Patient Centered Clinical Trials
As pharmaceutical companies compete to bring new drugs to market, there is an increasing emphasis on the need for patient centricity – to retain patient volunteers and produce quality data. We spoke to Duncan Cantor, Director of Communications, Boehringer Ingelheim, about the importance of patient centricity in clinical trials.
Recruitment of patient volunteers
The age-old problem facing researchers conducting drug trials is how to attract, engage and retain patient volunteers to participate continuously throughout all phases of a drug trial.
Another pressing issue in the research and development of new drugs is the ever-increasing cost of development, which is reflected in the higher cost of medicines when they are authorized for sale. Some patient groups have proposed that making drug trials more patient -centric can lower the cost of research and development. Moreover, making drug trials more patient-centric will increase participant retention and enhance pharmacovigilance.
In patient-centered approaches to clinical trials, patient volunteers are considered equal partners in managing their care and treatment. Indeed, the problem of attracting, engaging and retaining patient volunteers doesn't appear to stem from lack of interest or motivation to join drug trials, but from a paucity of information, lack of involvement in reporting outcomes, and restricted access to data generated from drug trials. Increasing evidence suggests that intensified patient involvement in research and development will not only drive costs down, but it will also help in pharmacovigilance efforts.
These days, pharmaceutical companies like Boehringer Ingelheim engage patient participation much earlier than the clinical trial stage. Indeed, according to Duncan Cantor, Director of Communications at the company, they closely collaborate with patient advocacy groups to highlight where there is an unmet need in a particular therapeutic area.
Lack of information for patients
Many patients are unaware of the existence of clinical drug trials that they can be involved in. They are unaware of the benefits that participating in drug trials may provide. They don’t realize that they will obtain better monitoring of their condition and access to better care from medical specialists if they participate in drug trials - even if they are allocated to a group that will receive the placebo.
Most patients will learn about clinical drug trials from their GPs. If their GPs are unaware of clinical drug trials that are appropriate for their patients, then the patients will never know about the existence of drug trials at all. One solution is for pharmaceutical companies and contract research organizations (CROs) to communicate regularly with patient advocacy groups with regards to the different drug trials they are undertaking. They could actively meet with patients in support groups in order to disseminate information directly to patients who can then make more informed choices about participation. The current stumbling block can be more accurately described as limited dissemination of information about clinical trials to the specific patient groups who need to know, rather than a total lack of information.
Cantor reports that at Boehringer Ingelheim, “Patient Advocacy Groups are engaged to review materials relating to clinical trials. They scrutinize the information to ensure that it is relevant to the patient and that the terminology used is easy to understand.”
Lack of patient involvement in reporting outcomes
Most drug trials rely on quantitative measures to determine the safety and efficacy of new drugs on patient volunteers. Very few pharmaceutical companies and CROs actively ask patients to provide qualitative data about their experiences with taking the drug. This is despite patients being in the best position to describe how a certain drug affects them and impacts their quality of life. Indeed, patient-reported outcomes can help in pharmacovigilance in two ways. Primarily, they enrich the data gathered during clinical trials. They also, importantly, provide data on potential risks of adverse drug reactions, which may or may not be measured by quantitative measures alone.
One particular measure adopted by Boehringer Ingelheim is to ask patient volunteers at the post-clinical stages to complete quality of life questionnaires. Health outcomes are reviewed to determine the efficacy of medicines in the long-term.
The involvement of patient volunteers in drug trials consists mainly of them attending the trial site to undergo various tests and measurements. Researchers haven’t yet fully realized the benefit of training patients in self-measuring and self-managing, which can reduce travel costs and minimize disruption for patients. Furthermore, the more involved patient volunteers become in the drug trial process, the more engaged they become. High levels of patient engagement result in increased patient retention and a more useful trial. Patients who feel that their participation is valued and their views are heard will be more likely to stay on as volunteers until the last phase of the trial, which addresses the very real problem of low retention rates in trials.
Lack of access to data gathered during trials
Most patients are interested in knowing the outcome of any trials they have been involved in. They want to be able to access the results of the trials in a language that they can understand. If the results are provided to the patients, then the patients can provide further input, which can influence the way the drug will be developed. In other words, patient involvement allows cross-validation of the quantitative results with qualitative, subjective data. The data becomes collaborative and more meaningful. Research suggests that patients participate in drug trials for altruistic motivations; they want to contribute something to medical science and to contribute to the well-being of other patients in the future. By making data gathering a collaborative, patient-centric effort, any altruistic motivation is strengthened.
Cantor confirms that efforts are being undertaken to gain more patient input into clinical trials. He says, “Patients are at the heart of everything we do and are involved throughout the clinical trial process. Patient engagement is key. We provide patients with information sheets with a link to the clinical-trials.gov website so they can find out more information relating to the trial that they are participating in. Once the trial has been completed patients are provided with a summary of the trial data. Additionally, investigators will share a patient’s individual data with them as requested.”
Lack of continual monitoring of patients
To be truly patient-centric, data relating to the effects of drugs on patients must continue to be collected during the periods in-between the phases of the drug trial and even after the drug has been approved for use. The purpose of data collection may change as the trial progresses. During the first three phases, the aim is to discover adverse effects and efficacy of the drug. In-between the phases, the purpose is to determine which side-effects manifest in the long-term, enabling the appropriate risk management mechanisms to be developed. As more risks are identified, the more efficiently these risks can be managed. The ultimate aim is to manage risks effectively so that the impact of future adverse drug reactions can be minimized or prevented altogether.
The process of continually monitoring patients can be achieved via questionnaires and health outcomes. Cantor says, “At the pre-clinical stage, Patient Advocacy Groups help highlight where there is an unmet need in a particular therapy area. They play an integral role particularly in relation to orphan drugs. At the clinical stage, patient groups review materials and ensure that protocols are viable. At the post-clinical stages, quality of life questionnaires and health outcomes are reviewed, as well as the long-term efficacy of our medicines.”
The issue of attracting, engaging, and retaining the involvement of patients in drug trials can best be addressed when the patients know the benefits they will personally derive from participating in clinical trials. Involving patients actively as partners, and not merely as passive recipients of care, will not only predict retention in drug trials, but it will also enrich the data collected, making management of risks relating to drug safety more efficient. Patient-centricity will not only aid pharmacovigilance, it will also help drive down costs of research and development of drugs. Ultimately, when patients win, everybody else wins.
For more information on Patient Centric Clinical Trials Europe, click here.
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