Clinical trials are research studies specifically evaluating and calibrating a new approach for dealing with medical, surgical, or behavioral issues. The research could also be for testing a new drug or diet relevant as a medical intervention or a medical device. By going through a clinical trial, the researchers determine the efficacy, side effects, and effect on the quality of life before introducing their findings to the public; in the market. The most important aspect of a research trial is the involvement of participants. No research and no trial can be carried out without patient recruits. This is also the most challenging aspect. Inadequate patient recruitment and retention is the cause of stalled research. A trial may be amply funded or have brilliant researchers and caregivers on its team. Still, if appropriate participants/volunteers are not available for the various trial stages, the entire exercise is a conjecture.
Patient recruitment, retention, and population diversity are the most disruptive challenges. A new treatment can only be developed if participants take it forward. Potential participants shy away from enrolling and remaining in clinical trials until closure. There are many reasons for this reluctance.
The challenges to a clinical research study regarding the recruitment and retention of volunteers are more than often guided by the type of study, the availability of medical treatment in the community or area, the probable or possible risks that a volunteer can foresee, lack of knowledge and comprehension of the clinical processes, disruptive frequency of traveling and follow up visits, and finally the burden, distrust, and wariness of researchers. Here are 5 reasons why your clinical trials are not attracting patients.
When clinical trial research is conceived and planned, the load on the patient is also measured qualitatively. The burden on the volunteer begins from the interview to check for their fitment appropriateness. For a prospective participant, the effort that he has to put in, starting from reaching the trial site, submitting his medical health records, and undergoing invasive physical and psychological tests, results in participant fatigue. Apart from this, the financial effort required on the volunteer’s part: spending money on transport - discourages him from contemplating volunteering for a research trial.
A patient/volunteer will not want to travel to far-off trial sites if there are satisfactory and adequate medical facilities in his community and area. It has been found that a patient suffering from a chronic or terminal ailment is more than willing to participate in a research trial. This is particularly true for patients who cannot afford treatment or live in a remote area and cannot access medical facilities readily. Therefore, a trial targeting a population of an area replete with medical facilities can only really hope to recruit patients from that area if the trial is for an ailment that is eluding treatment.
Studies have found that target populations need more knowledge and awareness to pay more attention to a call for participation in a clinical trial. Sometimes, patients need to be made aware of a clinical trial program that could help treat their medical issues. It is challenging for volunteer patients to dig out reliable information about trial research, either online or offline; using the limited information at their disposal is even more complex and therefore causes avoidance. This means that the research sponsors have yet to initiate an aggressive advertising campaign to attract the target population, or there is a perceived imbalance of benefits and burdens by the prospective volunteers. Another detriment to attracting participants is their need for more personal knowledge of the trial and its processes. This means that researchers need to sensitize and dissipate knowledge and its benefits among people. Communication channels between prospects and research personnel need to be opened. A widespread campaign to improve public and patient awareness of clinical research and its outcomes has to be disseminated amongst them to fill in the discouraging gaps in public knowledge.
When a clinical trial is launched in the public domain, it faces the risk of laying dormant because of a need for an adequate number of participants. The prospective participants deliberately ignore it for the personal risks they recognize resulting from participation. They see that the long processes they have to navigate would be tiresomely coupled with the physical discomfort they might suffer due to invasive probing.
This might not be all, as the new treatment administered to them could cause side effects that would seriously disturb the established pattern of their daily life.
The discouraging perception also includes skepticism about the efficacy of the new treatment over the standard treatment they have been receiving. The fear that the new treatment will not work and they would have lost time, having discontinued the practiced treatment, makes prospective volunteers avoid it.
Another risk of participation, as perceived by participants, is that they may not be a part of the new treatment group. This means they do not experience the new drug or device, and they could be relegated to the control group that gets the standard practiced medicine or a placebo.
It is feared that prospective participants give research trials a wide berth. Every volunteer needs to submit their medical records and history. These records become the property of the trial and can be accessed and used by other research trials. The volunteer has to provide permission for this.
A clinical trial study only carries a small team of researchers. Often the investigators’ list of patients and some drawn from local clinics and medical centers, suffice to sustain a trial. But the problem lies in the reluctance of local medical practitioners to refer their patients to other doctors or researchers. The reasons could range from personal to professional. Essentially it is due to a weak communication system between doctors, researchers, and patients, or it could be about losing patients, and it can be about appearing incompetent to the local public. To overcome this hurdle, an incentivized referral program for physicians must be implemented.
Clinical research is the basis of medical advancement and innovation. It requires proactive participation from volunteers but the stubborn avoidance on the latter’s part leads to research that is not very thorough. To encourage patient participation, it is most advisable for research trials to have a patient-centric approach. This means accommodating patients with any and every measure that can convenience them. It includes telehealth calls, at home-visits, wearable devices, and mobile apps that access their health status without displacing them from the comfort of their homes. Prospective participants will readily volunteer if they and their families are not greatly inconvenienced, with the promise of achieving better health and quality of life.
At Mahalo Health, we provide digital healthcare software and decentralized healthcare platforms to facilitate medical organizations to reach out to a broader consumer base with their services and treatments. Contact us to discuss your strategy for decentralized clinical trials today.
