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Clinical trial awareness, attitudes, and participation among ...



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  • 1. Original Contribution Clinical trial awareness, attitudes, and participation among patients with cancer and oncologists Laurie Fenton,1 Maureen Rigney, LICSW,1 and Roy S. Herbst, MD, PhD2 Lung Cancer Alliance, Washington, DC; 2Department of Thoracic/Head and Neck Medical Oncology, 1 The University of Texas M. D. Anderson Cancer Center, Houston, TX Low accrual rates may affect the completion of clinical trials essential to the development of new cancer therapies. Patient and physician attitudes and awareness of clinical trials directly impact clinical trial participation and are critical for the progress of cancer research. We undertook a study to assess the views of oncology patients and physicians regarding clinical trials. We analyzed data from a US national online survey conducted among 200 patients with lung cancer, 206 patients with other cancers, and 200 oncologists between August 9 and 18, 2006. Participants were consistent as a group, providing a number of perceived advantages and disadvantages to enrolling in trials. Sixteen percent of the pa- tients were aware of relevant clinical trials at the time of treatment decisions, and physicians were cited as the patient’s primary source of clinical trial information. Eighty-one percent of the patients reported that they did not discuss clinical trial participation with their physicians, although 84% of oncologists reported that they usually or always discussed clinical trials with patients. The study’s findings suggest that low awareness and misperceptions about clinical trials are key barri- ers to clinical trial participation among patients. Although multiple factors influence patients’ and physicians’ decisions to participate in clinical trials, better overall communication between patients and oncologists about clinical trials is needed. M arked improvements in cancer patients making decisions regarding clinical trial therapy over recent years have participation, they have a direct impact on a pa- been possible with the com- tient’s likelihood of participating in a trial.7 pletion of carefully designed Experience from trials to date indicates that it prospective clinical trials.1,2 would be valuable to further investigate patient Achieving enrollment goals in these trials is critical perceptions of the clinical trials process and the role to establish adequate statistical power and to per- that physicians play in encouraging patients with mit the generalization of results to the overall in- cancer to participate in these trials.1,2 We under- tended population.2 took the present study to gain further insight into Unfortunately, fewer than 10% of patients with the predominant barriers to participation by assess- cancer participate in clinical trials.1–5 Low accrual ing patient and physician views of clinical trials. rates impede the development of new cancer thera- The need for clinical trials for lung cancer ther- pies by prolonging the duration of trials, delaying apies is particularly strong, because lung cancer is analysis of results, preventing the achievement of common and associated with short survival times. statistical goals, and even leading to early closure Therefore, we designed this study to determine of important studies.2,6 The low rate of clinical trial whether the views of patients with lung cancer accrual remains a central issue in oncology. about clinical trials differed from the overall patient Previous studies have examined the problem of population surveyed.8,9 recruitment and participation in oncology trials Manuscript received November 25, 2008; and have identified enrollment barriers for patients, accepted April 6, 2009. such as geography, a desire for noninvestigational Correspondence to: Laurie Fenton, Lung Cancer Alliance, 888 therapies, fear of randomization, age, socioeconom- 16th Street NW, Suite 150, Washington, DC 20006; telephone: ic status, education level, type of cancer, and dif- 202-463-2080; fax: 202-463-7497; e-mail: lfenton@lungcancer- ficulties with third-party payers.2–4,7 As physicians are often an important source of information for Commun Oncol 2009;6:207–213, 228 © 2009 Elsevier Inc. All rights reserved. Volume 6/Number 5 May 2009 ■ COMMUNITY ONCOLOGY 207
  • 2. OrIGINAL CONTrIbUTION Fenton/rigney/Herbst Materials and methods cer patient sample and the oncologist cologists of the patients surveyed. All sample was ±7.0 percentage points at of the data were analyzed using paired We analyzed data collected by a the 95% confidence level. Although Student t tests. We report only those private research firm (Shugoll Re- patients with all types of cancer par- findings that are statistically signifi- search, Bethesda, Maryland) through ticipated in the study, we restricted cant at the 95% confidence level. a national US online survey of 406 our subanalyses to the patients with patients with cancer (200 with lung lung cancer only. Results cancer and 206 with other types) Two separate surveys with closed- Patient demographics and and 200 oncologists from August 9 ended questions were used: one for treatment history through August 18, 2006. Survey re- the patients and the other for the on- spondents were part of an online pan- cologists. The patient survey was de- A total of 406 patients (54% male el of approximately 6 million people signed to identify the patient’s current and 46% female) responded to the sur- (screened on a variety of issues, in- and past cancer treatments, to measure vey, 200 (49%) of whom had lung can- cluding diseases they have) who have awareness of and participation in clini- cer. Ninety-five percent of the respon- agreed to participate in online surveys cal trials, and to assess attitudes toward dents were white, and their mean age maintained by Harris Interactive. clinical trial participation and health- was 64 years, with the majority (66%) Harris Interactive maintains a spe- related entities. The oncologist sur- between the ages of 55 and 74 years. cialty panel of people having chronic vey was designed to describe the on- Sixty-three percent of all patients illnesses, including cancer, who were cologist’s type of practice, to measure had received treatment for their can- invited to participate in this survey. clinical trial participation, to assess cer, with the most common treatment The survey accuracy for the total awareness and attitudes toward clini- modalities being surgery (69%), radia- sample of 406 patients was ±5.0 per- cal trials, and to identify information tion therapy (50%), and chemotherapy centage points at the 95% confidence preferences and practices. Of note, the (46%). Additional treatments included level. The accuracy for the lung can- oncologists surveyed were not the on- other oral medications, targeted ther- apies, and radioactive seed implants. Patients with lung cancer were more Patients (%) likely to have received chemotherapy 35 (55% vs 38%) and less likely to have used other oral medications (8% vs 20%) than patients with other cancer 30 30 30 30 28 types. All cancer patients (n = 406) 26 26 The majority of patient respondents 25 Lung cancer patients (n = 200) reported having Medicare or Medi- caid (32%) or private health insurance 20 20 (60%). Patients who required treatment usually received it at a community hos- 16 15 pital (41%) or at a major teaching or re- search hospital (33%). Compared with 10 10 10 those with other cancer types, patients with lung cancer were less likely to re- 5 5 ceive treatment at an outpatient cen- 4 4 4 4 4 3 ter affiliated with a community hos- 2 0 pital (19% vs 32%). The respondents were divided between residing in large co on nc t/ a rch ith ct ng m me t/ er e nc t/ w (37%), medium (24%), and small (24%) on ca en Tr the eat tes ca en th no ng ea w i do tori er cu / s en rke t st er ow at a n or N O y tm e m tr la tk di res lps /l ic re e e at t/m t by oni bl at r metropolitan areas and rural areas r m ea no ed n’ on e to e ra tre H m Do fo tr et dg e t y -e sur cu r se in fo (15%). Sixty-four percent of all patients bl lo no tting po cu ssi rt tm C fo x Po fin cu y e ea reported traveling 20 or fewer miles to ef st rl Ea La receive their treatment with 36% travel- Advantages of clinical trial participation ling more than 20 miles for treatment. FIGURE 1 Patient-perceived advantages of clinical trial participation. Patients with cancer reported Notably, lung cancer patients were more three primary advantages to clinical trial participation. Note: percentages may add up to greater than likely to travel more than 20 miles to re- 100 because multiple responses were accepted. ceive treatment (41%). 208 COMMUNITY ONCOLOGY ■ May 2009
  • 3. Cancer trial awareness and participation OrIGINAL CONTrIIbUTION Forty-seven percent of patients had Oncologist demographics and prostate cancer (92%). Forty-eight received their cancer diagnosis with- and practice types percent noted that more than half of in the past 5 years. However, patients Ninety-nine percent of responding their patients had cancers that had with lung cancer were more likely to oncologists were medical oncologists, progressed to advanced stages. have a recent diagnosis (10% within 60% of whom had been in practice ≥ the past year) versus all patients (2% 11 years (mean, 14 years). Eighty-two Patient awareness of and within the past year). The cancer had percent of the physician respondents participation in clinical trials not spread to other parts of the body were male, 67% were in a private or Survey results indicated that the in 88% of patients, and 35% of patients office-based practice, 41% were af- large majority of patients with can- had stage I or earlier cancer. Notably, filiated with a major teaching or re- cer were familiar with the term clin- the lung cancer subgroup was more search hospital, and 79% reported ical trials, with 82% reporting being likely than the subgroup with other serving as a primary investigator of a either very familiar (32%) or some- malignancies to have a diagnosis of clinical trial. These oncologists were what familiar (50%). However, fewer stage IV cancer (11% vs 6%) and to in- located throughout the United States, patients with lung cancer (28%) com- dicate that their cancer had spread to and 83% were in an urban or subur- pared with those with other cancer other areas of their bodies (8% vs 0%). ban practice setting. types (37%) reported that they were Overall, patient respondents were On average, the oncologists report- very familiar with the term. most likely to have received treatment ed spending 88% of their time with Patients were fairly consistent in from a radiation oncologist, with 44% patient care, and 73% reported treat- providing a number of perceived ad- of all patients reporting treatment by ing more than 80 patients per month. vantages and disadvantages to partici- these specialists. Of note, the patients More than 90% of the oncologists in- pating in clinical trials. The three ad- treated for lung cancer were more likely dicated that they treat the more com- vantages most often mentioned were to be seen by a general or thoracic sur- mon cancers, including lymphoma and helping with research and finding a geon than those treated for other types leukemia (96%), breast cancer (95%), cure, obtaining a possible treatment of cancer (46% vs 28%, respectively). colon cancer (95%), lung cancer (93%), or cure for their own type of cancer, Patients (%) 35 34 31 30 All cancer patients (n = 406) 27 26 Lung cancer patients (n = 200) 25 20 20 19 17 15 15 10 9 9 5 6 6 6 6 5 4 3 3 3 2 2 2 2 1 0 fe of ow / h t/ cti to lin / pi n er e r p he t h ma e g w on ea / ak at ea a kn ork du on in th no ga t in um en fe e ef k s n ot ve g g ill ar y de um ct gr rse m su ing N e Ris O m ef c he ati un w tk at re an r m gu a h he e o y ns sc c of o/ eiv lts ot n’ us s w ma tre mo ch s/ t lo co su n Do sk g ec e ay en re ay sid in Ri ca es gs e ac f r m Be iv el ho eni sm ill Dru pl k o Ti eb ce d ur nv ug re ay s n Ri co Dr M In Disadvantages of clinical trial participation FIGURE 2 Patient-perceived disadvantages of clinical trial participation. Patients with cancer reported four primary disadvantages to clinical trial participation. Note: percentages may add up to greater than 100 because multiple responses were accepted. Volume 6/Number 5 May 2009 ■ COMMUNITY ONCOLOGY 209
  • 4. OrIGINAL CONTrIbUTION Fenton/rigney/Herbst cal journals (11%). interested in participating if they still Patients (%) Eighty-one percent of all the pa- required treatment and a new drug 60 tients reported that they did not dis- was being developed. This number All cancer patients (n = 72) cuss clinical trial participation with was higher in the subgroup of patients Lung cancer patients (n = 45) 50 50 their physicians at the time they with lung cancer (77%) than in the 47 were making treatment decisions. group with other cancer types (62%). 44 The patients with lung cancer were 40 more likely to have had such discus- Oncologist attitudes toward 36 sions with their physicians than were referring patients to clinical trials 30 the patients with other cancer types Nearly all of the oncologists (95%) (22% vs 13%). Sixty percent of pa- had searched for a clinical trial that tients reported that their physicians met the needs of a patient, and only 20 were more likely to initiate a discus- 3% had not referred any patients to sion about clinical trials whereas 35% clinical trials in the past year. Howev- 10 of patients reported that they initiat- er, 66% of the oncologists reported re- 7 7 7 ed the discussion. Half of the patients ferring 20 or fewer patients during this 2 surveyed also reported that their phy- time period. Further, few of them re- 0 sicians remained neutral during the ferred patients to a hospital other than discussion (Figure 3). their own for clinical trials. Among tio d tio d ci ag ed n tio pa e pa e ci ag ci ag rti ur ag n n tio d those who had referred patients for ac pa e rti ur rti ur pa isco ur n re pa nco pa o co Patient attitudes toward sc er trials, 77% reported that only 25% or r d en Di th E O no er clinical trial participation fewer of their referrals were to a com- th ei N Physician reaction regarding Only 7% of all patients surveyed peting or other hospital. clinical trial participation had participated in a clinical trial, Oncologists reported that the although reported participation was main obstacles to referring patients FIGURE 3 Patient-reported physician reaction regard- ing clinical trial participation among patients who dis- more common among the patients with cancer to clinical trials were fear cussed trial participation with their physicians. Although with lung cancer than among those or hesitation among patients (50%), results are based upon a small number of respondents, with other types of cancer (11% vs the grave condition of patients (49%), approximately half of the patients discussing participa- 4%). The primary reasons that the lack of interest among patients (44%), tion with their physicians reported that their physicians remained neutral during the discussion, neither encour- patients gave for participating in a and finding clinical trials close enough aging nor discouraging participation. trial were that their physicians rec- to be considered (42%). The main ob- ommended it (45%), they wanted to stacles to referring patients with lung help advance the understanding and cancer were similar (Table 2). Addi- and having early exposure to the lat- treatment of cancer (41%), and they tional obstacles to referral included est treatments not yet on the market considered the trial treatment to be having to learn about the trials and (Figure 1). On the other hand, the more advanced or state of the art application and administration issues, patients cited four primary disadvan- (35%; Table 1). Conversely, the pa- among others. tages to clinical trial participation: the tients cited lack of awareness of ap- risk of side effects, a concern regarding propriate trials as the chief barrier to Oncologist clinical trial efficacy of untested agents, the risk of participation, with 65% of those who discussions with patients receiving a placebo, and the possibil- had not participated in a trial giving The oncologists estimated that ity that the drug may cause harm or this reason. Other barriers the pa- about 60% of patients ask about clini- make their disease worse (Figure 2). tients mentioned included satisfac- cal trials. When patients initiate these Overall, 16% of all patients were tion with their current therapy (23%), discussions, the oncologists reported aware of relevant clinical trials at fear of possible side effects (14%), primarily providing objective counsel- the time that they were considering and a failure to meet inclusion crite- ing (79%) and reassurance that the trial treatment options. By far, their main ria (13%). Patients with lung cancer is something for the patients to consid- source of information about clinical were less likely to be concerned about er (78%). In addition, they mentioned trials was physicians, cited by 79%. side effects than their peers with oth- that they provide patients with contact Other sources included the Internet er cancer types (10% vs 17%). information for the trial leaders (65%), (26%), information at a physician’s The majority of patients expressed Internet sites or support groups (44%), office (14%), support groups (13%), interest in clinical trials, with 69% and their nursing staff (33%), so the friends or relatives (11%), and medi- overall indicating that they would be patients can gather more information 210 COMMUNITY ONCOLOGY ■ May 2009
  • 5. Cancer trial awareness and participation OrIGINAL CONTrIIbUTION about a particular trial. TABLE 1 Fully 84% of the oncologist re- Patient-reported reasons for and barriers to clinical trial participation spondents said that they always (43%) All cancer Lung cancer or usually (41%) discuss clinical trial Reason for/barrier to participation patients, % patients, % participation with a patient if it is ap- reason for participation provided by those 29 21 propriate. The chief barriers to such a who participated in clinical trials (7%), n discussion with a patient who might recommended by doctor 45 48 qualify for a trial were inconvenience Advancing the understanding and treatment of cancer 41 48 of the trial location (25%), lack of pa- Trial treatment was considered more state-of-the-art care 35 29 tient interest (22%), and time con- Offered along with the standard course of treatment, 24 29 straints (19%). Other barriers men- so it couldn’t hurt tioned by the oncologists included My costs of care were covered in the trial 21 24 the patient not qualifying or the trial The second or third treatment stopped working 14 14 not being appropriate for the patient, My first treatment stopped working 7 10 the possibility that standard therapy might be more appropriate or effec- Other 3 0 tive for the patient, and inability of barrier to participation cited by those who did not 374 176 the patient to understand the trial or participate in clinical trials (92%), n give informed consent. Not aware of any trials appropriate for me 65 64 Current treatment is better/more effective 23 24 Oncologist perceptions of Fear of possible side effects 14 10 patients’ concerns Did not meet the criteria to participate 13 12 A large proportion of the oncolo- Did not want to change doctors 11 10 gists (89%) reported that they had pa- Did not want to wait to begin treatment 11 7 tients who declined to participate in Fear of getting a placebo 10 8 a clinical trial that might have been appropriate for them. According to Concern about insurance/coverage issues 10 11 these respondents, patients hesitate or Inconvenient follow-up location 6 6 decline to participate in clinical trials Made an earlier treatment decision that made me 6 5 largely because of concerns about be- unable to meet the criteria to participate ing given a placebo, fear of side effects, Trial location would mean relocating or being away 6 5 from my home/family the inconvenience of the trial location, or the need to relocate away from Time commitment was too much 5 5 home or family (Table 3). Out-of-pocket expenses were too high 5 6 My family objected/had some concerns 2 2 Oncologist awareness of and Other 5 5 attitudes toward clinical trials The oncologists surveyed report- who do not closely follow clinical drugs will replace the need for che- ed being well informed about trials in trials, 87% noted that this was due motherapy and will improve overall their general area but also not having to a lack of time, and 41% noted that survival; newer drugs must be tar- time to follow ongoing trials. A total annual symposia and continuing ed- geted to the specific molecular and of 50% responded that they are aware ucation programs keep them as in- genetic makeup of a specific type of of all (7%) or most (43%) clinical tri- formed as they need to be. cancer and show improved survival. als of new agents in their geograph- Many of the oncologists surveyed However, the oncologists were keenly ic area. Although most oncologists had not developed strong opinions interested in drugs that will improve closely follow the existence and find- about criteria to determine whether the quality of life for their patients, ings of ongoing clinical trials, many they would participate in a clinical and 72% agreed that if two drugs noted that they are unable to do so trial of a particular drug. The major- are equivalent in improving survival because of time constraints. Specifi- ity neither agreed nor disagreed with rates, the one improving quality of cally, 66% reported following trials the following statements: newer drugs life would be preferred. Further, only in progress closely, whereas only 10% must be more convenient to admin- 22% agreed that there would be con- follow them very closely and 24% do ister; newer drugs must demonstrate siderable value in a new drug that im- not follow them at all. Among those progression-free survival; new cancer proves the time to disease progression Volume 6/Number 5 May 2009 ■ COMMUNITY ONCOLOGY 211
  • 6. OrIGINAL CONTrIbUTION Fenton/rigney/Herbst TABLE 2 but does not improve quality of life. that clear communication between Oncologist-reported obstacles to referring patients and oncologists about clinical Oncologist information trial participation is lacking and that patients with lung cancer to clinical trials preferences and practices better methods for discussing the op- Obstacle Oncologists, % Fully 98% of the surveyed oncol- tion of clinical trial participation with Number of respondents 200 ogists expressed fair to strong inter- patients are needed. This observation Fear or hesitation among patients 49 est in learning about available clini- regarding lack of clinical trial aware- Condition of patient is too grave 48 cal trials; however, only 37% had a ness among patients and suboptimal to benefit from trial participation systematic method for remaining communication between patients and Finding clinical trials close enough 43 current regarding trials. Online da- physicians about trial participation is to be considered tabases were overwhelmingly pre- supported by previous studies that in- Lack of interest among patients 42 ferred sources of information, cited vestigated clinical trial enrollment.10 Learning about clinical trials that 33 by 93% of those surveyed. The re- One limitation of our study is that match the patient’s condition (inclusion/exclusion criteria) spondents also cited oncology confer- the majority of patients who partici- ences (66%), the National Cancer In- pated had earlier-stage disease. Many Ease of application and 21 administration (CrOs, forms, stitute (NCI) and National Institutes oncology trials, particularly in lung etc) for patient’s enrollment of Health (NIH) Web sites (55%), cancer, are conducted in populations Coordination of patient care once 15 oncology medical newsletters (53%), with late-stage disease. Hence, the pa- in a trial and word of mouth from other oncol- tients surveyed are less likely to have Affordability for the patient 15 ogists (50%) as their primary sourc- had discussions with their oncolo- Loss of patient to another 13 es of clinical trial information. Some gist about clinical trials, and some re- physician/facility 71% of the oncologists rated the op- sponses may have differed in a group I do not treat lung cancer 3 portunity to learn of nearby trials as with more advanced cancer. Other 2 something that would be particularly In the oncologist portion of the sur- helpful, and 57% would find it very vey, nearly all of the physicians indicated CrO = contract research organization helpful to have information available that they search for trials for their pa- to refer physicians to clinical trials oc- tients. Although the oncologists in this TABLE 3 curring at their facilities. study reported that they were aware of most clinical trials for new cancer drugs, Oncologist-perceived reasons why patients Discussion their responses also indicate that keep- hesitate or decline to participate in clinical Although measures have been tak- ing current on these trials can be chal- trials en to reduce barriers to participation lenging for physicians. Reason Oncologists, % in clinical trials and to better inform This survey revealed important Number of respondents 200 patients with cancer about these trials, discrepancies between oncologist Fear of being given placebo 67 the results of our survey indicate that views of patient beliefs about clini- Fear of side effects 61 the needs of patients with cancer and cal trials versus patients’ actual be- Inconvenient trial location 59 oncologists still are not being met. liefs about clinical trials. For example, Trial location means relocating 53 The survey’s results indicated a 49% of oncologists indicated that pa- away from home/family considerable lack of awareness among tients’ fear of clinical trials is an ob- Patient too weak or gravely ill to 47 patients with cancer about the clini- stacle to referring them for participa- participate cal trials that might be available to tion in trials of lung cancer therapies, Not wanting to delay treatment 45 them. Concerns, fears, and misper- and a majority believed that patients Health insurance or coverage issues 38 ceptions about the quality of care and fear of receiving a placebo (67%) or Time commitment for treatment and 34 the chances for treatment benefit may side effects (61%) is a noteworthy follow-up deter the few patients who are aware reason why patients hesitate or de- Family concerns 33 of clinical trials from enrolling in one. cline to participate. In contrast, only a Out-of-pocket expenses 33 Other barriers mentioned by the pa- minority of patients with lung cancer tients, including preferences for cur- noted that fear of receiving a placebo Paperwork or contract issues 28 rent treatment, distance from the (8%) or side effects (10%) was a bar- belief that current treatment is better 27 cancer center, relationship with their rier to their participating in a clinical Feeling like a guinea pig/being 4 medical team, and insurance denial, trial. Taken together, these findings experimented on are similar to those described in ear- suggest that oncologists believe that Other 1 lier studies.2–4 These findings suggest patients are more fearful of trial par- 212 COMMUNITY ONCOLOGY ■ May 2009
  • 7. Cancer trial awareness and participation OrIGINAL CONTrIIbUTION ticipation than patients really are. If a general or thoracic surgeon, had re- cians about trials and helping them oncologists understand that patients ceived their cancer diagnosis more re- navigate the enrollment process.18 Fi- are not averse to participating, it is cently, had to travel farther to receive nally, establishing allowances to help likely that both communication about treatment, and were more likely to ex- maintain the physician-patient rela- the existence of trials and overall par- press interest in clinical trials. tionship when trials are available at ticipation would increase. Suggestions for overcoming some other or competing institutions could Several studies, including this one, barriers to patient awareness and pa- also decrease barriers to patient en- have shown that the physician is the tient accrual to clinical trials include rollment in clinical trials. This would main factor in determining a patient’s providing consumer-friendly, unbi- alleviate concerns of physicians who enrollment in a clinical trial.7 Howev- ased information about these trials fear losing control of their patients’ er, some important differences in per- to patients with cancer. Specifically, care and also adequately compensate ceptions exist between patients and patients should be introduced to in- physicians for the time it takes to re- physicians. For example, although the formation about treatment options, fer patients to other centers. survey results suggested that 84% of including clinical trials, by the oncol- oncologists believe that they discuss ogist and the clinical research associ- Conclusion clinical trials with eligible patients, ate.3 They should also be made aware The results of this survey reinforce 81% of patients indicated that they of the potential benefits of clinical the notion that the physician has the were unaware of available and appro- trial participation, as the perception best opportunity to inform patients priate clinical trials when they were of personal benefit has been signifi- about clinical trials and also has the exploring treatment options. Pos- cantly correlated with a patient’s deci- greatest influence on how patients sible explanations for the difference sion to enter into clinical trials. perceive clinical trials. The first step in these responses may be that phy- In this survey, physicians report- in alleviating many of the barriers to sicians mention clinical trials only if ed that they would like improved clinical trial enrollment, confirmed by they believe that the trial has experi- resources to search for trials, which this survey’s results, is better commu- mental merit, the patient meets ideal confirms findings of earlier studies nication between patients and their eligibility requirements, and trial par- suggesting such resources could help oncologists about clinical trials. ticipation would not be a burden to engage oncologists in clinical trials.5 Acknowledgments: We thank Lee the patient.2,11,12 Physicians can search for clinical tri- Ann Swenson, who provided medical As suggested by this study and als registered on the NCI’s Web sites writing support funded by AstraZen- shown in other studies,13–15 patients are ( or http:// eca Pharmaceuticals LP. often willing to participate in clinical, but, because trials, but a large number do not meet of time constraints and other fac- References the eligibility criteria. For example, of tors, it may be more useful if current 1. Paskett ED, Cooper MR, Stark N, et al. 1,411 patients treated in the UK Na- information about trials in the phy- Clinical trial enrollment of rural patients with cancer. Cancer Pract 2002;10:28–35. tional Cancer Research Network in sician’s local area were readily acces- 2. Lara PN Jr, Higdon R, Lim N, et al. Pro- 2002, 40% did not have any trials avail- sible.16 National governmental ef- spective evaluation of cancer clinical trial ac- able to them, and 28% were immediate- forts have also been made to involve crual patterns: identifying potential barriers to ly excluded, as they did not meet entry physicians in clinical trials through enrollment. J Clin Oncol 2001;19:1728–1733. 3. Wright JR, Crooks D, Ellis PM, Mings criteria.13 In another study conducted at the use of Cooperative Group Out- D, Whelan TJ. Factors that influence the re- a community-based center in Wiscon- reach Programs by making it easier cruitment of patients to phase III studies in on- sin, the center did not have an appro- for physicians to accrue patients to cology: the perspective of the clinical research priate trial for the diagnosis and stage cooperative group studies. Similarly, associate. Cancer 2002;95:1584–1591. 4. Tournoux C, Katsahian S, Chevret S, of disease for 58% of the 1,012 patients Community Clinical Oncology Pro- Levy V. Factors influencing inclusion of pa- receiving a new diagnosis of cancer be- grams allow potential investigators to tients with malignancies in clinical trials. Can- tween 2003 and 2004.15 participate in most cooperative group cer 2006;106:258–270. Although the issues surrounding trials.5 Community physicians also 5. Cohen GI. Clinical research by community oncologists. CA Cancer J Clin 2003;53:73–81. clinical trial participation may largely have the option of joining the Cancer 6. Demmy TL, Yasko JM, Collyar DE, et transcend cancer type, we found that Trials Support Unit, which promotes al. Managing accrual in cooperative group clin- compared with patients with other unrestricted access to NCI-sponsored ical trials. J Clin Oncol 2004;22:2997–3002. types of cancer, patients with lung phase III trials outside of one’s co- 7. Mannel RS, Walker JL, Gould N, et al. Impact of individual physicians on enrollment cancer had more advanced disease at operative group.17 In addition, clini- of patients into clinical trials. Am J Clin Oncol diagnosis, were more likely to have re- cal trial nurses may help play a role 2003;26:171–173. ceived chemotherapy and to have seen in recruitment by informing physi- continued on page 228 Volume 6/Number 5 May 2009 ■ COMMUNITY ONCOLOGY 213
  • 8. Clinical trial awareness continued from page 213 8. American Cancer Society. Cancer Facts 13. Corrie P, Shaw J, Harris R. Rate limit- ABOUT THE AUTHORS & Figures 2008. ing factors in recruitment of patients to clinical Affiliations: Ms. Fenton is President and Chief STT/content/STT_1x_Cancer_Facts_and_ trials in cancer research: descriptive study. BMJ Executive Officer of the Lung Cancer Alliance, Figures_2008.asp?from=fast. Accessed May 5, 2003;327:320–321. Washington, DC; Ms. Rigney is a Licensed In- 2009. 14. Comis RL, Miller JD, Aldige CR, dependent Clinical Social Worker and Director 9. National Comprehensive Cancer Network. Krebs L, Stoval E. Public attitudes toward par- of Patient Services at the Lung Cancer Alliance, Non-Small Cell Lung Cancer. NCCN Clini- ticipation in cancer clinical trials. J Clin Oncol Washington, DC; and Dr. Herbst is a Professor of Medicine and of Cancer Biology, in the De- cal Practice Guidelines in Oncology – v.2.2009. 2003;21:830–835. partment of Thoracic/Head and Neck Medical 15. Go RS, Frisby KA, Lee JA, et al. Clini- Oncology, The University of Texas M. D. Ander- nscl.pdf. Accessed May 5, 2009. cal trial accrual among new cancer patients son Cancer Center, Houston, TX. 10. Ellis PM. Attitudes towards and par- at a community-based cancer center. Cancer Conflicts of interest: Dr. Herbst is an advisor ticipation in randomised clinical trials in on- 2006;106:426–433. for Amgen, AstraZeneca, Bristol-Myers Squibb, cology: a review of the literature. Ann Oncol 16. Embi PJ, Jain A, Clark J, Bizjack S, Hor- and Prolex. He has received grant and research 2000;11:939–945. nung R, Harris CM. Effect of a clinical trial alert support from Amgen, AstraZeneca, Bristol- Myers Squibb, Eli Lilly, Genentech, and sanofi- 11. Kaas R, Hart AAM, Rutgers EJT. The system on physician participation in trial recruit- aventis. He is a paid consultant for Amgen, impact of the physician on the accrual to ran- ment. Arch Intern Med 2005;165:2272–2277. AstraZeneca, Bristol-Myers Squibb, Eli Lilly, domized clinical trials in patients with primary 17. Venook AP, Blanke CD, Goldberg RM, Genentech, ImClone Systems, Pfizer Inc, and operable breast cancer. Breast 2005;14:310–316. et al. Assessing the combination of FOLFOX sanofi-aventis. He has participated in the speak- 12. Benson AB III, Pregler JP, Bean JA, and FOLFIRI with bevacizumab, cetuximab, er’s bureau for Eli Lilly and Genentech, and has received research funding from Amgen, Astra- Rademaker AW, Eshler B, Anderson K. On- or both in metastatic colorectal cancer. Com- Zeneca, Bristol-Myers Squibb, and Genentech. cologists’ reluctance to accrue patients onto mun Oncol 2006;3:593–598. Ms. Fenton and Ms. Rigney do not have any clinical trials: an Illinois Cancer Center study. J 18. Barrett R. A nurse’s primer on recruit- conflicts of interest to report. Clin Oncol 1991;9:2067–2075. ing participants for clinical trials. Oncol Nurs 228 COMMUNITY ONCOLOGY ■ May 2009