Form 1 Survey

CGH CTCT LMIC Survey - 2023

Start of Block: Intro and Screening

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OMB#: 0925-0766

Expiration Date: 09/30/2026

Public reporting burden for this collection of information is estimated to average no more than 15 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0766). Do not return the completed form to this address.

Intro The NCI Center for Global Health is conducting a survey to help us gain a better understanding of the current landscape of cancer therapeutic clinical trials in low- and middle-income countries (LMICs). If you are or ever have been a clinician with experience designing or carrying out a cancer therapeutic clinical trial in an LMIC, we invite you to participate in this brief survey so we can learn about your thoughts and opinions regarding concrete steps that might be taken to advance clinical trials in LMICs.

This survey is anonymous and voluntary. If published, the results will be presented in an aggregated, de-identified format. There is no compensation for survey completion. All questions are optional, and you may exit the survey at any time.

For any questions, please contact [email protected].

Q1 Are you or have you ever been a clinician, as defined by the NCI to mean a health professional who takes care of patients?

• Yes

• No

Skip To: Q5 If Are you or have you ever been a clinician, as defined by the NCI to mean a health professional wh... = No

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Q2 Have you ever been a member of the research team for a cancer therapeutic clinical trial with at least one recruitment site/facility in a low- and middle-income country (LMIC), as defined by the World Bank?

• Yes

• No

Skip To: End of Block If Have you ever been a member of the research team for a cancer therapeutic clinical trial with at... = Yes

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Q3 Are you interested in being involved in conducting cancer therapeutic clinical trials in LMICs?

• Yes

• No

Skip To: End of Survey If Are you interested in being involved in conducting cancer therapeutic clinical trials in LMICs? = No

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Q4 In your experience, what have been the primary barriers that have prevented you from leading or being involved in cancer therapeutic clinical trials in LMICs? Please choose no more than three. 

• I don’t know where to start

• I don’t have the proper training

• I don’t have the time

• I don’t have the funding

• I don’t know who to partner with

• My institution does not have the necessary infrastructure

• My institution does not support clinical research

• Clinical trials are not made available in my setting

• Other (please specify) __________________________________________________

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Q5 Thank you for taking the time to complete the above questions. You do not meet our eligibility criteria for this survey. If you are aware of other individuals who meet the eligibility criteria of this survey, we invite you to share this survey link with them.

Skip To: End of Survey If Thank you for taking the time to complete the above questions. You do not meet our eligibility cr... Is Displayed

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End of Block: Intro and Screening

Start of Block: Survey - Professional Background

Q6 In the remainder of this survey, the term "clinical trials" refers to cancer therapeutic clinical trials with at least one recruitment site in an LMIC.

Q7 What is your primary specialty? Select one.

• General practice

• Radiotherapy

• Surgery

• Hematology

• Gynecology-Oncology

• Medical oncology

• Clinical oncology

• Nursing

• Pathology

• Palliative care

• Pharmacy

• Radiology

• Researcher

• Internal medicine

• Other (please specify) __________________________________________________

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Q8 Please select the option(s) that best represents your work setting. Select all that apply.

• Academic, such as a college or university

• Public hospital, health center, or clinic

• Private hospital, health center, or clinic

• Non-profit organization

• Industry/pharmaceutical company

• Government, such as a Ministry of Health

• Other (please specify) __________________________________________________

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End of Block: Survey - Professional Background

Start of Block: Survey - Challenges

Q9 The next series of questions will ask you to rate potential challenges you may have experienced in carrying out a cancer therapeutic clinical trial in an LMIC. 

Q10 Based on your experience, please rate the following human capacity challenges by the impact they’ve had on your ability to carry out a cancer therapeutic clinical trial in an LMIC.

	No impact	Slight impact	Moderate impact	Large impact
Lack of research training
Personnel shortage
Lack of dedicated research time
Competing priorities
Lack of provider awareness of trials
Lack of mentorship
Other human capacity challenges (please specify)

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Q11 Based on your experience, please rate the following infrastructure and resources challenges by the impact they’ve had on your ability to carry out a cancer therapeutic clinical trial in an LMIC.

	No impact	Slight impact	Moderate impact	Large impact
Lack of access to drugs or products
Equipment shortages, supply chain disruptions, or broken malfunctioning/damaged equipment
Difficulties with data management systems
Space or storage shortage
Insufficient biobanking
Insufficient diagnostics
Other infrastructure and resource challenges, (please specify)

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Q12 Based on your experience, please rate the following ethical and regulatory systems challenges by the impact they’ve had on your ability to carry out a cancer therapeutic clinical trial in an LMIC.

	No impact	Slight impact	Moderate impact	Large impact
Decision delays
Burdensome procedures (e.g., complicated, repetitive, unclear)
Lack of trained regulatory authorities
Other ethical and regulatory systems challenges (please specify)

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Q13 Based on your experience, please rate the following financial challenges by the impact they’ve had on your ability to carry out a cancer therapeutic clinical trial in an LMIC.

	No impact	Slight impact	Moderate impact	Large impact
Difficulty obtaining funding for investigator-initiated trials
Difficulty obtaining funding in general
Complex grant application/ funding process
Excessive trial costs
Lack of interest by pharmaceutical companies
Other financial challenges (please specify)

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Q14 Based on your experience, please rate the following administrative challenges by the impact they’ve had on your ability to carry out a cancer therapeutic clinical trial in an LMIC.

	No impact	Slight impact	Moderate impact	Large impact
Lack of institutional support for research
Lack of institutional experience with trial management
Other administrative challenges (please specify)

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Q15 Based on your experience, please rate the following healthcare or sociopolitical challenges by the impact they’ve had on your ability to carry out a cancer therapeutic clinical trial in an LMIC.

	No impact	Slight impact	Moderate impact	Large impact
Fragmented healthcare system
Coordination of efforts to implement cancer clinical trials
Lack of government political will
Difficulties identifying collaborators/partners
Other healthcare of sociopolitical challenges (please specify)

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Q16 Based on your experience, please rate the following trial design challenges by the impact they’ve had on your ability to carry out a cancer therapeutic clinical trial in an LMIC.

	No impact	Slight impact	Moderate impact	Large impact
Irrelevant study questions
Inappropriate standard therapy arm
Increasing complexity of trials
Other trial design challenges (please specify)

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Q17 Based on your experience, please rate the following patient enrollment challenges by the impact they’ve had on your ability to carry out a cancer therapeutic clinical trial in an LMIC.

	No impact	Slight impact	Moderate impact	Large impact
Lack of insurance coverage
Difficulties accessing care by patients (e.g., travel costs, missing work)
Restrictive eligibility
Distrust of clinical research or medical providers
Lack of clinical trials awareness
Other patient enrollment challenges (please specify)

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Q18 Please comment on any of the challenges listed in the previous questions, or share other challenges that you have experienced:

________________________________________________________________

________________________________________________________________

________________________________________________________________

________________________________________________________________

________________________________________________________________

End of Block: Survey - Challenges

Start of Block: Survey - Strategies/Opportunities

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Intro The next two questions will ask you about strategies to increase opportunities to conduct cancer therapeutic clinical trials in LMICs. 

Q19 In your opinion, what should the cancer research community prioritize to increase opportunities/capacities to conduct cancer therapeutic clinical trials in LMICs? Please rate the following strategies by level of importance.

	Not at all important	Slightly important	Moderately important	Very important	Extremely important
Build or strengthen partnerships (e.g.; regional, in-country, cross-income, etc.),
Build human capacity (e.g., training, protected time, etc.)
Create or improve ethical or regulatory systems (e.g., reform systems, train authorities)
Strengthen material capacity or infrastructure (e.g., access to drugs, equipment, biobanking, etc.)
Create a research environment (data collection and management systems, research incentives, awareness, etc.)
Improve funding (e.g.; funding opportunities for LMICs, simplify grant process, etc.)
Build government political will (e.g., lobby for funding, increase awareness, etc.)
Engage community (e.g., community gatherings, advertisements, etc.)

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Q20 Please comment on any of the strategies in the previous question, or share other strategies that you think the cancer research community should prioritize:

________________________________________________________________

________________________________________________________________

________________________________________________________________

________________________________________________________________

________________________________________________________________

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End of Block: Survey - Strategies/Opportunities

Start of Block: Survey - Priorities

Intro The next two questions will ask you about the types of clinical trials you think a network should focus on.

Q21 What should be the phase focus of a cancer therapeutic clinical trials network in LMICs? Select all that apply.

• Early phase development (i.e., trials evaluating safety and tolerability of a new treatment).

• Late phase approval (i.e., trials evaluating efficacy of a new treatment)

• De-escalation/efficiency/pragmatic designs (i.e., trials evaluating effectiveness in routine practice or innovative ways of delivering guideline accepted therapies)

• Other (please specify) __________________________________________________

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Q22 What should be the geographic focus of a cancer therapeutic trials network in LMICs? 

• Multinational trials with HIC and LMIC sites

• Multinational trials with LMIC sites only

• Trials restricted to one LMIC

• Other (please specify) __________________________________________________

End of Block: Survey - Priorities

Start of Block: Survey - CT Involvement

Intro The next series of questions will you ask you about your experience with cancer therapeutic clinical trials in LMICs.

Q23 What has been your level of involvement in clinical trials? Select all that apply.

• Principal Investigator (PI), individual responsible for scientific and technical direction of study (e.g., concept development, protocol writing, data collection supervision, etc.)

• Site Principal Investigator (PI), individual responsible for the conduct of a clinical study at a site, but not responsible for study design (e.g., site activation, recruitment, etc.)

• Co-investigator, individual who makes substantial contributions to a clinical study, but who does not have the overall responsibility and authority of the PI (e.g., data collection, analysis, or interpretation, etc.)

• Other member of research team (please specify) __________________________________________________

Q24 Which trial phaserepresents most of the clinical trials you’ve been involved in? Select one.

• Phase 1, to evaluate safety and identify side effects

• Phase 2, to determine effectiveness and evaluate safety

• Phase 3, to confirm its effectiveness, monitor side effects, compare it with standard or equivalent treatments

• Phase 4 (post-market), to seek more information about its risks, benefits, and optimal use following approval as well as learning more about side effects, especially rare side effects

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Q25 Which cancer site(s) represents most of the clinical trials you’ve been involved in? Select all that apply.

• Breast

• Cervical

• Colorectal

• Esophageal

• HIV-associated

• Leukemia

• Lip, oral cavity

• Liver

• Lung

• Lymphoma

• Pancreas

• Pediatric

• Prostate

• Stomach

• Other (please specify) __________________________________________________

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Q26 Among the clinical trials you have been involved in, approximately what percentage recruited most or all participants in LMICs? Select one.

• Less than 25% of trials recruited most or all participants from a facility in an LMIC

• 25-50% of trials recruited most or all participants from a facility in an LMIC

• 51-75% of trials recruited most or all participants from a facility in an LMIC

• 76-100% of trials recruited most or all participants from a facility in an LMIC

• Unsure/I don't know

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Q27 What percentage of the clinical trials you’ve been involved with have received funding (all or in part) from each category:

	None	1-25%	26-50%	51-75%	76-100%
Industry or pharmaceutical
Governmental organization
Academic institution:
Other (please specify)

End of Block: Survey - CT Involvement

Start of Block: Survey - Demographic Questions

Intro The following questions about your identity and background will be kept private. Responses are anonymous and will be reported in aggregate. Your responses will be used to better understand our results.

Q28 Are you: (Select all that apply)

• Female

• Male

• Transgender, non-binary, or another gender

• ⊗Decline to answer

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Q29 Please select your current career stage:

• Student

• Trainee (fellow, resident)

• Early-career (completed terminal degree or post-graduate training within the past 10 years)

• Mid-career (10-20 years)

• Late-career (≥20 years)

• Other (please specify) __________________________________________________

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Q30 Please share your primary country of residence: (Primary residence is where you normally spend most of your days in one year.)

▼ Afghanistan ... Zimbabwe

Q31 Please share the country of your primary institutional affiliation:

▼ Afghanistan ... Zimbabwe

End of Block: Survey - Demographic Questions

Start of Block: Survey - Final questions

Q32  Please provide any additional comments: 

________________________________________________________________

________________________________________________________________

________________________________________________________________

________________________________________________________________

________________________________________________________________

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Q33 This survey is anonymous; however, if you agree to be contacted for further comment related to this area, please provide your name and email address. This is entirely optional, and your responses will not be connected to you in any way.

• First/given name: __________________________________________________

• Last/Surname: __________________________________________________

• Email address: __________________________________________________

End of Block: Survey - Final questions

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