• 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 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:
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]
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
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.