Clinical Trial Insights™: Frequently Asked Questions

Clinical Trial Insights™ (CTI) is market research designed to deliver the voices of clinical trial study subjects to clinical trial sponsors. While clinical trial data provides trial sponsors with information about the efficacy and safety of study medications, the human experience of study subjects during the trial is also an extremely valuable component in the drug development process. Clinical trial study subjects who have received an active dose of a study medication are among the first people to ever experience the therapeutic effects of the medication. CTI exists to collect insights about the clinical trial experience of study subjects. These insights are often used to better understand the patient journey, develop patient support programs, and gather evidence needed to differentiate brands.
The simple answer is NO. Study subjects are never asked to evaluate sites or site staff. From time to time study subjects may comment about a site or site staff. When this happens, please bear in mind:

• CTI is single-blind market research. Therefore, identifying information of study subjects is never shared with sponsors.

• Any mention of local geography, staff names, or any other information that could unblind a patient or site to the sponsor is carefully redacted to maintain single blind status.

In cases where CTI is conducted using a web survey comprised exclusively of closed-ended questions, there is no risk of an adverse event being reported.
In cases where CTI is conducted using telephone or in-person interviews, study subjects sometimes mention adverse experiences that occurred during a trial. At Clinical SCORE, it is our duty to report these adverse experiences to sponsors. Therefore:
• All Clinical Score interviewers are trained and certified to report adverse experiences and product quality complaints using training materials provided by the sponsor.

• CTI interviews always take place after a trial is completed, in other words, after database lock. In every case so far, adverse experiences mentioned during our interviews had been previously reported to the investigator, and therefore the sponsor, during the trial.

• At the very beginning of every interview, we read the following verbatim statement:

I will now describe the process we follow in all studies where a respondent might mention side effects from a drug they are taking.
Different patients sometimes respond in different ways to the same medicine, and some side effects may not be discovered until many people have used a medicine over a period of time. For this reason, we are now required to pass on to our client, who is a pharmaceutical company, details of any side effects/product complaints related to their own products, or any reports of drug exposure to their products during pregnancy, that are mentioned during the course of market research.
Although what you say will, of course, be treated in confidence, should you mention during the discussion a side effect when you, or someone you know, became ill after taking one of our client’s medicines, or someone used a product when they were pregnant, or any other problem you have had with one of our client’s medicines, we will need to report this to the pharmaceutical company, so that they can learn more about the safety of their medicines.
On that basis, would you be willing to allow us to pass your name and contact details to the manufacturer so that they can contact you for further details about your experience? The manufacturer will only use this information for the purpose of investigating the possible side effect or issue.
Are you willing to participate in the interview on this basis?
 Yes [CONTINUE]  No [CONTINUE]

If NO, ASK:

If you would prefer not to be contacted directly by the client, then we, as the third party conducting this research, would contact you on behalf of the client to collect this information so that you can remain anonymous.

Are you willing to participate in the interview on this basis?
 Yes [CONTINUE]  No [CLOSE, EXCLUDE RESPONDENT]

Always. Clinical SCORE does not contact sites or members of site staff asking to discuss any clinical study without approval and authorization in writing from the study sponsor. Our methods, procedures, invitation letters, discussion guides, stimuli and all other CTI related plans and materials are reviewed and approved by the sponsor for every project. The sponsors internal approval process typically includes review and sign-off from study teams, R&D / Operations management, legal and compliance teams. Clinical SCORE’s site outreach process inviting sites to participate in CTI, always begins with an email authorizing our research which is sent directly to site staff by a representative of the sponsor study team. A typical CTI sponsor authorization letter looks like this: Clinical SCORE can provide a copy of this authorization letter to site staff upon request.
CTI™ is market research, not clinical research, and is therefore typically not subject to IRB approval. While working with sponsors, our plans and materials are sometimes submitted to IRB’s for review and approval. If this happens, Clinical SCORE works with site staff on a case-by-case basis.
Clinical SCORE strives to provide objective, unbiased insights for the benefit of all stakeholders. We recognize the value of maintaining single-blind status to maintain anonymity and objectivity while protecting the confidentiality of study subjects. Our processes and practices reflect this commitment in every detail. Our recruitment procedures are designed never to reveal identifying information to sponsors, and never reveal active vs. placebo to study subjects or site staff. In addition, names, geographic features and other potentially revealing information is redacted from transcripts and removed from recordings.
Yes. We compensate sites, site staff and patients according to fair market value for their time and effort. Honoraria is paid to investigators, study coordinators, patients and caregivers who complete web surveys and in-depth interviews as respondents in our research. In addition, we are authorized to compensate sites at fair market value for their time and effort to help us recruit study subjects for our research.
Clinical SCORE compensates sites at fair market value for their time and effort to help us recruit study subjects to our research. These payments are not excluded from the “Sunshine Act” reporting requirements. Therefore, Clinical SCORE reports to the sponsor fair market value payments made specifically for time and effort to help us recruit patients to participate in our research. This reporting does not “unblind” patients, nor does it indicate to sponsors which site staff (e.g. investigator and/or study coordinator) participate or do not participate in web surveys, telephone interviews or in-person interviews. In this way, payments are reported in full compliance with the law, while anonymity and confidentiality of market research responses are preserved for site staff and patients.

Concerning participation in market research, e.g. providing answers to a web survey or telephone/in-person interview, the following is excerpted from “The Physician Payments Sunshine Act” published jointly by the Marketing Research Association (MRA), Council of American Survey Research Organizations (CASRO), and the Pharmaceutical Marketing Research Group (PMRG) available here.
On August 1, 2013, the first reporting period under the Physician Payment Sunshine Act began. Part of the Patient Protection and Affordable Care Act, it requires pharmaceutical and medical device manufacturers to publicly report many types of payments made to health care professionals, which will be public. The Sunshine Act was intended to bring transparency to these relationships, in order to minimize manufacturers’ influence on health care professionals’ prescribing behavior.

Excluded: Payments to health care professionals for participating in survey, opinion and marketing research
Because payments to physicians for participating in pharmaceutical and medical device marketing research are typically made by research companies rather than manufacturer-sponsors, and to health care professionals whose identities are unknown to the manufacturer-sponsors, those payments are excluded from reporting under the Sunshine Act law: SEC. 1128G (e)(10)(A): The term ‘payment or other transfer of value’ means a transfer of anything of value. Such term does not include a transfer of anything of value that is made indirectly to a covered recipient through a third party in connection with an activity or service in the case where the applicable manufacturer is unaware of the identity of the covered recipient.

The Centers for Medicare and Medicaid Services (CMS) issued final rules implementing the Sunshine Act and reiterated this exclusion: 42 CFR § 403.904(i)(1): Indirect payments or other transfers of value… where the applicable manufacturer is unaware of the identity of the covered recipient. An applicable manufacturer is unaware of the identity of a covered recipient if the applicable manufacturer does not know… the identity of the covered recipient during the reporting year or by the end of the second quarter of the following reporting year.
Read the full article here

Some site staff, such as investigators and study coordinators, may be asked to participate in an in-depth interview. Interviews are typically conducted by telephone and range from 30-60 minutes in length. Participants will be compensated for their time and effort at fair market value for participating in the interview. All interviews are 100% voluntary and scheduled at the convenience of the participant. Anonymity and confidentiality are strictly maintained. Payments to health care professionals for participating in survey, opinion and marketing research are excluded from reporting requirements of the physician payments “Sunshine Act”
All patients who voluntarily “opt-in” to participate in CTI market research must complete a web survey. Web surveys are typically 10 minutes in length but may be longer in some cases. Some patients who complete the web survey will be invited to participate in an in-depth interview by telephone or in-person. Patients who participated in the trial will be compensated for their time and effort at fair market value for participating in a web survey and/or interview. All interviews are 100% voluntary and scheduled at the convenience of the participant. Anonymity and confidentiality are strictly maintained.
Clinical SCORE compensates sites at fair market value for their time and effort to assist us in recruiting patients who participated in a clinical trial. Clinical SCORE will provide information and outreach materials site staff can pass along to patients who participated in the clinical study. These materials invite patients who participated in a clinical trial to contact Clinical SCORE of their own volition by way of e-mail, telephone or clicking a link to complete a web survey. Clinical SCORE’s process requires that patients have their study subject ID and site number available. Site number and study subject ID must be provided to patients by site staff.