Participation of the Elderly Population in Clinical Trials
Enrollment in clinical trials relies heavily on physicians, creating many barriers for the elderly. Both physician bias and perception have been shown to be impediments to enrollment of older persons in clinical trials. Therefore, it is imperative to create a cultural shift among oncologists to boost trial enrollment of older patients.
The factors influencing physician culture can be complex and difficult to manipulate. One commonly cited issue is the lack of data on toxicity and survival rates among elderly patients, a challenge that may enable bias. Physicians report that how elderly patients are likely to tolerate a specific treatment has not been well elucidated, a barrier that creates unknown variables favoring conservative treatment for this patient population. Because of the low numbers of participation among elderly patients in clinical trials, the problem of lacking data on treatment tolerance is further compounded. Although some studies have demonstrated that age itself does not change tolerance to treatment, additional studies are needed to further clarify this issue. As more specific data become available, physician attitudes toward trial participation are likely to change.
It is important to increase trials specifically targeting elderly patients, because older patients with cancer may require more thorough care when instituting systemic therapy compared with younger patients with cancer. This is due to the biological changes of aging and uncertainties of the pharmacokinetic profiles of some medications, including chemotherapy, which is a concern common among oncologists that may hinder patient enrollment. Studies of pharmacodynamics and pharmacokinetics directed at elderly populations will be important for solving these challenges.
Late-stage clinical trials can also stratify patients based on age, and increasing data on the elderly patient population may improve treatment and decrease physician-related barriers. The prognoses of elderly patients referred to a phase 1 study are comparable with the rest of the study population. In fact, elderly patients enrolled in phase 1 trials had improved survival rates when compared with elderly patients who did not receive treatment during a phase 1 trial. However, some physicians do not perceive clinical trials as being beneficial for their patients. Therefore, increasing data on the older population, as well as changing physician perceptions, will be important in increasing the numbers of trials specifically targeting the elderly, possibly acting as the key to shifting physician attitudes away from age bias.
The most common patient-related challenges relate to understanding the benefits of clinical trials and the logistics of clinical trial enrollment. Solutions to these problems are complex and can be approached in different manners. For example, controversy exists as to whether increased patient information will increase levels of enrollment in clinical trials among the elderly. By contrast, logistical issues have been an easier challenge to address.
Transportation is difficult among older patients who, compared with younger patients, more frequently require help from a family member or friend for travel. In addition, older patients have increased time requirements for transportation. Housing is also more complicated among elderly patients. Among older persons, a small inconvenience can become a major issue, such as having access to an elevator. Communication is a key factor in facilitating clinical trial participation, with research indicating that more time is often required for nurses to effectively communicate with the geriatric population, in particular elderly patients who are frail.
Ensuring that trials are accessible is important with any study population, but this is especially true among older patients. Accessibility can be achieved by providing funding for transportation, housing, and coordination, provided that no ethical dilemmas are presented. Although it is unethical to provide direct monetary incentives for trial enrollment, financial support to offset logistical barriers is considered appropriate. Solutions such as home visits and flexible scheduling have also been proposed. Additional research staffing may be needed to account for the extra time and resources required for enrolling older patients into clinical trials.
Increasing the number of research personnel was rated by oncologists as the most important method to increase trial accrual among the elderly. A team approach involving family members, physicians, support staff, and others provides the most effective method to overcoming logistical barriers to patient enrollment. An increase in logistical support will be a key feature in attracting more elderly patients to clinical trials, and, although the data on patient-related solutions are sparse, improving logistical support, follow-up methods, and patient education are likely to increase enrollment among this patient population.
Issues of eligibility and availability to clinical trials continue to be the most obvious trial-related barriers to enrollment among elderly patients. Therefore, increasing the number of trials aimed at this target population, with protocols specifically written to include elderly patients, will help address these challenges. Trial design must adapt to fit the needs of this unique population. For example, assessing patient status through the use of a comprehensive geriatric assessment rather than through traditional methods might improve cancer treatment in the geriatric population. Researchers should also aim to create study criteria that allow the inclusion of additional elderly participants without interfering with survival statistics. Several methods have been identified for evaluating life expectancy rates and functional status among patients with cancer, and, although these improve the ability of researchers to evaluate patient eligibility, these methods must be further studied and refined. There is a trend in the right direction, but more is needed to address the problem.
Designers of clinical trials must also anticipate the increased costs and time associated with treating an elderly population. Providing extra funding for trials aimed at older populations has the potential to offset these limitations, thus improving data, which could then be used in clinical practice. Members of the team should also have an affinity with older patients and be cognizant that extra time and financial resources will be required when conducting research on frail patients. Resource barriers are a key target when considering clinical trials in an elderly population. Data are lacking on practical and specific solutions to trial-related barriers, which is indicative of the overall issues limiting enrollment in this population. Increased funding for these studies as well as involving the elderly population in breaching these barriers will be crucial when moving forward.
Solutions
Physician-related
Enrollment in clinical trials relies heavily on physicians, creating many barriers for the elderly. Both physician bias and perception have been shown to be impediments to enrollment of older persons in clinical trials. Therefore, it is imperative to create a cultural shift among oncologists to boost trial enrollment of older patients.
The factors influencing physician culture can be complex and difficult to manipulate. One commonly cited issue is the lack of data on toxicity and survival rates among elderly patients, a challenge that may enable bias. Physicians report that how elderly patients are likely to tolerate a specific treatment has not been well elucidated, a barrier that creates unknown variables favoring conservative treatment for this patient population. Because of the low numbers of participation among elderly patients in clinical trials, the problem of lacking data on treatment tolerance is further compounded. Although some studies have demonstrated that age itself does not change tolerance to treatment, additional studies are needed to further clarify this issue. As more specific data become available, physician attitudes toward trial participation are likely to change.
It is important to increase trials specifically targeting elderly patients, because older patients with cancer may require more thorough care when instituting systemic therapy compared with younger patients with cancer. This is due to the biological changes of aging and uncertainties of the pharmacokinetic profiles of some medications, including chemotherapy, which is a concern common among oncologists that may hinder patient enrollment. Studies of pharmacodynamics and pharmacokinetics directed at elderly populations will be important for solving these challenges.
Late-stage clinical trials can also stratify patients based on age, and increasing data on the elderly patient population may improve treatment and decrease physician-related barriers. The prognoses of elderly patients referred to a phase 1 study are comparable with the rest of the study population. In fact, elderly patients enrolled in phase 1 trials had improved survival rates when compared with elderly patients who did not receive treatment during a phase 1 trial. However, some physicians do not perceive clinical trials as being beneficial for their patients. Therefore, increasing data on the older population, as well as changing physician perceptions, will be important in increasing the numbers of trials specifically targeting the elderly, possibly acting as the key to shifting physician attitudes away from age bias.
Patient-Related
The most common patient-related challenges relate to understanding the benefits of clinical trials and the logistics of clinical trial enrollment. Solutions to these problems are complex and can be approached in different manners. For example, controversy exists as to whether increased patient information will increase levels of enrollment in clinical trials among the elderly. By contrast, logistical issues have been an easier challenge to address.
Transportation is difficult among older patients who, compared with younger patients, more frequently require help from a family member or friend for travel. In addition, older patients have increased time requirements for transportation. Housing is also more complicated among elderly patients. Among older persons, a small inconvenience can become a major issue, such as having access to an elevator. Communication is a key factor in facilitating clinical trial participation, with research indicating that more time is often required for nurses to effectively communicate with the geriatric population, in particular elderly patients who are frail.
Ensuring that trials are accessible is important with any study population, but this is especially true among older patients. Accessibility can be achieved by providing funding for transportation, housing, and coordination, provided that no ethical dilemmas are presented. Although it is unethical to provide direct monetary incentives for trial enrollment, financial support to offset logistical barriers is considered appropriate. Solutions such as home visits and flexible scheduling have also been proposed. Additional research staffing may be needed to account for the extra time and resources required for enrolling older patients into clinical trials.
Increasing the number of research personnel was rated by oncologists as the most important method to increase trial accrual among the elderly. A team approach involving family members, physicians, support staff, and others provides the most effective method to overcoming logistical barriers to patient enrollment. An increase in logistical support will be a key feature in attracting more elderly patients to clinical trials, and, although the data on patient-related solutions are sparse, improving logistical support, follow-up methods, and patient education are likely to increase enrollment among this patient population.
Trial-Related
Issues of eligibility and availability to clinical trials continue to be the most obvious trial-related barriers to enrollment among elderly patients. Therefore, increasing the number of trials aimed at this target population, with protocols specifically written to include elderly patients, will help address these challenges. Trial design must adapt to fit the needs of this unique population. For example, assessing patient status through the use of a comprehensive geriatric assessment rather than through traditional methods might improve cancer treatment in the geriatric population. Researchers should also aim to create study criteria that allow the inclusion of additional elderly participants without interfering with survival statistics. Several methods have been identified for evaluating life expectancy rates and functional status among patients with cancer, and, although these improve the ability of researchers to evaluate patient eligibility, these methods must be further studied and refined. There is a trend in the right direction, but more is needed to address the problem.
Designers of clinical trials must also anticipate the increased costs and time associated with treating an elderly population. Providing extra funding for trials aimed at older populations has the potential to offset these limitations, thus improving data, which could then be used in clinical practice. Members of the team should also have an affinity with older patients and be cognizant that extra time and financial resources will be required when conducting research on frail patients. Resource barriers are a key target when considering clinical trials in an elderly population. Data are lacking on practical and specific solutions to trial-related barriers, which is indicative of the overall issues limiting enrollment in this population. Increased funding for these studies as well as involving the elderly population in breaching these barriers will be crucial when moving forward.