Clinical Trials Research: making the most of Research Opportunities as a Psychiatric Trainee

Briess D, Rao C, Bacon N, Geddes J.

Aims and Method

Research has recently been driven up the governmental agenda with increases in funding and the creation of the UK Clinical Research Collaboration.  An independent review of clinical trials research in the UK was undertaken which highlighted the need for this immediate action to improve the research environment. Further to this drive for improvement, we examined SpRs current research practice with a survey designed using a novel form of electronic distribution. This created a rapid, efficient and low cost method to assess research practice, specifically exploring interest in clinical trials research.

Results

Over 90 responses were received within 5 days and the vast majority had an interest in clinical research. However, only a minority had experience in clinical trials with only 4 having some specialist training in becoming a clinical trials Investigator. Currently only 5 respondents were actively involved in clinical trials research.

Clinical implications

It is of substantial concern that such low numbers of SpRs are trained and involved in clinical trials research. With evidence-based medicine informing practice, what will inform evidence-based medicine if UK clinicians are not involved in generating the building blocks of this evidence? Within the UKCRC commissioned report, psychiatric disease was placed as one of the specific therapeutic areas requiring a focus for clinical trials. It is therefore imperative that these skills are encouraged, with opportunities available for SpRs to participate and train as Investigators. Basic competency as an Investigator should ideally be achieved at this pre-Consultant level, so that confident involvement in clinical trials, producing high quality and efficient data, can occur as a Consultant.

Introduction

Much has been written and discussed about the value of the Specialist Registrar (SpR) research day. Currently two sessions per week remains protected time for SpRs to become involved in research. Although plans for higher specialist training (HST) have not been finalized, as specialty training in the UK is in a period of change, it is uncertain whether the research day will continue.

There are relevant drivers in the wider context of NHS research and development. Research was placed high-up on the Governmental agenda, in the March 2004 Budget, which introduced increases to NHS Research and Development (NHS R&D) funding as well as the creation of the UK Clinical Research Collaboration (UKCRC). The following year, a report was published by the academic careers subcommittee of Modernizing Medical Careers (MMC) and the UKCRC (UKCRC & MMC report, 2005), making recommendations for training the researchers. The core proposal of the report was to ensure that there is an explicit academic training pathway during the specialist training period. Their recommendations were to develop dedicated academic teaching programs in strong host environments, in partnership between Universities and local NHS Trusts and Deaneries. It is the MMC/UKCRC sub-committee that will be liaising closely with the statutory regulator of training, the Postgraduate Medical Education and Training Board (PMETB), to resolve the problems currently facing academic staff. Specifically, the MMC/UKCRC sub-committee have urged that substantial efforts are made to develop academic training programs in those specialties that have shown significant decline in their academic activity. Psychiatry is one such specialty.

Clinical research in the UK has been discussed extensively in recent years. The UKCRC commissioned McKinsey and Company, a management consulting firm, to conduct a review of the state of clinical trials research in the UK (McKinsey report, 2005). The report concluded that the UK should aspire to ‘a single system that reliably delivers distinctive quality and rapid access at reasonable cost’. This conclusion firmly throws down the gauntlet to ensure efficient and high quality operational processes, it also highlights the need to establish well trained and effective investigators at the sharp end.

We used an electronic distribution system to conduct a national survey to discover the research interests of SpRs. We sought to identify what research was being performed in SpR protected research sessions and any difficulties that occurred. Specifically, we wanted to explore the level of SpR involvement and/or interest in clinical trials research and the opportunities they have for training, supervision and gaining practical experience.

Method

An electronic questionnaire was sent to SpR grade psychiatrists in the UK as a link in a targeted electronic clinical bulletin by Doctors.net.uk (DNUK). This is the largest medical network in the UK with a membership of over 127,000 doctors. An independent company, Doctors.net.uk was founded in 1998 with the aim of helping doctors deliver better healthcare through modernising medical communication. The invitation email stated:

Dear Colleague
Doctors.net.uk invites you to participate in an online survey
concerning research within SPR grade Psychiatrists
If you would like to complete this survey, then please go to the
questionnaire which is located at:
http://www.doctors.net.uk/login/?shorturlid=3535

The results of the study will be used for market research purposes only and all responses will be kept in strictest confidence.  Please be assured that your participation in this study is STRICTLY CONFIDENTIAL and your details will not be divulged to any third party.

The electronic questionnaire was sent in February 2006 to all 391 SpRs (in all sub-specialties) registered with DNUK nationwide. The questionnaire asked:

 

1) Year of graduation

2) Gender

3) Do you have an interest in participating actively in research?

3a) If Yes – Are you more interested in clinical (eg involving patient trials of treatments) or non-clinical (eg animal) research?

4) Have you had any research experience before you became a SpR?

4a) If Yes - Was this experience in randomized clinical trials (commercial or academic)?

4b) If Yes - Have you had any specialist training in becoming a Clinical Trials Investigator?

5) Have you had any specialist training in research methodology?

6) Have you had any specialist training in statistics or clinical epidemiology?

7) Does your SpR program have a Research Director (RD)?

5a) If Yes - Has the RD given you advice about research opportunities?

8) What type of research are you undertaking for your research day?

9) What aspects of research do you find difficult?

10) Would you be prepared for us to contact you by telephone or email for further information?

10a) If Yes – Please could you supply your contact number and/or email address.

Results

The electronic questionnaire remained live for 5 days and was completed by 91 respondents (23%).

Of the 91 respondents, 67% graduated in the 1990’s and 27% in 2000 or beyond; 57% of the respondents were male and 43% were female. When asked about their interest in actively participating in research, 92% (84) had such an interest but 8% did not. Of those 84 respondents with an interest, 80% had more of an interest in clinical research, 2% were more interested in non-clinical and 15% were interested in both types equally. Regarding research experience prior to becoming a SpR, 65% (59) had some experience but 35% had not. However, out of those 59 respondents, only 20% (12) had this experience in randomized controlled trials (RCTs) and from those, only 33% (4) had some specialist training in becoming a clinical trials investigator. Of the original 91 respondents, 52% had specialist training in research methodology and 51% had specialist training in epidemiology and statistics. Within the SpR programs, 78% (71) had a research director of which 70% (50) had received some advice from. There was a wide variety of research projects undertaken with 5% (5) currently involved in clinical trials. A diversity of difficulties was experienced, however of the key problems expressed, 22% (20) finding difficulties with ethical approval, 14% (13) having inadequate training and supervision, 13% (12) giving lack of time as an issue and 9% (8) described funding as a problem.

 

Item

Yes

No

Clinical (C)

Non-clinical (NC)

C & NC equally

Do you have an interest in participating actively in research

84 (92%)

7 (8%)

     

If yes - Are you more interested in clinical or non-clinical research

   

67 (80%)

2 (2%)

15 (18%)

Have you had any research experience before you became a SpR

59 (65%)

32 (35%)

     

If Yes - Was this experience in randomized clinical trials

12 (20%)

47 (80%)

     

If Yes - Have you had any specialist training in becoming a Clinical Trials Investigator

4 (33%)

8 (67%)

     

Have you had any specialist training in research methodology

47 (52%)

44 (48%)

     

Have you had any specialist training in statistics or clinical epidemiology

46 (51%)

45 (49%)

     

Does your SpR program have a Research Director (RD)

71 (78%)

20 (22%)

     

If Yes - Has the RD given you advice about research opportunities

50 (70%)

21 (30%)

     

Table 1: Results of quantitative aspects of the questionnaire

Discussion

 

Although the response rate to this survey appears quite low when compared to similar SpR postal surveys, absolute numbers of respondents were high (Williams and Curran, 1998; Vassilas et al, 2002; Petrie et al, 2004). The electronic survey has particular advantages with the speed of data collection and databasing being much faster than by postal surveys. Practice, based on the experience of approximately 80 surveys completed by Doctors.net.uk each week, indicates that allowing the electronic survey to remain live for longer that 5 days would not have had a substantial effect on increasing the number of respondents. Due to self-selection effects, it is likely that the respondents in this survey are highly motivated to undertake research. This was also reflected by more than 90% respondents having an interest in participating actively in research. There were more male than female respondents and the vast majority had an interest in clinical research. Most had gained some experience in research before becoming a SpR and about half had received training in research methodology. However, experience in RCTs was limited, with only very few receiving training in becoming an investigator. A number of difficulties were described, but problems with ethical approval, poor training and supervision featured the most. This was similar to findings by a survey in 1998 (Williams & Curran, 1998) which highlighted insufficient supervision and support as difficulties faced by senior registrars during their research day.

A large majority had a research director and had received advice from them. However, it is clear that in order to reconcile the goals of the UKCRC and higher specialist training with the findings of this survey, clinical trials research needs to be more actively encouraged. The ability to plan, conduct and communicate research is a current requirement of higher specialist training (Ramchandani et al, 2001). A previous study (Allsopp et al, 2002) showed that only half of psychiatric SpRs have had research published and gaining publications still remains the cornerstone of career progression. However, although publishing research is important, as discussed in a paper by the RCPsych Collegiate Trainees’ Committee (Ramchandani et al, 2001), as a single goal of the research day, purely aiming to publish may lead to important educational opportunities being missed. We believe it is the journey rather than the destination that should fulfill the educational objectives.

Clinical trials research can place the investigator within a team, allowing collaboration and offering shared learning. The skills that SpRs learn by becoming an investigator are legion and highly translatable, ideally integrative, into normal clinical practice. Skills learned as an investigator can improve clinical effectiveness, as well as enhancing the clinical application of evidence-based medicine. Both fundamental to becoming a new Consultant.

Acknowledgments

Thanks are due to Doctors.net.uk and to the SpRs who completed the questionnaire.

 

References

REPORT OF THE ACADEMIC CAREERS SUB-COMMITTEE OF MODERNISING MEDICAL CAREERS AND THE UK CLINICAL RESEARCH COLLABORATION (2005) Medically- and dentally-qualified academic staff: Recommendations for training the researchers and educators of the future.

McKINSEY AND COMPANY REPORT (2005) Clinical research in the UK: Towards a system that reliably delivers distinctive quality and rapid access at reasonable cost

WILLIAMS, C. J., CURRAN, S. (1998) Research by senior registrars in psychiatry. Psychiatric Bulletin, 22, 102-104

ALLSOPP, L., ALLEN, R., FOWLER, L., et al (2002) Research in psychiatric higher specialist training: a survey of specialist registrars. Psychiatric Bulletin, 26, 272 –274.

RAMCHANDANI, P.,  CORBY, C., et al (2001) The place and purpose of research training for specialist registrars: a view from the Collegiate Trainees’ Committee (CTC) of the Royal College of Psychiatrists. Ir J Psych Med, 18(1), 29-31

PETRIE, R., ANDERSON, K., ELIZABETH, H., et al (2004) Research activity of specialist registrars. Psychiatric Bulletin, 28, 180-82

AUTHORS

David Briess

Specialist Registrar in General Adult Psychiatry, Mental Health Unit, Heatherwood Hospital, Ascot

Chandrashekar Rao

Specialist Registrar in General Adult Psychiatry, Department of Psychiatry, St Tydfil’s Hospital, Merthyr Tydfil

Neil Bacon

Founder, Doctors.net.uk Ltd, Abingdon, Oxford

John Geddes

Professor of Epidemiological Psychiatry, Department of Psychiatry, Warneford Hospital, Oxford

Declaration of interest

JG is Principal Investigator and DB and CR are Investigators in the BALANCE program of clinical trials in bipolar disorder. NB is founder of Doctors.net.uk.

First Published June 2006

 


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