Dear Doctor:

The Tufts Center for the Study of Drug Development (Tufts CSDD) is conducting a survey aimed at understanding physician perceptions of and experiences with clinical research. This survey is being distributed nationwide to all physicians affiliated with professional societies, associations, and academic medical centers. The results of this survey are highly anticipated by policy makers and research professionals in government, academia, and the private sector.

Your participation and input are invaluable. The survey should take no more than 15 minutes to complete and should be completed in one sitting. All responses will be considered confidential, and analysis will be presented in aggregate form only. Based on feedback from physicians who wanted more time, the deadline for completing and submitting the survey has been extended to Friday, December 8th. If you are interested in receiving a summary report of the survey results, please provide your contact information in the appropriate fields at the end of the survey.

Thank you in advance for your time and valuable input.

Best Regards,

Kenneth I Kaitin, Ph.D.
Director, Tufts CSDD
Associate Professor of Medicine, Tufts University School of Medicine


Background Information

This section is intended to collect descriptive and background information on physician demographics, practice characteristics and patient population and determines clinical trial involvement.




Please tell us about yourself.

1. Gender       Male Female

2. Age

3. Please identify your race (select all that apply):

American Indian or Alaska Native
Asian
Hispanic or Latino
Black or African American
Native Hawaiian or Other Pacific Islander
White (non-Hispanic)
Some Other Race - please identify

4. Highest degree(s) you received and the years you received them in:

M.D. - Year Received
Ph.D. - Year Received
Masters- Year Received
Bachelors- Year Received
Other (specify) - Year Received

5. What board certifications do you currently have?



6. How many languages are you fluent in?

Please specify languages:

7. Medical specialty:

Sub-specialty (if applicable):

8. Have you received Good Clinical Practice (GCP) training and certification?

Trained?  Yes No

If yes, who provided the training?

Certified?  Yes No

If yes, who provided the certification?

 



Please tell us about your medical practice.

9. Practice location: City State

10. Which of the following best describes the medical/research community that you presently serve?

Inner city
Urban
Suburban
Rural

11. Which of the following best describes your practice setting?

Private Practice
Group Practice
Community Health Clinic
Academic Medical Center
Unaffiliated Hospital
VA Hospital
Research Center/Consortium
Other - specify

12. Which of the following infrastructure items do you have in your practice?

Electronic medical records
Internet
Special record-keeping room/area
Specialized medical equipment (specify)

13. Are other people in your staff trained and certified in GCP?

Trained?  Yes No

If yes, who provided the training?

Certified?  Yes No

If yes, who provided the certification?




Please tell us about your patient population.

14. In your total practice (research plus private), how many patients do you serve?

Note: For questions 15-17, the aggregate percentages should approximate 100%.

15. Of these patients, how many are:

% Male
% Female

16. Approximately what percentage of the patients that you see are:

% American Indian or Alaska Native
% Asian
% Black or African American
% Hispanic or Latino
% Native Hawaiian or Other Pacific Islander
% White (non-Hispanic)
% Some other race - specify

17. Approximately what percentage of your patients are:

% Pediatric (17 or under)
% Adults (18 to 64)
% Geriatric (65 and over)




Please tell us about your involvement in clinical research.

18. Have you ever conducted/been involved in a clinical trial?  Yes No

19. If yes, in what capacity? (select all that apply)

Principal Investigator (PI)
Co-/Sub-investigator
Referring Physician
Other (specify)

20. If you refer your patients into clinical trials, on average, how many do you refer each year?

21. If you have never conducted/been involved in a clinical trial, how interested are you in participating in clinical trials?

Very

Somewhat

Not at all





Instructions:

If you have conducted / been involved in a clinical trial, please complete questions 22-42 to describe your experience to us.

If you have not conducted/been involved in a clinical trial, please click here to go to question 43.
 

Your Clinical Trial Experience

22. How many trials have you conducted in total?

23. What year did you begin conducting trials?

24. Who sponsored your first trial?

Government
Foundation
Industry
Other - explain:

25. How did you first become involved in clinical trials?

As a secondary investigator or sub-investigator
NIH study/government grant
Investigator initiated study
Directly recruited by sponsor company, contract research organization (CRO
      or site management organization (SMO)
Other - explain:

26. Which of the following is the most frequent method that you have used to secure clinical trial grants?

A pharmaceutical/biotech company contacted me
I proactively contacted a pharmaceutical/biotech company
A government agency contacted me (i.e. NIH)
I applied for a grant from a government agency (i.e. NIH)
I was referred to trial through an institutional office or site network
Other - specify:

27. Does your institution/sponsor require you to recruit a diverse subject population?

 Yes No

28. Does your institution/sponsor monitor retention rates of subjects in your clinical trials?

 Yes No

29. Does your institution/sponsor require post-trial benefits for your participants?

 Yes No

30. Are you currently involved in conducting trials?  Yes No

If no, what year did you stop conducting trials?

If no, why did you discontinue involvement?

31. How many trials did you initiate in:

2003:
2004:
2005:
2006 (to date):

Please answer the following questions regarding the clinical trials that you have conducted.

If you no longer conduct clinical trials, please answer with information thinking about your past clinical trials.

32. What percentage of all of your trials are sponsored by: (note: the aggregate percentages should equal 100%)

% Government
% Foundation
% Industry
% Other - specify

33. In which of the following therapeutic areas have you conducted trials? (select all that apply)

Anti-infective

Analgesic/Anesthetic

Cardiovascular

Central Nervous System

Dermatology
Endocrine
Gastrointestinal
Immunology/Infectious Disease
Musculoskeletal
Oncology
Ophthalmology
Pulmonary/Respiratory
Other (specify)

34. Which of the following have you investigated in a clinical trial? (select all that apply)

Chemical entity

Biological entity

Vaccine

Device

35. Which best describes the primary location where you conduct clinical research?

Academic
Community based group/private practice
Hospital
Dedicated research site/SMO
Other - specify:

36. Please estimate the percentage of industry trials that you have conducted that were/are: (note: the aggregate percentages should equal 100%)

% Phase I studies
% Phase II studies
% Phase III studies
% Post-approval studies

37. What percentage of all of your trials is monitored by a contract research organization (CRO)?

%

38. What percent of your current salary (or practice’s total revenue) comes from clinical trial grants?

% Current salary
% Practice’s revenue

39. What percent of your last complete year of salary (or practice’s revenue) came from clinical trial grants?

% Current salary
% Practice’s revenue

40. Have you ever participated in FDA-sanctioned trials?  Yes No

If yes, have you ever signed a FDA 1572 form?  Yes No

41. Have you ever been audited by the FDA for a clinical trial?  Yes No

If yes, was the audit(s) study-oriented or investigator-oriented?

Study-oriented
Investigator-oriented
Both

If yes, were there any mandatory actions required as a result of the audit?

For study-oriented audit:  Yes No

For investigator-oriented audit:  Yes No

42. Thinking about where you conduct your clinical trials, which of the following are in place at your site? (select all that apply)

Full-time study coordinators - How many?
Part -time study coordinators - How many?
Dedicated office space for clinical research documents
Secure investigational drug supply cabinet
Dedicated area for visiting study monitors
Clinical research data collection system
Dedicated and secured (locked) room for inputting clinical research data
Dedicated refrigerator for sensitive study medication
Electronic medical records
Internet access
Other (specify)

 

Your Ideas and Opinions

43. What are the top three reasons why you want to participate as an investigator in clinical trials?

1.
2.
3.

44. What are the top three concerns you have about participating as an investigator in clinical trials?

1.
2.
3.

45. Do you find that there are barriers to your participation as an investigator in clinical research?

 Yes No

If yes, please elaborate (select all that apply):

Lack of access: in the past I have not been invited to participate in clinical trials
Infrastructural needs in my office (i.e.: equipment, supplies, office design, etc.)
Personnel needs in my office (i.e.: dedicated study coordinator)
Time constraints (I do not have enough time to participate in clinical trials)
Grant payment amount not worth effort and record keeping required for clinical
      trial
My patients are not willing to participate
Other - specify:

46. If you mentioned that your patients are not willing to participate, which of the following reasons capture their reluctance? (select all that apply)

They do not trust the healthcare system
They do not trust the pharmaceutical/biotech industry
They have cultural barriers
      Please elaborate
They have religious beliefs that prevent their participation
They have language barriers
They have trouble paying for and/or securing transportation
They require child care
They believe the risks of the trial outweigh the benefits
Other - specify:

47. What factors do you think would motivate your patients to volunteer to participate in clinical research?

48. In your opinion, how important is your gender and race/ethnicity in influencing the willingness of patients of similar gender and race/ethnicity to participate in clinical trials?

Not Important
Somewhat Important
Important
Very Important


Thank you for taking the time to respond to this survey. If we have additional questions for clarification and to elaborate, may we contact you?

Yes

No

Would you like to receive a summary report of the survey results?

Yes

No

Please provide the following contact information so that we can reach you if we have further questions and/or we can send you the survey results:

Name

Address

City

State

Phone

Fax

Email

Best Time to Contact You
Mornings Afternoons Evenings

Best or preferred method of contact:
Phone Email Other (specify)


For more information about this survey, please contact:

Laura B. Faden
Research Assistant
192 South Street, Suite 550
Boston, MA 02111
Tel: 617-636-2160
Email: laura.faden@tufts.edu


© 2006 Tufts Center for the Study of Drug Development

Online Interactive Survey Created by Illumina Interactive, Boston, MA