UNCORRECTED PROOF Glaucoma Clinical Trials Dear Editor: Regulatory clinical trials are dependent upon adequate re- cruiting to attain a sample size sufficiently to assess safety and efficacy of a new medicine or device. However, poten- tial study subjects may only wish to participate if the trial aligns with their own personal motivations for performing a clinical trial. Recently, Wendler et al 1 invited clinical trial participants with human immunodeficiency virus (HIV) to complete a survey on their motivation for participating in a study. They found most respondents hoped to benefit personally but also wished to help others despite being treated for a life-threatening illness. Unfortunately, little information exists that examines pa- tient motivation for performing an ophthalmic clinical trial. Potentially, a patient’s reason for participating might differ with a vision versus a life-threatening illness. This study evaluated the motivation of glaucoma study subjects for performing clinical trials. This study prospectively evaluated patients using a ques- tionnaire at 2 clinical sites (ALR and EDS performed the survey). We included consecutive patients who had partic- ipated in a current or past glaucoma clinical trial as they appeared in clinic for their routine or clinical trial appoint- ment. A Health Insurance Portability and Accountability Act of 1996 (HIPAA) waiver was previously obtained for all participating subjects and no identifying information was collected for the study. We excluded patients who declined to participate or who could not understand English. Each subject completed the survey during their clinic appointment with the aid of a family or staff member if required. The survey was developed by one of the authors (WCS). Partially completed surveys were accepted if 50% of questions were answered. Complete demographics and survey results, total and per site, are found in Table 1 (available at http://aaojournal.org). As seen in Table 1, several questions differed statistically between sites. The subjects’ primary medical motivation for participat- ing in clinical research was to be helped by the study medicine (n = 121, 61%), while their primary nonmedical reason was to assist mankind (n = 145, 73%). The most positive aspect of participating was their interaction with the clinic staff (n = 141, 71%). In contrast, 139 (70%) listed no negatives about performing the clinical trial, while 27 (14%) complained of stress of induced by examinations and visits. More than 60% believed their participation provided a greater understanding of the medication’s clinical use, effi- cacy, and safety, while benefiting the care of other patients. In total, 180 subjects (95%) thought their participation was completely or essentially non-coerced, while 12 (6%) felt some coercion or did not answer (n = 8, 4%). Further- more, 186 (93%) believed their privacy was completely or essentially protected, while 8 (4%) thought there was some compromise or did not answer (n = 6, 3%). Regarding overall experience, 189 (94%) noted it was positive to very positive while 65 (33%) indicated they felt more or, at least as, comfortable being treated in a clinical trial as in the regular clinic. Furthermore, 166 (83%) stated they received at least neutral, but usually positive, support for their participation from their closest personal confidant, and 100 (50%) said they plan to do another trial, while an additional 85 (43%) indicated “maybe.” There are at least 2 broad clinical lessons to derive from these results: first, in approaching potential study subjects investigators should realize that they generally believe they are helping other patients. However, each patient is an individual and has personal motivation for trial participa- tion. Furthermore, most patients also believe they are as- sisting their physician and that the most attractive aspect to participating in trials is the positive interactions with the staff. Consequently, a caring, service-oriented relationship of the investigator to their patients might further help study subject recruiting. Second, a small minority of subjects, even after signing informed consent and a HIPAA waiver, may feel at least some pressure to do a trial or that their privacy was com- promised. Therefore, some subjects may be more sensitive than others over free choice and privacy. Accordingly, if a subject appears unusually anxious during the trial asking about coercion or privacy issues might help address any concerns. In addition, enquiring about their support at home might uncover that a close confidant was negative about the subject’s inclusion and may allow their fears also to be addressed. Furthermore, a number of patients failed to men- tion to their closest confidant that they were even partici- pating in a research study. Possibly, enlisting these individuals close to the patient might better help them to overcome any fears or misunderstandings resulting from their participation. In summary, this survey suggests clinical study subjects, while generally wishing to be helped by the study medicine, usually indicate altruistic motives in performing research studies. Furthermore, in a well-controlled clinical study environment, subjects generally report a positive experience and usually would consider performing another trial. Fur- ther research is warranted to understand better the motiva- tion for individuals undergoing research trials. Motivation may vary by disease, by the degree of visual loss, and other possible factors such as the level of education of the patient. WILLIAM C. STEWART, MD JEANETTE A. STEWART, RN Dallas, Texas ALAN L. ROBIN, MD AMY HENNESSY, MD, MPH Baltimore, Maryland ELIZABETH D. SHARPE, MD Mt. Pleasant, South Carolina Reference 1. Wendler D, Krohmal B, Emanuel EJ, Grady C; ESPRIT Group. Why patients continue to participate in clinical re- search. Arch Intern Med 2008;168:1294 –9. 1 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 AQ: 1 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 tapraid3/z7f-ophtha/z7f-ophtha/z7f99908/z7f6441d08z comp1 S=1 11/25/09 10:43 Art: 5639