A more actively involved patient population is essential in clinical trials. Clinical trials aren’t something that should be done on patients, but rather it should be done with patients. Their involvement provides insight on more than just the scientific effect or results of a specific treatment; they provide information on how to improve quality of life during a specific treatment. A more patient centered approach translates to a patient gaining a more active role in health care systems. It takes into account the needs and values of the individual. This is a shift that should be embraced within the clinical trials arena.
Currently, there is a gap between patients and clinical trials. Patients feel they lack the information necessary to decide if they should or shouldn’t participate in clinical trials. The information they receive is often written in a language they do not totally comprehend. They then feel too many questions are being unanswered, and oftentimes it is not clear who has the answers. It is only when patients are made to understand they are not just a source for data that they will truly feel a sense of commitment to clinical trials.
Can patient participation in clinical trials empower patients?
Patient participation translates to their involvement in decision making or expressing opinions about clinical trials, which may include sharing information, feelings and accepting instructions from the clinical trial team.
Best practices can be examined to help awareness of oncology trials and improve patient recruitment. When examining best practices, there are a number of aspects which, in my opinion, should be taken into account, such as: the ‘key stakeholders’, and the communication method or language.
The key stakeholders are considered to be everyone involved in the process of the clinical trial from beginning to end. The key stakeholders may also include a patient’s relative or caregiver. The latter may play a role in obtaining a patient’s consent for the clinical trial.
The communication method or language is important during all stages of the clinical trial. Rule number one to apply: the patient is not a researcher or an academic. Consider the terminology used when giving information to the patient about the clinical trial. Patient organizations may play a more significant role in translating this information into a language which will be better understood by the patient. Consider having one point of contact for the patient. It is important for a patient to be able to reach out to someone for voicing concerns, and to know that these concerns will be addressed appropriately. This person may act as a go-between among the patients and researchers.
Discussing patient experiences to improve quality of life
Discussing current patient experiences within clinical trials may help determine ways of improving quality of life. Participating in a clinical trial may affect a patient’s quality of life in more ways than one would expect. Consider the potential stress a patient may have committing to a trial that has no evidence of being successful. Patient organizations’ involvement in clinical trials may help to provide information on patient experiences within clinical trials, which in turn can be used to help improve quality of life. When involving patient organizations, ensure there is no conflict of interest that may result in the breach of a patient’s trust towards the patient organization, or the clinical trial.
Involving Patient Organizations
Patient organizations may help provide additional information on other issues to help bridge the gap between patients and clinical studies. Some of these issues may be how to build trust between patient and researchers, to understand the players in the patient’s decision making process, how to discuss feelings of fear, potential stress from involvement in a clinical trial, coverage of additional costs, privacy, and the team responsible for the clinical trial.
Whatever the reason a patient may have to participate in a clinical trial, it is important to build on mutual trust. A patient should be reassured that his or her best interest is at heart. Most patients will take the opinion of friends, relatives or other loved ones into consideration before giving consent to participate in a clinical trial. It is thus of importance that the patient is able to translate the information obtained about the clinical trial to any of the above. Consider asking if the patient would like to include a third person in the process. Some patients may be afraid of being used as ‘guinea pigs’. Create an atmosphere in which the patient is comfortable discussing fears or doubts.
Participating in a clinical trial, may result in additional stress. Think about additional stress from having to organize additional hospital visits, or maybe additional hospital overnight stays. The potential of additional stress should be addressed, and discussed even without the patient having mentioned it as a possible challenge. Patients may question if there are additional costs involved in participating in a clinical trial. As many patients consider having cancer a life or death situation, they may find it to be inappropriate to ask questions about additional costs. Patient organizations may help patients feel more at ease raising cost-related questions.
Confidentiality, Privacy and Security
When discussing patient participation in clinical trials, it is important to address confidentiality, privacy and the security of the information being collected before, during and after the trial. A well informed patient may result in the patient being more involved. Questions about confidentiality, privacy and the security of information may be raised during different stages of the clinical trial, and should be addressed accordingly. A patient may become more involved when it is clear the different people involved in the clinical trial, and their specific roles.
It is thus not a question if patients should be involved in clinical trials, but how to work better with patient organizations and patients to bridge the gap between them and clinical trials. In the end the patient will benefit most.
By Robert S. Greene, President HungerNdThirst Foundation
Advocate for Awareness Smell and Taste Changes in Oncology Patients
Advocate for Patient Participation in Clinical Trials