Abstract
Introduction
Management of a clinical condition is patient centric. Interdisciplinary coordination plays an influential role in patient management. Pharmacology deals with the study of drugs. Clinical pharmacology deals with applied aspects of pharmacology in addition to clinical research.
Methodology
We set up a survey to assess the perceptions of clinical pharmacologists (CPs) regarding their roles and about clinical pharmacology courses in India. The survey was administered via a Google questionnaire sent via LinkedIn, Email, or WhatsApp to 100 CP’s working in India.
Results
Respondents to the questionnaire were working as CPs. They were either postgraduate in pharmacology (MD pharmacology (doctor of medicine in pharmacology) 60.2%) or had a super-specialization degree in clinical pharmacology (DM clinical pharmacology (doctorate in medicine in clinical pharmacology) (34.7%)) or other pharma postgraduates. They were working in pharmaceutical companies (41.8%), hospitals (26.5%), or academic institutions (30.6%). When the responses from the respondents were stratified by qualification or experience, they showed that most of the CPs felt that the CPs played a significant role in academia, pharmaceutical organizations, hospitals, and drug regulatory bodies.
Conclusions
All the CPs opined that training during the postgraduation course was not sufficient to be qualified as CP. There was no consensus among the CPs on the benefit of existing certification courses in clinical research. However, they felt that the centres offering these courses should be accredited, and the curriculum should be uniform. Respondents opined that CPs’ patient management role could be improved by collaborating with clinicians and organizing workshops and conferences.
Supplementary Information
The online version contains supplementary material available at 10.1007/s00228-022-03409-9.
Keywords: Clinical pharmacology, Clinical pharmacologist, Pharmacology, Post-graduation, Survey
Introduction
Detailed interpretation of drug pharmaceutical, pharmacokinetic, pharmacodynamic, and therapeutic phase data is essential to ensure the appropriate use of drugs. A clinical pharmacologist is a medical professional trained in the multidisciplinary aspects of pharmacology and clinical research to develop new drugs and their role in hospital patient management [1]. A medical pharmacologist is a medical graduate who completed a postgraduation/master degree in pharmacology. A clinical pharmacist is a health professional and an expert on drugs who plays a significant role in health care, especially in the hospital [2].
After graduating from medical school, medical students can pursue a 3-year postgraduate degree in pharmacology (doctor of medicine, MD), during which they will be trained in pharmacology, applied pharmacology, and a few areas of clinical pharmacology [3]. A postgraduate degree in pharmacology can lead to employment opportunities in scientific sectors like research and development, and hospitals. After completing the postgraduate pharmacology course, a 3-year program for super specialization in clinical pharmacology (doctorate of medicine, DM) is also available in India, which is similar to a Ph.D. program in Western countries, during which they will learn more about the clinical applications of pharmacology, pharmacodynamics, pharmacokinetics, pharmacovigilance, drug development, and in-depth clinical research knowledge [4].
The MD pharmacology course curriculum differs from that required for clinical pharmacologists in the pharmaceutical industry [5]. This gap can be a crucial factor in their career. With experience over time, a medical pharmacologist can become a clinical pharmacologist (CP). Internationally, there are concerns about the strategies to address clinical pharmacology education and prescribing competence in medical graduates [6].
In addition to their role in the hospitals, drug regulatory bodies require a clinical pharmacologist (CP) for health technology assessments, monitoring, and inspection of clinical research activities undertaken in the country, etc. Accordingly, the expectations of regulatory bodies from CPs vary, depending on the job profile [7]. Many young medical pharmacologists are interested in drug development in the pharmaceutical industry. The work profile of clinical pharmacologists is very varied, and they are expected to play multiple roles in industry, academia, and research [8, 9]. Hence, considering the lack of knowledge of CP's job requirements, many pharmacologists opt for training in clinical research. Different courses are available for students aspiring in clinical research to bridge the knowledge gap. However, no uniformity in the training curriculum leads to a confused state of mind for the employees or organizations when they hire these so-called CPs. In addition, the course duration and the fee structure of these courses vary greatly. We surveyed 100 clinical pharmacologists regarding their roles and responsibilities in their workplace. The survey also involved their opinions on the clinical pharmacology teaching curriculum and suggestions to improve awareness and the workforce.
Methodology
After discussion with expert clinical pharmacologists and pharmacologists, we developed a questionnaire with the primary objective of capturing the roles played by clinical pharmacologists in India. The questionnaire was composed of 19 questions: yes/no, multiple-choice, or multiple select. Our institutional ethics committee approved the study. Subsequently, we designed the final survey questionnaire on Google Forms. The link to the survey questionnaire was sent to the CPs through social media—LinkedIn, WhatsApp, and email. We collected the responses to the questionnaire from 100 participants, with the inclusion criteria being CPs of either gender who were willing to participate in the survey and complete the questionnaire. The questionnaire also included a question regarding their consent for participation in the survey. Consented participants completed the survey questionnaire, and their responses were considered for analysis.
Statistical analysis plan
In the survey questionnaire, most questions were either multiple choice or multiple select types. The survey results were analyzed using Microsoft Excel 2022 and IBM SPSS Stat.0 version. The responses to the survey questions are presented as frequencies and percentages. Overall, as well as group percentages, are provided to understand the scarcity in the course curriculum of the CPs. The groups are formulated by their qualifications (MD, DM, & others) and years of experience (< 5 years & ≥ 5 years). The respondents’ work experience is presented as mean and standard deviation for each group.
Results
One hundred participants working as clinical pharmacologists in different sectors provided their responses to the survey questionnaire. Of the 100 respondents, one participant did not provide consent for the survey after initiation, and one participant was still pursuing his postgraduation in medical pharmacology. So, the final data set includes the responses of 98 participants. Table 1 contains the details of the participants and their answers.
Table 1.
Responses given by the clinical pharmacologists to the survey questions
| Question details | Characteristics | n | % |
|---|---|---|---|
| Qualification of the respondents | MD pharmacology | 59 | 60.2 |
| DM clinical pharmacology | 34 | 34.7 | |
| Others | 5 | 5.1 | |
| Respondent’s place of work | Pharmaceutical company | 41 | 41.8 |
| Hospital | 26 | 26.5 | |
| Academic institution | 30 | 30.6 | |
| Drug regulator | 1 | 1 | |
| Professional experience of respondents (years) (median, range) | 6 (0–45) | ||
| Clinical research activities they undertake as part of their job | Clinical trial operations—conducting clinical trials and data management | 63 | 64.3 |
| Committee member who reviews and approves new drug applications | 18 | 18.4 | |
| Committee member who reviews and approves clinical research studies | 42 | 42.9 | |
| Pharmacovigilance-related activities | 69 | 70.4 | |
| Development of standard treatment guidelines in collaboration with different clinical departments, including antibiotic policy | 24 | 24.5 | |
| Training students in clinical pharmacology | 62 | 63.3 | |
| Pharmacometrics | 11 | 11.2 | |
| CPs who responded no to the question that “the number of clinical pharmacologists was adequate in India.” | 72 | 73.4 | |
| CPs responded yes to the question of “whether the clinical pharmacologists are getting adequate support or representation in government organizations, academia, and pharmaceutical organizations.” | 8 | 8.2 | |
| The responses given by the CPs to the question regarding the adequacy of clinical pharmacology training in the course curriculum of PG | Agree | 15 | 15.3 |
| Neutral | 15 | 15.3 | |
| Disagree | 68 | 69.4 | |
| CPs who responded yes to the question about whether it is advantageous to have a certificate course in clinical pharmacology | Agree | 49 | 50 |
| Neutral | 17 | 17.3 | |
| Disagree | 32 | 32.7 | |
| CPs who had any certifications other than those related to clinical pharmacology | 52 | 53.1 | |
| Certifications offered by the organizations | Private | 36 | 66.7 |
| Government | 18 | 33.3 | |
| CPs who had the benefit of having certifications for the career growth (n = 52) | 44 | 84.6 | |
| Responses given by the CPs to the question regarding the uniformity of course curricula of the extra certifications provided by all the centers on the clinical pharmacology teaching programs | Agree | 71 | 72.4 |
| Neutral | 18 | 18.4 | |
| Disagree | 9 | 9.2 | |
| Responses given by the CPs to the question regarding the inclusion of curriculum of additional clinical pharmacology courses in the course of PG pharmacology teaching programs | Agree | 80 | 81.6 |
| Neutral | 12 | 12.2 | |
| Disagree | 6 | 6.1 | |
| The response given by the CPs to the question regarding the situations where a clinical pharmacologist plays a significant role | Academia | 91 | 92.9 |
| Pharmaceutical organizations | 97 | 99 | |
| Government regulatory bodies | 92 | 93.9 | |
| Hospitals | 90 | 91.8 | |
| All | 82 | 83.7 | |
| The response from CPs to the question regarding the roles played by a clinical pharmacologist in a hospital? | OPD consultation | 61 | 62.2 |
| Ethics committee consultation | 88 | 89.8 | |
| Clinical trial designing | 90 | 91.8 | |
| Clinical trial auditing & inspection | 89 | 90.8 | |
| Pharmacovigilance | 88 | 89.8 | |
| Prescription audit | 92 | 93.9 | |
| Therapeutic drug monitoring | 94 | 95.9 | |
| All | 51 | 52 | |
| CPs who responded yes to the question that there is a need to increase the awareness of clinical pharmacology nationally as well as internationally | 95 | 96.9 | |
| The responses given by the CPs to the question regarding the methods to increase the awareness of clinical pharmacology? | Increased awareness among other specialties by healthy collaborations, organizing workshops and conferences | 93 | 94.9 |
| Organizing clinical pharmacology outpatient clinics in specialty hospitals | 70 | 71.4 | |
| Increasing awareness among the government representatives and medical councils to create posts and a career path for clinical pharmacologists | 79 | 80.6 | |
| Special courses for aspiring students in government and private institutes | 52 | 53.1 | |
| Student exchange/training programs with the universities in overseas for doctoral or research fellowship studies | 65 | 66.3 | |
| Provide evidence to the hospital management of the cases managed by clinical pharmacologists | 71 | 72.4 | |
| All | 32 | 32.7 | |
CP clinical pharmacologist, DM doctorate of medicine, MD doctor of medicine, OPD outpatient department, PG postgraduation
Respondents were either postgraduates in pharmacology (doctor of medicine (MD) in pharmacology) or those with a super specialization degree in clinical pharmacology (doctorate in medicine (DM) in clinical pharmacology) or those with a Pharm-D degree. DM clinical pharmacologists (DM CPs) are pharmacology postgraduates who have completed a 3-year super specialization in clinical pharmacology and therapeutics as subjects and are trained in various aspects of clinical research, medical affairs, pharmacovigilance, therapeutics, etc. Survey respondents comprised 60.2% MD pharmacologists (MD CPs), 34.7% DM clinical pharmacologists (DM CPs), and the rest were PharmDs (Table 1). 74.5% of the participants opined that more trained CPs are required. 32.7% (32 of 98) of the respondents felt that the additional certificate courses were not valuable, of which 53% (i.e., 17 of 32) were MD CPs, and 41.2% (i.e., 14 of 32) were DM CPs. Among the CPs who completed certification courses, courses offered by private organizations were preferred over those provided by Government organizations (66.6 vs. 33.4%, respectively, for private and government institutions). Among all the participants, 96.9% agreed that there is a need to increase awareness of clinical pharmacology nationally and internationally. About 50% (49 of 98) of the respondents opined that the additional certificate courses in the clinical research were beneficial, of which 34 responses were from MD CPs (Table 1).
Respondents were categorized based on experience as those with < 5 years or ≥ 5 years. There were 38 and 60 respondents in the respective groups with an average duration of the experience of 2.62 ± 1.395 years and 13.33 ± 9.39 years, respectively. In the DM CP group and MD CP group, there was an equal number of CPs with ≥ 5 years’ experience (46.7% vs. 50.0%) (Table 2).
Table 2.
Responses based on the experience of the clinical pharmacologists
| Characteristics with respect to the duration of the experience | < 5 years (%) | ≥ 5 years (%) | |
|---|---|---|---|
| Qualification | MD pharmacology | 29 (76.3) | 30 (50) |
| DM clinical pharmacology | 6 (15.8) | 28 (46.7) | |
| Others | 3 (7.9) | 2 (3.3) | |
| Place of work | Academic institution | 16 (42.1) | 14 (23.3) |
| Hospital | 9 (23.6) | 17 (28.3) | |
| Pharmaceutical company | 13 (34.2) | 28 (46.6) | |
| Drug regulator | 0 (0.0) | 1 (1.6) | |
| Advantageous to have a certificate course in clinical pharmacology | Agree | 22 (57.9) | 27 (45) |
| Neutral | 6 (15.8) | 11 (18.3) | |
| Disagree | 10 (26.3) | 22 (36.7) | |
| Have certifications other than those related to clinical pharmacology (n = 52) | Certification is beneficial to career growth | 17 (89.4) | 27 (81.9) |
| Certification is not beneficial to career growth | 2 (10.5) | 6 (18.1) | |
| Course curricula of the extra certifications should be uniform for all the centers which provide the clinical pharmacology teaching programs | Agree | 30 (78.9) | 41 (68.3) |
| Neutral | 4 (10.5) | 14 (23.3) | |
| Disagree | 4 (10.5) | 5 (8.3) | |
| Curricula of additional clinical pharmacology courses should be included in the course curriculum of PG pharmacology teaching programs | Agree | 31 (81.6) | 49 (81.7) |
| Neutral | 4 (10.5) | 8 (13.3) | |
| Disagree | 3 (7.9) | 3 (5.0) | |
| Responses given to the question regarding the situations where clinical pharmacologists play a significant role | Academia | 36 (94.7) | 55 (91.7) |
| Pharmaceutical organizations | 38 (100.0) | 59 (98.3) | |
| Government regulatory bodies | 36 (94.7) | 56 (93.3) | |
| Hospitals | 34 (89.5) | 56 (93.3) | |
| All | 31 81.6) | 51 (85.0) | |
| Responses given to the question regarding clinical pharmacologists’ roles in a hospital | OPD consultation | 25 (65.8) | 36 (60.0) |
| Ethics committee consultation | 34 (89.5) | 54 (90.0) | |
| Clinical trial designing | 32 (84.2) | 58 (96.7) | |
| Clinical trial auditing & inspection | 34 (89.5) | 55 (91.7) | |
| Pharmacovigilance | 35 (92.1) | 53 (88.3) | |
| Prescription audit | 36 (94.7) | 56 (93.3) | |
| Therapeutic drug monitoring | 36 (94.7) | 58 (96.7) | |
| All | 21 (55.3) | 30 (50) | |
| Responses given to the question regarding how to increase the awareness of clinical pharmacology? | Increased awareness among other specialties by healthy collaborations, organizing workshops and conferences | 38 (100.0) | 55 (91.7) |
| Organizing clinical pharmacology outpatient clinics in specialty hospitals | 30 (78.9) | 40 (66.7) | |
| Increasing awareness among the government representatives, medical councils to create posts and a career path for clinical pharmacologists | 31 (81.6) | 48 (80) | |
| Special courses for aspiring students in government and private institutes | 21 (55.3) | 31 (51.7) | |
| Student exchange/training programs with the universities in overseas for doctoral or research fellowship studies | 24 (63.2) | 41 (68.3) | |
| Provide evidence to the hospital management of the cases managed by clinical pharmacologists | 29 (76.3) | 42 (70) | |
| All | 14 (36.8) | 18 (30.0) | |
CP clinical pharmacologist, DM doctorate of medicine, MD doctor of medicine, OPD outpatient department, PG postgraduation
Our results show that, regardless of the duration of experience of the CPs, all opined that CPs are not getting adequate support or representation in government, academia, and pharmaceutical organizations and that they have a multidisciplinary role in the health sector as in hospital activities, outpatient department (OPD) consultations, pharmacovigilance and prescription audit, and therapeutic drug monitoring. In addition, the results show that CPs play a significant role in the ethics committee proceedings, clinical trial designing, auditing, and inspections (Table 2).
A significantly higher proportion of MD CPs was working in the pharmaceutical industry compared to DM CPs (50.8% vs. 29.4%) (Table 3). Among the DM CPs, 35.3%, 32.4, and 29.4% had positions in educational institutions, hospitals, and pharmaceutical companies, respectively. In contrast, among the MD CPs, a majority (50.8%) were employed by pharmaceutical companies. Regarding the course curriculum in postgraduation, 43 of 59 and 23 of 34 MD and DM CPs, respectively, opined that it is not up to the requirement of a CP. This conclusion was the same when the responses were categorized regardless of the duration of the responding CPs’ experience. Among the 98 participants, 55 (56.1%) had at least one additional certificate course related to clinical research, of whom 35 (59.3%) were MD CPs and 16 (47.1%) were DM CPs. Among those with certifications, 44 (84.6%) agreed, and 8 (15.4%) disagreed about the benefits of these certifications on their career growth. This response was robust, regardless of the responding CP’s qualification. Based on their experience, respondents felt that CPs play a significant multidisciplinary role in academia, pharmaceutical companies, hospitals, and regulatory bodies. When the results were classified based on their qualification, 45 of 59 (76.3%) MD CPs and 32 of 34 (94.1%) DM CPs opined that their role was multidisciplinary.
Table 3.
Responses based on the qualification of the clinical pharmacologists
| Characteristics concerning qualifications | MD CPs (%) | DM CPs (%) | Others (%) | |
|---|---|---|---|---|
| Place of work | Academic institution | 17 (28.8) | 12 (35.3) | 1 (20.0) |
| Hospital | 12 (20.3) | 11 (32.4) | 3 (60.0) | |
| Pharmaceutical company | 30 (50.8) | 10 (29.4) | 1 (20.0) | |
| Drug regulator | 0 (0.0) | 1 (2.9) | 0 (0.0) | |
| Clinical pharmacology training sufficient in the course curriculum of PG | Agree | 7 (11.9) | 5 (14.7) | 3 (60.0) |
| Neutral | 9 (15.3) | 6 (17.6) | 0 (0.0) | |
| Disagree | 43 (72.9) | 23 (67.6) | 2 (40.0) | |
| Advantageous to have a certificate course in clinical pharmacology | Agree | 34 (57.6) | 12 (35.3) | 3 (60.0) |
| Neutral | 8 (13.6) | 8 (23.5) | 1 (20.0) | |
| Disagree | 17 (28.8) | 14 (41.2) | 1 (20.0) | |
| Any certifications other than those related to clinical pharmacology | Yes | 35 (59.3) | 16 (47.1) | 4 (20.0) |
| No | 24 (40.7) | 18 (52.9) | 1 (80.0) | |
| Have certifications other than those related to clinical pharmacology (n = 52) | Certification is beneficial to career growth | 28 (80.0) | 15 (93.8) | 1 (100) |
| Certification is not beneficial to career growth | 7 (20.0) | 1 (6.2) | 0 (0.0) | |
| Have certifications other than those related to clinical pharmacology (n = 52) | Certification offered by private organizations | 24 (68.6) | 10 (62.5) | 1 (100) |
| Certification offered by government organizations | 11 (31.4) | 6 (37.5) | 0 (0) | |
| Course curricula of the extra certifications should be uniform for all the centers which provide the clinical pharmacology teaching programs | Agree | 45 (76.3) | 23 (67.6) | 3 (60.0) |
| Neutral | 7 (11.9) | 10 (29.4) | 1 (20.0) | |
| Disagree | 7 (11.9) | 1 (2.9) | 1 (20.0) | |
| Curricula of additional clinical pharmacology courses should be included in the course curriculum of PG pharmacology teaching programs | Agree | 50 (84.7) | 25 (73.5) | 5 (100.0) |
| Neutral | 6 (10.2) | 6 (17.6) | 0 (0.0) | |
| Disagree | 3 (5.1) | 3 (8.8) | 0 (0.0) | |
| Situations where clinical pharmacologists play a major role | Academia | 53 (89.8) | 33 (97.1) | 5 (100) |
| Pharmaceutical organizations | 59 (100.0) | 33 (97.1) | 5 (100) | |
| Government regulatory bodies | 53 (89.8) | 34 (100) | 5 (100) | |
| Hospitals | 51 (86.4) | 34 (100) | 5 (100) | |
| All | 45 (76.3) | 32 (94.1) | 5 (100.0) | |
| What roles in your opinion do clinical pharmacologists play in a hospital? | OPD consultation | 32 (54.2) | 26 (76.5) | 3 (60.0) |
| Ethics committee consultation | 52 (88.1) | 32 (94.1) | 4 (80.0) | |
| Clinical trial designing | 54 (91.5) | 33 (97.1) | 3 (60.0) | |
| Clinical trial auditing & inspection | 52 (88.1) | 33 (97.1) | 4 (80.0) | |
| Pharmacovigilance | 52 (88.1) | 31 (91.2) | 5 (100.0) | |
| Prescription audit | 57 (96.6) | 30 (88.2) | 5 (100.0) | |
| Therapeutic drug monitoring | 56 (94.9) | 33 (97.1) | 5 (100.0) | |
| All | 27 (45.8) | 21 (61.8) | 3 (60.0) | |
| How to increase the awareness of clinical pharmacology? | Increased awareness among other specialties by healthy collaborations, organizing workshops and conferences | 54 (91.5) | 34 (100.0) | 5 (100.0) |
| Organizing clinical pharmacology outpatient clinics in specialty hospitals | 43 (72.9) | 23 (67.6) | 4 (80.0) | |
| Increasing awareness among the government representatives, medical councils to create posts and a career path for clinical pharmacologists | 47 (79.7) | 31 (91.2) | 1 (20.0) | |
| Special courses for aspiring students in government and private institutes | 31 (52.5) | 18 (52.9) | 3 (60.0) | |
| Student exchange/training programs with the universities in the overseas for doctoral or research fellowship studies | 40 (67.8) | 23 (67.6) | 2 (40.0) | |
| Provide evidence to the hospital management of the cases managed by clinical pharmacologists | 37 (62.7) | 29 (85.3) | 5 (100.0) | |
| All | 20 (33.9) | 12 (35.3) | 0 (0) | |
CP clinical pharmacologist, DM doctorate of medicine, MD doctor of medicine, OPD outpatient department, PG postgraduation
Regarding the roles a CP plays in a hospital, 27 of 59 (45.8%) MD CPs and 21 of 34 (61.8%) DM CPs opined that CPs could play multiple roles. Compared to MD CPs, more DM CPs opined that they could do OPD consultations in a hospital (32 of 59 vs. 26 of 34, i.e., 76.5% vs. 54.2%) (Table 3). A similar observation was noted when their responses were stratified based on their qualification and experience.
Regarding the course curriculum, most of the CPs felt the need and importance of uniformity in the certification courses offered by all the centers. In addition, they also opined that the content of these courses should be part of the postgraduation courses. The results were similar when stratified by participants’ qualifications or experience (Table 2).
Discussion
In this study, we captured the responses and opinions of clinical pharmacologists from India working in different fields as clinical pharmacologists via a questionnaire. Pharmacology postgraduation (MD pharmacology) is a 3-year course pursued after a medical student completes their graduation from medical school. During the course, they will be taught pharmacology, applied pharmacology, and a few aspects of clinical pharmacology. A pharmacology degree can open up careers in scientific areas like research and drug development. After medical graduates complete their postgraduation in pharmacology, they will be eligible to pursue a super specialty course in clinical pharmacology (DM clinical pharmacology & therapeutics), a 3-year program. During the course, students will be trained in more of the clinical aspects of pharmacology—pharmacokinetics, pharmacodynamics, pharmacovigilance, drug development, and in-depth knowledge of clinical research. We observed from our study results that the course curricula in the postgraduation need to be updated. In addition, we also observed that the respondents felt that the existing course curricula were not as per the requirements for future clinical pharmacologists’ roles and responsibilities.
Based on prior experience and after discussions with experts, the British Pharmacological Society (BPS) has developed a core curriculum in pharmacology for undergraduates. The factors considered by them were in line with the observations made in our survey [10]. BPS also stressed the need for a dynamic pharmacology curriculum. Dikshit RK from India opined that the existing curriculum of clinical pharmacology training is inadequate and needs to be updated, which matches our survey results too [11]. In 2006, the European Union of Medical Specialists (UEMS) designed specialized additive training for medical graduates. The course contained an equal duration of 18 months of training in pharmacology and clinical pharmacology. Subsequently, in 2015, additive specialty was replaced by specialization in clinical pharmacology. As observed in our study, Melisa J. Wallace from Swansea University and Subhrojyoti Bhowmick from India also opined that a more significant number of expert clinical pharmacologists is needed to cope with the recent surge in clinical research activities in industries, hospitals, and academic institutes [12]. Our results also show that CPs are not getting adequate support or representation in government, academia, and pharmaceutical organizations. This observation implies that there should be a sufficient number of CPs in these organizations for effective drug development.
Simon Maxwell and Tom Walley, ex-Vice President and ex-Chairman of the clinical section committee of the British Pharmacology Society, stressed the importance of training medical graduates in clinical pharmacology. They suggested that training in safe, effective, and cost-effective drug prescribing methods was needed for medical graduates. Considering clinical pharmacologists’ roles in patient management, the authors opined that clinical pharmacology and therapeutics (CPT) as a separate clinical discipline would benefit the patients [13]. They opined that the importance of training in CPT should be stressed, and CPs should be part of the rational prescribing in primary care. J. C. Mucklow also suggested that CPT training is essential and opined that organizing problem-based learning and practical training to develop prescribing skills and seminars and workshops will significantly impact training in CPT [14].
Clinical pharmacologists’ support is required to efficiently manage vulnerable populations like pediatric, geriatric, and pregnant women, susceptible to polypharmacy and drug-drug interactions. Elderly patients have decreased functional reserves, which made the American Geriatrics Society Expert Panel on the Care of Older Adults with Multimorbidity suggest that the clinical pharmacologist’s role in patient management in a hospital is vital [15].
The results of our study concur with those of Avinash Arivazhahan from India in that a trained CP could play a multidisciplinary role in conducting research activities such as being part of the scientific/ethics review committees and running the clinical trial units in addition to patient-related services such as the pharmacovigilance programs, therapeutic drug monitoring, and drug information services, among others [16]. Avinash Arivazhahan also opined that the medical pharmacology postgraduate course falls short of what CP requires to play diverse roles in the pharmaceutical industry. For those who want to work in the pharmaceutical industry after graduation, observership programs should be made available.
Kazeem A. Oshikoya from Nigeria found that medical students and interns received inadequate CPT teaching in Nigeria. They also stated that both theoretical and practical CPT instruction should cover the concepts of rational prescribing, child medication dosage calculations, and pharmacovigilance [17].
COVID-19 pandemic has made most of the clinical research training online, and no practical training was organized during the pandemic in India. Furthermore, various certifications and diploma courses in clinical research are being introduced by multiple institutions. Experts’ opinions from our survey suggest that these courses have to be uniform, and the training has to be taken up by the experts in the field of clinical trials.
Training from the drug regulatory bodies must be imparted to the aspirants of clinical pharmacology. Training programs offered by institutes in clinical pharmacology, clinical research should provide skills and competency that meet the needs of society and contribute to public health (Table 2) [18]. Drug regulatory bodies should regularly organize workshops and conferences to sensitize medical graduates and pharmacologists about the importance of CPs. Corporate training institutes should be accredited for clinical research/clinical pharmacology training. The training should be provided by experts in clinical research. CPs should be given practical exposure to handling clinical trials and hospital patient management.
We have tabulated the issues that our survey identified and possible solutions for the same in Table 4. In our institute, we did initiate a clinical pharmacology training course, “Fellowship in Oncotherapeutics,” with one aspirant in clinical pharmacology having an annual take-up. The student will be trained in clinical research, pharmacokinetics, pharmacometrics, pharmacovigilance, and responding to queries raised by clinicians. After completing the fellowship, they should be able to find jobs in their area of interest in industry or academia, where they will in turn provide quality education to the young aspirants. So, we suggest other institutes should also initiate similar training for the aspirants.
Table 4.
Problems identified during the survey and possible solutions
| Issues identified | Possible solutions |
|---|---|
| The scope of applied pharmacology is not adequately explained during postgraduation | Optimizing and framing of syllabus considering the prospects of CP |
| Inadequate training in postgraduation |
Experts in CP should provide training to the aspirants Organizing workshops/conferences in clinical pharmacology Providing industrial experience/observership to postgraduates |
| Institutes lacking proper infrastructure are providing certification in clinical pharmacology/clinical research |
• To raise the standards of the institutes to the level of accreditation by the CDSCO • Govt. bodies like ICMR should come forward to offer courses in clinical research |
| Lack of awareness about clinical pharmacology in the medical sector |
• Increased awareness among other specialties by beneficial collaborations, organizing workshops, and conferences • Organizing clinical pharmacology outpatient clinics in multi-specialty hospitals • Increasing awareness among the government representatives and medical councils to create positions and a career path for clinical pharmacologists • Offering courses for aspiring students in government and private institutes • Student exchange/training programs with universities overseas for doctoral or research fellowship studies • Provide evidence to the hospital management of the cases managed by clinical pharmacologists |
CDSCO Central Drugs standard control organization, CP clinical pharmacologist, ICMR Indian Council for Medical Research
Conclusion
Clinical pharmacologists play a multidisciplinary role in health care. Incorporating clinical pharmacology training during the postgraduation course in pharmacology is necessary to cope with the increased demand for trained clinical pharmacologists.
Supplementary Information
Below is the link to the electronic supplementary material.
Author contribution
M. N. and D. V. are involved in the study concept, design and data collection. M. N., A. P., and S. H. were involved in data analysis and manuscript writing. M. N. was involved in the overall study conduct. M. N., D. V., A. P., and S. H. have reviewed the manuscript. M. N. and A. P. have addressed the reviewers’ comments.
Data availability
All the required data about the study are present in the manuscript. We are happy to provide additional data if the reviewer or the editor requires further data.
Declarations
Ethical approval
Institutional Ethics Committee III of our institute has approved the study.
Consent to participate
All the participants provided consent to participate in the study.
Consent to publish
All the authors give consent for publishing the manuscript in the European Journal of Clinical Pharmacology.
Competing interests
The authors declare no competing interests.
Footnotes
Publisher's Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
References
- 1.Moore N. The role of the clinical pharmacologist in the management of adverse drug reactions. Drug Saf. 2001;24(1):1–7. doi: 10.2165/00002018-200124010-00001. [DOI] [PubMed] [Google Scholar]
- 2.Clinical pharmacists: bridging the gap between patients and physicians - PMC. Available date 27 Jul 2022, from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4281611/ [DOI] [PMC free article] [PubMed]
- 3.Ghosh RK, Ghosh SM, Datta S. Training of postgraduate pharmacologists in India–the need for alignment with the emerging roles in the pharmaceutical industry. J Postgrad Med. 2010;56(2):168–169. doi: 10.4103/0022-3859.65288. [DOI] [PubMed] [Google Scholar]
- 4.Badyal DK, Desai C, Tripathi SK, Dhaneria SP, Chandy SJ, Bezbaruah BK. Postgraduate pharmacology curriculum in medical institutions in India: time for need-based appraisal and modifications. Indian J Pharmacol. 2014;46(6):584–589. doi: 10.4103/0253-7613.144903. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 5.Richards D. An agenda for UK clinical pharmacology: developing and delivering clinical pharmacology in pharmaceutical companies. Br J Clin Pharmacol. 2012;73(6):870–873. doi: 10.1111/j.1365-2125.2012.04227.x. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 6.Maxwell SRJ, Cameron IT, Webb DJ. Prescribing safety: ensuring that new graduates are prepared. Lancet Lond Engl. 2015;385(9968):579–581. doi: 10.1016/S0140-6736(14)62339-4. [DOI] [PubMed] [Google Scholar]
- 7.Aronson JK. What do clinical pharmacologists do? A questionnaire survey of senior UK clinical pharmacologists. Br J Clin Pharmacol. 2012;73(2):161–169. doi: 10.1111/j.1365-2125.2011.04079.x. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 8.nmcteam (2021) When to Hire a Clinical Pharmacologist: Benefits of Outsourcing [Internet]. PK / PD and Clinical Pharmacology Consultants. Available date 18 Jul 2022, from: https://www.nuventra.com/resources/blog/when-to-hire-a-clinical-pharmacologist/
- 9.Clinical Pharmacology—The Quarterback of Drug Development (2017) ACRP. Available date 18 Jul 2022, from: https://acrpnet.org/2017/06/01/clinical-pharmacology-quarterback-drug-development/
- 10.Wallace MJ, Zecharia A, Guilding C, Tucker S, McFadzean I. Developing a new undergraduate pharmacology core curriculum: the British Pharmacological Society Delphi Method. Pharmacol Res Perspect. 2021;9(4):e00832. doi: 10.1002/prp2.832. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 11.Dikshit R. Postgraduate education in medical pharmacology. Indian J Pharmacol. 2007;39(4):171. doi: 10.4103/0253-7613.36533. [DOI] [Google Scholar]
- 12.Bhowmick S, Shenoy AK. Evolving role of clinical pharmacologists in Indian accredited hospitals. J Pharmacol Pharmacother. 2018;9(3):121–125. doi: 10.4103/jpp.JPP_82_18. [DOI] [Google Scholar]
- 13.Maxwell S, Walley T. Teaching safe and effective prescribing in UK medical schools: a core curriculum for tomorrow’s doctors. Br J Clin Pharmacol. 2003;55(6):496–503. doi: 10.1046/j.1365-2125.2003.01878.x. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 14.Mucklow JC. Postgraduate education in clinical pharmacology and therapeutics. Br J Clin Pharmacol. 1998;45(4):339–346. doi: 10.1046/j.1365-2125.1998.t01-1-00700.x. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 15.American Geriatrics Society Expert Panel on the Care of Older Adults with Multimorbidity (2012) Patient-centered care for older adults with multiple chronic conditions: a stepwise approach from the American Geriatrics Society: American Geriatrics Society Expert Panel on the Care of Older Adults with Multimorbidity. J Am Geriatr Soc 60(10):1957–68 [DOI] [PMC free article] [PubMed]
- 16.Arivazhahan A, Raj GM, Puttur DS, Atal S, George MM, Bairy L. Career Vistas for Indian medical pharmacologists: a comprehensive review. J Pharmacol Pharmacother. 2021;12(2):29–36. [Google Scholar]
- 17.Oshikoya KA, Senbanjo IO, Amole OO. Interns’ knowledge of clinical pharmacology and therapeutics after undergraduate and on-going internship training in Nigeria: a pilot study. BMC Med Educ. 2009;9(1):50. doi: 10.1186/1472-6920-9-50. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 18.Kshirsagar NA, Bachhav SS, Kulkarni LA, Vijaykumar (2013) Clinical pharmacology training in India: status and need. Indian J Pharmacol 45(5):429–33 [DOI] [PMC free article] [PubMed]
Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Data Availability Statement
All the required data about the study are present in the manuscript. We are happy to provide additional data if the reviewer or the editor requires further data.