Letter to The Editor
Patients, even who are enrolled in clinical trials, need good doctors. Good medical practice (GMP) refers to what is expected of all doctors practicing medicine, while good clinical practice (GCP) provides international quality standards for clinical trials involving human subjects [1]. It’s noteworthy to point out that GMP and GCP rules are not always superimposable, neither meet the same objectives.
There is a growing acceptance that clinical trials should acknowledge the unique characteristics of each patient and seek to individualize patient care [2]. Those purposes may also be extended to the evaluation of individual doctor performance, in order to assess quality of physician behavior and its impact on patient outcome [3,4]. However, analyzing doctor performance is challenging, and no single, valid, reliable, and practical measure of performance exists [5]. A prototype of a patient-reported grading scale for individual doctor performance is suggested in Table 1.
Table 1. Doctor performance status
|
0 |
Performs medical examination at each visit, empathic, good communication skills. |
|
1 |
Performs medical examination at almost every visit, partially empathic, average communication skills. |
|
2 |
Performs medical examination occasionally, poor-empathic, substandard communication skills. Attending more than 50% of scheduled appointments. |
|
3 |
Performs medical examination occasionally, poor-empathic, substandard communication skills. Attending less than 50% of scheduled appointments. |
|
4 |
Never performs medical examination. Attending scheduled appointments occasionally. |
|
5 |
Always absent. |
Intra-study variability of doctor performance should be addressed and no longer underestimated, to avoid unexpected regressions to mediocrity of doctor-patient interactions during clinical trial conduct.
Compliance with ethical standards
The author did not receive any funding for this work.
Conflict of Interest: Dr. A. Musolino has received research grants from: Roche; EISAI; Transgenomics. He has received speaker honorarium from: Roche; EISAI; Macrogenics; Pfizer; Lilly; Novartis. Dr. A. Musolino does not own any company’s stock.
Ethical approval: This article does not contain any studies with human participants or animals performed by the author.
References
- Integrated addendum to ICH E6(R1): Guideline for good clinical practice: https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R2__Step_4_2016_1109.pdf.
- Kent DM, Steyerberg E, van Klaveren D et al (2018) Personalized evidence based medicine: predictive approaches to heterogeneous treatment effects. Br Med 363: 4245.
- Ann M, Bode AM, Dong Z (2018) Recent advances in precision oncology research. NPJ Precis Oncol 2: 11.
- Franks P, Jerant AF, Fiscella K et al (2006) Studying physician effects on patient outcomes: physician interactional style and performance on quality of care indicators. Soc Sci Med 62: 422–32.
- Leep Hunderfund AN, Park YS, Hafferty FW et al (2017) A Multifaceted Organizational Physician Assessment Program: Validity Evidence and Implications for the use of Performance Data. Mayo Clin Proc Innov Qual Outcome 1:130–140.