Lymphoma einformation Project (LeIP) CLINICAL TRIALS Lymphoma Situation Analysis Report
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1 Lymphoma einformation Project (LeIP) CLINICAL TRIALS 2012 Lymphoma Situation Analysis Report Worldwide Network of Lymphoma Patient Groups The largest barrier for clinical trial enrolment is the lack of appropriate information provided to the patient.
2 CONTENTS 1 INTRODUCTION ISSUE ANALYSIS 2 CONCLUSIONS 3 RECOMMENDATIONS REFERENCES 5-16 DETAILED LC MEMBER SURVEY RESPONSES
3 INTRODUCTION Based on the premise that the research and testing of new drugs saves lives, clinical trials are a necessity and are believed to be an important treatment option for many lymphoma patients. However, between 1997 and 2009, the average number of patients enrolled for all clinical trials worldwide per approved FDA drug decreased by 62% (3). Although no statistical evidence could be found, it is the general industry consensus of medical and pharmaceutical companies that there has been a decrease in clinical trial enrolment in lymphomas as well increasing numbers of subtypes which raises the need even more for specific patients for clinical trials. It is common knowledge that the earlier a patient is informed, i.e. at the diagnosis stage, the greater the opportunity to assist in their treatment decision. However, the 2012 Global Patient Survey (1) found that although lymphoma patients were willing to learn more about clinical trials with the purpose of enroling in them, their lack of understanding beginning at the diagnosis stage and carrying through to the time at which they were approached for participation was the most significant barrier to enrolment. Therefore, in an effort to understand the disconnect between the importance of clinical trials and actual enrolment, the willingness of patients to enrol should they be provided with ample information at the diagnosis stage, and the lack of patient understanding about clinical trials, the Lymphoma Coalition surveyed its global member patient organisations this past year. In the hopes of better understanding this disconnect from the member organisation perspective both globally and by country LC explored : Patient organisation perceptions of both enrolment rates and their acceptability; Barriers to enrolment and other environmental impacts on these rates; Patient organisation clinical trial education of patients particularly for those who have been newly diagnosed; and Communication and potential opportunities to connect with patients at the diagnosis stage. Respondents from a total of 19 countries from around the globe, including 29 leaders of patient organisations and those managing the program service for patients responded to the survey. (See Table 1) Using the findings of this clinical trials survey along with results of the 2012 Global Patient Survey (1), this report will compare the perceptions of patient organisations with the realities of lymphoma patient communities in an attempt to explore issues and possible solutions. ISSUE ANALYSIS The 2012 Global Patient Survey (1) determined that as many as 69% of the 25% of patients approached to participate in a clinical trial had agreed to do so. Of those who had not been approached to participate, 37% would have been willing to do so while 55% had been at least willing to learn more about them before making a decision, the results of which did not differ materially from those of the 2010 survey (2). It was determined that half of the patient organisations surveyed recognized the lack of information being provided to patients as being the largest barrier for clinical trial enrolment (See Table 4). This conclusion is in alignment with results of both the 2012 (1) and 2010 (2) Global Patient surveys where the lack of information for patients about clinical trials was the major reason for not wanting to participate in them. It is also in alignment with results from Phase I of LeIP that determined that as many as 70% of member countries do not have a website with information about clinical trial availability specifically for their own countries. (See Table 5) At the time of diagnosis, only 51% of patients understood what a clinical trial was and newly diagnosed patients were the least likely to be approached for clinical trials and had the least degree of willingness to participate, the major reasons being their lack of understanding and trust in a clinical trial treatment. In addition, only 39% of the patient organisations respondents reported that patients in their countries had access to an online clinical trials web site while as many as 50% of these organisations were not aware of any resource at all. (See Table 6) Three quarters of the patient organisations surveyed also perceived that the clinical trials enrolment process in their country was either somewhat or mostly inefficient. (See Table 7) Therefore, although patients are willing to participate in clinical trials, there is an inadequacy of information available. Should newly diagnosed patients come to patient organisations for information about the availability of clinical trials in their country, they believe it would be on average, very important for them to respond to these requests for this information and support. (See Table 8) 55% were prepared to source information about clinical trials in their country either on their own or through pharmaceutical companies, and the approaches used to help patients ranged from simply referring them to a website, to actively searching for an appropriate clinical trial for them. (See Tables 11 & 12) Lymphoma einformation Project (LeIP) - Clinical Trials 1
4 Although patient organisations were just as willing to provide much needed clinical trial information to newly diagnosed patients as patients were to enrol in them, their sources for procuring this information and the approaches used have varied across member organisations. Patient organisations acknowledged they were not a primary source of clinical trial information for patients, their belief being that two thirds of patients would find out about clinical trials either through their own internet search or through a healthcare professional. (See Table 13) If patient organisations were willing to provide patients with information and support about clinical trials, but are simply reacting to their requests, rather than proactively taking on the role of being key connectors or enablers between patients and the trials available, this begs the question, wherein lies the disconnect? The fact that newly diagnosed patients were not being given clinical trial information and support earlier on in their patient journey is also unfortunate, as the earlier a patient is informed, the greater the opportunity to assist them in their treatment decisions. Patient organisations perceived that an average of 11% of lymphoma patients had enrolled in clinical trials around the world (See Table 2). The majority (64%) of these estimates were made using educated guesses. (See Table 3) Although there is an industry consensus that clinical trial enrolments are lower than they should be, as many as 75% of patient organisations perceived, based on their educated best guess, that clinical trial enrolment rates were either moderately or very acceptable, while only 25% believed them not to be acceptable at all. (See Table 14) Therefore, although patient organisations know that the lack of information about clinical trials is the major barrier to patient enrolment, some may be unable to assist patients insofar as they lack information themselves. The Clinical Trials survey also explored the extent to which patient organisations were able to connect with newly diagnosed patients, and found that 70% were able to connect rarely or sometimes before these patients began treatment. (See Table 15). It appears that of those patient organisations that participated in the survey, 10% were able to connect with newly diagnosed patients (See Table 16). It is interesting to note however, that these patient organisations combined have 260K+ individuals registered in their data bases and are communicating with the lymphoma community on an ongoing basis, and so have an infrastructure set up where they would be able to in fact connect with this segment of the patient population. Patient organisations connect equally with the patient through a number of means including telephone, in person, through referrals from healthcare professionals, and by having their educational materials handed out by clinics and healthcare professionals. (See Table 17) 62% thought it was never to sometimes possible to build relationships with institutions or healthcare professionals that would allow them to connect with newly diagnosed patients (See Table 18). However, the 2012 Global Patient Survey (1) determined that of the 25% of patients approached to participate in a clinical trial, 72% were approached by a healthcare professional, whereas patient organisations believed that only 36% would approach them for clinical trial information (See Table 13). We can assume then that there is a lot of missed opportunity for patient organisations to not only connect with, but also to strengthen relationships with patients to offer support and information alongside the healthcare community at the newly diagnosed stage. CONCLUSIONS Patient organisations have a golden opportunity to play a role in facilitating clinical trial enrolment by providing clinical trial information to patients who are open and willing to exploring them as an important option to treatment. The greatest opportunity for such patient assistance exists with newly diagnosed patients. Patients receive the bulk of their information about clinical trials from healthcare professionals, who have the initial relationship with patients. Knowledge about clinical trials and the approaches used to both collect and disseminate information is not consistent across patient organisations. While there is a missed opportunity for patient organisations to connect with and strengthen newly diagnosed patient relationships, there is also a lack of a formalized structure or process by which to do so. Lymphoma Coalition recommends that a formal process be developed to assist in connecting the newly diagnosed patient and the local patient organisation. Achievement of this goal will require: The education of patient organisations so they fully understand not only the implications of clinical trials, but also the importance of their role in proactively providing information to patients; 2 Lymphoma einformation Project (LeIP) - Clinical Trials
5 The development of a standardized, global mechanism to have patient organisations work alongside healthcare professionals with a particular emphasis on newly diagnosed patients, that would have the primary objective of support as well as guidance around understanding the clinical trials process; and The development of a structured, formal process that will keep patient organisations up to date on the newest developments in clinical trials so they can advocate for these changes in their own countries. RECOMMENDATIONS It is therefore recommended that: There be further exploration and development of an action plan with patient organisations to determine how they can best become better connected with the healthcare community with the purpose of working with them to build relationships with the newly diagnosed patient; The information within the LC global database be further mined and developed to ensure that member countries have access to clinical trial availability information especially in a language they understand; A toolbox that would assist patient organisations in understanding how to educate the newly diagnosed patient about clinical trials and support them in their patient journey; and The development of a protocol for information gathering and dissemination for treatment altering clinical trials. REFERENCES 1. Lymphoma Coalition Global Patient Survey slides Lymphoma Coalition Global Patient Survey global-patient-survey Tufts Center for the Study of Drug Development LC will further explore these recommendations in Phase II of LeIP. SURVEY RESPONSES The following pages are the detailed survey responses from the LC Member Clincial Trials Survey executed in August Lymphoma einformation Project (LeIP) - Clinical Trials 3
6 Lymphoma einformation Project (LeIP) 2012 CLINICAL TRIALS LYMPHOMA COALITION MEMBERS SURVEY RESPONSES NOTE TO READER: If similar responses for a country were provided by more than one respondent in that country, then only 1 response was entered. However, if responses differed between respondents then their individual responses were included in the results (in brackets).
7 Table 1 Number of Responses Lymphoma einformation Project (LeIP) - Clinical Trials 5
8 Table 2 From your experience, what do you believe the rate is for cancer centres and doctors to recruit the patients they need for clinical trials? Table 3 What source did you use to get clinical trial enrolment rates? 6 Lymphoma einformation Project (LeIP) - Clinical Trials
9 Table 4 What are the barriers in your country for enrolling in clinical trials? Lymphoma einformation Project (LeIP) - Clinical Trials 7
10 Table 5 Clinical Trials Website Availability by Country Table 6 Is there an online search website for clinical trials in your country? 8 Lymphoma einformation Project (LeIP) - Clinical Trials
11 Table 7 How efficient is the clinical trials enrolment process? Table 8 If a newly diagnosed patient came to you for information and support, how important do you think it would be to inform them about the availability of lymphoma/ctt clinical trials in your country? * The patient organisation in Barbados did not think this was important at all primarily because clinical trials are not funded (See Table 9) and never available in that country (See Tables 2 & 3). Patients also tend not to inquire about this information even though they believe their organisation has a lot of opportunity to connect with newly diagnosed patients (See Tables 15 & 16). ** The patient organisation in Japan may not believe it is important for them to inform newly diagnosed patients about the availability of clinical trials because patients there may tend only to follow their doctors recommendations for treatment within their extensive network of cancer treatment centres. If the patient organisation is not integrated within Japan s health care community, then provision of this information to patients may be more difficult. (See Tables 16 & 17) Lymphoma einformation Project (LeIP) - Clinical Trials 9
12 Table 9 Who funds clinical trials in your country? Table 10 How available do you believe clinical trials are in your country? 10 Lymphoma einformation Project (LeIP) - Clinical Trials
13 Table 11 What specific information would you provide them with? We would Lymphoma einformation Project (LeIP) - Clinical Trials 11
14 Table 12 How would you find out about clinical trials in your country? Table 13 Where do you think newly diagnosed patients might go to find out about clinical trials in lymphoma/cll in your country? 12 Lymphoma einformation Project (LeIP) - Clinical Trials
15 Table 14 How acceptable do you think these enrolment rates are? Table 15 How often does your organisation have the opportunity to connect with newly diagnosed lymphoma/cll patients before they begin treatment? Lymphoma einformation Project (LeIP) - Clinical Trials 13
16 Table 16 What percentage of newly diagnosed lymphoma/cll patients does your organisation connect with before they begin treatment? 14 Lymphoma einformation Project (LeIP) - Clinical Trials
17 Table 17 In what form does your organisation connect with the patient? Lymphoma einformation Project (LeIP) - Clinical Trials 15
18 Table 18 Is it possible to build relationships with any institutions or health care professionals that will allow you to connect with patients as soon as they are diagnosed? Table 20 Is there a place where standard of care is formally recorded for lymphoma subtypes for your country? 16 Lymphoma einformation Project (LeIP) - Clinical Trials
19 CLINICAL TRIALS Worldwide Network of Lymphoma Patient Groups Contact us if you are a patient organisation that focuses on lymphoma, including CLL, or if you are interested in starting a patient organisation Southdown Road, #228 Mississauga, ON L5J 2Z1 karen@lymphomacoalition.org Phone:
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