With several years of experience and data, Verified Clinical Trials dispels several myths regarding professional subjects and research subject misbehavior in clinical trials research.
GARDEN CITY, NEW YORK (PRWEB) AUGUST 05, 2016
Verified Clinical Trials dispels several common myths regarding duplicate enrollment in clinical trials and the issues surrounding the professional research subject. Based on 6 years of mature data, the evidence illustrates that a research subject database registry such as Verified Clinical Trials, is an effective tool in thwarting attempted duplicate enrollment in clinical trials. In turn, this will reduce placebo rates, liabilities, while improving safety and data quality. The Verified Clinical Trials research subject database registry is the largest research subject database registry protecting the majority of phase 1 clinical trial pharmacology units (CPUs) and many later phase clinical trials as well. This tool prevents several other important protocol violations too. Mitchell Efros MD FACS FACS, President and CEO of Verified Clinical Trials and Kerri Weingard, ANP COO of Verified Clinical Trials outline several of the challenges and discussion points regarding the professional subject and duplicate enrollment in clinical trials. The use of the Verified Clinical Trials research subject database registry is an effective tool to combat these problems.
Myth # 1 ”Professional subjects are only found in healthy volunteer phase 1 clinical trials”
FACT: While the issue of the professional research subject and duplicate enrollment is most prevalent in healthy volunteer phase 1 studies, the same problems plague phase 2 -4 clinical trials. In phase 1-4 clinical trials, the incidence of duplicate enrollment is highest in pain, substance abuse, psychiatry and other subjective disease states. In these instances there may be as much as a 12% incidence of attempted protocol violations related to study history and participation. Moreover, Verified Clinical Trials data proves the abundance of crossover from phase 2-4 to healthy phase 1 clinical trials. In these cases, all too often the “healthy volunteer” becomes a “depressed” patient. Safety and data issues arise when subjects attempt to enroll in studies sequentially and too soon mixing IP with unknown side effects.
FACT: While the issue of the professional research subject and duplicate enrollment is most prevalent in healthy volunteer phase 1 studies, the same problems plague phase 2 -4 clinical trials. In phase 1-4 clinical trials, the incidence of duplicate enrollment is highest in pain, substance abuse, psychiatry and other subjective disease states. In these instances there may be as much as a 12% incidence of attempted protocol violations related to study history and participation. Moreover, Verified Clinical Trials data proves the abundance of crossover from phase 2-4 to healthy phase 1 clinical trials. In these cases, all too often the “healthy volunteer” becomes a “depressed” patient. Safety and data issues arise when subjects attempt to enroll in studies sequentially and too soon mixing IP with unknown side effects.
Myth # 2 “A small number of poor quality subjects will not hurt or impact our data and outcomes”.
FACT: Nonadherence is a major problem in clinical trials of new medications.It does not take a large number of subjects that skew the data. These issues have been detailed in several recent publications. The article Medication nonadherence, “professional subjects,” and apparent placebo responders: overlapping challenges for medications development further highlights the issues.
FACT: Nonadherence is a major problem in clinical trials of new medications.It does not take a large number of subjects that skew the data. These issues have been detailed in several recent publications. The article Medication nonadherence, “professional subjects,” and apparent placebo responders: overlapping challenges for medications development further highlights the issues.
Myth # 3 “If all sites and companies do not participate in the registry there is no value in use of Verified Clinical Trials”.
FACT: Use of Verified Clinical Trials will provide numerous protections despite lack of 100% uptake as of yet. The cohort of sites and companies partnering with Verified Clinical Trials has expanded exponentially and continues to do so. The system will “protect yourself against yourself” in phase 2-4 trials. Verified Clinical Trials data shows that many subjects will enter the same study but at different sites. Once the subject learns how to gain access to the trial, they use the same formula to screen at other sites. In these cases, the subject may be taking more than the allotted dose or may not in fact take the IP at all. This raises obvious concerns for safety as well as placebo rates. While ALL cases of duplicate enrollment & protocol violations may not be stopped just yet, the system does catch and prevent many of the attempts.
FACT: Use of Verified Clinical Trials will provide numerous protections despite lack of 100% uptake as of yet. The cohort of sites and companies partnering with Verified Clinical Trials has expanded exponentially and continues to do so. The system will “protect yourself against yourself” in phase 2-4 trials. Verified Clinical Trials data shows that many subjects will enter the same study but at different sites. Once the subject learns how to gain access to the trial, they use the same formula to screen at other sites. In these cases, the subject may be taking more than the allotted dose or may not in fact take the IP at all. This raises obvious concerns for safety as well as placebo rates. While ALL cases of duplicate enrollment & protocol violations may not be stopped just yet, the system does catch and prevent many of the attempts.
Myth #3 “Use of an IVRS/IWRS or other in house methods can prevent duplicate enrollment and protocol violations.
FACT: In these cases the protocol violation is detected typically after screening activities and payment to the subject if they are detected at all. All of the screening activities and time spent is wasted. This method will never catch subjects if they are in different trials and with different CROs or sponsors. In fact, in most instances it will not uncover this problem even within the same company. The time to ferret out the occurrences without the use of Verified Clinical Trials costs more on the back end. Most often, it is not until too late that this can ever be uncovered.
Myth #4 “You must have surrounding sites participating because our subjects do not travel and there is no value otherwise”.
FACT: In these cases the protocol violation is detected typically after screening activities and payment to the subject if they are detected at all. All of the screening activities and time spent is wasted. This method will never catch subjects if they are in different trials and with different CROs or sponsors. In fact, in most instances it will not uncover this problem even within the same company. The time to ferret out the occurrences without the use of Verified Clinical Trials costs more on the back end. Most often, it is not until too late that this can ever be uncovered.
Myth #4 “You must have surrounding sites participating because our subjects do not travel and there is no value otherwise”.
FACT: When sites are close to one another the incidence of duplicate enrollment protections is higher. However, the research subjects are travelling thousands of miles on a regular basis. Verified Clinical Trials experience and data highlights this issue extremely well. Many of our phase 2/3 sites or CRUs are isolated by large distances from other sites yet have remarkable activity with attempted protocol violations and duplicate enrollment. The website JALR.org is a website dedicated to research volunteers. Pages from this site detail the network and how research subjects have shared transportation and share houses in order to travel across North America to participate long distance.
Myth # 5 “We do not pay our research subjects…”
FACT: All too often we hear from CROs or sponsors that the subjects are not paid to participate. In truth, all subjects are “compensated” for their time and travel. These payments are often tax free and not reported. In a poor economy it is a means of survival for some. When combined with evaluation and treatment at no cost it makes screening and enrollment a worthwhile venture. Many subjects participate in several studies at a time.
FACT: All too often we hear from CROs or sponsors that the subjects are not paid to participate. In truth, all subjects are “compensated” for their time and travel. These payments are often tax free and not reported. In a poor economy it is a means of survival for some. When combined with evaluation and treatment at no cost it makes screening and enrollment a worthwhile venture. Many subjects participate in several studies at a time.
Myth # 6 “You can successfully check for many protocol violations related to prior investigational product (IP) exposure and study participation history without a tool such as Verified Clinical Trials”
FACT: Many of the inclusion and exclusion listed in every protocol cannot be accurately verified and ascertained without use of Verified Clinical Trials. Knowing prior study history and enrollment with washout dates is impossible to know. Ensuring appropriate half-lives, screen failures at other sites for the same study, exposure to special IP such as biologics and radioactive IP is impossible.
Myth # 7 “Use of a database registry such as Verified Clinical Trials is too expensive”
FACT: Many of the inclusion and exclusion listed in every protocol cannot be accurately verified and ascertained without use of Verified Clinical Trials. Knowing prior study history and enrollment with washout dates is impossible to know. Ensuring appropriate half-lives, screen failures at other sites for the same study, exposure to special IP such as biologics and radioactive IP is impossible.
Myth # 7 “Use of a database registry such as Verified Clinical Trials is too expensive”
FACT: Verified Clinical Trials is a low cost insurance policy. The average price is typically less than the cost of consenting a subject for the study. In fact, Verified Clinical Trials will actually save time and money by preventing poor quality subjects from entering your clinical trial. Most importantly, Verified Clinical Trials may actually prevent a clinical trial from failure resulting in the need to repeat the study or abandon the IP. In a recent trial, Verified Clinical Trials saved the sponsor more than $100,000 by weeding out poor quality professional research subjects that were attempting to dual enroll or re-screen after screen failure at other sites. The subjects were stopped before screening activities and screening costs.
Verified Clinical Trials:
Verified Clinical Trials is a forward thinking company developed by experts active in the clinical research community to proactively improve research subject safety and data quality in clinical research trials. Verified Clinical Trials halts duplicate enrollment in clinical trials and defines itself as the world’s leader in the field of database registries in clinical trial research. Verified Clinical Trials is the only clinical research database registry designed specifically to enhance the quality of both early and late phase trials, and has the scalability to reach all sites nationally as well as on a global level. Verified Clinical Trials offers numerous other value-added services to the clinical research site, CRO, and Pharmaceutical Sponsor that prove invaluable with regards to financial and legal issues and liabilities. Verified Clinical Trials prevents several other key protocol deviations. For more information, RSVP to or visit http://www.verifiedclinicaltrials.com.
Verified Clinical Trials is a forward thinking company developed by experts active in the clinical research community to proactively improve research subject safety and data quality in clinical research trials. Verified Clinical Trials halts duplicate enrollment in clinical trials and defines itself as the world’s leader in the field of database registries in clinical trial research. Verified Clinical Trials is the only clinical research database registry designed specifically to enhance the quality of both early and late phase trials, and has the scalability to reach all sites nationally as well as on a global level. Verified Clinical Trials offers numerous other value-added services to the clinical research site, CRO, and Pharmaceutical Sponsor that prove invaluable with regards to financial and legal issues and liabilities. Verified Clinical Trials prevents several other key protocol deviations. For more information, RSVP to or visit http://www.verifiedclinicaltrials.com.
Verified Clinical Trials Contact:
Mitchell Efros MD FACS
CEO
Phone: (516) 998-7499
email: drefros(at)verifiedclinicaltrials(dot)com
Contact:
Mitchell Efros MD FACS
Verified Clinical Trials
(516) 220-9205
Mitchell Efros MD FACS
CEO
Phone: (516) 998-7499
email: drefros(at)verifiedclinicaltrials(dot)com
Contact:
Mitchell Efros MD FACS
Verified Clinical Trials
(516) 220-9205
