Revisiting endpoints in clinical research: Quality of cure above simply cure

Advances and opportunities in medical science during the past decade have placed health-care professionals in an exigent position to keep themselves abreast of the state of the science. Clinical research is an important player in discovering new treatments for various diseases as well as new ways to detect, diagnose, and reduce the risk of disease. It also helps researchers and doctors decide if the side effects of a new treatment are acceptable when weighed against the benefits offered by the new treatment. Overall, this scientific way of improving clinical sciences creates uniformity and uplifts the standards of clinical care.

Often, we are face with the conundrum of available evidence and their impact to advance clinical practice. The evidences which have been obtained by robustly designed studies with absolute rigor with minimal or no bias that would have otherwise affected the validity of the research’s results should ideally be the one leading clinical practice. This will eventually help clinicians to speak a common language which is evidence based.

It is imperative nowadays to bring about a change in clinical trial endpoints and to use innovative methods as in new clinical trial methodologies. This will address to the dynamic challenges being faced in health-care profession in terms of changing patient demographics, disease presentation, outcomes, and patient expectations. Patient-reported outcomes such as quality of life (QOL) are being increasingly used as an endpoint in various clinical trials to assess the effects of various diseases and their management on patients’ lives.^[1]

Recently, QOL is being widely accepted that there has been a growing acceptance of the view that the goals of any disease management, and especially cancer treatment, should be focused about QOL as much as survival benefits. Findings from studies involving QOL suggest that QOL instruments as part of clinical practice have the potential to improve the quality of care that patients receive as well as their overall quality of survivorship. QOL tools at present are quite extensive and hence are sometimes faced with challenges such as somewhat lower compliance amongst patients. The way forward should be shorter and concise QOL tools and possibly in more than one formats which must include electronic versions so as to increase their compliance and acceptability. To keep pace with the changing needs and to address the unmet needs of clinical practice, it is time we also look up to innovative endpoints such as employability and impact of social engagements alike after patients have completed treatment.^[2]

Especially in India, where clinicians are always faced with the conundrum to whether do clinical practice or do research, a definitive impetus from the decision-making bodies is paramount to give optimal resources and time to budding clinical researchers. The clinicians are always in a dilemma to whether manage the immense volumes of patients or to devote time for research.^[3] Critique and appraisal of clinical research findings are fundamental roles of health-care professionals. We must realize that the primary epicenter for conducting clinical research is the investigators and they must be provided with ample time and resources and encouraged to think about innovative ideas to conduct research. One of the most daunting challenges in the coming years is to educate health-care professionals to churn out research ideas with apt endpoints which would address the needs of not only the Indian population but also the global society as a whole.