Plain language summaries: the need for transparency in the field of cell and gene therapy

Written by Harriet Stanwix

Cell and gene therapy appears – to laypeople – to be balancing on a knife edge between science and fiction. Cell and gene therapy research is heavy with technical language, and the field is constantly pushing the boundaries of what humankind once thought possible. This, coupled with the high-stakes nature of what cell and gene therapy deals with, means it is an easy target for misinformation and harmful practices. Therefore, it is understandable that laypeople find it difficult to trust the science, especially in the wake of COVID-19, which is why it is so important for researchers to harness the power of plain language summaries (PLS).  

PLS are plainly written summaries of scientific studies which are easy for laypeople to understand and can include diagrams or infographics. PLS are beginning to gain traction and have a multitude of benefits for both scientists and patients, including that they can help to stop the spread of misinformation. In a 2020 interview, Laertis Ikonomou, Chair of the International Society for Cellular Therapy (ISCT; Canada), stated that “the problem of unproven cell therapies is a global one”. He went onto explain that “patients have suffered serious injuries and even death because of these procedures” and that “some clinics encourage people to take on debts or crowdfund to pay for expensive treatments, which can affect their ability to afford proven therapies and cause psychological harm.” Recognizing that change was necessary, the ISCT launched the Presidential Task Force on the Use of Unproven and/or Unethical Cell & Gene Therapies, to monitor the situation and protect patients. PLS could arm patients with knowledge that could protect them and may also encourage them to take part in legitimate studies.  

In a later interview with RegMedNet, Bruce Levine – (University of Pennsylvania, PA, USA, and President, ISCT) – highlighted the importance of communication between clinicians and patients and advised that careful consideration should be given. He stated, “the cell and gene therapy industry has an obligation to patients and the public to present what is scientifically and clinically validated”. Levine went on to add that communication with patients provides patients with information about what to look for and helps them understand the kinds of questions they should be asking when it comes to advanced therapies”. The promotion and use of PLS could be an integral part of this open and honest dialogue between clinicians and patients.  

The uptake of PLS in the field of regenerative medicine has been slow, but there is much evidence demonstrating that patients desire accurate information. A study published in Therapeutic Innovation & Regulatory Science found that patients ranked PLS as the third most important source of medical information. Not only that, the researchers also discovered that a major theme emerging from the patient surveys was the importance of knowledge and the sense of empowerment it engenders. The patients viewed PLS as tools to facilitate knowledge sharing and making important information available. As Levine expressed in his interview with RegMedNet, “[cell and gene therapy] can’t make progress in the development of new medicines without [patient] participation”. In a very real sense, cell and gene therapy requires a symbiotic relationship with patients and laypeople, and PLS are the place to start.

Sources:  

Pushparajah DS, Manning E, Michels E, Arnaudeau-Bégard C. Value of Developing Plain Language Summaries of Scientific and Clinical Articles: A Survey of Patients and Physicians. Ther Innov Regul Sci. 52, 474481(2018). 

RegMedNet. Producing ethical regenerative medicine with Industry 4.0: an interview with Bruce Levine. https://www.regmednet.com/producing-ethical-regenerative-medicine-with-industry-4-0-an-interview-with-bruce-levine/. [Accessed 08 March 2022]. 

RegMedNet. ISCT 2020: emerging issues in unproven cell therapies – an interview with Laertis Ikonomou. https://www.regmednet.com/isct-2020-emerging-issues-in-unproven-cell-therapies-an-interview-with-laertis-ikonomou/. [Accessed 08 March 2022]. 

The Medicine Maker. The Cell Therapy Guardians. https://themedicinemaker.com/manufacture/the-cell-therapy-guardians. [Accessed 11 March 2022].