Clinical trials play a key role in developing a critical evidence-base in healthcare and medical research. The outcomes of clinical trials help determine whether new treatments or procedures provide the intended benefits for patients and their carers. However, the outcome evaluation alone often cannot answer all the questions about why some interventions work or and some don't. It is increasingly recognized that the context in which clinical trials are carried out will affect and interact with the implementation of the intervention resulting in a variation of outcomes. In addition, there are interesting questions such as “How did participants perceive the intervention?” or “Were the possible benefits from the intervention worth the resources used in terms of time, money and other inconveniences?” Such questions can be systematically investigated using process evaluations.
Process evaluations are important in the interpretation and understanding of clinical trial outcomes. Process evaluations can provide insights into the causal mechanisms of interventions, the contextual factors, and inform end-users as to whether an intervention is ineffective due to implementation failure or failure of the intervention itself. Such methods are commonly carried out in conjunction with outcome evaluations using mixed research methods before, during or after the implementation of an intervention or procedure- and have become an important part of clinical trials. The methodology of process evaluations for healthcare and public health interventions is a field that has gradually developed since 1960’s and have become more complex so as to address the complexities inherent to health care systems. The methodology embraces implementation research frameworks such as REAIM (Reach, Effectiveness, Adoption, Implementation and Maintenance) which provide a systematic approach in organizing the conceptual thinking about key process components. More recently, many researchers across countries have adopted, adapted and/or developed their own frameworks to conduct process evaluation in clinical trials.
This Research Topic aims to explore the methodologies used in the process evaluation of clinical trials in healthcare and medical research, providing reflections of lessons learnt and empirical case studies that would further develop this field. The secondary aim is to gain an understanding of the benefits and challenges in the implementation of process evaluations of clinical trials. Here, we encourage submissions that can move the clinical trials field forward highlighting the theoretical and practical elements in the planning, implementation and management of process evaluations. Consequently, we welcome contributions from researchers and clinicians who are involved in conducting clinical trials and have experience conducting process evaluations in these trials. We encourage manuscripts that are either empirical or theoretical in nature.
Clinical trials play a key role in developing a critical evidence-base in healthcare and medical research. The outcomes of clinical trials help determine whether new treatments or procedures provide the intended benefits for patients and their carers. However, the outcome evaluation alone often cannot answer all the questions about why some interventions work or and some don't. It is increasingly recognized that the context in which clinical trials are carried out will affect and interact with the implementation of the intervention resulting in a variation of outcomes. In addition, there are interesting questions such as “How did participants perceive the intervention?” or “Were the possible benefits from the intervention worth the resources used in terms of time, money and other inconveniences?” Such questions can be systematically investigated using process evaluations.
Process evaluations are important in the interpretation and understanding of clinical trial outcomes. Process evaluations can provide insights into the causal mechanisms of interventions, the contextual factors, and inform end-users as to whether an intervention is ineffective due to implementation failure or failure of the intervention itself. Such methods are commonly carried out in conjunction with outcome evaluations using mixed research methods before, during or after the implementation of an intervention or procedure- and have become an important part of clinical trials. The methodology of process evaluations for healthcare and public health interventions is a field that has gradually developed since 1960’s and have become more complex so as to address the complexities inherent to health care systems. The methodology embraces implementation research frameworks such as REAIM (Reach, Effectiveness, Adoption, Implementation and Maintenance) which provide a systematic approach in organizing the conceptual thinking about key process components. More recently, many researchers across countries have adopted, adapted and/or developed their own frameworks to conduct process evaluation in clinical trials.
This Research Topic aims to explore the methodologies used in the process evaluation of clinical trials in healthcare and medical research, providing reflections of lessons learnt and empirical case studies that would further develop this field. The secondary aim is to gain an understanding of the benefits and challenges in the implementation of process evaluations of clinical trials. Here, we encourage submissions that can move the clinical trials field forward highlighting the theoretical and practical elements in the planning, implementation and management of process evaluations. Consequently, we welcome contributions from researchers and clinicians who are involved in conducting clinical trials and have experience conducting process evaluations in these trials. We encourage manuscripts that are either empirical or theoretical in nature.
