Incentivizing Recruitment and Retention to Address Enrollment Challenges in Clinical Research

Dickert, Neal W.; Halpern, Scott D.; Butler, Javed

doi:10.1161/circoutcomes.113.000176

Cited by 10 publications

(16 citation statements)

References 22 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…According to Dickert et al the recruitment for reduced cardiac ejection fraction trial to assess the use of Warfarin versus Aspirin took more than seven years. Whereas, a successful randomization of 7141 subjects in less than three years was achieved for a study that intended to prove the clinical effectiveness of Nesiritidein decompensated heart failure [3]. The specific rational for the variation in recruitment is not clear and differ from site to site and study to another.…”

Section: Informed Consent Processmentioning

confidence: 99%

“…The specific rational for the variation in recruitment is not clear and differ from site to site and study to another. Unfortunately, clinical knowledge may be negatively impacted by slow recruitment and insufficient retention; variability in subject's attributes and withdrawal rates may lead to restriction of the generalizability of the study outcome [3]. Furthermore, poor recruitment consumes the resources, increases the cost, and may lead to moving research outside United States.…”

Section: Informed Consent Processmentioning

confidence: 99%

“…Also, I am going to highlight some ethical concerns and considerations that related to recruiting human subjects in clinical research. Recruitment and retention of research subjects is crucial for medical advancement and providing data that contribute in directing practice and policy [3]. Informed consent is a critical element in subject recruitment process and it is a crucial step for conducting an ethical research.…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Human subjects in clinical trials: Ethical considerations and concerns

Ahmad¹,

Al-Sayed²

2018

J Transl Sci

View full text Add to dashboard Cite

Human subjects in clinical trials: Ethical considerations and concernsGood Clinical Practice (GCP) is international guideline to ensure that clinical trials are designed, conducted, implemented, monitored, audited, recorded, analyzed, and reported scientifically and ethically. It also aims to protect human subject rights, integrity, and confidentiality. In 1997 GCP became effective, though not legally acknowledged at that point. In 2004, in the United Kingdom/Europe GCP became a legal obligation for all clinical trials involving investigational products. Historically, unethical and horrific research took place during the World War II by German clinicians at Nazi war cantonment, which led to the establishment of Nuremberg Code in 1947 [4]. The Universal Declaration of Human Rights became effective by the United Nation as a result of inhuman trials conducted during the World War II. In 1964, the Declaration of Helsinki was emerged and adopted by the World Medical Association and served as a backbone for the ethical principles that formulated the current International Conference on Harmonization (ICH)-GCP guidelines. In 1962, the Kefauver-Harris Amendments were adopted and required the FDA to assess all new drugs for safety and efficacy as a result of thalidomide tragedy that led to the born of 10,000 infants with fetal limb deformities in more than 20 countries worldwide [4].

show abstract

Section: Informed Consent Processmentioning

confidence: 99%

Section: Informed Consent Processmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Human subjects in clinical trials: Ethical considerations and concerns

Ahmad¹,

Al-Sayed²

2018

J Transl Sci

View full text Add to dashboard Cite

show abstract

“…This resulted in enrollment of fewer patients than the targeted sample size and reduced the study's power. 4,5 There is a dearth of evidence regarding why challenges to trial enrollment exist and what interventions can help improve recruitment. Novel informatics-based strategies offer exciting potential for increasing enrollment, but it remains important to understand why patients who decline to participate make this decision.…”

Section: Introductionmentioning

confidence: 99%

Why Do Patients Decline Heart Failure Trials, and What Should We Do About It?

Shore

Speight

Kelkar

et al. 2019

Preprint

View full text Add to dashboard Cite

Background: Low patient enrollment in randomized clinical trials (RCTs) escalates costs, leads to under-representation of real-world patient populations, and delays generation of knowledge. Limited data exists on why patients decline participation in RCTs and what factors may lead to increased participation rates. Methods: In-person and telephone interviews were conducted with 19 patients with congestive heart failure who declined participation in RCTs. Interviews were conducted using a structured interview guide. Interviews were transcribed verbatim, and qualitative descriptive analysis was performed. Results: Participants’ median age was 63 years (IQR 51.5-69), 42% were female, and 53% were Black or African-American. Only 6 participants could accurately describe the intervention and clearly understood design of the trial in which they were asked to participate. Most participants made the decision not to participate quickly; only 1 participant took time to deliberate. The most common reasons for not participating were concern for adverse events from the intervention being studied (n=15) and perception of participation being too burdensome (n=10). The most common suggestion provided to increase participant recruitment was involving primary care physicians or cardiologists known to the patients. Conclusion: These findings suggest that patients often decide not to participate in clinical trials quickly, with relatively minimal understanding of the trial. Reasons for declining were heterogeneous, but the most common suggestions for improvement were engaging physicians known to them in the process of recruitment and making participation less burdensome. Addressing these issues may reduce barriers to participation and enhance respect for patients.

show abstract

“…Public desire to find currently recruiting trials dovetails with recruitment needs among investigators [4][5][6], a well-documented challenge to the efficient translation of new therapies into better treatments for patients [7,8]. Research has demonstrated that many patients are unaware of how to find information about clinical trials [9,10] and are often unable to interpret available information [11,12].…”

Section: Introductionmentioning

confidence: 99%

Connecting the public with clinical trial options: The ResearchMatch Trials Today tool

Pulley

Jerome

Bernard

et al. 2018

J. Clin. Trans. Sci.

View full text Add to dashboard Cite

Potential participants seek information about clinical trials for many reasons, but the process can be challenging. We analyzed 101,249 searches in ResearchMatch Trials Today, a free interface to recruiting trials from ClinicalTrials.gov. Searches from March 2015 to November 2016 included a broad range of conditions and healthy volunteer concepts, including 12,649 unique topics. Trials Today data indicate that it is being used to identify trials on a variety of topics.

show abstract

Incentivizing Recruitment and Retention to Address Enrollment Challenges in Clinical Research

Cited by 10 publications

References 22 publications

Human subjects in clinical trials: Ethical considerations and concerns

Human subjects in clinical trials: Ethical considerations and concerns

Why Do Patients Decline Heart Failure Trials, and What Should We Do About It?

Connecting the public with clinical trial options: The ResearchMatch Trials Today tool

Contact Info

Product

Resources

About