Assessment of the information on investigational oral treatment provided to patients in clinical trials

Abstract

Background Sponsors of clinical trials (CTs) provide information for patients about the objective of the trial, describe the treatment and alternatives and answer other related questions. Purpose To evaluate the information provided to patients by the CT sponsors and to assess the need to develop a complementary information form. Materials and methods A cross-sectional, descriptive study was conducted during August 2011. The informed consent, patient information forms (PIFs) and patient diaries were reviewed. In these documents the quality of the following items was checked: a) Posology: high (description of the dose, allowed delays and route of administration), medium (only refers to the dose) and low (no references or details about drug information). b) Adverse events (AE): information present or not. c) Interactions with the study drug. Documents were divided in those that were detailed and those that did not give any information. Results At the time of analysis there were 104 active trials. In 35 (33.7%) the pharmacist dispensed the investigational oral drug to patients. In all trials a PIF was provided, in 15 (42.9%) patients had an identity card and in 13 (37.1%) a diary. Regarding to the type and quality of the information contained in these documents it was found that the dose schedule and route of administration were described in all the CTs. However only in 24 (68.6%) of trials was the quality of information about the posology high, in 6 medium (17.1%) and in 5 low (14.3%). AEs were described in all the documents reviewed but the interacting drugs were specified only in 19 (54.3%) of them. Conclusions The information provided by the sponsors is in some cases deficient or confusing. For this reason the clinical trials department of the pharmacy department decided to make a complementary information form which will contain: simplified information about the dose schedule, route of administration, storage and how to contact the pharmacy.