Clinical trials tranformation intiative-decentralized clinical trials: a review article

  • Shirisha Jakkula Intern at Clinosol Research Pvt. Limited, Ameerpet, Hyderabad, Telangana, India
    jakkulashirisha.53@gmail.com
  • Pravalika Pasupuleti Intern at Clinosol Research Pvt. Limited, Ameerpet, Hyderabad, Telangana, India
  • C.S.Mujeebuddin Founder and CEO of Clinosol Research Pvt. Limited, Ameerpet, Hyderabad, Telangana, India
  • Ravindra Pratap Gaur Associate Manager, Clinical Operations-Covance, Bengaluru, Karnataka, India
  • Sujay S Patil Assistant Manager, Clinical Research & PV- Bharat Serums and Vaccines, Mumbai Suburban district, Maharashtra, India

Abstract

In clinical research, Decentralized clinical trials (DCTs) can provide opportunities to maximize efficiencies. Unlike the traditional clinical trial model, Decentralized Clinical Trials (DCTs) promote telemedicine, mobile/local healthcare providers (HCPs), mobile/web-based technology, and direct distribution of Investigational Medicinal Products (IMP) to patients, among other things.  Hence, DCTs are in the spotlight as technology, infrastructure, and knowledge providing a backbone in clinical research.


Background: Advances in electronic communication, data storage, emerging technologies, and biosensor development provides new opportunities to exchange information, such as the patient is tested from their home locations and are with locations distant from the investigator. Trials that take place at locations distant from the investigator (i.e., spectrum: CCTs → Hybrid Models → DCTs) in any or all study-related procedures and data is collected electronically fall in the category of the decentralized clinical trial. Trials should be designed to integrate the current healthcare system of the study subject, optimize convenience for study subjects and take advantage of existing programs and data sources including The study subjects themselves through the utilization of telecommunication, videoconferences, mobile or internet-based tools for patient reporting, mobile technology tools and biosensors. Local healthcare providers, home-based healthcare services, pharmacies, clinics, regional hospitals, their perceived obstacles have impeded the widespread use of mobile devices in clinical trials. To encourage solutions to these challenges, The Clinical Trial Transformation Initiative (CTTI) has released best practices and practical methods to advance solutions to these issues that clinical trial sponsors can now use.


Conclusion: Decentralized clinical trials are not only operationally feasible and show high recruitment rates, have better compliance, lower dropout rates, and are conducted faster. DCT meets the goal of the industry in being low-risk, high returns trials and can offer a reliable, time-based, and cost-effective approach.

Keywords: Decentralized clinical trials, Clinical Trials Transformation Initiative, Healthcare providers, Telemedicine

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References

1. Pew Research Center. Internet/broadband fact sheet. Pew Research Center: Internet, Science & Tech. 2017 Jan 12.
2. Thomas L, Capistrant G. 50 State telemedicine gaps analysis: physician practice standards and licensure. Washington DC: American Telemedicine Association; 2017.
3. Center for Connected Health Policy. State Telehealth Laws and Reimbursement Policies: a comprehensive scan of the 50 states and the district of Columbia. Public Health Institute; 2018.
4. Clinical Trials Transformation Initiative. Decentralized Clinical Trials. Published September 2018.https://www.ctticlinicaltrials.org/sites/www.ctticlinicaltrials.org/files/dct_recommendations.
5. https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act.
6. Clinical Trials Transformation Initiative. Program: Mobile Clinical Trials (MCT).Clinical Trials Transformation Initiative.
7. Clinical Trials Transformation Initiative. Investigator community, https://www.ctti-clinicaltrials.org/projects/investigator-community (accessed 17 July 2017).
8. Clinical Trials Transformation Initiative. Decentralized Clinical Trials. Published September 2018. https://www.ctti-clinicaltrials.org/projects/decentralized-clinical-trials.
9. Clinical Trials Transformation Initiative. Expert meeting: legal & regulatory issues affecting the adoption of mobile clinical trials. Clinical Trials Transformation Initiative. https://www.ctti-clinicaltrials.org/briefing-room/meetings/legal-regulatory-issuesaffecting-adoption-mobile-clinical-trials.
10. Clinical Trials Transformation Initiative. CTTI recommendations: decentralized clinical trials. Clinical Trials Transformation Initiative, 2018. https://www.ctti-clinicaltrials.org/projects/decentralized-clinical-trials
11. Corneli A, Hallinan Z, Hamre G, Perry B, Goldsack JC, Calvert SB, Forrest A. The Clinical Trials Transformation Initiative: Methodology supporting the mission. Clin Trials. 2018 Feb;15(1_suppl):13-18. PMID: 29452520. https://doi.org/10.1177/1740774518755054
12. Clinical Trials Transformation Initiative. Use case for developing novel endpoints generated using mobile technology: diabetes mellitus. Clinical Trials Transformation Initiative.https://www.ctti-clinicaltrials.org/files/usecase-diabetes.pdf
13. Clinical Trials Transformation Initiative. Use case for developing novel endpoints generated using mobile technology: Duchenne muscular distrophy. Clinical Trials Transformation https://www.ctti-clinicaltrials.org/files/usecase-duchenne.pdf
14. Clinical Trials Transformation Initiative. Use case for developing novel endpoints generated using mobile technology: heart failure. Clinical Trials Transformation Initiative. https://www.ctti-clinicaltrials.org/files/usecase-heartfailure.pdf
15. Clinical Trials Transformation Initiative. Use case for developing novel endpoints generated using mobile technology: Parkinson’s disease. Clinical Trials Tranformation Initiative. https://www.ctti-clinicaltrials.org/files/usecase-parkinson.pdf
16. Clinical Trials Transformation Initiative. CTTI recommendations: advancing the use of mobile technologies for data capture & improved clinical trials. Clinical Trials Transformation Initiative, 2018.
17. US Food and Drug Administration. Critical path innovation meetings, guidance for industry. Silver Spring, MD: US Department of Health and Human Services; 2015. Available from: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM417627.pdf
18. US Food and Drug Administration. Guidance for industry, formal meetings between the FDA and sponsors or applicants of PDUFA products, draft guidance. Silver Spring, MD: US Department of Health and Human Services; 2017. Available from: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM590547.pdf
19. US Food and Drug Administration. About FDA, request a meeting on drugs. Silver Spring, MD: US Food and Drug Administration.https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm542986.htm
20. US Food and Drug Administration. Requests for feedback on medical device submissions: the pre-submission program and meetings with Food and Drug Administration Staff, Guidance for Industry and Food and Drug Administration Staff. Silver Spring, MD: US Department of Health and Human Services; 2017. Available from: https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm311176.pdf
21. US Food and Drug Administration. Medical devices, Contact Us—Division of Industry and Consumer Education (DICE). Silver Spring, MD: US Food and Drug Administration. Availablefrom
:https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ContactDivisionofIndustryandConsumerEducation/default.htm
22. US Food and Drug Administration. About FDA, CDRH management directory by organization. Silver Spring, MD: US Food and Drug Administration. Available from: https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHOffices/ucm127854.htm.
23. Clinical Trials Transformation Initiative. Project: engaging patients and sites. Clinical Trials Transformation Initiative.
24. Johansson T, Wild C. Telemedicine in acute stroke management: systematic review. Int J Technol Assess Health Care. 2010 Apr;26(2):149-55. doi: 10.1017/S0266462310000139. PMID: 20392317. https://pubmed.ncbi.nlm.nih.gov/20392317/
25. Rubin MN, Demaerschalk BM. The use of telemedicine in the management of acute stroke. Neurosurg Focus. 2014 Jan;36(1):E4. doi: 10.3171/2013.11.FOCUS13428. PMID: 24380481. https://pubmed.ncbi.nlm.nih.gov/24380481/
26. Trettel A, Eissing L, Augustin M. Telemedicine in dermatology: findings and experiences worldwide - a systematic literature review. J Eur Acad Dermatol Venereol. 2018 Feb;32(2):215-224. doi: 10.1111/jdv.14341. Epub 2017 Jul 4. PMID: 28516492.https://doi.org/10.1111/jdv.14341
27. Tensen E, van der Heijden JP, Jaspers MW, Witkamp L. Two Decades of Teledermatology: Current Status and Integration in National Healthcare Systems. Curr Dermatol Rep. 2016;5:96-104. doi: 10.1007/s13671-016-0136-7. Epub 2016 Mar 28. PMID: 27182461; PMCID: PMC4848332. https://pubmed.ncbi.nlm.nih.gov/27182461/
28. Armstrong AW, Johnson MA, Lin S, Maverakis E, Fazel N, Liu FT. Patient-centered, direct-access online care for management of atopic dermatitis: a randomized clinical trial. JAMA Dermatol. 2015 Feb;151(2):154-60. doi: 10.1001/jamadermatol.2014.2299. PMID: 25338198. https://pubmed.ncbi.nlm.nih.gov/25338198/
29. De Las Cuevas C, Arredondo MT, Cabrera MF, Sulzenbacher H, Meise U. Randomized clinical trial of telepsychiatry through videoconference versus face-to-face conventional psychiatric treatment. Telemed J E Health. 2006 Jun;12(3):341-50. doi: 10.1089/tmj.2006.12.341. PMID: 16796502. https://doi.org/10.1089/tmj.2006.12.341.
30. Fortney JC, Pyne JM, Edlund MJ, Williams DK, Robinson DE, Mittal D, Henderson KL. A randomized trial of telemedicine-based collaborative care for depression. J Gen Intern Med. 2007 Aug;22(8):1086-93. doi: 10.1007/s11606-007-0201-9. Epub 2007 May 10. PMID: 17492326; PMCID: PMC2305730. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2305730/
31. Ruskin PE, Silver-Aylaian M, Kling MA, Reed SA, Bradham DD, Hebel JR, Barrett D, Knowles F 3rd, Hauser P. Treatment outcomes in depression: comparison of remote treatment through telepsychiatry to in-person treatment. Am J Psychiatry. 2004 Aug;161(8):1471-6. doi: 10.1176/appi.ajp.161.8.1471. PMID: 15285975. https://doi.org/10.1176/appi.ajp.161.8.1471
32. Chakrabarti S. Usefulness of telepsychiatry: A critical evaluation of videoconferencing-based approaches. World J Psychiatry. 2015 Sep 22;5(3):286-304. doi: 10.5498/wjp.v5.i3.286. PMID: 26425443; PMCID: PMC4582305. https://pubmed.ncbi.nlm.nih.gov/26425443/
33. Hilty DM, Ferrer DC, Parish MB, Johnston B, Callahan EJ, Yellowlees PM. The effectiveness of telemental health: a 2013 review. Telemed J E Health. 2013 Jun;19(6):444-54. doi: 10.1089/tmj.2013.0075. PMID: 23697504; PMCID: PMC3662387. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3662387/pdf/tmj.2013.0075.pdf.
34. Clinical Trials Transformation Initiative. Decentralized Clinical Trials. Published September 2018. https://www.ctti-clinicaltrials.org/projects/decentralized-clinical-trials.
35. US Food and Drug Administration. Information sheet guidance for sponsors, clinical investigators, and IRBs, frequently asked questions—statement of investigator (Form FDA 1572). Silver Spring, MD: US Department of Health and Human Services; 2010. Available from: https://www.fda.gov/media/78830/download
36. US Food and Drug Administration. Guidance for industry, use of electronic records and electronic signatures in clinical investigation under 21 CFR Part 11—questions and answers. Silver Spring, MD: US Department of Health and Human Services; 2017. Available from: https://www.fda.gov/files/drugs/published/Use-of-Electronic-Records-and-Electronic-Signatures-in-Clinical-Investigations-Under-21-CFR-Part-11-%E2%80%93.pdf
37. US Food and Drug Administration. Guidance for clinical investigators, sponsors, and IRBs, Investigational New Drug Applications (INDs)—determining whether human research studies can be conducted without an IND. Silver Spring, MD: US Department of Health and Human Services; 2013. Available from: https://www.fda.gov/files/drugs/published/Investigational-New-Drug-Applications-%28INDs%29-Determining-Whether-Human-Research-Studies-Can-Be-Conducted-Without-an-IND.pdf
38. US Food and Drug Administration. Guidance for Industry, E6(R2) good clinical practice: integrated addendum to ICH E6(R1). Silver Spring, MD: US Department of Health and Human Services; 2018. Available from: https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm464506.pdf
39. CFR Part 11 – Electronic Records; Electronic Signatures – Scope and Application. https://www.ecfr.gov/cgi-bin/text-idx?SID=4c027dfe319a51445149b900541c0c23&mc=true&node=pt21.1.11&rgn=div5
40. CFR Part 50 – Protection of Human Subjects. https://www.ecfr.gov/cgi-bin/textidx?SID=4c027dfe319a51445149b900541c0c23&mc=true&node=pt21.1.50&rgn=div%205.
41. CFR Part 54 – Financial Disclosure by Clinical Investigators. https://www.ecfr.gov/cgi-bin/text-idx?SID=4c027dfe319a51445149b900541c0c23&mc=true&node=pt21.1.54&rgn=div5.
42. CFR Part 56 – Institutional Review Boards. https://www.ecfr.gov/cgi-bin/text-idx?SID=4c027dfe319a51445149b900541c0c23&mc=true&node=pt21.1.56&rgn=div5.
43. CFR Part 312 – Investigational New Drug Application. https://www.ecfr.gov/cgi-bin/text-idx?SID=b8147c0d7c1f90ca79c5335a4408338f&mc=true&node=pt21.5.312&rgn=div5
44. CFR Part 812 – Investigational Device Exemptions. https://www.ecfr.gov/cgi-bin/text-idx?SID=f7a65692fc86e106adeae20f10241509&mc=true&tpl=/ecfrbrowse/Title21/21cfr812_main_02.tpl.
45. Clinical Trials Transformation Initiative. CTTI Recommendations: developing novel endpoints generated by mobile technology for use in clinical trials. Clinical Trials Transformation Initiative. https://www.ctti-clinicaltrials.org/files/novelendpoints-recs.pdf
46. US Food and Drug Administration. Guidance for industry, investigator responsibilities—protecting the rights, safety, and welfare of study subjects. Silver Spring, MD: US Department of Health and Human Services; 2009. https://www.fda.gov/media/77765/download.
47. US Food and Drug Administration. Guidance for IRBs, clinical investigators, and sponsors, IRB responsibilities for reviewing the qualifications of investigators, adequacy of research sites, and the determination of whether an IND/IDE is needed. Silver Spring, MD: US Department of Health and Human Services; 2013. https://www.fda.gov/files/drugs/published/Investigational-New-Drug-Applications-%28INDs%29-Determining-Whether-Human-Research-Studies-Can-Be-Conducted-Without-an-IND.pdf.
48. Ali Z, Zibert JR, Thomsen SF. Virtual Clinical Trials: Perspectives in Dermatology. Dermatology. 2020;236(4):375-382. doi: 10.1159/000506418. Epub 2020 Mar 3. PMID: 32126560. https://doi.org/10.1159/000506418.
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04-10-2021
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How to Cite
Jakkula, S., P. Pasupuleti, M. C.S, R. P. Gaur, and S. S. Patil. “Clinical Trials Tranformation Intiative-Decentralized Clinical Trials: A Review Article”. World Journal of Current Medical and Pharmaceutical Research, Vol. 3, no. 5, Oct. 2021, pp. 107-15, doi:10.37022/wjcmpr.v3i5.190.
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Review Articles