Top

Published in:

Open Access 01-12-2019 | Commentary

Reducing research waste by promoting informed responses to invitations to participate in clinical trials

Authors: Katie Gillies, Iain Chalmers, Paul Glasziou, Diana Elbourne, Jim Elliott, Shaun Treweek

Published in: Trials | Issue 1/2019

Abstract

Poor recruitment to, and retention in, clinical trials is a source of research waste that could be reduced by more informed choices about participation. Barriers to effective recruitment and retention can be wide-ranging but relevance of the questions being addressed by trials and the outcomes that they are assessing are key for potential participants. Decisions about trial participation should be informed by general and trial-specific information and by considering broader assessments of ‘informedness’ and how they impact on both recruitment and retention. We suggest that more informed decisions about trial participation should encourage personally appropriate decisions, increase recruitment and retention, and reduce research waste and increase its value.

Salman RA-S, Beller E, Kagan J, Hemminki E, Phillips RS, Savulescu J, Macleod M, Wisely J, Chalmers I. Increasing value and reducing waste in biomedical research regulation and management. Lancet. 2014;383:27–36.

Bower P, Brueton V, Gamble C, Treweek S, Smith CT, Young B, Williamson P. Interventions to improve recruitment and retention in clinical trials: a survey and workshop to assess current practice and future priorities. Trials. 2014;15:399. https://doi.org/10.1186/1745-6215-15-399.CrossRefPubMedPubMedCentral

Carlisle B, Kimmelman J, Ramsay T, MacKinnon N. Unsuccessful trial accrual and human subjects’ protections: an empirical analysis of recently closed trials. Clin Trials. 2015;12:77–83. https://doi.org/10.1177/1740774514558307.CrossRefPubMed

Briel M, Elger B, von Elm E, Satalkar P. Insufficient recruitment and premature discontinuation of clinical trials in Switzerland: qualitative study with trialists and other stakeholders. Swiss Med Wkly. 2017;147:w14556. https://doi.org/10.4414/smw.2017.14556.CrossRefPubMed

Treweek S, Mitchell E, Pitkethly M, Cook J, Kjeldstrøm M, Johansen M, Taskila TK, Sullivan F, Wilson S, Jackson C, Jones R, Lockhart P. Strategies to improve recruitment to randomised controlled trials. Cochrane Database Syst Rev. 2010;(4):MR000013. https://doi.org/10.1002/14651858.MR000013.pub5.

Brueton VC, Tierney J, Stenning S, Harding S, Meredith S, Nazareth I, Rait G. Strategies to improve retention in randomised trials. Cochrane Database Syst Rev. 2013;(12):MR000032. https://doi.org/10.1002/14651858.MR000032.pub2.

Avenell A, Grant AM, McGee M, McPherson G, Campbell MK, McGee MA, et al. The effects of an open design on trial participant recruitment, compliance and retention—a randomized controlled trial comparison with a blinded, placebo-controlled design. Clin Trials. 2004;1(6):490–8.CrossRef

Limkakeng A, Phadtare A, Shah J, Vaghasia M, Wei DY, et al. Willingness to participate in clinical trials among patients of Chinese heritage: a meta-synthesis. PLoS One. 2013;8(1):e51328. https://doi.org/10.1371/journal.pone.0051328.CrossRefPubMedPubMedCentral

Rivers R, August EM, Sehovic I, Green BL, Quinn GP. A systematic review of the factors influencing African Americans’ participation in cancer clinical trials. Contemp Clin Trials. 2013;35:13–32.CrossRef

10.

Wilman E, Megone C, Oliver S, Duley L, Gyte G, Wright JM. The ethical issues regarding consent to clinical trials with pre-term or sick neonates: a systematic review (framework synthesis) of the empirical research. Trials. 2015;16:502.CrossRef

11.

Nalubega S, Evans C. Participant views and experiences of participating in HIV research in sub-Saharan Africa: a qualitative systematic review. JBI Database System Rev Implement Rep. 2015;13:330–420.CrossRef

12.

Chalmers I, Bracken MB, Djulbegovic B, Garattini S, Grant J, Gulmezoglu AM, Ioannidis JPA, Oliver S. How to increase value and reduce waste when research priorities are set. Lancet. 2014;383:7–16.CrossRef

13.

Elwyn G, Crowe S, Fenton MA, Firkins L, Versnel J, Walker S, Cook I, Holgate S, Higgins B, Gelder C. Identifying and prioritizing uncertainties: patient and clinician engagement in the identification of research questions. J Eval Clin Pract. 2010;16:627–31. https://doi.org/10.1111/j.1365-2753.2009.01262.x.CrossRefPubMed

14.

Bruton A, Lee A, Yardley L, Raftery J, Arden-Close E, Kirby S, Zhu S, Thiruvothiyur M, Webley F, Taylor L, Gibson D, Yao G, Stafford-Watson M, Versnel J, Moore M, George S, Little P, Djukanovic R, Price D, Pavord ID, Holgate ST, Thomas M. Physiotherapy breathing retraining for asthma: a randomised controlled trial. Lancet Respir Med. 2017. https://doi.org/10.1016/S2213-2600(17)30474-5.CrossRef

15.

Hunt K, Wyke S, Gray C, Anderson A, Brady A, Bunn C, Donnan P, Fenwick E, Grieve E, Leishmann J, Mutrie N, Rauchhaus P, White A, Treweek S. Football Fans in Training (FFIT): a pragmatic randomized controlled trial of a gender-sensitised weight loss and healthy living programme delivered to men aged 35-65 by Scottish Premier League (SPL) football clubs. Lancet. 2014;383:1211–21.CrossRef

16.

Evans I, Thornton H, Chalmers I, Glasziou P. Testing treatments. Better research for better healthcare. 2nd ed. London: Pinter & Martin; 2011.

17.

Crowe S, Fenton M, Hall M, Chalmers I. Patients’, clinicians’ and the research communities’ priorities for treatment research: there is an important mismatch. Res Involv Engagem. 2015;1:2. https://doi.org/10.1186/s40900-015-0003-x http://www.researchinvolvement.com/content/1/1/2.CrossRefPubMedPubMedCentral

18.

Kirkby HM, Calvert M, Draper H, Keeley T, Wilson S. What potential research participants want to know about research: a systematic review. BMJ Open. 2012;2(3). https://doi.org/10.1136/bmjopen-2011-000509.CrossRef

19.

Falagas ME, Korbila IP, Giannopoulou KP, Kondilis BK, Peppas G. Informed consent: how much and what do patients understand? Am J Surg. 2009;198:420–35.CrossRef

20.

Gillies K, Entwistle V, Treweek SP, Fraser C, Williamson PR, Campbell MK. Evaluation of interventions for informed consent for randomised controlled trials (ELICIT): protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey. Trials. 2015;16:484.CrossRef

21.

Chalmers I, Oxman AD, Austvoll-Dahlgren A, Ryan-Vig S, Pannell S, Sewankambo N, Semakula D, Nsangi A, Barqouni L, Glasziou P, Mahtani K, Nunan D, Heneghan C, Badenoch D. Key concepts for informed health choices: a framework for helping people learn how to assess treatment claims and make informed choices. BMJ Evid Based Med. 2018;23:29–33.CrossRef

22.

Donovan JL, Rooshenas L, Jepson M, Elliott D, Wade J, Avery K, Mills N, Wilson C, Paramasivan S, Blazeby JM. Optimising recruitment and informed consent in randomised controlled trials: the development and implementation of the Quintet Recruitment Intervention (QRI). Trials. 2016;17:283.CrossRef

23.

Chauhan RC, Purty AJ, Singh N. Consent for audio-video recording of informed consent process in rural South India. Perspect Clin Res. 2015;6:159–62. https://doi.org/10.4103/2229-3485.159941.CrossRefPubMedPubMedCentral

24.

Gillies K, Huang W, Skea Z, Brehaut J, Cotton S. Patient information leaflets (PILs) for UK randomised controlled trials: a feasibility study exploring whether they contain information to support decision making about trial participation. Trials. 2014;15:62.CrossRef

25.

Gillies K, Skea ZC, Campbell MK. Decision aids for randomised controlled trials: a qualitative exploration of stakeholders’ views. BMJ Open. 2014;4(8):e005734.CrossRef

26.

Juraskova I, Butow P, Bonner C, Bell ML, Smith AB, Seccombe M, Boyle F, Reaby L, Cuzick J, Forbes JF. Improving decision making about clinical trial participation—a randomised controlled trial of a decision aid for women considering participation in the IBIS-II breast cancer prevention trial. Br J Cancer. 2014;111:1–7. https://doi.org/10.1038/bjc.2014.144.CrossRefPubMedPubMedCentral

27.

Politi MC, Kuzemchak MD, Kaphingst KA, Perkins H, Liu J, Byrne MM. Decision aids can support cancer clinical trials decisions: results of a randomized trial. Oncologist. 2016;21:1461–70.CrossRef

28.

Grady C, Cummings SR, Rowbotham MC, McConnell MV, Ashley EA, Kang G. Informed consent. N Engl J Med. 2017;376:856–67. https://doi.org/10.1056/NEJMra1603773.CrossRefPubMed

29.

Enhancing the use of scientific evidence to judge the potential benefits and harms of medicines. Academy of Medical Sciences 2017.

30.

https://www.healthline.com/health/diabetesmine/innovation/we-are-not-waiting#3. Accessed 18 Sept 2019.

31.

Global Patient and Public Involvement (PPI) network. https://consumers.cochrane.org/news/international_network. Accessed 18 Sept 2019.

32.

Nsangi A, Semakula D, Oxman AD, Austvoll-Dahlgren A, Oxman M, Rosenbaum S, Morelli A, Glenton C, Lewin S, Nyirazinyoye L, Kaseje M, Chalmers I, Fretheim A, Ding Y, Sewankambo NK. Effects of the informed health choices primary school intervention on the ability of children in Uganda to assess the reliability of claims about treatment effects: a cluster-randomised trial. Lancet. 2017;390:374–88. https://doi.org/10.1016/S0140-6736(17)31226-6.CrossRefPubMed

33.

Semakula D, Nsangi A, Oxman AD, Oxman M, Austvoll-Dahlgren A, Rosenbaum S, Morelli A, Glenton C, Lewin S, Nyirazinyoye L, Kaseje M, Chalmers I, Fretheim A, Kristoffersen DT, Sewankambo NK. Effects of the Informed Health Choices podcast on the ability of parents of primary school children in Uganda to assess claims about treatment effects: a randomised trial. Lancet. 2017;390:389. https://doi.org/10.1016/S0140-6736(17)31225-4.CrossRefPubMed

34.

Chalmers I. Managers should help to address important uncertainties about the effects of treatments. BAMM (British Association of Medical Managers) News. 2004, June: 3–4.

Title: Reducing research waste by promoting informed responses to invitations to participate in clinical trials
Authors: Katie Gillies
Iain Chalmers
Paul Glasziou
Diana Elbourne
Jim Elliott
Shaun Treweek
Publication date: 01-12-2019
Publisher: BioMed Central
Published in: Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-019-3704-x

At a glance: The STEP trials

Springer Medicine

Reducing research waste by promoting informed responses to invitations to participate in clinical trials

Abstract

At a glance: The STEP trials

Springer Medicine

Abstract

Please log in to get access to this content

Other articles of this Issue 1/2019

Evaluating the analgesic effect and advantage of transcutaneous electrical acupoint stimulation combined with opioid drugs for moderate to severe cancer-related pain: a study protocol for a randomized controlled trial

Sensory integration therapy versus usual care for sensory processing difficulties in autism spectrum disorder in children: study protocol for a pragmatic randomised controlled trial

Are stage-based health information messages effective and good value for money in improving maternal newborn and child health outcomes in India? Protocol for an individually randomized controlled trial

Hypotension Prediction Index software for management of hypotension during moderate- to high-risk noncardiac surgery: protocol for a randomized trial

Gabapentin as add-on to morphine for severe neuropathic or mixed pain in children from age 3 months to 18 years - evaluation of the safety, pharmacokinetics, and efficacy of a new gabapentin liquid formulation: study protocol for a randomized controlled trial

Comparing the effect of auricular acupressure and body acupressure on pain and duration of the first stage of labor: study protocol for a randomized controlled trial