Abstract:

Clinical research and innovation continue to play an important role in the advancement of evidence based clinical practice regardless of its complex multi-step processes and accordingly related challenges.

Despite the adaption of technology and quality systems, site management organizations (SMOs) still face significant operational challenges to execute the studies effectively. SMOs administering various clinical trials in multiple clinical sites and operate with a vast number of clinical trial staff. Therefore, the need for effective management strategies, well trained multi-skilled staff, teamwork, and collaboration of all sites are very crucial. This review article lists most of the SMOs operational challenges as well as potential innovative solutions needed to enhance their management process.

Keywords: Clinical Trials; Multi-Sites Trial Management; Inter-institutional Collaboration

References:

[1].     Forjuoh, S. N., Helduser, J. W., Bolin, J. N, and Ory, M. G. (2015). 5:3 DOI: 10.4172/2167-0870.1000219. Challenges Associated with Multi-institutional Multi-site Clinical Trial Collaborations: Lessons from a Diabetes Self-Management Interventions Study in Primary Car.

[2].     Le, R., (2018). How to support & Develop Research- Naïve Clinical Sites/An Investment for the Future of Clinical Research.

[3].     Rand Corp. Europe. www.rand.org. Enabling NHS staff to contribute to research: reflecting on current practice and informing future opportunities.

[4].     Rhaman, S., Md Anwarul, A., Majunder, Shaban, S. F., Moslehuddin, A., Bin Addulrahman, k., D’Souza, U. JA, (2011). Physician participation in clinical research and trials: issues and approaches.

[5].     Cullen, H., Effective Project Management for Clinical Trials/A Business Approach.

[6].     Parvathaneni, M., (2017). Inventi Rapid: Clinical Research Vol. 2018, Issue 1 [ISSN 0976-383X], Implementation of Project Management in Clinical Research.

[7].     Lim, W. S., Meakin, G., Brittain, C., Bewick, T., and Duley Improving, T., (2017). Lim et al. Trials (2017) 18:546. DOI 10.1186/s13063-017-2290-z. Improving Readiness for Recruitment through Simulated Trial Activation: The Adjuvant Steroids in Adults with Pandemic Influenza (ASAP) Trial.

[8].     The Impact of Strategic Communication on Clinical Trial Performance. A FIRECREST CLINICAL WHITE PAPER. www.firecrestclinical.com/userfiles/docs/BrendanWhitePaper.pdf.

[9].     Don, D., (2017). What Are Some of The Biggest Challenges of Conducting A Clinical Trial?

[10]. Covanceadmin, (2013). Addressing Operational Challenges in Conducting Clinical Trials [Infographic].

[11]. Butryn, T., Wojda, T. R., Cornejo, K. V., Papadimos, T. J., (2016). Keys to Success in Clinical Trials: A Practical Review.