Being a research subject in clinical research; from the patient’s perspective
The PatientPartner project focuses on the needs of actually taking part in and informing patients on clinical trials and research as well as the active involvement of patient organisations in the clinical trial development process. In the paragraph below we present a short summary of some of the perceived benefits and barriers that have been described in the literature. As the literature is extensive on the subject of being a research subject in clinical trials we have selected those articles that look at the topic of being a research subject t in a clinical trial from the patient perspective.
From the literature it is known that only 2-3% of all patients participate in clinical research (4), (5) This low number is mainly due to a lack of awareness that patients have on what clinical trial research (5) (4) (6) (7) (8) (9) combined with ethical concerns they have about e.g. randomisation in clinical trials (6) (7).
Other frequently heard of barriers in taking part as a research subject in a clinical trial have been described as some of the following.
- Lack of feedback of results (10).
- Inconveniences with regards to practicalities of trial (11).
- Patients do not understand information provided and informed consent (10).
So why do some patients make the decision to participate as a subject in a clinical trial?
First of all most patients take part in clinical trials to make a contribution to the advancement of therapies; if not for themselves then for a future patient (10) (12). Furthermore some patients take part in clinical trials because of the perception of receiving better treatment from their doctors e.g. increased surveillance (12). Finally some patients take part to make a contribution to the scientific process of the clinical research study.
One might say that the reasons to take part as a research subject in a clinical trial is because it out favours the reasons for not participating. However the evidence tells us that participation rates are falling (8) and that new strategies for the recruitment of patients to clinical trials need to be sought after. As knowledge about and understanding of clinical trials has been identified as being the central part to greater participation (8, 9); the more the patients are informed about the importance of research, the more ready they are to become involved (13), it has been suggested that recruitment can be improved by better collaboration between the research community and patient groups. One of the most useful strategies would be for the scientific community to maintain a close relationship with patient groups fully informing them of clinical trials that are being conducted regionally and nationally, thus giving them the tools to spread this knowledge amongst their member base.
Some patient groups already inform potential participants like the European patient organisation for Breast Cancer Patients EUROPA DONNA who has published a booklet, ‘Clinical Trials and Breast Cancer’ (www.europadonna.org).
Other patient organisations provide information, as well as pointing their members towards sources of information, such as websites of national and international research consortiums (9).
Another identified key in getting sufficient numbers of patients to the trial is the informed consent procedure. Informed consent is seen as the backbone of any clinical trial, informing the participant on all matters that concern the clinical trial procedure, asking him/her for their agreement in order to proceed with the trial. Furthermore it has been proven that an informed and trusting patient who participates in clinical research willingly is more likely to enhance the process. As informed consent is a document that is highly regulated in its form and its content it has been suggested that patient advocates might also play a role in either adapting the information in the informed consent to more be more patient friendly i or to assist potential participants in the decision making process (10).