Patients' information sheets and multicentre studies

Abstract

Service Users Research Endeavour (SURE) is a patients' representative group at the Liverpool Heart and Chest Hospital, UK. One of our main functions is to check the clarity of patients' information sheets. We would like to bring to your attention what we find to be a lack of consistency in the information sheets that accompany commercial multicentre studies.Patients' information sheets should give a fully comprehensive idea of what the study means and what is expected from participating individuals. But they should also be concise and in a language easily understood by patients and laypeople. In May, 2008, the UK's National Research Ethics Service introduced the requirement for a lay summary with each new clinical research application, but there does not seem to be any way of enforcing this requirement. In our experience, when dealing with commercial multicentre studies with a central site responsible for drafting and circulating patients' information sheets, the lay summary is often missing from the submitted documentation.Our experience with one study led us to write directly to the sponsoring pharmaceutical company. In this case, the patients' information sheet was 18 pages long and written in complicated language that was not very meaningful to a layperson and even less so to a sick patient. The company then produced a one-page lay summary that was clear and informative and very welcome to the SURE group members.In general terms, lay groups might feel that there is a lack of cooperation from big pharmaceutical companies in the production of lay summaries, but our experience shows that direct communication can have the desired result. However, a direct approach should not be necessary if companies followed the guidelines issued by the National Research Ethics Service.We declare that we have no conflicts of interest. Service Users Research Endeavour (SURE) is a patients' representative group at the Liverpool Heart and Chest Hospital, UK. One of our main functions is to check the clarity of patients' information sheets. We would like to bring to your attention what we find to be a lack of consistency in the information sheets that accompany commercial multicentre studies. Patients' information sheets should give a fully comprehensive idea of what the study means and what is expected from participating individuals. But they should also be concise and in a language easily understood by patients and laypeople. In May, 2008, the UK's National Research Ethics Service introduced the requirement for a lay summary with each new clinical research application, but there does not seem to be any way of enforcing this requirement. In our experience, when dealing with commercial multicentre studies with a central site responsible for drafting and circulating patients' information sheets, the lay summary is often missing from the submitted documentation. Our experience with one study led us to write directly to the sponsoring pharmaceutical company. In this case, the patients' information sheet was 18 pages long and written in complicated language that was not very meaningful to a layperson and even less so to a sick patient. The company then produced a one-page lay summary that was clear and informative and very welcome to the SURE group members. In general terms, lay groups might feel that there is a lack of cooperation from big pharmaceutical companies in the production of lay summaries, but our experience shows that direct communication can have the desired result. However, a direct approach should not be necessary if companies followed the guidelines issued by the National Research Ethics Service. We declare that we have no conflicts of interest.