DrugDev Investigator Questionnaire 2015

Dear Dr. DrugDev is pleased to invite you to participate in our annual investigator survey. In addition to continuing to track clinical trial burden and the value of new solutions, our added focus for the 2015 survey is to better understand current access to technology and the impact of this technology on the clinical research process.

Your feedback is very important to us at DrugDev as well as to the broader research community. The answers from this survey have a real effect on how the industry invests in clinical trials. For example, Drugdev uses your views to determine which services to provide, and initiatives such as Investigator Databank will drive standards and simplify process for sites based in part on your answers.

Last year’s survey results were presented in a poster at DIA and published in Applied Clinical Trials. We remain committed to publishing the results from the 2015 survey as well (and will share them with you) in order to continue to make sure that the industry is aware of investigator and site opinions related to clinical research operations.

We know you’re incredibly busy, so we really appreciate your time answering these questions (should take no more than 20 minutes), and so we’re offering you entry into a draw for one of five Amazon Gift Cards worth $500 (for all entries received by 11.59pm on Friday 20th March). Just make sure you check your contact details at the end of the questionnaire, and then keep an eye on your inbox! Alternatively, you can opt to have DrugDev donate $25 to the Red Cross on your behalf. Click here for terms and conditions of the Amazon Gift Card draw. If you wish to access the full questionnaire in PDF format before entering your answers online please click here.

Notice: This questionnaire is intended only for the use of the individual or entity to which it is addressed and may contain information that is privileged, confidential and exempt from disclosure. If the reader of this message is not the intended recipient, or an employee or agent responsible for delivering the message to the intended recipient, you are hereby notified that any disclosure, dissemination, distribution or copying of the communication is strictly prohibited. If you have received this communication in error, please notify the sender immediately. Thank you in advance.

Administrative Activities related to Clinical Trials

2) How burdensome are the following administrative activities associated with the operation of a clinical trial?*

Extremely

burdensome Very

burdensome Somewhat

burdensome A little

burdensome Not at all

burdensome

NA/ Don’t Know

Completing feasibility surveys ( ) ( ) ( ) ( ) ( ) ( )

Completing site information forms

( ) ( ) ( ) ( ) ( ) ( )

Taking GCP training ( ) ( ) ( ) ( ) ( ) ( )

Budgeting for clinical trials ( ) ( ) ( ) ( ) ( ) ( )

Completing contracting & regulatory documents

( ) ( ) ( ) ( ) ( ) ( )

Working with ethics committees

( ) ( ) ( ) ( ) ( ) ( )

Interacting with remote site monitors

( ) ( ) ( ) ( ) ( ) ( )

Interacting with on-site monitors

( ) ( ) ( ) ( ) ( ) ( )

Tracking clinical trial supplies ( ) ( ) ( ) ( ) ( ) ( )

Reporting SAEs ( ) ( ) ( ) ( ) ( ) ( )

Getting paid on-time for the study

( ) ( ) ( ) ( ) ( ) ( )

Recruiting patients ( ) ( ) ( ) ( ) ( ) ( )

Retaining patients in the study ( ) ( ) ( ) ( ) ( ) ( )

3) What is the most burdensome task you face regarding the activities mentioned above, or any others not already mentioned, in relation to clinical trials?

____________________________________________ ____________________________________________ ____________________________________________ ____________________________________________

4) How valuable would the following functions be to you and your site?*

Extremel

y valuable

Very valuable

Somewhat valuable

A little valuable

Not at all

valuable

Cross-sponsor sharing of your contract preferences so that, when possible, future study contracts can be sent to you already tailored to your preferences

( ) ( ) ( ) ( ) ( )

Use of the same investigator payments system for every study across multiple sponsors

( ) ( ) ( ) ( ) ( )

Guaranteed payment within 30 days ( ) ( ) ( ) ( ) ( )

A website where you can upload your CV so that multiple research sponsors can access the document and thus, reduce the number of documents that need to be collected on study start-up

( ) ( ) ( ) ( ) ( )

You would only need to complete GCP training once every three years if you upload your GCP training certificates to a central website accessible across multiple study sponsors.

( ) ( ) ( ) ( ) ( )

Help finding patients outside of your practice through a centrally organized, multi-channel media campaign.

( ) ( ) ( ) ( ) ( )

Help finding patients outside of your practice through a centrally organized, network of bloggers, disease advocates,

( ) ( ) ( ) ( ) ( )

nurses, and other community leaders at the local level

Access to an on-line screening tool where you can pre-qualify your own patients and/or referrals against the study criteria

( ) ( ) ( ) ( ) ( )

Access to a single platform that allows you to interact with your patients through sharing documents, sending SMS messages, and reimbursing them (i.e., a patient trial space)

( ) ( ) ( ) ( ) ( )

5) Do you have other suggestions on how we can further reduce investigator burden, thinking of what would most benefit you when conducting clinical trials?

____________________________________________ ____________________________________________ ____________________________________________ ____________________________________________

6) We have received conflicting suggestions as to the preferred time frame for investigator payments for clinical trials. What is your preferred timeframe for payment associated with clinical trial activities?*

( ) Every 30 days (monthly) ( ) Every 90 days (quarterly) ( ) Every 180 days (bi-annually)

Access to Technology – General

7) Does your staff have access to devices to assist in the collection of clinical trial data (e.g., laptops, tablets, dedicated desktop computers)?*

( ) Yes, all of my staff have access to a device ( ) Yes, but only some of my staff have access to a device ( ) No, my staff do not have access to a device for the capture of clinical trial data

8) What is the primary type of device available to your staff?*

[ ] Desktop computer [ ] PC compatible laptop [ ] Mac compatible laptop [ ] Android tablet/mobile phone [ ] Apple tablet/mobile phone [ ] Other: _________________________________________________*

9) What is the primary type of device available to your staff?*

[ ] Desktop computer [ ] PC compatible laptop

[ ] Mac compatible laptop [ ] Android tablet/mobile phone [ ] Apple tablet/mobile phone [ ] Other: _________________________________________________*

10) Would you be willing to supply your staff with devices to assist in the collection of clinical trial data?*

( ) Yes ( ) No, I don’t have budget ( ) No, my institution doesn’t allow this ( ) No, I would expect the sponsor to provide these if they were needed

11) Does your staff have access to Wi-Fi/internet at your site?*

( ) Yes ( ) No

12) Does your staff’s Wi-Fi/internet access extend to the rooms where you conduct patient exams?*

( ) Yes ( ) No

13) Are you willing to supply Wi-Fi/internet access to your staff to facilitate the collection of clinical trial data at your site?*

( ) Yes ( ) No

Access to Technology – Electronic Medical Records (EMR)

14) Do you use an electronic medical record (EMR) system at your site?*

( ) No ( ) Yes

15) Which EMR system do you use? (Please select all that apply)*

[ ] Abraxas / Merge [ ] ADP AdvancedMD [ ] Advanced Data Systems [ ] AllScripts [ ] AmazingCharts [ ] Aprima [ ] AthenaHealth

[ ] CareCloud [ ] Cerner [ ] CompuGroup [ ] CPSI [ ] CureMD [ ] eClinicalWorks [ ] eMDs [ ] Emdeon [ ] EpicSystems [ ] GE Healthcare [ ] Greenway [ ] iPatientCare [ ] Kareo [ ] McKesson [ ] Meditab [ ] Nextech [ ] NextGen [ ] NueMD [ ] Optum [ ] Platinum Systems [ ] Practice Fusion [ ] Praxis [ ] Siemens Healthcare

[ ] SOAPware [ ] T-system [ ] Vitera [ ] Other (Please specify):: _________________________________________________*

16) Do you currently use your EMR System to collect clinical trial data?*

( ) Yes ( ) No

17) Assuming that the technology were available and provided to you, how interested would you be using electronic medical records to support clinical trial research at your site for the following activities?*

Extremely

interested

Very interested

Somewhat interested

A little interested

Not at all interested

Use of medical records/EMR data to provide study-level protocol feasibility information

( ) ( ) ( ) ( ) ( )

Use of medical records/EMR to identify potential subjects for a study

( ) ( ) ( ) ( ) ( )

Flags in the EMR system to alert site staff that a patient is a ( ) ( ) ( ) ( ) ( )

potential candidate for a study

Flags in the EMR system to alert site staff that a patient is already in a clinical study

( ) ( ) ( ) ( ) ( )

Automated population of clinical trial case report forms based on EMR data

( ) ( ) ( ) ( ) ( )

Use of EMR data as supporting documentation for clinical trial case report forms

( ) ( ) ( ) ( ) ( )

Access to Technology – Electronic Informed Consent

18) What proportion of the studies that you are currently working on use an electronic informed consent for subjects?*

( ) 100% (all studies using electronic informed consent) ( ) 75% to 99% of studies ( ) 50% to 74% of studies ( ) 25% to 29% of studies ( ) 1% to 24% of studies ( ) 0% (no studies using electronic informed consent)

19) How helpful would the following features be in supporting you in using an electronic informed consent tool?*

Extremely helpful

Very helpful

Somewhat helpful

A little helpful

Not at all

helpful

Training from the sponsor for the investigator prior to showing ICF to patients

( ) ( ) ( ) ( ) ( )

Introductory video from the sponsor to introduce the e-consent to the patient

( ) ( ) ( ) ( ) ( )

Electronic ICF available on a tablet device ( ) ( ) ( ) ( ) ( )

Electronic signature for ICF on a tablet device ( ) ( ) ( ) ( ) ( )

Version tracking of ICF via an electronic system ( ) ( ) ( ) ( ) ( )

ICF written in layman’s language ( ) ( ) ( ) ( ) ( )

A general educational session for clinical staff on e-consent for sites via webinar

( ) ( ) ( ) ( ) ( )

Site SOPs and guidelines for using e-consent with patients ( ) ( ) ( ) ( ) ( )

20) How useful would the following be in helping your patients in using an electronic informed consent tool? *

Extremely useful

Very useful

Somewhat useful

A little

useful

Not at all useful

ICF written in layman’s language ( ) ( ) ( ) ( ) ( )

Training video explaining what the clinical trial is for ( ) ( ) ( ) ( ) ( )

Opportunity to mark questions ( ) ( ) ( ) ( ) ( )

Key words defined and explained ( ) ( ) ( ) ( ) ( )

Visual representation of trial procedures and visits ( ) ( ) ( ) ( ) ( )

ICF audio track (i.e. Patients can listen to the ICF as well as reading it) ( ) ( ) ( ) ( ) ( )

Access to Technology – The Future

21) In your opinion, how likely is it that the following advances in technology will become a gold standard for clinical trials in the next 3 years?*

Extremely likely

Very likely

Somewhat likely

A little

Not at all

likely likely

Use of Electronic medical records to recruit patients ( ) ( ) ( ) ( ) ( )

E-Source – creating trial data source records electronically based on EMR/EHR data

( ) ( ) ( ) ( ) ( )

Electronic patient informed consent ( ) ( ) ( ) ( ) ( )

100% electronic document storage (i.e., paperless clinical trials) ( ) ( ) ( ) ( ) ( )

In-home patient biometric monitoring to collect clinical trial data ( ) ( ) ( ) ( ) ( )

Electronic Drug adherence solutions (i.e., tracks patient adherence to medication)

( ) ( ) ( ) ( ) ( )

Risk-based monitoring ( ) ( ) ( ) ( ) ( )

Accepted use of e-signatures by clinical staff on trial documentation ( ) ( ) ( ) ( ) ( )

22) In your opinion, which of the following has the greatest potential to decrease administrative burden for investigators? *

Extremely likely

Very likely

Somewhat likely

A little likely

Not at all likely

Use of Electronic medical records to recruit patients ( ) ( ) ( ) ( ) ( )

E-Source – creating trial data source records electronically based on EMR/EHR data

( ) ( ) ( ) ( ) ( )

Electronic patient informed consent ( ) ( ) ( ) ( ) ( )

100% Electronic document storage (i.e., paperless clinical trials) ( ) ( ) ( ) ( ) ( )

In-home patient biometric monitoring to collect clinical trial data ( ) ( ) ( ) ( ) ( )

Electronic Drug adherence solutions (i.e., tracks patient adherence to medication)

( ) ( ) ( ) ( ) ( )

Risk-based monitoring ( ) ( ) ( ) ( ) ( )

Accepted use of e-signatures by clinical staff on trial documentation ( ) ( ) ( ) ( ) ( )

Investigator/Site Characteristics

23) Which of the following best describes your type of site?*

( ) Academic ( ) Cancer Centre/Hospital ( ) Clinic ( ) Clinical Research Unit

( ) Community/Private ( ) Hospital Private ( ) Hospital Public ( ) Network ( ) Portfolio Site ( ) Primary Care Centre ( ) Private Clinical Research Unit ( ) Research Group ( ) Site Management Organisation (SMO) ( ) University Hospital ( ) Other (Please specify):: _________________________________________________*

24) What proportion of the trials that you have worked on in the past 3 years are sponsored by a pharmaceutical company (i.e., as opposed to an Investigator Initiated Trial, Government/Academic grants, self-directed research, etc)?*

( ) 100% (all studies being conducted for pharmaceutical companies) ( ) 75% to 99% of studies ( ) 50% to 74% of studies ( ) 25% to 29% of studies ( ) 1% to 24% of studies ( ) 0% (no studies being conducted for pharmaceutical companies)

25) Which of the following data capture tools do you use for your non-pharmaceutical company research (please select all that apply)?*

[ ] Paper [ ] Microsoft Access [ ] Microsoft Excel [ ] Medidata Rave [ ] Oracle InForm [ ] Merge eClinical OS [ ] REDCap [ ] Other (Please specify):: _________________________________________________*

26) What therapeutic area(s) do you work in? (Please select all that apply)*

[ ] Auto immune [ ] Cardiovascular [ ] Critical Care [ ] Dermatology [ ] Infectious Disease [ ] Men's Health [ ] Metabolic/ Endocrine [ ] Musculoskeletal [ ] Neuroscience [ ] Oncology

[ ] Osteoporosis [ ] Pain [ ] Pediatrics [ ] Psychiatry [ ] Respiratory [ ] Vaccines [ ] Virology [ ] Women's health

27) What is your primary therapeutic area? (Please select one)*

( ) Auto immune ( ) Cardiovascular ( ) Critical Care ( ) Dermatology ( ) Infectious Disease ( ) Men's Health ( ) Metabolic/ Endocrine ( ) Musculoskeletal ( ) Neuroscience ( ) Oncology ( ) Osteoporosis ( ) Pain

( ) Pediatrics ( ) Psychiatry ( ) Respiratory ( ) Vaccines ( ) Virology ( ) Women's health

28) How many clinical trials you have been involved with in the last 5 years?*

( ) 0-1 ( ) 2-4 ( ) 5-10 ( ) >10

29) Please specify your preference for $25 Charitable donation or entry into the draw to win a $500 Amazon Voucher.*

( ) Red Cross Donation ( ) Entry into the amazon voucher draw

Investigator contact details

Dr.

Email Please note: Making changes to your preferred email address here will be used for contacting you in future for additional clinical trial opportunities*: _________________________________________________ Phone*: _________________________________________________ Fax: _________________________________________________

Site Name and Address

Institution*: _________________________________________________ Address*: _________________________________________________ City*: _________________________________________________ State/Province: _________________________________________________

Country*

( ) Argentina ( ) Australia ( ) Brazil

( ) Egypt ( ) France ( ) Germany ( ) India ( ) South Africa ( ) Thailand ( ) United Kingdom ( ) United States

Nearly Finished!!!

DrugDev are collaborating with Janssen, Lilly, Merck, Novartis and Pfizer on a centralized Investigator Databank to (1) reduce the administrative burden of participating in clinical trials and (2) make it easier for your site to be contacted by all of the participating sponsors. Do you want more information about the Investigator Databank including how to register?*

( ) Yes, I'd like more information about the Investigator Databank ( ) No, I don’t need more information because I am already registered for the Investigator Databank ( ) No, I do not wish to receive more information about the Investigator Databank

The investigator Databank is a global collaboration between Janssen, Lilly, Merck, Pfizer, and Novartis (with more companies to come) to share investigator information that each company has on file with one another. Through sharing, the Investigator Databank intends to reduce administrative burden and increase trial opportunities for investigators by sharing information,

such as GCP training records and trial participation history, currently collected by different sponsors. In order to achieve its goals, the Participating Companies need your permission to share with one another information that each has in its own records related to you and your site's clinical research activities as follows:

• Institutional Details: Institution name • Investigator's name (first and last), business mailing address, telephone details and e-mail address • Good Clinical Practice Training Details for investigators (GCP training; date(s) and related Sponsor of GCP training) • Clinical Trial Details for those trials for which enrolment has been completed (e.g., protocol title, phase, protocol

number, therapeutic area, indication, number of patients consented, enrolled, and completed per protocol) • The following dates relevant for the individual site: site opened, first patient consented, last patient consented, first

patient enrolled, last patient enrolled, and last patient last visit

Any information entered or uploaded into the InvestigatorDatabank.org website by you or one of your delegates will also be shared including, but not limited to your CV, GCP training certificates, investigator profile information, and non-protocol specific site profile forms. All group companies of the Participating Companies worldwide will have access to the data. The Investigator Databank is hosted by DrugDev Inc., US. You have no legal duty to provide your personal information, nor to allow its use and sharing as hereby requested. Participation is dependent on your free will and consent. If you would like to be included, please click the button below agreeing that you: Authorize the Databank Host, DrugDev and the Participating Companies (current participants are Merck, Janssen, Lilly, Novartis and Pfizer but which may change and be added to from time to time as notified to you) and their authorized representatives, i.e. group companies worldwide and business partners to place the clinical research related information about you and you site in the Investigator Databank for use by the Participating Companies as described above. In order to protect such data about you and the site, the Participating Companies and the Investigator Databank Host, DrugDev have entered into the appropriate agreements establishing measures as required by the applicable local laws and regulations and will do so every time a new Participating Company adheres to this project. Give your permission to the Databank Host, DrugDev and any of the Participating Companies to use the contact and other

information entered into the investigator database to qualify and contact you for purposes as described above. DrugDev wishes to supplement the Investigator Databank with information that you have provided through your participation in DrugDev, in accordance with its policy and terms of use. Once you have opted in, your consent for inclusion in the Investigator Databank will be in effect until such time as you revoke your consent, which you may do any time or when the Investigator Databank initiative ends. You will be able access a copy of your and your site’s data through the www.InvestigatorDatabank.org website or by contacting support@investigatordatabank.org. *

( ) Yes, I agree to opt-in to the Investigator Databank ( ) No, I do not wish to opt-in to the Investigator Databank at this time

Thank You!

Thank you for taking the time to complete this survey. Should you have any questions, please contact us at: sarah.merkel@drugdev.com