Clinical research is a clear form of social good; testing the efficacy of new forms of treatments that can change and save lives. The impact of new treatments and drugs can be seen in improving health outcomes, but for those who take part in trials “there remains no consensus on the best method of disseminating study findings” or informing them of outcomes. [i]
The 2008 declaration of Helsinki states that making clinical trials results available to the public is an ethical duty. It proposes that: “All medical research subjects should be given the option of being informed about the general outcome and results of the study.”[ii]
Writing in the BMJ, clinical research participant Cynthia Chauhan describes the importance of engaging and informing participants: “Including patients’ voices from inception through to the completion of trials, as well as focusing on the emotional, social, and financial aspects of trial participation for patients, can make participation easier for more of us.”[iii]
The majority of those involved in clinical trials appear to agree, with 75% of clinical trial participants surveyed in one study agreeing that ‘patients should be informed of trial results’. [iv]
So, the question is: what’s the best way to engage and inform those who take part in clinical trials?
For the inquisitive participant, the results of the majority of clinical trials conducted in Europe and the USA are published and freely available on international databases. But with an estimated 25% of the European and US populations considered ‘scientifically illiterate’ unpicking the meaning of clinical trials can be challenging and potentially frustrating. [v]
It’s for this reason that the new EU Clinical Trials Regulation, due to come into force in 2019, includes a requirement upon all researchers to provide summary results of all clinical trials in a format and a style that can be understood by ‘laypeople’.[vi]
While not explicitly aimed at participants, these short and simple summaries could provide a useful mechanism to share more widely the impact, outcomes and benefits of trial participation – among those who have taken part, and the wider general public.
Feedback Best Practice
In 2014, the European Commission produced outline Summary of Clinical Trial Results for Laypersons guidance for those creating summaries for the general public. They include common sense advice like:[vii]
- Develop the summary for a general public audience and do not assume any prior knowledge of the trial.
- Develop the layout and content for each section in terms of style, language and literacy level to meet the needs of the general public.
- Keep the document as short as possible, and focus on unambiguous, factual information.
- Ensure that no promotional content is included.
- Follow health literacy and numeracy principles.
The Commission advises that these summaries are written for a reader with an International Adult Literacy Survey (IALS) reading proficiency of 2 -3, roughly that of someone who had completed secondary or high school.
The European Medical Writers Association favours brevity, suggesting that: “anything beyond two pages seems inappropriate.” [viii] Best practice suggests communications are short, snappy and written in plain English.
Define patients as a stakeholder and an audience
Those conducting trials are required to post results and summaries no later than a year after trial completion. The EU expects that those running trials will do more than simply post a summary, encouraging them to provide: “direct feedback to patients who have taken part in their trials including an acknowledgement of their contribution and an expression of thanks for their time.” Simply publishing a summary online isn’t enough.[ix]
Every clinical trial should be accompanied with a communications plan that identifies your key audiences, stakeholders and communications methods. The Communications Handbook for Clinical Trials proposes that communication with participants should be considered a key priority, and one of the first – and most important – actions in this plan.[x]
Within the accompanying plan, those running trials should use various methods to engage participants, including newsletters, websites, social media and direct communication. The UK’s 100,000 Genomes Project demonstrates a progressive approach to communication, with the programme supported by solid clinical information and professionally produced marketing collateral.
The Centre for Disease Control and Prevention in the USA has produced some guidelines on creating simple communications the public, including information on how to incorporate images and pictures into text, as well as guidance on best practice.
Whatever communications methods you choose, research into effective trial feedback concludes that feedback and results should be shared quickly with participants. The authors caution that “interest in a study quickly wanes for both patients and centres”, and that “dissemination of results is needed if it is to have any impact at all.”[xi]
Large amounts of research has focused on the removing the barriers to clinical research participation, but little has focused on engaging existing participants. There is no agreed best-practice, with trial managers encouraged to identify the best methods for communicating their own cohorts.
Engaging and informing participants in the outcomes of research isn’t just a demonstration of respect; as the testimony of Cynthia Chauhan attests, it can prove a valuable and effective tool in encouraging them and their wider communities to take part in further research too.
[i] Darbyshire JL, Prce HC. Disseminating results to clinical trial participants: a qualitative review of patient understanding in a post-trial population. BMJ Open 2012;2:e001252. doi: 10.1136/bmjopen-2012-001252 http://bmjopen.bmj.com/content/2/5/e001252#ref-11
[ii] World Medical Association, WMA declaration of Helsinki – ethical principles for medical research involving human subjects, Online. Available from: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/ [Last accessed: 18.12.2017]
[iv]Moorcraft, S., Marriott, C., Peckitt, C., Cunningham, D., Chau, I., Starling, N., Watkins, D. and Rao, S. (2016). Patients’ willingness to participate in clinical trials and their views on aspects of cancer research: results of a prospective patient survey. Trials, 17(1). https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-015-1105-3
[vi] Official Journal of the European Union, Regulation. Online. Available from: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/reg_2014_536/reg_2014_536_en.pdf [Last accessed:18.12.2017]
[vii] European Commission, Summary of Clinical Trial Results for Laypersons. Online. Available from: https://ec.europa.eu/health/sites/health/files/files/clinicaltrials/2016_06_pc_guidelines/gl_3_consult.pdf [Last accessed: 18.12.2017]
[viii] Sroka-Saidi, K. Boggetti, B. Schindler, T M. Transferring regulation into practice: The challenges of the new layperson summary. The European Medical Writers Association 2015 DOI: 10.1179/2047480614Z.000000000274
[ix] European Commission, Summary of Clinical Trial Results for Laypersons. Online. Available from: https://ec.europa.eu/health/sites/health/files/files/clinicaltrials/2016_06_pc_guidelines/gl_3_consult.pdf [Last accessed: 18.12.2017]
[x] Communications Handbook for Clinical Trials: Strategies, Tips, and Tools to Manage Controversy, Convey Your Message, and Disseminate Results. Online. Available from: https://www.fhi360.org/resource/communications-handbook-clinical-trials-strategies-tips-and-tools-manage-controversy-convey [Last accessed: 18.12.2017]