Medicine development is changing as a result of the complexity and cost of clinical research increasing, as well as the emphasis on personalized medicine and patient empowerment. Clinical trial participants and the sponsor typically work together to assess the safety and efficacy of a molecule used as an experimental therapy.
Typically, the sponsor’s ability to conduct the study is considered when designing trials. Due to this, numerous expensive and complicated trials may be performed without considering the patient’s convenience or needs.
Sponsors need a solid plan to connect with their patients in today’s challenging and competitive drug development environment. A contract research organisation (CRO) can assist in fostering these connections and utilizing patient input as a differentiator and competitive edge for hiring.
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What Exactly Are Patient-Centered Clinical Trials?
Volunteer patients are critical to the success of any modern clinical trial. However, the volunteer experience may sometimes be overlooked despite a research center’s best efforts. Some participants may believe that communication could be improved throughout the process. Unfortunately, this reduces the volunteer’s willingness to return for additional clinical trials.
According to a recent study, failure to enroll participants led to the termination of 19% of 2,579 clinical trials. Even if enough volunteers sign up, the study may fall short if too many drop out before it is finished. A different study found that, on average, 50% of participants in randomized trials of weight loss medications gave up after a year.
Why Is a Patient-Centric Approach Important For Clinical Trials?
- Simply put, there can only be a clinical trial with participants. Ultimately, patient retention and recruitment determine whether research projects advance or are postponed. A clinical trial must make every effort to manage patient centricity appropriately.
- Clinical trial site design, the period is key to creating genuinely patient-centric trials. The secret is to foster collaboration between participants and sponsors. Taking part in a clinical trial requires a significant time commitment, so we should commit to providing them with as much support as we can along the way.
- It is well known that sponsors must gather data during their trials to support their commercial activity. However, as clinical trials become more intricate with more procedures and visits, it is essential to consider the long-term effects of such intense visits on patients and site staff.
- Running two smaller, more straightforward trials rather than one complicated trial will increase enrollment more quickly, participant satisfaction will increase, and more patients and physicians will be motivated to participate in clinical research.
- Examining the schedule of assessments in great detail is a crucial component of patient-centric trial design. What kinds of reviews are being planned, for instance, and how much time will participants need to spend on-site for those assessments to be completed? How many blood tests will they have throughout the trial? What is the study’s duration?
- Including the voices of many different functional groups in a meeting is crucial, but it’s just as essential to include the participants’ voices. Working with community groups and advocacy organizations is one way to accomplish this.
These groups can help researchers determine whether or not the study they are designing will place an undue burden on them. Ultimately, it comes down to working together to ensure that investigations are as patient-centric as possible.
- Furthermore, the absence of patient-related difficulties can shorten trial wait times, improve trial outcomes, and hasten the commercialization of medicines, devices, and therapies.
Patient-centricity ultimately speeds up recruitment and retention, reduces wait times, and enhances clinical research outcomes. It is, therefore, a tactic that should be adopted.
What Are The Advantages?
Adopting a patient-centric strategy has a wide range of advantages.
- Patient centricity can increase patient recruitment and retention rates by making the clinical trial process more effective and accommodating for patients.
- Greater patient engagement – A patient-centric approach can encourage patients to participate more, enhancing the data’s quality and producing better results.
- Greater patient involvement in the clinical trial process increases the likelihood that the data collected will be accurate and trustworthy. This may raise the standard of better results.
- Improved patient safety – By making it more straightforward for patients to report adverse events and ensure that they are fully informed about the risks and benefits of participating in a clinical trial, a patient-centric approach can help to improve patient safety.
In conclusion, patient centricity is essential in clinical trial design because it significantly increases retention by fostering a sense of support, respect, and value among participants.