Letter to the Editor Received: August 10, 2013 Accepted after revision: August 30, 2013 Published online: November 6, 2013
Oncology 2013;85:297–298 DOI: 10.1159/000355688
Improving Clinical Trial Recruitment: Experience of a Tertiary Renal Oncology Centre Han Hsi Wong Charlotte Siegler Samantha Grainger Kamarul Ahmad Zaki Athena Matakidou Tim Eisen Kate Fife
Clinical trials are vital for bringing new therapies to patients. Since the establishment of the National Institute for Health Research Cancer Research Network in 2001, the UK has become the top recruiter of patients into oncology trials in the world [1]. In a report published last year, the recruitment rate in the UK was 18.3% of the country’s total cancer incidence, compared to around 5% in the USA and mainland Europe [2]. This high figure could partly be related to the availability of drugs via the National Health Service. In the UK, the National Institute for Health and Care Excellence (NICE) is responsible for approving drugs based on their effectiveness and cost. Treatments not approved by NICE can sometimes be obtained via a lengthy and uncertain special-funding request, or as part of a clinical trial. A recent Cochrane meta-analysis has identified some strategies that might improve recruitment into randomised controlled trials, including telephone reminders and open-trial designs [3]. We felt that it is time to take a snapshot of the recruitment practice in our hospital in recent years, with a specific focus on renal-cell carcinoma, a disease that underwent an unprecedented change in treatment paradigm with the emergence of targeted therapies. Addenbrooke’s Hospital is a regional referral centre for renal cancer patients in the
east of England and has an active clinical trial portfolio. We performed a retrospective study using data from our trials database. All new patients who attended the renal oncology clinic from 2009 to 2011 were included. During this period, there were 12 clinical trials open for recruitment. A total of 325 new patients were seen in our clinic, 101 (31.1%) of whom agreed to enter at least one trial. Nine, 28 and 64 patients entered phase I, II and III trials, respectively. Of these, 36% agreed to enter into an adjuvant trial after primary surgery, 43% into first-line treatment trials for advanced disease and 21% into second-line trials after previous systemic therapies. The median age was 61 years for those who wanted to enter into trials compared to 67 years for those who did not (p < 0.001). The median Eastern Cooperative Oncology Group performance status was 0 and 1, respectively (p < 0.001). There were relatively more males in the trial compared to the non-trial group (75.3 and 67.9%, respectively); 83.2% (84/101) and 80.8% (181/224) of patients, respectively, were still alive at the time of analysis. Our recruitment rate improved yearly with 27.0% (27/100), 32.4% (33/102) and 33.3% (41/123) from 2009 to 2011, respectively. We found that 18.8% (19/101) did not go on to participate in trials due to
© 2013 S. Karger AG, Basel 0030–2414/13/0855–0297$38.00/0 E-Mail [email protected] www.karger.com/ocl
screen failure. Most screen failures were because of unexpected radiological findings (7/19 = 36.8%) or abnormal blood/ urine tests (5/19 = 26.3%). One patient (5.3%) failed to enter into a trial as he missed the recruitment window. However, the screen failure rate improved yearly from 29.6% (8/27) in 2009 to 21.2% (7/33) in 2010 and 9.8% (4/41) in 2011. In summary, we found that a third of new patients seen in our renal oncology clinic consented to take part in clinical trials. Preliminary study suggested that this rate is much higher than other oncology clinics in our hospital; this is presumably due to the scarcity of NICE-approved treatment options and the large number of trials that could be offered as well as having oncologists that are experienced in and enthusiastic about clinical trials. Importantly, we found that the recruitment and screen failure rates improved with time. We believe that these improvements were brought about by some of the following changes made over the years. Since 2009, each patient is discussed and identified for possible trial inclusion at a preclinic meeting that involves the clinicians and trial nurses. To facilitate patient recruitment, we ensure that at least two trial nurses are present at each clinic (crosscover if one is on leave). Eligible patients are given written information about the
Han Hsi Wong Box 193 Addenbrooke’s Hospital, Hills Road Cambridge CB2 0QQ (UK) E-Mail han.wong @ addenbrookes.nhs.uk
Downloaded by: University of Florida, Gainesville and Jacksonville 128.227.24.141 - 1/4/2018 3:17:13 PM
Cambridge University Health Partners, Addenbrooke’s Hospital, Cambridge, UK
298
which can easily happen in a busy clinic. Since 2010, we provide regular training in trial protocols for trials nurses and clinical staff, especially those who have just started working in our clinic. This is done by ensuring that trial information is readily available (in the form of e-mails, the hospital intranet and printed information on the clinic’s shelves) as well as a face-to-face meeting with the lead clinician to confirm understanding of the trial and the overall recruitment practices.
Oncology 2013;85:297–298 DOI: 10.1159/000355688
References 1 Sinha G: United Kingdom becomes the cancer clinical trials recruitment capital of the world. J Natl Cancer Inst 2007;99:420–422. 2 Review Working Party: NCRI Clinical Studies Group Review 2011–12. Leeds, National Institute for Health Research Cancer Research Network, 2012. 3 Treweek S, Lockhart P, Pitkethly M, et al: Methods to improve recruitment to randomised controlled trials: Cochrane systematic review and meta-analysis. BMJ Open 2013;3:e002360.
Wong/Siegler/Grainger/Zaki/Matakidou/ Eisen/Fife
Downloaded by: University of Florida, Gainesville and Jacksonville 128.227.24.141 - 1/4/2018 3:17:13 PM
trial to take home, and are phoned afterwards in an effort to ensure their understanding and continuing interest in the trial. We do not use websites or local advertising for recruitment, as we feel that offers of trial entry need a more individualised approach. Trial eligibility is also carefully checked by at least two team members before a trial is offered. We started doing this in 2010 when we realised that some screen failures were the result of not checking the eligibility criteria properly,
Oncology 2013;85:297–298 DOI: 10.1159/000355688
Improving Clinical Trial Recruitment: Experience of a Tertiary Renal Oncology Centre Han Hsi Wong Charlotte Siegler Samantha Grainger Kamarul Ahmad Zaki Athena Matakidou Tim Eisen Kate Fife
Clinical trials are vital for bringing new therapies to patients. Since the establishment of the National Institute for Health Research Cancer Research Network in 2001, the UK has become the top recruiter of patients into oncology trials in the world [1]. In a report published last year, the recruitment rate in the UK was 18.3% of the country’s total cancer incidence, compared to around 5% in the USA and mainland Europe [2]. This high figure could partly be related to the availability of drugs via the National Health Service. In the UK, the National Institute for Health and Care Excellence (NICE) is responsible for approving drugs based on their effectiveness and cost. Treatments not approved by NICE can sometimes be obtained via a lengthy and uncertain special-funding request, or as part of a clinical trial. A recent Cochrane meta-analysis has identified some strategies that might improve recruitment into randomised controlled trials, including telephone reminders and open-trial designs [3]. We felt that it is time to take a snapshot of the recruitment practice in our hospital in recent years, with a specific focus on renal-cell carcinoma, a disease that underwent an unprecedented change in treatment paradigm with the emergence of targeted therapies. Addenbrooke’s Hospital is a regional referral centre for renal cancer patients in the
east of England and has an active clinical trial portfolio. We performed a retrospective study using data from our trials database. All new patients who attended the renal oncology clinic from 2009 to 2011 were included. During this period, there were 12 clinical trials open for recruitment. A total of 325 new patients were seen in our clinic, 101 (31.1%) of whom agreed to enter at least one trial. Nine, 28 and 64 patients entered phase I, II and III trials, respectively. Of these, 36% agreed to enter into an adjuvant trial after primary surgery, 43% into first-line treatment trials for advanced disease and 21% into second-line trials after previous systemic therapies. The median age was 61 years for those who wanted to enter into trials compared to 67 years for those who did not (p < 0.001). The median Eastern Cooperative Oncology Group performance status was 0 and 1, respectively (p < 0.001). There were relatively more males in the trial compared to the non-trial group (75.3 and 67.9%, respectively); 83.2% (84/101) and 80.8% (181/224) of patients, respectively, were still alive at the time of analysis. Our recruitment rate improved yearly with 27.0% (27/100), 32.4% (33/102) and 33.3% (41/123) from 2009 to 2011, respectively. We found that 18.8% (19/101) did not go on to participate in trials due to
© 2013 S. Karger AG, Basel 0030–2414/13/0855–0297$38.00/0 E-Mail [email protected] www.karger.com/ocl
screen failure. Most screen failures were because of unexpected radiological findings (7/19 = 36.8%) or abnormal blood/ urine tests (5/19 = 26.3%). One patient (5.3%) failed to enter into a trial as he missed the recruitment window. However, the screen failure rate improved yearly from 29.6% (8/27) in 2009 to 21.2% (7/33) in 2010 and 9.8% (4/41) in 2011. In summary, we found that a third of new patients seen in our renal oncology clinic consented to take part in clinical trials. Preliminary study suggested that this rate is much higher than other oncology clinics in our hospital; this is presumably due to the scarcity of NICE-approved treatment options and the large number of trials that could be offered as well as having oncologists that are experienced in and enthusiastic about clinical trials. Importantly, we found that the recruitment and screen failure rates improved with time. We believe that these improvements were brought about by some of the following changes made over the years. Since 2009, each patient is discussed and identified for possible trial inclusion at a preclinic meeting that involves the clinicians and trial nurses. To facilitate patient recruitment, we ensure that at least two trial nurses are present at each clinic (crosscover if one is on leave). Eligible patients are given written information about the
Han Hsi Wong Box 193 Addenbrooke’s Hospital, Hills Road Cambridge CB2 0QQ (UK) E-Mail han.wong @ addenbrookes.nhs.uk
Downloaded by: University of Florida, Gainesville and Jacksonville 128.227.24.141 - 1/4/2018 3:17:13 PM
Cambridge University Health Partners, Addenbrooke’s Hospital, Cambridge, UK
298
which can easily happen in a busy clinic. Since 2010, we provide regular training in trial protocols for trials nurses and clinical staff, especially those who have just started working in our clinic. This is done by ensuring that trial information is readily available (in the form of e-mails, the hospital intranet and printed information on the clinic’s shelves) as well as a face-to-face meeting with the lead clinician to confirm understanding of the trial and the overall recruitment practices.
Oncology 2013;85:297–298 DOI: 10.1159/000355688
References 1 Sinha G: United Kingdom becomes the cancer clinical trials recruitment capital of the world. J Natl Cancer Inst 2007;99:420–422. 2 Review Working Party: NCRI Clinical Studies Group Review 2011–12. Leeds, National Institute for Health Research Cancer Research Network, 2012. 3 Treweek S, Lockhart P, Pitkethly M, et al: Methods to improve recruitment to randomised controlled trials: Cochrane systematic review and meta-analysis. BMJ Open 2013;3:e002360.
Wong/Siegler/Grainger/Zaki/Matakidou/ Eisen/Fife
Downloaded by: University of Florida, Gainesville and Jacksonville 128.227.24.141 - 1/4/2018 3:17:13 PM
trial to take home, and are phoned afterwards in an effort to ensure their understanding and continuing interest in the trial. We do not use websites or local advertising for recruitment, as we feel that offers of trial entry need a more individualised approach. Trial eligibility is also carefully checked by at least two team members before a trial is offered. We started doing this in 2010 when we realised that some screen failures were the result of not checking the eligibility criteria properly,
