The future of clinical trials and drug development: 2050
A workshop held at the 18th Annual Conference of the Pharmaceutical Contract Management Group in Krakow on 9 September 2022 asked over 200 delegates what the clinical trial landscape would look like in 2050. Issues considered included who will be running the pharmaceutical industry in 2050; how ‘hea...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
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BioExcel Publishing Ltd
2023-01-01
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| Series: | Drugs in Context |
| Subjects: | |
| Online Access: | https://www.drugsincontext.com/the-future-of-clinical-trials-and-drug-development-2050/ |
| _version_ | 1797808870653952000 |
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| author | Timothy C Hardman Rob Aitchison Richard Scaife Jean Edwards Gill Slater on behalf of the Committee of the Pharmaceutical Contract Management Group |
| author_facet | Timothy C Hardman Rob Aitchison Richard Scaife Jean Edwards Gill Slater on behalf of the Committee of the Pharmaceutical Contract Management Group |
| author_sort | Timothy C Hardman |
| collection | DOAJ |
| description | A workshop held at the 18th Annual Conference of the Pharmaceutical Contract Management Group in Krakow on 9 September 2022 asked over 200 delegates what the clinical trial landscape would look like in 2050. Issues considered included who will be running the pharmaceutical industry in 2050; how ‘health chips’, wearables and diagnostics will impact on finding the right patients to study; how will artificial intelligence be designing and controlling clinical trials; and what will the role of the Clinical Research Associate, the critical observer, documenter and conductor of a clinical trial need to look like by 2050. The consensus was that, by 2050, if you are working in clinical trials, you will be a data scientist. We can expect to see an increasing role of new technologies and a new three-phase registration model for novel therapies. The first phase will involve an aspect of quality evaluation and biological proof-of-concept probably involving more preclinical modelling and engineered human cell lines and fewer animal studies than currently used. Once registered, new products will enter a period of adaptive clinical development (delivered as a single study) intended to establish safety. This phase will most likely take around 1–2 years and explore tailored options for administration. Investigations will most likely be conducted in patients, possibly in a ‘patient-in-a-box’ setting (hospital or healthcare centre, virtual or microsite). On completion of safety licencing, drugs will begin an assessment of efficacy in partnership with those responsible for reimbursement – testing will be performed in patients, possibly where individual patient involvement in safety testing will offer some reimbursement deal for future treatment. Change is coming, though its precise form will likely depend on the creativity and vision of sponsors, regulators and payers. |
| first_indexed | 2024-03-13T06:44:06Z |
| format | Article |
| id | doaj.art-37e553d98af14ff69754bad71979b7c7 |
| institution | Directory Open Access Journal |
| issn | 1740-4398 |
| language | English |
| last_indexed | 2024-03-13T06:44:06Z |
| publishDate | 2023-01-01 |
| publisher | BioExcel Publishing Ltd |
| record_format | Article |
| series | Drugs in Context |
| spelling | doaj.art-37e553d98af14ff69754bad71979b7c72023-06-08T11:06:50ZengBioExcel Publishing LtdDrugs in Context1740-43982023-01-011211110.7573/dic.2023-2-2The future of clinical trials and drug development: 2050Timothy C HardmanRob AitchisonRichard ScaifeJean EdwardsGill Slateron behalf of the Committee of the Pharmaceutical Contract Management GroupA workshop held at the 18th Annual Conference of the Pharmaceutical Contract Management Group in Krakow on 9 September 2022 asked over 200 delegates what the clinical trial landscape would look like in 2050. Issues considered included who will be running the pharmaceutical industry in 2050; how ‘health chips’, wearables and diagnostics will impact on finding the right patients to study; how will artificial intelligence be designing and controlling clinical trials; and what will the role of the Clinical Research Associate, the critical observer, documenter and conductor of a clinical trial need to look like by 2050. The consensus was that, by 2050, if you are working in clinical trials, you will be a data scientist. We can expect to see an increasing role of new technologies and a new three-phase registration model for novel therapies. The first phase will involve an aspect of quality evaluation and biological proof-of-concept probably involving more preclinical modelling and engineered human cell lines and fewer animal studies than currently used. Once registered, new products will enter a period of adaptive clinical development (delivered as a single study) intended to establish safety. This phase will most likely take around 1–2 years and explore tailored options for administration. Investigations will most likely be conducted in patients, possibly in a ‘patient-in-a-box’ setting (hospital or healthcare centre, virtual or microsite). On completion of safety licencing, drugs will begin an assessment of efficacy in partnership with those responsible for reimbursement – testing will be performed in patients, possibly where individual patient involvement in safety testing will offer some reimbursement deal for future treatment. Change is coming, though its precise form will likely depend on the creativity and vision of sponsors, regulators and payers.https://www.drugsincontext.com/the-future-of-clinical-trials-and-drug-development-2050/artificial intelligenceclinical trialsinnovationregulatory frameworktrial data |
| spellingShingle | Timothy C Hardman Rob Aitchison Richard Scaife Jean Edwards Gill Slater on behalf of the Committee of the Pharmaceutical Contract Management Group The future of clinical trials and drug development: 2050 Drugs in Context artificial intelligence clinical trials innovation regulatory framework trial data |
| title | The future of clinical trials and drug development: 2050 |
| title_full | The future of clinical trials and drug development: 2050 |
| title_fullStr | The future of clinical trials and drug development: 2050 |
| title_full_unstemmed | The future of clinical trials and drug development: 2050 |
| title_short | The future of clinical trials and drug development: 2050 |
| title_sort | future of clinical trials and drug development 2050 |
| topic | artificial intelligence clinical trials innovation regulatory framework trial data |
| url | https://www.drugsincontext.com/the-future-of-clinical-trials-and-drug-development-2050/ |
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