Clinical Trials, its Difficulties & the Solution

1. Clinical Trials Its Difficulties & the Solution

2. Summary: Every clinical trial has a protocol, or action plan, for conducting the trial. Each study has its own rules about who can take part. Technology is already playing a massive role in improving many aspects of trials. If an interim statistical analysis showed that a clinical trial has no scientific value/power. It is not feasible to reach the planned outcomes. Introduction: Clinical trials are research studies that test how well new medical approaches work in people. Each study answers scientific questions and tries to find better ways to prevent, screen for, diagnose, or treat a disease. Clinical trials may also compare a new treatment to a treatment that is already available. Every clinical trial has a protocol, or action plan, for conducting the trial. The plan describes what will be done in the study, how it will be conducted, and why each part of the study is necessary. Each study has its own rules about who can take part. Some studies need volunteers with a certain disease. Some need healthy people. Others want just men or just women. An Institutional Review Board (IRB) reviews, monitors, and approves many clinical trials. It is an independent committee of physicians, statisticians, and members of the community. Its role is to: Make sure that the study is ethical Protect the rights and welfare of the participants Make sure that the risks are reasonable when compared to the potential benefits In the United States, a clinical trial must have an IRB if it is studying a drug, biological product, or medical device that the Food and Drug Administration (FDA) regulates, or it is funded or carried out by the federal government.

3. What difficulties (those who do) clinical trials face? According to WHO: 1.Coordination of manufacturing activities 2.Clarity of trial protocol and case report forms 3.Ethical/regulatory review(s) 4.Site capacity, management, and experience 5.Management of different partners 6.Contracting and agreements 7.Trial timeline 8.Overlapping/parallel activities According to Report have been made by the Clinical trials innovation center in KNect365 website:

4. 1.Complexity of Trials (21% of respondents): Clinical trials have been growing increasingly complex for years, and those running them are feeling the pressure to design trials ‘that give the right answers, in the most simple and unobtrusive way for patients, that are acceptable to regulators and payers. 2.Regulations (15%): A predictable concern for an industry so heavily regulated, many respondents feel constrained by the complexity of the guidelines they follow. Additionally, the variations between different regulatory bodies, and the challenges that brings, comes up repeatedly. 3.Spiralling Costs (15%): An inevitable result of the above two issues, the cost of trials is at an all-time high. Increasing complexity and tight timelines is putting more pressure on the need for resources to implement and control every step. 4.Patient access (12%): Patient recruitment and retention are a major challenge for those running trials, with a high percentage not meeting targets and drop-out rates increasing. 5.Staff Roles & Responsibilities (9%): As the complexity and rate of change in trials both continue to increase, hiring and training the right staff is getting equally tricky. Respondents commented that ‘working in a constantly dynamic environment both in and out of the company’ means that ‘roles and responsibilities are evolving’.

5. 6.Technology (9%): Technology is already playing a massive role in improving many aspects of trials and is rightly seen as one of the great hopes for future. However, with it, there are a whole raft of new challenges facing those running, participating in and regulating trials. 7.Governance and oversight (9%): Strategic partnerships, vendors, study sites, CROs; partnerships are playing a more important role in almost every aspect of trials today and the management of them can often prove challenging. 8.New drugs (5%): Brand new classes of drug require different ways of running trials. Cell therapies, genomics, personalised treatments and whatever ‘the next big breakthrough is’ were all mentioned by the respondents as creating new issues in ‘demonstrating clinical effectiveness’. Quora website has published a question, which is (What are some of the biggest challenges with setting up and conducting clinical trials?): 1.Gunjan Bhardwaj, CEO & Founder at Innoplexus: His answer was: "Pharmaceutical companies and investigators both can face major challenges in clinical trials, from financial constraints to unfavourable study results and patient difficulties. One of the biggest challenges is recruiting enough patients to provide an effective clinical trial or study. Nearly 80% of clinical trials fail to meet their enrolment timelines and up to 50% of research sites enrol

6. only one or even no patients. This problem creates enormous expenses and really no way to completely regain the financial loss without a successful clinical trial." 2.Nicole Gomez, is a professional Trainer at PWAC Business Solutions. His answer was: "Different challenges for Conducting Clinical Trials are: i.Understand how does clinical research fit into how a drug is developed internationally ii.Gain a clear picture of the different phases of clinical research iii.Understand the terminology and the key tools of clinical research iv.Understand the roles and responsibilities of the key people involved in clinical trial v.Gain knowledge on how clinical trials are set up and run globally vi.Know what is required for clinical trials to meet the Clinical Trials Directives and the New GCP directives vii.Understand how data from Clinical Trials is managed viii.Learn about regulatory control of international clinical trials

7. According to good clinical practice network: According to Evans, S. and Pocock, S. (2001) and Lievre, M. et al. (2001), there are several solid and valid reasons for early discontinuation of a clinical study (especially with outcomes that include death, disability, etc.): b.Early evidence that an investigational drug (IP) is beneficial for a condition under study/a solid statistical evidence that an IP is better than the comparator. c.Early evidence that an IP is, in contrary, harmful (ADRs, SAEs, SUSARs, etc.). d.If an interim statistical analysis showed that a clinical trial has no scientific (statistical) value/power. e.It is not feasible to reach the planned outcomes. How can Smartway Pharmaceuticals help source comparator drugs? We provide: 1.Customised service to achieve all the clinical trial supply requirements. 2.We reduce the logistical burden. 3.Offering a range of specialist transport options. 4.Storage facilities for cold chain products Moreover, Smartway Pharmaceuticals supply: 1.Comparator Sourcing https://www.smartwaypharma.co.uk/clinical-trials-supply/comparator- sourcing/ 2.Reference Listing Drugs https://www.smartwaypharma.co.uk/clinical-trials-supply/reference-listing- drugs-rlds/ 3.Biosimilars https://www.smartwaypharma.co.uk/clinical-trials-supply/biosimilars/

8. Reference: 1.https://medlineplus.gov/clinicaltrials.html 2.https://www.who.int/phi/DAY1_08_Wahid1_PM_SaoPaulo2015.pdf 3.https://knect365.com/clinical-trials-innovation/article/e414c9b9-8de9- 4525-8fe6-fe6264d36df0/report-biggest-challenges-clinical-trials-pt-1 4.https://www.quora.com/What-are-some-of-the-biggest-challenges-with- setting-up-and-conducting-clinical-trials 5.https://www.ahajournals.org/doi/10.1161/CIRCHEARTFAILURE.111.96 5707 6.https://www.jstor.org/stable/29716428?seq=1#page_scan_tab_contents