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NEW PARADIGMS WITHIN CLINICAL TRIALS

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Anushree Reddy

Clinical Research Training studies are always in need of volunteers. Without these volunteers, medications and treatments cannot be approved by the concerned authorities and thus cannot reach the patients.  Apart from gaining access to a potential treatment for a particular disease, other perks include receiving care at the topmost facilities, helping science, and making a potential impact on all those living in that particular condition. These studies generally offer generous compensation for your participation.As the best clinical research courses based on clinical trials strive to investigate if a potential treatment is both safe and effective, there is a certain level of risk associated with it.  When the recruited volunteers are chosen, there is a possibility that the treatment shall not be effective, and the volunteer can also be subjected to certain side-effects.

Four key trends are influencing aspects of trial design, duration, and success:

  1. Personalized Medicine:Advances in basic science, a rising number of biologics, and a growing understanding of disease bio-processes are enabling the development of orphan drugs targeting new disease pathways and molecular targets. As a result, the types of drugs under development are changing, as well as the strategies they utilize to treat disease. These include shifts from symptomatic therapies, which minimize disease symptoms, to disease-modifying therapies that slow or halt disease progression, and are better enabled by earlier identification of disease, as well as the emergence of next-gen biotherapeutics.
  2. CRO Outsourcing:As drug development processes have become more complex and regulations become more stringent, pharma has begun outsourcing most non-core activities to clinical research organizations (CROs) while retaining essential R&D in-house. CROs play an integral role in drug development as they enable pharma to lower their internal capacities in manufacturing and R&D, increase productivity, access new capabilities, shift fixed to variable costs, and improve their global reach.
  3. Digitization:By remotely enabling the capture of drug efficacy and safety data, digital health technologies are expected to improve patient safety, enable virtual trial formats and ease site work burden. Mobile health apps, wearables, and other software tools, are finding novel uses in clinical development. Sensors can directly record biometric measurements in real-time, while apps can track patient-reported outcomes (PROs) or experience measures (PREMS), which can be shared with clinicians. Telemedicine allows clinical assessments to be conducted remotely and reminders to be sent to maintain patient engagement and encourage drug adherence.
  4. COVID-19:The pandemic has impacted essentially all clinical operations and accelerated the evolution in virtual engagement dynamics between patients, sites, and sponsors. As a result, they are now rapidly adopting virtual trial technologies to keep their studies on track, running more efficiently, and offering added patient convenience. Regulatory agencies such as the FDA and NIH have also issued guidelines related to the conduct of trials during the outbreak of coronavirus, which are in complete support of incorporating virtual services.

 

Conclusion

Clinical research trainings are given to every professional involved in the trial. Clinical research trainings are continuously updated based on the disease and development of technology to ensure the complete safety of the participants of the trial.

 

 

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Anushree Reddy
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