A Guide for Writing a Protocol for a clinical trial

AbstrAct

Randomized controlled trial or randomized clinical trial (RCT) is an epidemiological experiment to study a new preventive or therapeutic regimen. It is most commonly used in assessing the effectiveness of health care services or health technologies such as pharmaceutical products (e.g. drugs or vaccines),medical devices or new surgical procedures. A simple description of a trial design is: patients’ recruitment and allocation into study and control groups, intervention, follow up and analysis and drawing of conclusions.A protocol for a clinical trial is a study plan, designed to describe objectives, background, methodology,organization, the participants, Internationale procedures and assessments tools of the trial. In this paper we will describe the different steps of preparing a sound and efficient trial protocol.

by Awad Mohamed Ahmed, Md

Professor of Medicine, University of Bahr Elghazal, Khartoum, Sudan

Guidelines for randomized clinical trial protocol
content: a systematic review
Abstract

Background: All randomized clinical trials (RCTs) require a protocol; however, numerous studies have highlighted protocol deficiencies. Reporting guidelines may improve the content of research reports and, if developed using robust methods, may increase the utility of reports to stakeholders. The objective of this study was to systematically identify and review RCT protocol guidelines, to assess their characteristics and methods of development, and to compare recommendations.

Methods: We conducted a systematic review of indexed literature (MEDLINE, EMBASE and the Cochrane Methodology Register from inception to September 2010; reference lists; related article features; forward citation searching) and a targeted search of supplementary sources, including a survey of major trial funding agencies in six countries. Records were eligible if they described a content guideline in English or French relevant to RCT protocols. Guidelines were excluded if they specified content for protocols for trials of specific procedures or conditions or were intended to assess trial quality. We extracted guideline characteristics and methods. Content was mapped for a subset of guidelines that described development methods or had institutional endorsement.

Results: Forty guidelines published in journals, books and institutional reports were included in the review; seven were specific to RCT protocols. Only eight (20%) described development methods which included informal consensus methods, pilot testing and formal validation; no guideline described all of these methods. No guideline described formal consensus methods or a systematic retrieval of empirical evidence to inform its development. The guidelines included a median of 23 concepts per guideline (interquartile range (IQR) = 14 to 34; range = 7 to 109).

Among the subset of guidelines (n = 23) for which content was mapped, approximately 380 concepts were explicitly addressed (median concepts per guideline IQR = 31 (24,80); range = 16 to 150); most concepts were addressed in a minority of guidelines.

Conclusions: Existing guidelines for RCT protocol content varied substantially in their recommendations. Few reports described the methods of guideline development, limiting comparisons of guideline validity. Given the importance of protocols to diverse stakeholders, we believe a systematically developed, evidence-informed guideline for clinical trial protocols is needed.