment of mild asthma; a qualitative study","volume":"175","author":"Foster","year":"2020","journal-title":"Respir Med"},{"key":"ref36","doi-asserted-by":"publisher","first-page":"166","DOI":"10.1186\/s12876-019-1085-y","article-title":"Patient views about the impact of ulcerative colitis and its management with drug treatment and surgery: a nested qualitative study within the CONSTRUCT trial","volume":"19","author":"Rapport","year":"2019","journal-title":"BMC Gastroenterol"},{"key":"ref37","doi-asserted-by":"publisher","first-page":"19","DOI":"10.1186\/s41687-018-0043-8","article-title":"Towards the use of mixed methods inquiry as best practice in health outcomes research","volume":"2","author":"Regnault","year":"2017","journal-title":"J Patient Rep Outcomes"},{"key":"ref38","volume-title":"Patient preference information\u2013voluntary submission, review in premarket approval applications, humanitarian device exemption applications, and De novo requests, and inclusion in decision summaries and device labeling","year":"2016"},{"key":"ref39","volume-title":"The patient\u2019s voice in the evaluation of medicines: how patients can contribute to assessment of benefit and risk","year":"2013"},{"key":"ref40","volume-title":"General methods\u2013version 6.0 Institut f\u00fcr Qualit\u00e4t und Wirtschaftlichkeit im Gesundheitswesen","year":"2020"},{"key":"ref41","volume-title":"CADTH framework for patient engagement in health technology assessment","year":"2022"},{"key":"ref42","volume-title":"Guidance for providing patient input","year":"2020"},{"key":"ref43","year":"2021"},{"key":"ref44","volume-title":"Pembrolizumab (Keytruda) HNSCC \u2013 Final Clinical Guidance Report","year":"2020"},{"key":"ref45","volume-title":"CADTH Canadian drug expert committee recommendation: Dupilumab (Dupixent\u2013Sanofi-Aventis Canada Inc.)","year":"2018"},{"key":"ref46","doi-asserted-by":"publisher","first-page":"2158","DOI":"10.1016\/j.clinthera.2017.09.013","article-title":"Understanding the patient experience with carcinoid syndrome: exit interviews from a randomized, placebo-controlled study of Telotristat ethyl","volume":"39","author":"Anthony","year":"2017","journal-title":"Clin Ther"},{"key":"ref47","doi-asserted-by":"publisher","first-page":"S474","DOI":"10.1016\/j.jval.2018.09.2921","article-title":"PSY223\u2013qualitative research in HAEMOPHILIA a: EMICIZUMAB transforms lifestyle of patients with inhibitor","volume":"21","author":"Lambert","year":"2018","journal-title":"Value Health"},{"key":"ref48","volume-title":"Patient-focused drug development: incorporating clinical outcome assessments into endpoints for regulatory decision-making","year":"2023"},{"key":"ref49","doi-asserted-by":"crossref","DOI":"10.4135\/9781446221792","volume-title":"Rethinking methods in psychology","author":"Smith","year":"1995"},{"key":"ref50","volume-title":"Basics of qualitative research techniques","author":"Strauss","year":"1998"},{"key":"ref51","doi-asserted-by":"publisher","first-page":"95","DOI":"10.1186\/s13023-018-0835-1","article-title":"How to address the challenges of evaluating treatment benefits-risks in rare diseases? A convergent mixed methods approach applied within a Merkel cell carcinoma phase 2 clinical trial","volume":"13","author":"Bharmal","year":"2018","journal-title":"Orphanet J Rare Dis"},{"key":"ref52","doi-asserted-by":"publisher","first-page":"183","DOI":"10.1016\/j.math.2016.09.008","article-title":"What do patients value about spinal manipulation and home exercise for back-related leg pain? A qualitative study within a controlled clinical trial","volume":"26","author":"Maiers","year":"2016","journal-title":"Man Ther"},{"key":"ref53","doi-asserted-by":"publisher","first-page":"1609406920965799","DOI":"10.1177\/1609406920965799","article-title":"Longitudinal qualitative methods in health behavior and nursing research: assumptions, design, analysis and lessons learned. International journal of qualitative","volume":"19","author":"Tuthill","year":"2020","journal-title":"Methods"}],"container-title":["Frontiers in Medicine"],"original-title":[],"link":[{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fmed.2023.1197529\/full","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,6,21]],"date-time":"2023-06-21T13:10:39Z","timestamp":1687353039000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fmed.2023.1197529\/full"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,6,20]]},"references-count":53,"alternative-id":["10.3389\/fmed.2023.1197529"],"URL":"https:\/\/doi.org\/10.3389\/fmed.2023.1197529","relation":{},"ISSN":["2296-858X"],"issn-type":[{"value":"2296-858X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,6,20]]},"article-number":"1197529"}}