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Date of Graduation

8-2006

Degree Type

Capstone Project (On-Campus Access Only)

Degree Name

Master of Science in Physician Assistant Studies

First Advisor

Mary Von PA-C

Abstract

Objective: A general overview of research subject demographic data, clinical trial participation, reason for clinical trial participation, and opinion of the drugg approval process while looking at any connection between no medical insurance and/or prescription drug coverage and research participation.

Design, Setting, and Participants: This survey was distributed to returning and first time clinical trial participants at two different study center sites in the greater Portland metropolitan area over the span of May and June, 2006. The first site is: Michael J. Noonan, MD of Allergy Associates Research Center, LLC of Southeast Portland and the second site is: James W. Baker, MD of Allergy, Asthma, and Dermatology Research Center, LLC of Lake Oswego. 79 total study subjects participated in this research survey, all 18 years of age or older.

Methods and Measuring Technigues: Surveys were distributed at both study center sites to all participants who met inclusion criteria. Measuring tools within the survey included: sex/gender, ethnicity, age, medical insurance, type of medical insurance, prescription drug coverage, socioeconomic status, education level, previous research participation, number of clinical trials completed, type of advertising responded to, reason for clinical trial participation, question as to whether. they would allow their children to potentially participate in research, previous fields of clinical trial participation, and questions addressing the drug approval process and issues regarding drug recall.

Results: There were 46 participants total, 15 males (32.6%) and 31 females (67.4%) [Figure A]. There were 44 Caucasians (95.6%), 1 Afirican American (2.2%) and 1 Asian American (2.2%) [Figure B]. Ages of participants included: 5 participants age 18-28 (10.9%), 7 participants age 29-39 (15.2%),12 participants age 40-50 (26.1%), 7 participants age 51-61 (15.2%),8 participants age 62-72 (17.4%),5 participants age 73+ (10.9%), and 1 participant who did not give their age (J [Figure C]. Of the 46 total participants, 33 (71.7%) had medical insurance and 13 (28.3%) did not [Figure F] and [Figure T]. Of those that had medical insurance, 26 (78.8%) had private insurance, 3 (9.1 %) had public, and 4 (12.1 %) had both private and public [Figure G]. Of the 33 (71.7%) that did have mediCal insurance, 26 (78.8%) had prescription drug coverage, 6 (18.2%) did not have prescription drug coverage,and 1 (3.0%) did not answer [Figure H]. In addition to the 6 (18.2%) participants with medical insurance but no prescription drug coverage, an additional 12 participants had neither medical insurance nor prescription drug coverage. The total number of participants without prescription drug coverage was 18 (39.1 %) [Figure S]. In looking at socioeconomic status: 6 participants (13.0%) made 10,000 per year or less, 22 participants (47.8%) made between 10,001-40,000 per year, 14 participants (30.4%) made between 40,001-80,000 per year, and 4 participants (8.7%) made between 80,001-120,000 per year [Figure D]. In looking at education level: 8 participants (17.4%) had a high school diploma/GED, 20 participants (43.5%) had a high school diploma/some college/or 2 year degree, 14 participants (30.4%) had a high school diploma/4 year. college degree, and 4 participants (8.7%) had a high school diploma/4 year college degree/graduate or professional degree [Figure E]. Of the 46 participants, 37 of them (80.4%) had previously participated in at least one clinical trial where as 9 participants (19.6%) were first time clinical trial volunteers [Figure I]. Of the 37 participants that had previous clinical trial experience, 21 participants (56.8%) completed between 1-5 trials, 5 participants (13.5%) completed between 6-10 trials, 6 participants (16.2%) completed between 11-15 trials, 4 participants (10.8%) completed between 16-20 trials, and 1 participant (2.7%) completed greater than 21 trials [Figure J]. Of the mediums available to advertise for study subjects, 15 participants (32.6%) were recruited by family/friends, 5 participants (10.9%) were recruited by clinician referral, 8 participants (17.4%) were recruited through the local newspaper, 4 participants (8.7%) were recruited over the radio, 3 participants (6.5%) were recruited via the internet, l' participant (2.2%) was recruited through a television ad, 1 participant (2.2%) was recruited from the workplace, and 9 participants (19.6%) were recruited through more than one medium cited previously [Figure K]. When asked what the main reason was for participating in clinical trial(s): 14 participants (30.4%) said they were helping to further medical technology, science, and research, 14 participants (30.4%) said they were doing research for personal reasons i.e. to cure their own condition, 9 participants (19.6%) were doing research for the financial reimbursement, 7 participants (15.2%) were doing research because no prescription drug coverage/free study medication, and 2 participants (4.3%) were doing research due to lack of medical insurance [Figure L]. Of the 46 participants; 43 (93.5%) of them would allow their children [17 years of age and younger] to do research, 3 participants (6.5%) would not [FigureM]. Of the 3 participants that would not allow their children to do research 2 participants (66.7%) said no because of unknown side effects of study medication, and 1 participant (33.3%) said no because of required procedures and testing such as blood draws, etc [Figure N]. Of the 37 participants who had previously done research, 31 participants (83.8%) 6 had done Pulmonology trials [asthma, COPD etc], 4 participants (10.8%) had done allergy trials [seasorial;perennial allergy], 2 participants (5.4%) had done mental health studies [depression, anxiety etc]. 2 of the Pulmonology trial participants had also participated in both cardiology studies and endocrine studies as well [Figure 0]. Out of the 46 participants, 36 (78.3%) had said that participation in a clinical trial had given them insight and awareness into how drugs are approved/not approved through the FDA than if they had never before participated in a clinical trial 10 participants (21.7%) said that participation did not give them any insight or awareness [Figure P]. Of the 46 participants, 41 (89.1 %) said that the media reporting on previously approved drugs being pulled from the market due to safety concerns would not make them not want to participant in research now. 5 (10.9%) said it would make them not want to participate in research now [Figure Q]. Of the 46 participants, 32 (69.6%) of them after discussing the news media regarding recall of a drug with a clinician having specific medical evidence would not change their mind about whether or not they would participate in a clinical trial. 13 (28.3 %) said that it would change their mind, and 1 participant (2.2%) did not respond to the question [Figure R]. There were a total of 33 participants, 18 (54.5%) male and 15 (45.5%) female [Figure A]. There were 29 (87.8%) Caucasian, 2 (6.1 %) Native American, 1 (3.0%) Hispanic American, and 1 (3.0%) Asian American [Figure B]. Ages of participants included: 5 participants (15.2%) between the ages of 18-28, 6 participants (18.2%) between the ages of29-39, 2 participants (6.1 %) between the ages of 40-50, 8 participants (24.2%) between the ages of 51-61, 11 participants (33.3%) between the ages of 62-72, and 1 participant (3.0%) 73 years old or greater [Figure C]. Of the 33 participants, 25 (75.8%) had medical insurance, and 8 (24.2%) did not [Figure F] and [Figure T]. Out of the 25 that had insurance, 19 participants (76.0%) had private medical insurance, 6 participants (24.0%) had public medical insurance. No participants had n both private and public medical insurance [Figure G]. Of the 25 participants that had medical insurance, 22 (88.. 0%) had prescription drug coverage, 3 (12.0%) did not. Of the 8 participants that did not have medical insurance, only 1 participant (12.5%) did have prescription drug coverage [Figure H]. 10 (30.3%) total participants were without prescription drug coverage [Figure S]. In looking at socioeconomic status: 3 participants (9.1 %) made 10,000 per year or less, 13 participants (39.4%) made between 10,001-40,000 per year, 10 participants (30.3%) made between 40,001-80,000 per year, 4 participants (12.1 %) made between 80,001-120,000 per year, and 3 participants (9.1 %) made 120,001 or greater per year[Figure D]. In looking at o education, 1 participant (3.0%) completed kindergarden through middle school only, 5 participants (15.2%) received a high school diploma/GED, 14participants (42.4%) received a high school diploma/some college/ or 2 year degree, 5 participants (15/2%) received a high school diploma/4 year college degree, and 8 participants (24.2%) received a high school diploma/4 year college degree/graduate or professional degree [Figure E]. Of the 33 study participants surveyed, 17 (51.5%) had previously participated in clinical research whereas 16 (48.5%) were first time clinical research volunteers [Figure I]. Of the 17 participants with previous research experience: 15 (88.2%) had done between 1-5 trials, 1 (5.9%) had done between 6-10 trials, and 1 (5.9%) had done between 16-20 trials [Figure J]. Of the mediums available to advertise for study subjects: 13 (39.4%) found out via the newspaper, 6 (18.2%) o found out via clinician referral, 5 (15.2%) found out via family/friends, 2 (6.1 ~) found out via the radio, 2 (6.1 %) found out via the internet, and 5 (15.2%) found out thru other means [private organization] [Figure K]. When asked what the main reason was for participating in clinical trial(s): 16 (48.5%) did it for personal reasons [to cure their own disease], 11 (33.3%) did it to further medical technology, science, and research, 4 (12.1 %) did it because of no prescription drug coverage/free study medication, and 2 (6.1 %) did it because they were not insured or received free medical care [Figure L]. Of the 10 people that did not have prescription drug coverage, 4 (40.0%) gave their main reason for study participation as having no prescription drug coverage/free study medication, 2 (20.0%) gave their main reason for study participation as having no medical insurance, 3 (30.0%) gave their main reason for study participation as personal reasons, and 1 (10.0%) gave their main reason for study participation as wanting to help further medical technology, science, and research. Of the 33 total participants, 24 (72.7%) would allow their children [age 17 years and younger] to do research, 9 (27.3%) would not allow their children to do research [Figure M]. Of the 9 participants that said they would not allow their children to do research, 4 (44.4%) said no because it would depend of the age of their children, 3 (33.3%) said no due to unknown side effects of study medication, and 2 (22.2%) said no for other reasons and sited "all of the above." [Figure N). Of the 17 participants that had previously done a clinical research study: 7 (41.2%) had done pulmonary studies, 8 (47.1 %) had done dermatology studies and 2 (11.8%) had done both dermatology and Pulmonology [Figure O]. When asked if participation in a clinical trial had given them insight and awareness into how drugs are approved/not approved through the FDA than if they had never before participated in a clinical trial, 21 (63.6%) said yes, 9 (27.3%) said no, and 3 (9.1 %) did not answer [Figure P]. When asked would the media reporting on previously approved drugs being pulled from the market due to safety concerns make them not want to participate in research now, 30 (90.9%) said no it would not, 3 (9.1 %) said yes it would [Figure Q]. When asked if after discussing the news media regarding recall of a drug with a clinician having specific medical evidence change their mind about whether or not they would participate in a clinical trial, 8 (24.2%) said yes it would, 25 (75.8%) said no it would not [Figure R].

Conclusion: There was a need at least in these local clinics for more minority recruitment and representation, specifically addressing the issue of race. The federal government defined minorities in research to also include women, the elderly, and children. Both clinics had represented women very well in their study populations, and older age groups were more common at both sites as well. Children were excluded in this particular study due to informed consent issues but both sites did conduct research with children. If they could expand their advertising to minority oriented o newsletters and/or community based health clinics, minority enrollment may increase. The majority of patient-subjects did have medical insurance and/or prescription drug coverage at both study sites. However, for the subset of participants that did not have medical insurance and/or prescription drug coverage, lack of those in addition to financial reimbursement for study participation, were main reasons for research participation more so than furthering of medical technology, science, and research and personal reasons although those were a close second. This could then potentially support the theory previously discussed known as "the therapeutic misconception" where patient-subjects confuse their participation in clinical trials with personalized medical care all the while receiving free care, and free medication despite being a part of a research study. This also brought back to life the controversy surrounding the financial reimbursement of patient-subjects for research participation, especially if it was a motivating factor for those participants without medical insurance and/or prescription drug coverage. As there continues to be issues with cost of insurance and the increasing number of Americans without medical coverage, although most participants in this study did have insurance, those that did not were more likely to participate because of free care and free medication in addition to financial gain. Recommendations in to how to curtail this aspect of clinical research is difficult at best, for there seems to be no easy answer ahead for the FDA, study sponsors, and clinic sites · as well as potential patient-subjects. Per the data, there really seemed to be no connection at all relating both socioeconomic status and/or education level to why patient-subjects participated in research, as those that didn't make much money annually still participated for altruistic reasons or for the better meant of their own condition and the same was noted for patient-subjects educational level as well. For those participants that did participate in clinical trials, there was a positive response regarding their attitudes toward the process relating to drug approval and the FDA in addition to being more educated when issues of drug safety and marketability came about. Patients who had done research were much more likely to continue to do research regardless if.certain drugs already approved were pulled due to safety concerns. This spoke volumes regarding informed consent, site to patient-subject education, and trust in the investigator and the team running the trials.

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