Guidelines to include feedback of patients in clinical trials


The impact of treatment on participants and their quality of life must be assessed more comprehensively, so it is imperative to make changes in international guidelines. The safety of participating patients and integrity of data collected depends on the protocols used for describing a clinical trial: objectives, design, methodology, statistical consideration, and organization.

Current protocols do not emphasize much on patient-reported outcomes (PROs). Most researchers have recommended that feedback must be collected from patients on how clinical trial affects overall quality of life.

According to a noted medical researcher at the University of Birmingham, feedback received from patients participating in a clinical trial can hold valuable information for following purposes: pharmaceutical labeling claims, clinical guidelines, health policy, shared-decision making.

Most clinical trials currently do not include information on quality of life and symptom data. This data must be collected to provide patient-centered care and to develop specific protocol guidelines.

Recommended changes to current protocols of clinical trials were published in the Journal of American Medical Association. This information was a joint-collaboration across universities of Toronto, Sydney, and Birmingham. It is important to understand the impact clinical trials have on cancer patients.

With this information, patients can then decide which line of treatment is most suitable for them. The side-effects of cancer treatments are often long-lasting and most clinical trials do not include this line of information. A cancer patient receiving treatment may live for years but their quality of life is severely impacted with these side-effects.

Patient-related outcomes (PROs) are classified as primary or secondary in clinical trial protocols; these outcomes need to be included in the current checklist guidelines of clinical trial protocol.

The PRO specific issues are as follows: trial rationale, eligibility criteria, objective, intervention, assessment time-points, proxy completion, and strategies for minimizing missing data.

The guidance prescribed in PROs is not prescriptive, but it provides a pathway for implementing a careful planning of PRO components of trials. Thus, PRO trial design improves, and the rationale for assessing PRO is improved. Thus, high quality analysis is ensured and reported, thereby improving the evidence base of PRO on a global scale.

Clinicians can use PROs effectively to make right decisions, thereby improving the line of recovery and treatment. This is a more effective strategy for comprehensively reporting personal experiences of patients with serious illness.

More guidelines must be consistently presented to help both patients and clinicians and to improve the outcome of prognosis. By improving the reporting of PRO data, the outcomes of patients with chronic diseases can be improved tremendously.




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