The Case for Access to Data Monitoring Committee Charters.

AbstractClinical trials investigating novel or high-risk interventions often use data monitoring committees (DMCs) to ensure that the participants' best interests are safeguarded. The typical DMC charter describes procedures by which the DMC operates, including important details concerning organizational structure, membership, meeting frequency, statistical monitoring guidelines, and contents of DMC reports for interim review. These charters, however, are not routinely publicly available; in some cases, their access could be important to the interpretation of trial results.

Deprioritization of Ongoing Clinical Trials.

To be ethical, clinical trials must exhibit a favorable risk-benefit balance at the time of their initiation. However, in some cases, the expected value of a study decreases while the study is ongoing, due to developments outside of the study itself, such as findings from other studies or an otherwise shifting evidence base. While such situations are acknowledged in the research community, they have not received sufficient attention, given the high costs of uninformative studies, both in material and human capital.

Characterization of key information sections in informed consent forms posted on ClinicalTrials.gov.

Introduction: Recent revisions to the US Federal Common Rule governing human studies funded or conducted by the federal government require the provision of a "concise and focused" key information (KI) section in informed consent forms (ICFs). We performed a systematic study to characterize KI sections of ICFs for federally funded trials available on ClinicalTrials.gov.

Bringing data monitoring committee charters into the sunlight.

Clinical trials investigating novel or high risk interventions, or studying vulnerable participants, often use a data monitoring committee to oversee the progress of the trial. The data monitoring committee serves both an ethical and a scientific function, by protecting the interests of trial participants while ensuring the integrity of the trial results. A data monitoring committee charter, which typically describes the procedures by which data monitoring committees operate, contains details about the data monitoring committee's organizational structure, membership, meeting frequency, sequential monitoring guidelines, and the overall contents of data monitoring committee reports for interim review.

How to limit uninformative trials: Results from a Delphi working group.

To be justifiable, clinical trials must test novel hypotheses and produce informative results. However, many trials fail on this score. A Delphi process was used to establish consensus on 35 recommendations across five domains related to the role of scientific review in preventing uninformative trials.

Ensuring the Scientific Value and Feasibility of Clinical Trials: A Qualitative Interview Study.

Background: Ethical and scientific principles require that clinical trials address an important question and have the resources needed to complete the study. However, there are no clear standards for review that would ensure that these principles are upheld.

Methods: We conducted semi-structured interviews with a convenience sample of nineteen experts in clinical trial design, conduct, and/or oversight to elucidate current practice and identify areas of need with respect to ensuring the scientific value and feasibility of clinical trials prior to initiation and while ongoing.

The proportion of randomized controlled trials that inform clinical practice.

Prior studies suggest that clinical trials are often hampered by problems in design, conduct, and reporting that limit their uptake in clinical practice. We have described 'informativeness' as the ability of a trial to guide clinical, policy, or research decisions. Little is known about the proportion of initiated trials that inform clinical practice.

Approach for reporting master protocol study designs on ClinicalTrials.gov: qualitative analysis.

Objective: To describe an approach for reporting master protocol research programs (MPRPs) that is consistent with existing good reporting practices and that uses structured information to convey the overall master protocol and design of each substudy.

Design: Qualitative analysis.

Data Sources: ClinicalTrials.

Completeness of clinical evidence citation in trial protocols: A cross-sectional analysis.

Background: Human protection policies require assessment of how proposed clinical trials relate to prior and ongoing studies testing similar hypotheses. We assessed the extent to which clinical trial protocols cited relevant published and ongoing clinical trials that would have been easily accessible with reference searches.

Methods: We created a random sample of trial protocols using ClinicalTrials.

Characterization of Informed Consent Forms Posted on ClinicalTrials.gov.

This cross-sectional study examines available forms and posting trends of registered trials as well as the frequency of form posting by funder type for trials initiated since the revised Common Rule was implemented.

Reaping the Bounty of Publicly Available Clinical Trial Consent Forms.

Public access to clinical trial consent forms, beyond those individuals involved in reviewing, conducting, or participating in a trial, has been notoriously poor, resulting in missed opportunities for empirical analysis and improvement, among other benefits. However, recent changes to the Common Rule and policies governing ClinicalTrials.gov promise to make trial consent forms more accessible to the public, including prospective trial participants, other trialists and IRBs, and those seeking to study research consent.