THE doctors were right. The death of our daughter was inevitable.
My husband and I trusted their judgement. They were highly respected doctors at one of Australia’s leading tertiary hospitals.
When offered the chance to participate in a clinical trial at this hospital a couple of years later, I agreed. Willingly. But I never found out what happened. I didn’t want to bother the investigators about the results, but I did wonder.
My brief and limited journey as a clinical trial participant is insignificant compared with the altruistic, hopeful and often long journey made by millions of participants around the world who make clinical trials possible.
Yet, although almost all participants want a summary of the results from their (and I do mean their) clinical trial, few ever receive one. And although they may support the concept, almost all clinical trial sponsors and investigators — for whatever reason — have never prepared or offered summaries for participants.
There is an ethical imperative to ensure clinical trial participants are offered a results summary.
I believe we’re at the tipping point for this to happen, as guidelines and regulations are set to change the status quo. The tipping point, however, could also be the tripping point.
Patients are becoming stronger advocates for their rights. Their efforts have contributed to catalysts for change, with recent laws and guidelines affecting sponsors and investigators.
These include, the European Parliament introducing a law that requires sponsors to prepare a layperson clinical trial results summary within 12 months of trial completion, which could affect trials conducted in Australia; the Principles Statement from US and European pharmaceutical industry associations, committing their members to make a clinical trial results summary available to participants; and the new Declaration of Helsinki , which explicitly requires investigators to offer a results summary to all clinical trial participants.
The need to meet this ethical obligation should be embedded in each trial protocol. Under the new SPIRIT guidelines (Standard Protocol Items: Recommendations for Intervention Trials), protocols must state how results will be shared with participants.
However, the step from awareness to action may prove to be the tripping point. Sponsors and investigators can’t ignore new regulations and guidelines, but will they be able to meet them?
Lack of time is the main reason researchers don’t publish their results and is likely to undermine efforts to prepare and discuss results summaries with participants. Sponsors have spent considerable money and time to meet regulatory results disclosure requirements. Now they will need more money and time to meet participant results summary requirements.
Fortunately, the cost of preparing a results summary is less than 0.01% of the cost of a pivotal clinical trial, but it takes time and training to write a summary.
Beyond time and money, however, investigators and sponsors need to focus on participants, not just at the start of the trial, but also at the end (Figure). Notably, trial recruitment — the most challenging, frustrating and expensive stage of most trials — may be improved by offering, as part of the recruitment process, results summaries to participants.
With trial recruitment efficiency and incentives, imagine the reverse consent form — patients would only sign your consent form if you signed theirs, obliging you to prepare and offer them a results summary. Imagine if failure to do this precluded you from gaining ethics approval for another trial or starting a new trial? Imagine if failure to provide results summaries was reported by the media?
I remain perplexed as to why the failure to meet this fundamental ethical obligation — an international problem — has not made front page news. I am also perplexed as to why something that may be able to enhance recruitment has not been given the attention it deserves.
Participants have the right to informed consent and the right to informed closure. As a clinical trial participant, I gave the former but never received the latter.
I hope future trial participants gain what they rightly deserve, a summary of the results from their trial — a trial that could not have happened without them.
Professor Karen Woolley is the division leader (Asia Pacific) of Envision Pharma Group, UK, adjunct professor at the University of the Sunshine Coast, Queensland, and director of the Sunshine Coast Hospital and Health Service, Queensland.
I thank my fellow researchers, Dr Janelle Keys and Dr Julie Monk (ProScribe – Envision Pharma Group), for the hours and intellect they gave to our research on clinical trial results summaries.
I provide medical writing education and services for not-for-profit and for-profit clients. I am a passionate advocate for and publish research on ethical medical writing practices. I am a voluntary leader of international not-for-profit medical writing associations and groups. I have conducted clinical trials in North America and the Asia-Pacific region for academic and industry employers.