The Most Important Compliance Best Practices You Need to Know

Clinical trials that fail to achieve their goals are often the result of poor budgetary planning and decisions.Given the various processes, individuals and committees involved in a clinical trial, budgeting can be a tricky process. A proper clinical budget is one that not just factors in the obvious costs, but also anticipates hidden ones and provides for unexpected situations or contingencies. This white paper explains why budgeting for a clinical trial is important, the various phases in clinical research and the budget related activities in each, the different kinds of clinical costs and five best practices that organizations should follow when creating and implementing a clinical study budget.

The Food and Drug Administration (FDA) has issued guidelines for adverse event reporting because adverse event reports were found to be inhibiting, rather than enhancing, the ability of IRBs to protect the human subjects.

This article describes the best practices to be followed in order to comply with the FDA's new guidelines on adverse event reporting to IRBs.

The Food and Drug Administration (FDA) receives spontaneous adverse event reports from health care professionals and consumers. A manufacturer, upon receiving an adverse event report from a patient or health care professional, has to send a report to FDA.  The U.S. Department of Health and Human Services (HHS) Food and Drug Administration Center for Biologics Evaluation and Research (CBER) has mandated reporting of adverse events and has issued guidance towards this end.

This article describes the best practices to be followed in the reporting of adverse events.

An ethics committee protects the rights and interests of the people in a clinical trial. The ethics committee is usually comprised of individuals from diverse backgrounds like local health care professionals, counselors, social workers, lawyers, and community representatives. Practices of ethics committees vary enormously across Europe, Australia, Canada, and USA.

This article gives an overview of best practices that ethics committees can follow in order to execute their roles and responsibilities in an effective and compliant manner.

The informed consent is process is a cornerstone in the ethical conduct of clinical trials and research on human subjects. Regulatory requirements for this important process varies from country to country.

This article gives an overview of best practices for getting informed consent from human subjects in various international jurisdictions.

These charts are intended to assist IRBs, institutions, and investigators in their decision-making process and should not be used as substitutes for consulting the regulations. OHRP cautions that the full text of applicable regulatory provisions should be considered in making final decisions.

Chart 1: Is an Activity,  Research Involving Human Subjects?

Chart 2: Is the Human Subjects Research Eligible for Exemption?

Chart 3: Does Exemption 45 CFR 46.101(b)(1) (for Educational Settings) Apply?

Chart 4: Does exemption 45 CFR 46.101(b)(2) or (b)(3) (for Tests, Surveys, Interviews, Public Behavior Observation) Apply?

Chart 5: Does Exemption 45 CFR 46.101(b)(4) (for Existing Data, Documents, Records and Specimens) Apply?

Chart 6: Does Exemption 45 CFR 46.101(b)(5) (for Public Benefit or Service Programs) Apply?

Chart 7: Does Exemption 45 CFR 46.101(b)(6) (for Food Taste and Acceptance Studies) Apply?

Chart 8: May the IRB Review Be Done by Expedited Procedures?

Chart 9: May the IRB Continuing Review Be Done by Expedited Procedures?

Chart 10: May Informed Consent Be Waived or Consent Elements Be Altered under 45 CFR 46.116(d)?

Chart 11: May Documentation of Informed Consent Be Waived Under 45 CFR 46.117(c)?

The guidance contained within this document is intended to apply to medical devices generally and combination products regulated as medical devices. It is not intended to cover in vitro diagnostic medical devices. Additionally, this document was drafted primarily to address the use of Clinical Investigations to support a marketing authorization application. Some aspects of this document may apply to studies conducted following commercial release of a device. Future GHTF documents will specifically address post-market clinical follow-up studies.

This document provides guidance on

• when a clinical investigation should be undertaken for a medical device to demonstrate compliance with the relevant Essential Principles (see GHTF/SG1/N041 – “Essential Principles of Safety and Performance of Medical Devices”); and
• the general principles of clinical investigation involving medical devices

Sections

• General Principles When Considering the Need for a Clinical Investigation
• General Principles of Clinical Investigation Design
• Ethical Considerations for Clinical Investigations

This document provides guidance in relation to:

1. the circumstances where a post-market clinical follow-up study is indicated;
2. the general principles of post-market clinical follow-up studies involving medical devices; and
3. the use of study information, including, for example, to provide information to update labelling.

This document does not apply to in vitro diagnostic devices.

It explains -

• The Circumstances Where A Post-Market Clinical Follow-Up Study Is Indicated
• The Elements Of A Post-Market Clinical Follow-Up Study
• The Use Of Study Information

The definitions and concepts contained within this document are intended to apply to the establishment and maintenance of conformity with the relevant Essential Principles for medical devices generally. Specific guidance will be developed in other documents in relation to in vitro diagnostic devices. Similarly, guidance about how to generate, compile and present clinical evidence for the purpose of demonstrating compliance with the Essential Principles for safety and performance of a medical device will be addressed in future documents.

Clinical Trial Data can be collected in any of the following methods: paper or electronic medical records, paper forms completed at a site, interactive voice response systems, local electronic data capture systems, or central web based systems. The quality of the data directly depends on the quality of the instrument used to make measurements. Proper data points collected result in a meaningful analysis of the entire Clinical Trial.

In this article, Charles H. Pierce, a clinical research expert, explains how data and safety monitoring is to be established.  Dr. Pierce also explains how committee members are chosen, and most importantly how to ensure that the member chosen are free from even the perception of a Conflict of Interest and that they will keep the information they acquire strictly confidential.

Clinical trials on Human participants needs strict vigilance and is conducted under high standards of quality assurance. Quality assurance of clinical trials in South Africa is achieved at a number of levels, through monitoring, audits and inspections. Clinical trials are a joint responsibility of the sponsor and the investigators. A proper comunication channel has to be established between the sponsor and the invetigators at every stage of the trial. Regular audits are necessary to ensure proper processes are followed and all regulatory compliances are considered. Independent regulatory authority may conduct announced or unannounced inspections at any stage of the trial to review the competency of the clinical trial site.

• Is the new medicine effective?
• Is it better than the existing medication?
• Has it reduced on the risks associated with the current system?
• Is it safe?

Clinical trials are ventured into only after successful pre-clinical studies which involve cell studies and animal studies. The results from these studies must be approved by FDA before clinical trials are started. Companies file the Investigational New Drug Application with FDA seeking permission to go ahead with clinical trials.

• Pre-clinical Studies
• Manufacturing Information
• Clinical protocols and investigator information

Fact about clinical trials:

• All clinical trials are voluntary
• Not all clinical trials are study treatments
• Not all clinical trials studying treatments, study drugs
• Not all clinical trials study new drugs
• Very few cancer trials involve a placebo

What it takes to be a volunteer? What are the risks – benefits and know-how before accepting to be a volunteer?

Clinical trials are backed by sponsors. Several cooperative groups, department of Veterans and Department of defense are part of the list of sponsors. Pharmaceutical and biotechnology companies who have researched on those possible treatments also become key sponsors for these trials as they have to prove the efficacy of that particular drug so that they can bring to the market.

Entails the following requirements to be furnished by researchers such as:

The drug passes through 6 years of rigorous laboratory tests in cell and animal studies before it reaches the clinical trial phase. Clinical trial phase takes equal amount of time or more to ensure the drug gives the expected outcome with minimal side-effects. Taking the example of cancer treatment, during the clinical trials itself, once the drug is administered, it takes months to collect data on the effect it has on the subject. Increasing awareness about such trials and increased participation from adults can help speed up the process of bringing new and better medicines into the market.

Clinical trials provide vital information to doctors as:

People volunteer to such trials when faced with critical illness such as cancer. Most of these do not attract media attention unless there are any casualties. But there has been no such eventuality during clinical trials. These give researchers a chance to identify any deviations from the actual outcome. To protect the rights of Human Volunteers and weed out malpractices, now there are stringent laws, requirements and procedures governing such trials.

You have a new drug but how do you test its efficacy? Clinical Trials are procedures in controlled and closely monitored environments of new drugs on humans - a purely voluntary effort. These trials give an insight to the doctors about the impact of the new drug and the probability of safety when administered to a mass. A lot of counseling is involved when it comes to hiring volunteers for trials provided the uncertainty of the outcome. It takes a well informed decision by the volunteer when he/she accepts to be part of such trials.

Harvard School of Public Health and other institutions have zeroed in on Nine Risk Factors as responsible for one-third of cancer deaths across the globe. This has been arrived after studying several research papers and survey findings including WHO’s Comparative Risk Assessment project. It entails a full impact study of these factors on 12 different types of cancers based on age, gender and geography. Smoking and Alcohol consumption have been found to be the most damaging.