Should patients be more involved in the design of clinical trials?

More and more processes in health care are oriented to be patient-centered. Every day there are more initiatives that aim to increase patient participation taking their goals, preferences, and values into account.

The patient empowerment and advocacy necessary for the best health care outcomes has reached a field previously considered limited to healthcare professionals and experts: clinical research. That is why, at Leapcure, we believe that “Inclusive Medical Innovation is Advocacy Led.”

For most patients, the understanding of the function and significance of a clinical trial still remains unknown or too complicated to address, but that is changing. More and more experts and health personnel are valuing how patient opinions, needs and feelings are necessary to create clinical trials that people trust and are eager to recommend to others. Patients want to know how the results obtained go beyond personal experience and evolution of the condition they have. As an example, we can extract some data from an article published in 2011 in the Journal of Clinical Epidemiology. 

It has been stated that 75% of patients with diabetes would prefer that clinical trials include variables that measure the impact of the disease on their quality of life, such as the onset of kidney failure and dialysis, or blindness, rather than surrogate variables such as HbA1c. (1) 

From the patient’s point of view, the priorities established by the protocols are not always those that they consider alleviating the situations related to their disease. In that sense, this could become a great opportunity to establish a communication channel in both directions and nourish with the opinion and knowledge of each interested party.

From the point of view of pharmaceutical companies and researchers, one of the most important variables is the change in patient willingness to participate in clinical trials. Studies that have considered patient sentiment for the protocol design and know in detail the needs of patients increase the probability of patients enrolling.

This affects clinical trial costs as well. According to an article published in Lancet in 2009, “The identification and proper handling of patient needs in clinical research will yield advantages in terms of clinical and economic benefits. It has been estimated that up to 80% of the expense involved in gathering evidence in research could be avoided.” (2) This variable is very important in terms of resources and the best way to use them.

At Leapcure, we always look for the best option that can be offered to patients. During our patient success processes, patients tell us that one of the reasons why people want to participate in clinical trials is to benefit their community and others in their same condition. For this, they need access to information in understandable language and also need to have the space to raise their doubts to the researchers.

The opportunity to develop patient-centered and patient-supported research is here and more and more companies and institutions are implementing these changes, generating an improvement in access, participation and overall patient experience.

(1) Murad MH,Shah ND,Van Houten HK,et al.Individuals with diabetes preferred that future trials use patient-important outcomes and provide pragmatic inferences. J Clin Epidemiol. 2011;64:743–748. 

(2) Chalmers I, Glasziou P. Avoidable waste in the production and reporting of research evidence. Lancet. 2009;374:86–89.

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